Seibel, U.S.D.J.
I. Background...408
A. Background Applicable to Both Cases...408
B. Background Related to Jennifer Danley...410
C. Background Related to Christie Hayes...411
II. Discussion...411
A. Legal Standard...411
B. Defendants' Clinical Experts...413
C. Plaintiffs' Causation Experts...427
D. Defendants' Regulatory Experts...461
E. Plaintiffs' Regulatory Expert — Suzanne Parisian, M.D....474
F. Plaintiffs' Epidemiological Expert — April Zambelli-Weiner, Ph.D....482
III. Conclusion...488
Danley v. Bayer, 13-CV-6856, and Hayes v. Bayer, 14-CV-288, are the first two cases selected for trial in the In re Mirena IUD Products Liability Litigation multidistrict litigation ("Mirena MDL"). Plaintiffs have sued three related companies, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer OY ("Bayer" or "Defendants"), alleging that Mirena, an intrauterine device ("IUD") perforated Plaintiffs' uteruses and caused them injuries, and that Defendants did not adequately warn Plaintiffs about the risks of Mirena. Plaintiffs Danley and Hayes have also brought claims alleging design
Before the Court is Plaintiffs' Omnibus Motion to Preclude the Expert Testimony of Defendants' Experts Steven Goldstein, M.D., Jay Goldberg, M.D., M.S.C.P., Michael Policar, M.D., M.P.H., Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M., Vanessa Dalton, M.D., M.P.H., Geri Hewitt, M.D., and Marcia Javitt, M.D., F.A.C.R., (Doc. 2702). Plaintiffs also move to preclude Defendants' regulatory experts, Dena Hixon, M.D., (Doc. 2705), and David Feigal, Jr., M.D., M.P.H., (Doc. 2724). Also before the Court are Defendants' motions to preclude the testimony of Plaintiffs' causation experts Roger Young, M.D., Ph.D., (Doc. 2694), John Jarrell, Ph. D., P.E., (Doc. 2679), Susan Wray, Ph.D., (Doc. 2691), and Richard Strassberg, M.D., (Doc. 2688). Defendants have also moved to preclude Plaintiffs' regulatory expert Suzanne Parisian, M.D., (Doc. 2685), and Plaintiffs' epidemiological expert April Zambelli-Weiner, Ph.D., (Doc. 2697).
The following facts, which are based on the record generated by these motions and Defendants' motions for summary judgment, (Docs.2756, 2762) — including Defendants' Local Rule 56.1 Statements and Plaintiffs' responses thereto, (Docs. 2851 ("Danley 56.1 Stmt. & Resp."), 2854 ("Hayes 56.1 Stmt. & Resp.")),
In 2000 the U.S. Food and Drug Administration ("FDA") approved the Mirena, a plastic T-shaped IUD that measures 1.26 by 1.26 inches, as safe and effective for intrauterine contraception. (Danley 56.1 Stmt. & Resp. ¶¶ 1-2.) Mirena provides contraceptive protection for up to five years, and has a cylinder in its stem that continuously releases a dose of the hormone levonorgestrel ("LNG"), (id. ¶ 3), a synthetic progestin. (Declaration of Diogenes P. Kekatos in Support of Plaintiffs' Omnibus Motion ("Kekatos Omnibus Decl."), (Doc. 2704), Ex. B, General Expert Report of Jay Goldberg, M.D., M.S.C.P. ("Goldberg Report"), at 8.) It must be prescribed and inserted by a healthcare professional. (Danley Stmt. & Resp. ¶ 4.) The Mirena has removal threads that permit the user to check its placement. (Id. ¶ 13.)
The Mirena label has undergone four changes to its warning regarding the risk of perforation since the FDA's initial approval in 2000.
The parties agree that Defendants warned against the possibility of uterine perforation during insertion. (Id. ¶ 9.) They also agree that Defendants did not warn against the possibility that perforation could occur after and unrelated to insertion, which Plaintiffs call "secondary perforation" or "spontaneous migration."
The parties also dispute the significance and validity of the European Active Surveillance Study on Intrauterine Devices ("EURAS") study. EURAS was a study of 61,448 women using Mirena or copper IUDs in six European countries who were followed between 2006 and 2013 to "identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems ... and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users." (Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of April Zambelli-Weiner, Ph.D. ("Cook Zambelli-Weiner Decl."), (Doc. 2699), Ex. E, Klaas Heinemann et al., Risk of Uterine Perforation with Levonorgestrel-Releasing and Copper Intrauterine Devices in the European Active Surveillance Study on Intrauterine Devices, 91 Contraception 274, 274 (2015) (hereinafter "Heinemann 2015").) The study concluded that uterine perforation was rare, and that there were no clinically significant differences in perforation rates between IUDs containing LNG and copper IUDs. (Id. at 274, 278-79.) EURAS was funded by Bayer, (Cook Zambelli-Weiner Decl. Ex. D, at 1), but overseen by an independent Safety Monitoring and Advisory Council consisting of "internationally acknowledged experts in the field," which made "recommendations and final decisions in all scientific matters" and which approved all study materials, (id. at 26).
The parties also dispute the capacity of two-dimensional ("2D") versus three-dimensional ("3D") ultrasound in detecting proper placement of a Mirena and signs of perforation. Defendants claim that "[t]wo-dimensional ultrasound imaging cannot rule out damage to the myometrium or a partial perforation at insertion," while Plaintiffs assert that Mirena's label "tells medical providers that they can confirm proper placement of a Mirena by utilizing 2-D ultrasound." (Danley 56.1 Stmt. & Resp. ¶ 60.)
Jennifer Danley used Mirena for contraception on two separate occasions. Her first Mirena was inserted on February 14, 2006 and removed without complication on March 4, 2010. (Danley 56.1 Stmt. & Resp. ¶¶ 16, 17, 26, 27.) Ms. Danley's second Mirena was inserted by Victoria Roebuck, a nurse practitioner, on June 29, 2011. (Id. ¶ 31.) On that occasion Ms. Danley signed a consent form indicating that she had read Mirena literature and had her questions answered, but Plaintiffs allege that Ms. Danley was not provided the Patient Information Booklet, (id. ¶ 33), although they concede she had gotten it before her first insertion, (id. ¶ 25). Immediately after Ms. Danley's second Mirena was inserted, she underwent a 2D ultrasound, and the ultrasound report said the IUD was seen "HIGH/RT." (Id. ¶¶ 35-36.) The parties dispute whether the ultrasound images show that Ms. Danley's uterus was perforated at insertion. (Id. ¶ 39.)
On January 3, 2013, Ms. Danley went to her healthcare provider after a positive home pregnancy test. (Id. ¶ 41.) Ms. Roebuck could not locate the threads of Ms. Danley's Mirena, and an ultrasound from that date showed no IUD in Ms. Danley's uterus. (Id. ¶ 43.) Ms. Danley's providers suspected that the IUD may
Ms. Hayes' Mirena was inserted by Dr. Merle Robboy on February 3, 2011. (Hayes 56.1 Stmt. & Resp. ¶ 17.) The parties dispute whether Ms. Hayes was provided with the Patient Information Booklet. (Id. ¶ 14.) Ms. Hayes was under anesthesia and conscious sedation during the insertion of her Mirena. (Id. ¶ 23.) Ms. Hayes presented to Dr. Robboy on September 29, 2011 for removal of her Mirena, and during the removal attempt the threads of Ms. Hayes' Mirena, which were still visible outside her cervix, broke off. (Id. ¶ 24-25.) Dr. Robboy noted that the Mirena was likely embedded in the uterine wall. (Id. ¶ 25.) On October 1, 2011, Ms. Hayes presented to Dr. John McHugh for removal of the IUD via hysteroscopy, which did not locate the Mirena inside Ms. Hayes' uterus. (Id. ¶¶ 26-27.) On October 26, 2011, Ms. Hayes' Mirena was found outside her uterus and removed via laparoscopic surgery. (Id. ¶ 36.)
The admissibility of expert testimony is governed principally by Rule 702:
Fed. R. Evid. 702. The party offering the testimony has the burden of establishing its admissibility by a preponderance of the evidence. See Fed. R. Evid. 702 advisory committee's note; Bourjaily v. United States, 483 U.S. 171, 175-76, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987). The standard for admissibility is the same at the summary judgment stage as it is at trial. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 143, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) ("On a motion for summary judgment, disputed issues of fact are resolved against the moving party.... But the question of admissibility of expert testimony is not such an issue of fact.").
Rule 702 represents a liberal standard of admissibility for expert opinions, as compared to the previous and more restrictive standard set out in Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923). See, e.g., Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 588-89, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (Frye test of general acceptance in the scientific community superseded by the Federal Rules; "a rigid `general acceptance' requirement would be at odds with the `liberal thrust' of the Federal Rules and their `general approach of relaxing the traditional barriers to "opinion" testimony'") (quoting Beech Aircraft Corp. v. Rainey, 488 U.S. 153, 109 S.Ct. 439, 102 L.Ed.2d 445, 169 (1988)). "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Id. at 596, 113 S.Ct. 2786. Despite the liberal standard, however, the district court still must ensure
First, the district court must determine whether an expert is qualified. Qualification "may be based on `a broad range of knowledge, skills, and training.'" In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 172 (S.D.N.Y.2009) (quoting In re TMI Litig., 193 F.3d 613, 664 (3d Cir.1999)). Courts within the Second Circuit have "liberally construed expert qualification requirements." In re Methyl Tertiary Butyl Ether ("MTBE") Prods. Liab. Litig., No. 00-CV-1898, 2008 WL 1971538, at *5 (S.D.N.Y. May 7, 2008) (internal quotation marks omitted).
Experts need not conduct studies of their own in order to opine on a topic; a review of other studies and scientific literature can be enough to qualify experts to testify and to make that proposed testimony reliable. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1042-43 (2d Cir.1995) (rejecting argument that because expert had "no experience performing or interpreting air quality studies" he was not qualified to testify);
Next, the district court must evaluate the reliability of proposed expert testimony. Daubert enumerated a list of factors that, although not constituting a "definitive checklist or test," a district court might consider in evaluating whether a proffered expert opinion has the required indicia of scientific reliability: whether a theory or technique had been and could be tested, whether it had been subjected to peer review, its error rate, and its degree of acceptance within the relevant scientific community. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. Rule 702 also requires a sufficiently rigorous analytical connection between the expert's methodology and conclusions. "[W]hen an
The Daubert factors "may or may not be pertinent in assessing reliability, depending on the nature of the issue, the expert's particular expertise, and the subject of his testimony." Kumho Tire Co., 526 U.S. at 150, 119 S.Ct. 1167 (internal quotation marks omitted). Indeed, expert testimony may be based on "experience alone — or experience in conjunction with other knowledge, skill, training or education." Fed. R. Evid. 702 advisory committee's note. "In certain fields, experience is the predominant, if not sole, basis for a great deal of reliable expert testimony." Id.; see Kumho Tire Co., 526 U.S. at 156, 119 S.Ct. 1167 ("[N]o one denies that an expert might draw a conclusion from a set of observations based on extensive and specialized experience."). In all cases, "the test of reliability is flexible," and a district court has "the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination." Kumho Tire Co., 526 U.S. at 141-42, 119 S.Ct. 1167 (emphasis in original and internal quotation marks omitted).
After determining that a witness is qualified to testify as an expert as to a particular matter and that the opinion is reliable, Rule 702 requires the district court to determine whether the expert's testimony will "help the trier of fact." Fed. R. Evid. 702. Although expert testimony can be very persuasive, see Nimely v. City of N.Y., 414 F.3d 381, 397 (2d Cir.2005), the testimony is still admissible if it is relevant and helpful. By definition, expert testimony that "usurp[s] either the role of the trial judge in instructing the jury as to the applicable law or the role of the jury in applying that law to the facts before it," United States v. Bilzerian, 926 F.2d 1285, 1294 (2d Cir.1991), does not "aid the jury in making a decision"; rather, it "undertakes to tell the jury what result to reach," and thus "attempts to substitute the expert's judgment for the jury's," United States v. Duncan, 42 F.3d 97, 101 (2d Cir.1994) (emphasis omitted).
Plaintiffs seek to exclude nine of Defendants' experts, and Defendants seek to exclude six of Plaintiffs' experts. Each motion and expert is discussed separately below.
Plaintiffs move in one omnibus motion, (Doc. 2702), to preclude seven of Defendants' experts from testifying on five subjects: (1) secondary perforation; (2) contractility
Plaintiffs and their experts contend that secondary perforation is the phenomenon of an IUD perforating (puncturing) a uterus that occurs after, and is unrelated to, its insertion. (Ps' Omnibus Mem. 2-3; Wray Report at 22.) Bayer and its experts opine that perforation can only occur in connection with the insertion of an IUD, although the perforation may be detected at a later time. (See, e.g., Goldstein Report at 27-28; Hewitt Report at 24-25.)
Plaintiffs and their experts allege that exposure to LNG, released by the Mirena as part of its contraceptive effect, causes the endometrium (the inner-most layer of the uterus)
Bayer's experts have opined that although 2D ultrasound is still a commonly used method to detect whether a Mirena has been properly placed — in other words, to determine whether perforation or damage occurred at insertion — this type of imaging cannot rule out such damage, and 3D ultrasounds produce higher quality images capable of more detailed detection. (See, e.g., Kekatos Omnibus Decl. Ex. G, General Expert Report of Marcia C. Javitt, M.D., F.A.C.R. ("Javitt Report"), at 4.) Plaintiffs argue that Defendants' experts should not be allowed to opine on the superiority of 3D imaging because 2D imaging is capable of detecting proper placement of an IUD; it is frequently used to ensure proper placement; and Bayer has never instructed or recommended that physicians use 3D ultrasounds to detect Mirena. (Ps' Omnibus Mem. 3-4.)
Bayer's medical experts opine that from a clinical perspective, the Mirena label has always been adequate to warn of its risks. (See, e.g., Kekatos Omnibus Decl. Ex. C, General Expert Report of Michael Policar, M.D., M.P.H. ("Policar Report"), at 36.) Plaintiffs argue that Defendants' Obstetrics and Gynecology ("OB/GYN") experts
Bayer's experts offer opinions regarding the scope and results of the EURAS IUD study. (See, e.g., Goldberg Report at 17-19.) Plaintiffs argue that Bayer's OB/GYN experts are not qualified to opine on the adequacy of the EURAS IUD study because they are not epidemiologists, biostatisticians or medical scientists. (Ps' Omnibus Mem. 4.)
Defendants' experts' qualifications and opinions are discussed below, followed by an analysis of each opinion that Plaintiffs seek to exclude.
Dr. Collins is an Associate Professor of nursing, specializing in nurse-midwifery, and a director of a nurse-midwifery education program at Vanderbilt University's School of Nursing. (Collins Report at 1; Declaration of Christopher J. Cook in Support of Defendants' Opposition to Plaintiffs' Omnibus Motion ("Cook Omnibus Decl."), (Doc. 2773), Ex. 7, Curriculum Vitae of Michelle Collins ("Collins CV").) She teaches courses that cover IUD content, including IUD insertion, and practices part-time in the nurse-midwifery clinical faculty practice. (Collins Report at 1.) Dr. Collins has prescribed and inserted "hundreds of IUDs," including ParaGard and Mirena. (Id.) Dr. Collins wrote a doctoral dissertation examining the effect of progestins, and one study she used included women with Mirena IUDs. (Id.) She teaches, writes and makes presentations in her field, including authoring a textbook chapter on hormonal contraception. (Id.; Collins CV.)
Dr. Collins opines on the benefits and risks of various types of contraception, including Mirena. (Collins Report at 3-13.) She concludes that the benefits associated with Mirena use outweigh its risks. (Id. at 26.) Dr. Collins discusses shortcomings associated with 2D ultrasound imaging of IUDs. (Id. at 18-19.) She additionally concludes that there is no evidence supporting Plaintiffs' theory of secondary or delayed perforation, and that perforation can only occur upon insertion of an IUD. (Id. at 22-25.) She dismisses several theories put forth to show that secondary perforation is possible, (id. at 23-25), and concludes that Mirena's label has always adequately outlined the proper risks from a medical perspective, (id. at 25-26).
Dr. Dalton is a tenured Associate Professor in the Department of Obstetrics and Gynecology, Division of Gynecology, at the University of Michigan. (Dalton Report at 1; Cook Omnibus Decl. Ex. 10, Curriculum Vitae of Vanessa Dalton ("Dalton CV").) She holds undergraduate, medical and public health degrees. (Dalton Report at 1.) Dr. Dalton has researched reproductive health services, including contraception, and she has served on committees for the American Congress of Obstetricians and Gynecologists ("ACOG"). (Id.) Dr. Dalton leads a weekly family planning clinic and consultative service providing counseling and provision of contraception, and she supervises or personally places 5 to 10 IUDs in a typical month. (Id. at 2.) More than half of her clinical practice is in "family planning related services." (Id.) She has studied and published on LNG-releasing IUDs and the possible complications from IUDs in post-partum women. (Cook Omnibus Decl. Exs. 11, 12.)
Dr. Goldberg is a board certified obstetrician/gynecologist and holds leadership positions in obstetrics and gynecology at Einstein Medical Center in Philadelphia. (Goldberg Report at 1.) Dr. Goldberg practices full-time as an OB/GYN and sees many patients for family planning and contraception. (Id.) He personally inserts several Mirena IUDs per month, and sometimes as many as five per week. (Id. at 10; Cook Omnibus Decl. Ex. 20, Deposition of Jay Goldberg ("Goldberg Dep."), at 57:11-18.) He has published dozens of peer-reviewed articles and is a manuscript referee for more than a score of medical journals. (Goldberg Report at 2; Cook Omnibus Decl. Ex. 6, Curriculum Vitae of Jay Goldberg ("Goldberg CV").) Dr. Goldberg opines generally on the benefits of contraception and IUDs and the mechanisms by which IUDs function. (Goldberg Report at 4-10.)
Dr. Goldberg concludes, based on available evidence and the general consensus in the scientific community, that perforation occurs, or at least initiates, at the time an IUD is inserted. (Id. at 13-14.) Dr. Goldberg opines that IUDs cannot move independently and dismisses potential theories by which spontaneous migration could occur. (Id. at 13-14, 23-30.) He also opines on the limitations of 2D ultrasound in detecting uterine perforation. (Id. at 14-15.) Dr. Goldberg discusses the EURAS-IUD study, and disagrees with some criticisms levied against it. (Id. at 17-19.) In addition, Dr. Goldberg concludes that the Mirena label has always adequately conveyed to prescribing physicians the risks of Mirena. (Id. at 21-23.)
Dr. Goldstein is a tenured professor at New York University School of Medicine in the department of Obstetrics and Gynecology. (Goldstein Report at 1.) Dr. Goldstein is the Director of Gynecologic Ultrasound and Co-Director of Bone Densitometry and Body Composition. (Id.) He has a half-time private practice, seeing patients of all ages as a gynecologist, and counsels and places IUDs. (Id. at 1-2.) Dr. Goldstein has written and edited textbooks on ultrasounds of the female pelvis, and published articles on 2D-versus-3D ultrasound, including specific discussions regarding the detection of IUD placement. (See, e.g., Cook Omnibus Decl. Ex. 44.) Dr. Goldstein opines generally on contraceptive methods, IUDs and the risk of perforation associated with IUDs. (Goldstein Report at 2-14.) Based on the EURAS-IUD study, he finds no statistically significant difference in the perforation rate of Mirena compared to other IUDs. (Id. at 10-14.)
Dr. Hewitt is an associate professor at Ohio State University College of Medicine in the OB/GYN and Pediatrics Departments. (Hewitt Report at 1.) Dr. Hewitt supervises and teaches residents and medical students on the gynecologic and labor and delivery services, and works in a practice providing the "full range of general adult OB/GYN, including well woman care, contraception and family planning, obstetrical services, and gynecologic surgery." (Id.) Dr. Hewitt counsels patients on contraception, and "routinely place[s]" IUDs. (Id. at 1-2.) She serves on committees and boards related to OB/GYN services. (Id. at 3.) Her teaching activities "include both educating trainees about the risks and benefits of IUDs, and training and supervising IUD placement." (Id. at 2.) She is co-author of a 2005 article on progestin-only contraceptives, including Mirena. (Cook Omnibus Decl. Ex. 9.)
Dr. Hewitt opines that spontaneous migration is not possible and that uterine perforation occurs or at least initiates at the time of insertion. (Hewitt Report at 18-20.) Dr. Hewitt dismisses theories espousing mechanisms by which a Mirena could spontaneously migrate. (Id. at 24-29.) She disagrees with Plaintiffs' epidemiological expert, Dr. Zambelli-Weiner, regarding her criticisms of the EURAS-IUD study. (Id. at 15-16.) Dr. Hewitt also opines that, as a prescribing doctor, the Mirena label "has always adequately and appropriately informed clinicians about the known risk of uterine perforation." (Id. at 30.)
Dr. Javitt is the Director of Medical Imaging at the Rambam Health Care Campus in Haifa, Israel, and served as the Section Head of Body MRI and of Genitourinary Radiology at Walter Reed Army Medical Center in Washington from 2002 to 2011. (Javitt Report at 1.) She is trained in Ultrasound, Computed Tomography and MRI, and has over 30 years of experience in radiology. (Id.) She has written textbooks, book chapters and peer-reviewed articles, focusing her research on imaging of the female pelvis. (Id.)
Dr. Javitt opines on the imaging of IUDs and the differences between 2D and 3D ultrasound technology. (Id. at 3-6.) She concludes that 3D ultrasound offers advantages over 2D ultrasound with respect to localizing IUDs within the uterine cavity. (Id. at 4.) Dr. Javitt opines that 2D ultrasound cannot always rule out that any portion of an IUD has entered the myometrium. (Id.) In addition, Dr. Javitt concludes that neither 2D nor 3D ultrasound can rule out injuries to the uterine wall caused by a uterine sound
Dr. Policar is a board certified OB/GYN. (Policar Report at 1.) He also has a Master's degree in Public Health. (Id.) Since October 2014, Dr. Policar has worked part-time training and supervising OB/GYN residents, mentoring post-residency Family Planning fellows, and serving on committees at San Francisco General Hospital. (Id. at 3.) Dr. Policar has previously held senior positions at the Planned Parenthood Federation of America, and as the national Medical Director was "responsible for creating and updating the clinical Standards and Guidelines that clinicians in every Planned Parenthood affiliate in the United States were expected to follow." (Id. at 1, 3.) He has had an extensive career in OB/GYN, including 34 years of clinical experience in family planning. (Id. at 1-3.) Dr. Policar is also a senior author of "Contraceptive Technology," a textbook on family planning. (Id. at 3.) Dr. Policar has inserted and removed IUDs, including Lippes Loop, Copper 7, Progestasert, ParaGard, Mirena and Skyla during his career, and he has supervised "between 2-4 Mirena insertions per week over the last 13 years." (Id. at 4.)
Dr. Policar opines that all perforations occur at the time of the IUD insertion procedure, although diagnosis may be delayed, and that it is an uncommon but possible scenario that an embedment that occurred at the time of placement progresses over time to form a complete perforation via which the IUD could be propelled into the abdominal cavity. (Id. at 20-21, 24.) Dr. Policar is unaware of any plausible mechanism by which an IUD could spontaneously migrate out of the uterus, and opines that such a concept is not accepted in the family planning community. (Id. at 20-21, 24.) In his report, Dr. Policar discusses the benefits of the EURAS-IUD study and writes that its "clinical import has been widely endorsed within the medical community." (Id. at 27.) Dr. Policar additionally opines on the limitations of 2D ultrasound, noting that 2D ultrasound can fail to diagnose an embedment in some circumstances. (Id. at 32.) Dr. Policar also concludes that the "Mirena label[s] over time have adequately informed clinicians of the salient clinical information" and that his understanding of the risks of perforation remained constant despite changes to the label. (Id. at 36.)
Bayer's experts' opinions on secondary perforation, contractility of the uterus and weakening of the uterus by LNG are closely related and will be discussed together. Plaintiffs first argue that Bayer's clinical experts lack the medical experience necessary to opine on these issues. A general thrust of Plaintiffs' arguments is that Defendants' experts have not personally studied uterine activity upon exposure to LNG or pointed to studies ruling out the possibility of secondary perforation. Not only is personal study not necessary, see McCullock, 61 F.3d at 1042-43; Cedar Petrochemicals, Inc., 769 F.Supp.2d at 284; In re Zyprexa, 489 F.Supp.2d at 282, but Defendants do not dispute that their own experts have not personally conducted such studies. Further, given that Defendants' experts are attempting to prove a negative — that secondary perforation does not exist — pointing to the absence of convincing studies or the weaknesses of studies on which Plaintiffs rely, and evaluating them in light of their clinical experience, training and research, is in these circumstances
Dr. Collins has both academic and clinical experience related to contraception in general and IUDs in particular. She has the qualifications and expertise in the field of family planning and OB/GYN necessary to allow her to opine on the efficacy of the Mirena IUD and Plaintiffs' theory of secondary perforation under Daubert's admissibility standard. See Daubert, 509 U.S. at 589, 113 S.Ct. 2786. Furthermore, Dr. Collins' academic research related to hormones and her dissertation topic indicate that she is qualified to testify regarding the effect of LNG on the uterus and uterine contractility. (See Collins Report 1.) Plaintiffs argue that all of Bayer's experts, including Dr. Collins, "blindly state that there is no evidence that secondary perforation actually occurs," (Ps' Omnibus Mem. 11), but this is not so. Instead, Dr. Collins' opinions on secondary perforation (like those of the other experts) are based on her experience as a clinician who has inserted and instructed others on the insertion of IUDs, and on a review of medical literature.
Plaintiffs additionally argue that Dr. Collins' opinion on secondary perforation is not reliable because she ignored contrary scientific literature and Bayer's own internal and public findings. (Ps' Omnibus Mem. 13.) Potentially conflicting statements by Bayer personnel are irrelevant for purposes of this Daubert motion.
Dr. Dalton's medical qualifications are sufficient for her to opine on the effect of LNG on the uterus and Plaintiffs' theory of secondary migration. See In re Zyprexa, 489 F.Supp.2d at 282. She has experience practicing as an OB/GYN and has had the opportunity to place and supervise the placement of many IUDs throughout her career. (Dalton Report at 2.) Although she has not performed any studies herself, this does not mean she is not qualified to give a medical opinion using her experience as well as a review of relevant scientific literature. See McCullock, 61 F.3d at 1042-43. Plaintiffs criticize Dr. Dalton because, in the section of her report where she concludes that LNG does not cause thinning of the uterine wall, she states only that she has not seen literature to that effect, rather than citing any study showing that such thinning does not occur. (Ps' Omnibus Mem. 17.) But her list of materials considered contains these studies, (Dalton Report app. B),
Plaintiffs move to exclude Dr. Goldberg's testimony, arguing that like Defendants' other experts, he is not qualified because he has not personally conducted studies related to secondary perforation and the effect of LNG on the uterus, and that his opinion on secondary perforation is not based on reliable scientific literature. (Ps' Omnibus Mem. 10.) Dr. Goldberg opines generally on uterine perforation, (Goldberg Report at 12-20), and on theories of spontaneous IUD migration, which he concludes are "just speculative hypotheses, without any sound scientific basis," (id. at 23). Dr. Goldberg's experience
Dr. Goldberg may not, however, opine on the impact of "lawsuit-generated scientific misinformation." (Goldberg Report at 29-30.)
Dr. Goldstein's opinions related to the effects of LNG on the uterus, uterine contractions and the possibility of secondary migration are sufficiently reliable and pass muster under Rule 702 and Daubert. Dr. Goldstein's clinical and academic experience qualify him to opine on whether LNG can contribute to uterine perforations and whether spontaneous migration can occur. See McCullock, 61 F.3d at 1043. Dr. Goldstein bases his opinions on his decades of experiences as a doctor and a review of scientific literature. See Deutsch, 768 F.Supp.2d at 482. Dr. Goldstein cites several studies for the proposition that uterine perforations occur, or at least initiate, at the time of insertion. (Goldstein Report at 28.) In addition, in his materials list Dr. Goldstein refers to studies that lend support for the proposition that LNG does not have a thinning effect on the myometrium, in that perforation rates do not differ between hormonal and copper IUDs. (See Goldstein Report app. C.) Dr. Goldstein also confronts contradictory studies, including Goldstuck. Plaintiffs can cross-examine to challenge Dr. Goldstein's credibility.
Dr. Hewitt is qualified to opine on the theory of spontaneous migration and potential effects of LNG on the uterus. Her opinion is "based on [her] education, training, experience, and [her] review of
Plaintiffs once again miss the mark in arguing that Dr. Policar is not qualified to testify regarding secondary perforation, uterine contractility or weakening of the uterus by LNG. (Ps' Omnibus Mem. 10-13, 15-18.) Like Bayer's other clinical experts, Dr. Policar is a distinguished practitioner with a long career in OB/GYN practice. He has co-authored a textbook on family planning titled "Contraceptive Technology," which is in its twentieth edition. (Policar Report at 3; Cook Omnibus Decl. Ex. 2.) Dr. Policar bases his opinions on his experience and also the "family planning literature over the past 25 years." (Policar Report at 20.) His disagreement with Plaintiffs' theories regarding perforation unrelated to insertion are grounded in his experience and in the literature, as is appropriate under Daubert. His testimony is also relevant to this case and helpful to the trier of fact. Plaintiffs may challenge Dr. Policar's theories and opinions on cross-examination. See In re Zyprexa, 489 F.Supp.2d at 285.
For the reasons stated above, Bayer's experts have demonstrated the requisite qualifications, reliability and helpfulness to the trier of fact to pass muster under Rule 702 and Daubert with respect to Plaintiffs' theory of secondary perforation, uterine contractility and the effects of LNG on the uterus. Plaintiffs' motion to exclude these experts from opining on these topics is denied.
Bayer's clinical experts all share similar backgrounds as healthcare providers who have experience prescribing and inserting IUDs, and all offer opinions regarding the adequacy of the Mirena label from the perspective of a medical practitioner who is familiar with Mirena and similar products. (See Collins Report at 25-26; Goldstein Report at 19-23; Goldberg Report at 21-23; Policar Report at 34-37; Dalton Report at 29-31; Hewitt Report at 29-30.) Plaintiffs argue that none of Defendants' experts are qualified to offer an opinion on labeling because they lack "any education or training with respect to FDA labeling." (Ps' Omnibus Mem. 19-20.) But none of Defendants' experts opine on FDA regulations or on the adequacy of the Mirena warning from a regulatory perspective. Rather, they only describe how they as clinicians have perceived the label and its wording with respect to perforation, and how, if at all, that wording affects their practices. As Dr. Goldstein said during his deposition:
(Cook Omnibus Decl. Ex. 19, Deposition of Steven Goldstein ("Goldstein Dep."), at 76:1-10.)
Plaintiffs argue that Defendants' experts should not be allowed to "testify in the absence of knowledge of the risks of Mirena," and that because Bayer's experts "ignore that secondary perforation is real, they are not equipped to offer an opinion on the adequacy of the Mirena labeling." (Plaintiffs' Reply Memorandum in Further Support of their Omnibus Motion ("Ps' Omnibus Reply"), (Doc. 2843), 5.) This argument does not withstand scrutiny. Defendants' experts do not ignore the argument that secondary perforation exists; rather, through their study of the literature and their own clinical experiences, they do not find the argument persuasive. The legitimacy of this claim is obviously hotly contested, and the Court does not offer an opinion on its validity, but it does not mean that Bayer's experts should not be able to opine on whether the label is adequate from a physician's perspective. It is precisely because Defendants' experts believe secondary perforation is not a real phenomenon that they think the label, despite not warning against it, is adequate — in other words, that the label conveys the legitimate risks of the product. Because Bayer's experts have based these opinions on a sound methodology, they have the requisite qualifications, and their testimony is helpful to the trier of fact, their views are admissible under Daubert. 509 U.S. at 590-91, 113 S.Ct. 2786. Should the jury be convinced that secondary perforation is possible, it will discount the experts' opinions about the label accordingly.
Bayer's clinical experts all have experience in inserting IUDs, including Mirena, and have familiarity with its label, how it is understood, and how it is discussed with patients. Plaintiffs' motion to exclude Bayer's clinical experts' testimony regarding those aspects of the Mirena label is therefore denied. Defendants' experts may not, however, opine on FDA regulations or whether the Mirena label complied with them, as these doctors are not qualified as experts on that subject.
Plaintiffs move to preclude all of Bayer's experts' opinions that 2D ultrasound is not capable of always accurately detecting the presence of a Mirena. Plaintiffs argue that Bayer has never instructed or recommended that 3D rather than 2D ultrasound is the preferred method of locating a Mirena. (Ps' Omnibus Mem. 18-19; Ps' Omnibus Reply 4-5.) In addition, Plaintiffs argue that "[t]here is no peer-reviewed literature to support the position that 2D ultrasound is incapable of detecting the presence of Mirena," and cite Defendants' experts' reports as stating 2D ultrasound is reliable in the IUD/Mirena context. (Ps' Omnibus Mem. 18.) These arguments mischaracterize Defendants' experts' reports and deposition testimony.
Bayer's clinical experts opine generally that 2D ultrasound can show whether an IUD is present in the uterus, but not necessarily whether a portion of an IUD has extended (or has become embedded) into the patient's myometrium. (See Collins Report at 18-19; Dalton Report at 23; Goldberg Report at 14-15; Goldstein Report at 17-18; Hewitt Report at 19-20; Policar Report at 32.) With the exception of Dr. Javitt, Defendants' experts do not offer lengthy opinions on this topic. These experts do not, as Plaintiffs seem to claim, offer opinions that 3D ultrasound is the standard of care or that "2D ultrasound is incapable of ensuring Mirena placement," (Ps' Omnibus Mem. 19); they only opine as to the limitations of 2D ultrasound in detecting perforation of the myometrium. If Plaintiffs disagree with the conclusions of Bayer's experts regarding those limitations, counsel may question them on cross-examination. But in doing so they must bear in mind that saying that 2D ultrasound cannot definitively rule out embedment or perforation is not the same thing as saying 2D ultrasound is unacceptable or 3D ultrasound is routinely required.
In addition, Plaintiffs characterize as "unsupportable" the experts' views that 2D ultrasound is incapable of ruling out uterine perforation, (Ps' Omnibus Reply 4), but this argument is unavailing not only because Defendants' experts set forth reliable bases (including studies) for that opinion, (Javitt Report at 4), but also in light of the fact that several of Plaintiffs' own experts have said the same thing.
Dr. Javitt, whose opinion focuses on 2D versus 3D ultrasound, is an accomplished radiologist and has served in leadership positions for national and international radiology committees that draft practice guidelines. (Javitt Report at 1.) She opines on the differences between 2D and 3D ultrasound technology, and concludes that a 2D ultrasound may not always be able to rule out that a portion of an IUD has entered the myometrium. (Id. at 4.) Dr. Javitt also opines that if the IUD is properly placed in the uterine cavity even 3D ultrasound cannot rule out injuries to the uterine wall caused by other objects, such as a uterine sound or an IUD inserter. (Id.) Dr. Javitt reaches this conclusion by analyzing several studies that lend support to her claims. (Id.) She is sufficiently qualified under Daubert to opine on ultrasound, and her report and proposed testimony are sufficiently reliable because she bases her opinions on her experience as a radiologist and on scientific literature. See Amorgianos, 303 F.3d at 266-67. Again, if Plaintiffs disagree with Dr. Javitt's conclusions, they can take it up on cross-examination. Their criticisms do not undermine her reliability, but rather go to the weight that should be given to her testimony. See id. at 267. In addition, Dr. Javitt's proposed testimony regarding the technical nature of ultrasound imaging would be helpful to assist a lay person in understanding the ways in which placement of the Mirena and possible perforations can be detected.
Plaintiffs also argue that because Bayer has never suggested that 3D ultrasound is necessary to ensure the location of a Mirena, it is "disingenuous" for Bayer's experts to offer testimony that 2D ultrasound may not be able to rule out perforation at insertion. (Ps' Omnibus Reply 4.) Although Plaintiffs are free to make this point during cross-examination, it does not warrant preclusion under Daubert. Plaintiffs do not cite any authority for the proposition that because Defendants never instructed patients or doctors to use one method, experts cannot opine on limitations of another method, or that their testimony should be excluded in such circumstances as "disingenuous." Any discrepancy between Defendants' statements and their experts' views at trial may be fodder for questioning and argument by Plaintiffs, but does not undermine the admissibility of the opinions. Dr. Javitt acknowledges in her report that when properly conducted, "2D U.S. [ultrasound] can reliably assess whether an IUD is located in or near the uterine cavity." (Javitt Report at 3.) She also points out, however, that even though 2D ultrasound can determine whether an IUD is in the uterine cavity, it cannot always rule out that an IUD located in the uterine cavity has also partially entered the myometrium. (Id. at 3-4.) This distinction seems entirely logical and does not undermine the reliability of Dr. Javitt's report or the opinions of other experts regarding 2D versus 3D ultrasound.
Defendants' experts, who are all experienced medical practitioners with academic and clinical expertise, are qualified to opine on the narrow issue of the limitations of 2D ultrasound in detecting perforation. In addition, they base their opinions on peer-reviewed studies. They thus pass muster under Daubert's reliability standard. See Daubert, 509 U.S. at 593, 113 S.Ct. 2786. These opinions are also helpful to the trier of fact because they relate to a technical, medical issue that would be beyond the ken of a lay person. For the reasons stated above, Plaintiffs' motion to exclude Defendants' experts' testimony
Plaintiffs move to exclude Bayer's clinical experts' opinions regarding epidemiological studies, including the EURAS IUD study, because they are not epidemiologists and therefore not qualified to testify as to these studies. (Ps' Omnibus Mem. 21-22.) This level of expertise, however is not required under Daubert. See In re Zyprexa, 489 F.Supp.2d at 282. Moreover, medical doctors do not need to be epidemiologists in order to testify regarding epidemiological studies. See, e.g., In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 11-CV-5304, 2013 WL 1558690, at *6 (D.N.J. Apr. 10, 2013) (doctor qualified to opine on clinical trials even though he was not an epidemiologist); Lyman v. Pfizer, Inc., No. 09-CV-262, 2012 WL 2971550, at *3 (D.Vt. July 20, 2012) ("A medical doctor does not have to be an epidemiologist in order to testify about epidemiological studies.").
Bayer's clinical experts' medical qualifications in the field of OB/GYN, their familiarly with IUDs, and their experience evaluating (and in some cases conducting) epidemiological studies as part of their clinical work and research suffice under Daubert and qualify them to opine on epidemiological studies, including the validity and sufficiency of the EURAS study. See In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 09-CV-10012, 2011 WL 6740363, at *6 (S.D.Ill.Dec. 22, 2011) (doctor's "extensive experiences qualife[d] him to give expert opin[ions] about the epidemiological studies that he ... reviewed"). Accordingly, Plaintiffs' motion to exclude Defendants' experts' opinions as to epidemiological studies is denied.
Plaintiffs next contend that Defendants' experts' testimony should be excluded under Daubert because it arguably contradicts statements made by Bayer employees. (Ps' Omnibus Mem. 14-15.) Plaintiffs do not cite any authority for this proposition. The one case that Plaintiffs cite in this section of their brief, Hilaire v. DeWalt Industrial Tool Co., 54 F.Supp.3d 223, 234 (E.D.N.Y.2014), does not support Plaintiffs' argument for exclusion based on alleged contrary statements made by a party. In fact, the court there remarked, echoing Daubert, that once testimony "has been found to be admissible, the adverse party is free to challenge any shaky or unreliable testimony," id. (internal quotation marks omitted), before the jury using "`vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof,'" id. at 235 (quoting Daubert, 509 U.S. at 596, 113 S.Ct. 2786) (emphasis added).
Plaintiffs further criticize Defendants' experts' testimony as unreliable for failing to consider Bayer's public positions and internal discussions related to secondary perforation. (Ps' Omnibus Reply 3-4.) To support their argument, Plaintiffs cite only Nimely, 414 F.3d at 396-97, which broadly states that when expert opinions are "based on data, a methodology, or studies that are simply inadequate to support the conclusions reached," that testimony should be excluded. Although this is certainly true under Daubert, it does not mean that potentially conflicting statements made by a party necessarily render that party's expert's testimony unreliable. The statements and public positions of Bayer are not scientific literature that an expert would be expected to confront in the exercise of intellectual rigor in the field. See In re Rezulin Prods. Liab. Litig.,
To whatever extent Defendants' public or internal statements conflict with its experts' opinions or its litigation positions in these cases, that will be a problem for Defendants that Plaintiffs may exploit via cross-examination and argument. But Defendants' experts' failure to confront alleged conflicting statements made by Bayer does not warrant exclusion under Daubert. See Huskey, 29 F.Supp.3d at 735 ("The plaintiffs also contend that [the expert's] opinion is unreliable because he did not review internal [company] documents that refute his conclusion ... [the expert's] failure to review particular documents goes to the weight of his opinion, not its admissibility.").
For the reasons stated above, all seven of Defendants' experts have the necessary qualifications and have utilized reliable methods in their opinions as required by Rule 702 and Daubert, and their testimony will assist the trier of fact. Accordingly, Plaintiffs' omnibus motion to exclude Bayer's clinical experts, (Doc. 2702), is DENIED.
Defendants move to preclude Drs. Young, Jarrell, Wray and Strassberg from offering opinions regarding general and specific causation. Each is discussed separately below.
Defendants move to preclude Dr. Young's expert testimony relating to his theory of how secondary perforation of an IUD can occur — his theory of general causation — on the grounds that the methodology upon which he bases his opinions is unreliable and that he takes impermissible speculative leaps in forming his conclusions. Dr. Young's general causation expert report and proposed testimony are offered by Plaintiffs to show a mechanism by which perforation of an IUD unrelated to insertion — in other words, secondary perforation or spontaneous migration — could occur. Dr. Young also offers a specific causation opinion that secondary perforation did occur in Ms. Danley's case. (Cook Young Decl. Ex. C, Expert Report of Roger C. Young, M.D., Ph.D. ("Young Danley Report").) For the reasons stated below, Defendants' motion is GRANTED with respect to both Dr. Young's general causation opinions and his specific causation opinions.
In his general causation report, Dr. Young opines on "potential mechanisms of secondary perforation of Mirena IUDs." (Young Report at 2.) He sets forth a "[b]iologically plausible mechanism for IUD uterine perforation" that consists of four steps. (Id. at 10-11.) The mechanism
Step 3 in Dr. Young's mechanism refers to perforation of the uterus by the IUD, which is the "phase where the IUD actively penetrates the uterine wall until some portion of the IUD protrudes through the wall into the abdominal cavity." (Id. at 14.) Dr. Young opines it is likely that the Mirena penetrates the uterus "by mechanical and chemical mechanisms." (Id. at 15.) The chemical mechanisms relate to the softening of the uterine tissue discussed at Steps 1 and 2, and the mechanical mechanisms refer to uterine contractions and the force required for the Mirena to perforate on its own. (Id.) Dr. Young acknowledges that the Mirena actually tends to reduce contractions, but finds that because it does not eliminate them, they can still contribute to secondary perforation. (Id.) Dr. Young estimates the amount of force created by the effect of uterine contractions on the Mirena using the size of Mirena and the force quantities found in one study examining the uterus and in another examining the heart. (Id. at 15-16.) The final stage in Dr. Young's analysis, Step 4, refers to "[t]ransmigration of IUD into abdominal cavity," which is when the IUD exits the uterus. (Id. at 16.) Dr. Young opines that once the IUD has partially penetrated, complete penetration is "accomplished when uterine contractions occur in response to the presence of a foreign body." (Id.) Dr. Young's mechanism is thus based upon the effects of LNG on the uterus, which he concludes enhances the risk of secondary perforation, and the forces generated by uterine contractions. (Id.) He additionally concludes that knowledge of "mechanisms of secondary perforation are well-known" in medical literature. (Id.)
Dr. Young is an experienced doctor specializing in OB/GYN. Dr. Young completed a residency in OB/GYN in 1986, and has since practiced obstetrics and gynecology in an academic setting. (Young Report at 3.) Dr. Young has served as a professor at the University of Vermont School of Medicine, Dartmouth Medical School, the Medical University of South Carolina and Duke University. (Id.) He is currently a professor at the University of Tennessee Health Sciences Center. (Id.) Dr. Young also has clinical experience in OB/GYN that has included caring for patients, supervising residents and teaching clinical medicine to medical students. (Id. at 4.) Dr. Young has learned, and subsequently taught, "how to place and remove copper 7, copper T, ParaGard and Mirena IUDs." (Id. at 6.)
Defendants argue that Dr. Young has "no specialized knowledge or experience concerning Mirena, perforation, or the biomechanics of the non-pregnant uterus." (Memorandum of Law in Support of Defendants' Motion to Exclude the Testimony of Roger C. Young, M.D., Ph.D. ("Ds' Young Mem.") 3.) Dr. Young's academic and clinical background in obstetrics and gynecology, however, as well as his specific research on the functioning of the uterus, including effects of hormones and uterine contractions, make him qualified to opine on the issue of whether an IUD such as Mirena is capable of perforating a uterus unrelated to insertion. See In re Zyprexa, 489 F.Supp.2d at 282. The Court must now determine whether Dr. Young's opinion and methodology meet Daubert's standards of reliability. See Daubert, 509 U.S. at 589, 113 S.Ct. 2786; Amorgianos, 303 F.3d at 266.
Defendants move to exclude the testimony of Dr. Young on the grounds that it is unreliable. (Ds' Young Mem. 6-9.) Dr. Young's report and proposed testimony — which purport to be scientific, and thus the sort of expert testimony to which the four Daubert reliability factors apply, see Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786 — fail to meet any of those four factors. First, Dr. Young's mechanism has never been tested or studied in human patients, nor has it undergone animal or in vitro
Expert testimony developed solely for litigation can weigh against reliability. See Eghnayem v. Bos. Sci. Corp., 57 F.Supp.3d 658, 670 (S.D.W.Va.2014); In re Rezulin, 369 F.Supp.2d at 420, 424. In addition, although the factors outlined in Daubert are not a "definitive checklist or test," Daubert, 509 U.S. at 593, 113 S.Ct. 2786, "when an expert is offering testimony that is presented as a scientific conclusion and the expert's method fails to satisfy any of the factors identified in Daubert, a court should pause and take a hard look before allowing a jury to consider it," In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 593 F.Supp.2d 549, 564 (S.D.N.Y.2008), on reconsideration in part (June 26, 2008) (emphasis in original). Because Dr. Young's mechanism does not meet any of the criteria listed in Daubert, the Court carefully scrutinizes Dr. Young's proposed testimony and concludes that it lacks a reliable methodology.
Expert testimony "must be supported by appropriate validation — i.e., good grounds, based on what is known." Daubert, 509 U.S. at 590, 113 S.Ct. 2786 (internal quotation marks omitted). Moreover, an expert, "whether basing testimony upon professional studies or personal experience, [must] employ[ ] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. 1167. In the scientific community, "[s]cientific methodology... is based on generating hypotheses and testing them to see if they can be falsified." Daubert, 509 U.S. at 593, 113 S.Ct. 2786. Dr. Young, however, was given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it might occur. (See Young Report at 2) ("I have been asked to offer an opinion as to the potential mechanisms of secondary perforation of Mirena IUDs."). No testing of the hypothesis was conducted. This exercise does not seem to have involved any scientific methodology, but rather consisted of reverse-engineering a theory to fit the desired outcome. This does not rise to the level of intellectual rigor employed in the medical or scientific field, see Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. 1167, and alone would warrant exclusion. See Faulkner v. Arista Records LLC, 46 F.Supp.3d 365, 381 (S.D.N.Y. 2014) ("[M]ethodology ... aimed at achieving one result ... is unreliable, and... must be excluded."); In re Accutane Prods. Liab., 511 F.Supp.2d 1288, 1296 (M.D.Fla.2007) ("While [the expert's] biological theory may be exactly right, at this point it is merely plausible, not proven, and biological possibility is not proof of causation."); Golod v. La Roche, 964 F.Supp. 841, 860-61 (S.D.N.Y.1997) ("[A]lthough [the expert's] theory may be biologically plausible, it does not constitute `scientific knowledge' within the meaning of Daubert. Instead, it is, at most, scientifically-grounded speculation: an untested and potentially untestable hypothesis. Although there may be circumstances in which a scientific hypothesis that is, practically speaking, untestable, would nevertheless be admissible, perhaps because of
Furthermore, apart from the requirement that the opinion constitute "scientific knowledge," as opposed to hypothetical speculation, an expert's analysis must be "reliable at every step." Amorgianos, 303 F.3d at 267. Defendants argue that Dr. Young's mechanism theory is unreliable because each step requires a "[s]peculative [l]eap[ ]." (Ds' Young Mem. 918.) At Steps 1 through 4 of his mechanism, Dr. Young cites studies and publications that he alleges support his theory of the mechanism for secondary perforation. A closer look, however, shows that Dr. Young draws impermissibly speculative conclusions from these studies that "exceed the limitations the authors themselves place[d] on the[se] stud[ies]." In re Accutane Prods. Liab., No. 04-MD-2523, 2009 WL 2496444, at *2 (M.D.Fla. Aug. 11, 2009), aff'd, 378 Fed.Appx. 929 (11th Cir.2010).
As part of Step 1 of his mechanism, Dr. Young opines that the IUD embeds into the uterine wall — the myometrium — after, and unrelated to, insertion. (Young Report at 11-12.) Dr. Young says this is possible due to the uterus's reaction to the IUD, a foreign body, being inside it, and the effect of LNG on the uterus. (Id.) Dr. Young relies on the Phillips study
Additionally, another important piece of Step 1 of Dr. Young's theory is his conclusion that uterine cells grow around the IUD, or "remodel," to attach it to the uterine wall. (8/19/15 Young Dep. at 172:10-173:8; Young Report at 11.) Dr. Young, however, disavowed the one article he cited to support this claim, and said that it does not actually support that proposition, (8/19/11 Young Dep. at 172:7-21, 177:24-178:2), and could not point to another study showing that uterine cells will grow around an IUD like Mirena, (id. at 172:22-173:20.) Dr. Young testified that he relied on two articles mentioned in his CV involving laboratory studies of cell growth on scaffolding. (Id. at 173:21-175:6.) Dr. Young's report does not discuss these studies, and during his deposition he did not explain why the growth of cells in these studies lends support to his theory that presence of an IUD leads to cell growth around it in the uterus. Indeed, he conceded that there are no studies that would support analogizing the two. (Id. at 176:13-22.) Dr. Young's analysis in this regard does not rise to the level of intellectual rigor generally seen in the scientific community, and thus does not meet the requirements of Rule 702 and Daubert.
Step 2 of Dr. Young's theory refers to penetration of the IUD into the uterine wall to a deeper level than embedding, a process helped by a softening in connective tissue due to the increased presence of LNG in the uterus. (Young Report at 13.) Dr. Young primarily relies on G.S. Anthony et al., Forces Required for Surgical Dilatation of the Pregnant and Non-Pregnant Human Cervix, 89 British J. Obstetrics & Gynaecology 913 (1982), (Compendium Ex. 2) ("Anthony study"), for the proposition that progestins such as LNG weaken uterine tissue. The authors of this study were analyzing the force required to dilate the cervix. The study specifically found no direct correlation "between circulating levels of [progesterone] and the cervical resistance in non-pregnant or early pregnant subjects." (Id. at 915.) Despite this finding that seemingly contradicts the proposition for which he cites it, Dr. Young believes this study supports his theory because the authors state that the study found "patients receiving Depo-Provera showed a significantly lower level of cervical resistance ... than did the cycling group." (Id. at 915.) Depo-Provera — a birth control shot that contains a progestin — is a different contraceptive than Mirena. The Anthony study did not attribute the weakening effect of Depo-Provera to progestin, and in fact
Moreover, at the end of his Step 2 analysis, Dr. Young acknowledges that LNG actually decreases the strength and frequency of uterine contractions, but argues that because they are not eliminated entirely, they still contribute to embedment. (Young Report at 13.) But he does not account for this diminishing effect in his analysis. "[A]ny theory that fails to explain information that would otherwise tend to cast doubt on that theory is inherently suspect." In re Rezulin, 369 F.Supp.2d at 425. The extrapolations and inferences Dr. Young makes at Step 2 of his analysis are just too speculative to suffice under Daubert.
At Step 3 of his analysis, Dr. Young relies in part on the Goldstuck study, supra note 14, to show that uterine contractions have sufficient force to penetrate the uterine wall. (Young Report at 14-15.) Although Goldstuck presents evidence relating to the force of uterine contractions in connection with an IUD, Dr. Young conceded that there were errors in the study's methods and findings. (8/19/15 Young Dep. at 304:6-307:5.) He said an important value for measuring uterine contractions that the authors of Goldstuck attributed to another article did not actually appear in that other article, and described the Goldstuck authors as being "disingenuous." (Id. at 304:15-305:11.) Nevertheless, Dr. Young continued to rely at least in part on the numbers generated by Goldstuck and said, without further explanation, that the author's errors "made in one way tended to counterbalance other errors that [the author] made." (Id. at 305:19-306:20.) Dr. Young seems to have performed some sort of calculation of his own to mitigate the errors he found in Goldstuck, (see id. at 303:4-8, 306:13-307:5, 318:10-323:5), but these calculations do not appear in his report nor were they apparent during his deposition. When asked to explain where he got some of the figures he used in that calculation, Dr. Young cited "just kind of my experience working with pregnant and nonpregnant tissue and just in terms of contractility of uterine tissue," (id. at 320:23-321:2), and said that he derived these calculations from his "experience and talking with the people who have done the research, [who] seem to be getting those values," (id. at 324:1-10.)
As in Step 2 of his theory, Dr. Young again does not account for the fact that Mirena actually decreases the strength and frequency of uterine contractions, even though he acknowledged that Goldstuck did not involve uterine contractions in women with Mirena, further underscoring his unreliable methodology. See Rezulin, 369 F.Supp.2d at 425. Dr. Young ultimately concludes that the contractile force of Mirena is 390 lbs/in
In light of their failure to meet the Daubert factors, absence of methodology, reverse reasoning and analytical gaps, Dr. Young's general causation opinions do not have sufficient indicia of reliability to pass muster under Daubert, and therefore they would not be helpful to a jury.
Dr. Young has also authored a case-specific causation opinion for Plaintiff Jennifer Danley, which Defendants move to exclude as contradictory and unreliable. Defendants also argue that because Dr. Young has not given a general causation opinion, or relied on another expert's general causation opinion, he may not give a specific causation opinion. (Ds' Young Mem. 20-21.) The records show that Ms. Danley's Mirena was inserted on June 29, 2011. (Cook Young Decl. Ex. I.) An ultrasound was performed to check the position of the Mirena immediately following placement, and the technician noted that the IUD was seen "HIGH/RT."
Dr. Young opines that Ms. Danley's second Mirena was inserted on June 29, 2011 without complications and the Mirena was correctly located within the uterine cavity. (Young Danley Report at 2.) He concludes that Ms. Danley did not experience symptoms at the time of or immediately after insertion that would suggest that perforation occurred at that time. (Id.) He also opines that an IUD has little or no contraceptive effect if it is located outside the uterine cavity, and notes Ms. Danley did not become pregnant until 18 months after insertion. (Id.) Dr. Young reasons that had Ms. Danley's uterus been perforated at the time of insertion, resulting in the Mirena's placement directly into the abdominal cavity, it "is unlikely it would have taken 18 months for her to become pregnant." (Id.) Dr. Young thus concludes that the Mirena entered Ms. Danley's abdominal cavity during the fall of 2012 due to secondary perforation, requiring an abdominal laparoscopy to remove the Mirena, which she would not have otherwise needed. (Id.)
Defendants argue that Dr. Young's specific causation is inadmissible because in his report on Ms. Danley, Dr. Young did not give a general causation opinion or rely on another expert's general causation opinion. (Ds' Young Mem. 20-21.) "`General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury.'" In re Rezulin, 369 F.Supp.2d at 402 (quoting In re Breast Implant Litig., 11 F.Supp.2d 1217, 1224 (D.Colo.1998)).
But because I have found that Dr. Young's general causation opinion is not based on a reliable methodology and is therefore inadmissible, his specific causation must also be excluded. See In re C.R. Bard, Inc., 948 F.Supp.2d at 605 ("[Expert's] specific causation opinions are based on her general causation opinions. In other words, her opinion as to each bellwether plaintiff is that the plaintiff suffered nerve injuries through one or both of the general causation mechanisms ... Because I found that [the expert's] general causation opinions are not based on reliable methodology and principles, her specific causations opinions — based on her general causation opinions — should also be excluded."); Rezulin, 441 F.Supp.2d at 578 (excluding experts' specific causation opinions for failing to offer opinions as to general causation). Dr. Young's specific causation opinion is therefore inadmissible on this ground.
In any event, in addition to being inadmissible because of lack of evidence of general causation, Dr. Young's methodology in reaching his conclusion that Ms. Danley experienced a secondary perforation of her Mirena is not based on a reliable methodology, warranting exclusion under Daubert. Dr. Young relies on the ultrasound that was taken following the insertion of Ms. Danley's Mirena and a lack of any post-insertion symptoms to conclude that the Mirena "was correctly located within the uterine cavity at this time." (Young Danley Report at 6.) That the IUD was in the uterine cavity, however, does not mean there was no injury upon insertion (whether from a sound, the inserter or the IUD). Further, Dr. Young acknowledged that 2D ultrasound cannot rule out the embedment of an arm of the
Moreover, Dr. Young opines that Ms. Danley became pregnant in late 2012 because the Mirena was in place (producing its contraceptive effects) until it perforated her uterus at that time, but he fails to account for or consider alternative evidence that could explain why Ms. Danley did not become pregnant sooner. For example, Dr. Young admitted that he would not know whether Ms. Danley and her husband were having intercourse while Ms. Danley was ovulating. (Id. at 424:1-9.) Ms. Danley also used condoms as birth control from 2003 to 2013, which would include the time her second Mirena was implanted. (Cook Young Decl. Ex. P, at JDanley-PFS-000080; Cook Young Decl. Ex. L, Deposition of Jennifer Danley ("J. Danley Dep."), at 132:10-12.) Ms. Danley was also breastfeeding her baby for seven months following the insertion of her second Mirena, (J. Danley Dep. at 200:8-15), which Dr. Young acknowledged would have "some contraceptive effect," although Dr. Young said the effect would not be "total," (8/20/15 Young Danley Dep. at 426:10-15). Dr. Young also acknowledges that if an IUD's drug reservoir is still within the myometrium it would have some reduced contraceptive effect, although he claims, without explanation, that this was not the case for Ms. Danley, (id. at 428:21-429:6), even though, according to him, it could take "[d]ays or weeks to years" for an IUD to penetrate into the uterine wall to a deeper level than embedding, (Young Report at 11). Dr. Young's failure to give "reasonable explanation[s]" for discounting or dismissing these alternative possibilities for why Ms. Danley did not become pregnant for 18 months undermines the reliability of his opinions. See Deutsch, 768 F.Supp.2d at 474 ("[E]ven though `an expert need not rule out every potential cause in order to satisfy Daubert, the expert's testimony must at least address obvious alternative causes and provide a reasonable explanation for dismissing specific alternative factors identified by the defendant.'" (quoting Israel v. Spring Indus. Inc., 98-CV-5106, 2006 WL 3196956, at *5 (E.D.N.Y. Nov. 3, 2006)).
Defendants' motion to exclude Dr. Young's proposed testimony regarding secondary perforation in the case of Ms. Danley is thus granted.
For the reasons stated above, Defendants' motion to exclude the proposed testimony and opinions of Dr. Young in their entirety is GRANTED.
Defendants move to exclude the expert testimony of John Jarrell, Ph.D., P.E. on the grounds that he is not qualified to opine on the effects of LNG on the uterus, the "sharpness" of Mirena, or IUDs in general. (Memorandum of Law in Support of Defendants' Motion to Exclude the Testimony of John Jarrell, Ph.D., P.E. ("Ds' Jarrell Mem."), (Doc. 2680), 3-7.) Defendants also move to exclude Dr. Jarrell's testimony on the grounds that it is unreliable and irrelevant. (Id. at 2-3.)
Dr. Jarrell offers five opinions in his expert report. (Cook Jarrell Decl. Ex. B, General Expert Report of John D. Jarrell, Ph.D., P.E. ("Jarrell Report"), at 3-4.) First, Dr. Jarrell opines that the hormone that Mirena releases into the uterine cavity, LNG, causes a thinning of the endometrium, the inner layer of the uterine wall. Second, Dr. Jarrell says the tips of the arms of the Mirena (the ends of the top of the "T" shape of the plastic device) are relatively sharp when compared to the smoother, adjacent surfaces of the Mirena. Third, he opines that although the Mirena generally has flexible arms, these arms become stiff and rigid when loaded in "constrained conditions," causing the device to transfer pressures to the uterus in response to contractions, leading to necrosis (or dead tissue), embedment, and sometimes perforation. Fourth, Dr. Jarrell states that pressure on uterine tissue, generated by uterine contractions, and the presence of a rigid Mirena, create sufficient force to lead to the rapid development of pressure wounds and injury to cells. Finally, Dr. Jarrell opines that an inflammatory response and FBR occurs when polyethylene and silicone polymers (synthetic materials found in Mirena) come in contact with "compromised tissues," enhancing damage and accelerating erosion in the uterus, and thus increasing the potential for migration. (Id. at 3-4.) In addition, during his deposition Dr. Jarrell opined that he found a manufacturing defect in the Mirena that he tested. (Jarrell Dep. at 190:18-191:12, 196:24-197:3.)
Dr. Jarrell is a "multi-discipline engineer specializing in the analysis of complex designs and failures involving materials, mechanical and biological systems." (Jarrell Report at 1.) Dr. Jarrell is "actively involved in engineering analysis, design, product development and research." (Id.) Dr. Jarrell has Bachelor's and Master's of Science degrees in Materials Science and Engineering, as well as a Doctorate in Biology, Medical Science and Engineering from Brown University. (Declaration of Diogenes P. Kekatos in Opposition to Defendants' Motion to Exclude the Testimony of John Jarrell, Ph.D., P.E. ("Kekatos Jarrell Decl."), (Doc. 2775), Ex. A, Jarrell Report app. B ("Jarrell CV"), at 1.) He has authored "multiple peer-reviewed publications and abstracts on materials, toxicity, cell interactions with materials, biomaterials, implants and coatings and a guide book on materials selection, friction and wear for medical device designers." (Jarrell Report at 2.) In addition, Dr. Jarrell has U.S. and foreign patents covering "active
Although Dr. Jarrell seems to be an accomplished and experienced biomedical engineer — he has experience in certain biomaterials and implants — he has no previous experience with IUDs or hormonal contraception like Mirena. (Jarrell Dep. at 84:7-85:8.)
Although Dr. Jarrell is not qualified to opine on alleged thinning effects of LNG on the endometrium, see Amorgianos, 303 F.3d at 267 (expert testimony inadmissible if any step in the analysis is unreliable), assuming he would rely on Plaintiffs' other experts for that proposition or that he does not intend to opine on this issue at trial,
Dr. Jarrell opines that the "tips of the Mirena arms contain relatively sharp edges compared to the smoother adjacent surfaces, based on [his] inspection under microscopy and with metrology." (Jarrell Report at 18.) The substance of Dr. Jarrell's "experiment" seems to have consisted of him squeezing a Mirena with a gloved hand and determining, based on his own tactile senses, that the tips are "relatively sharp" "compared to the smoother surfaces that are adjacent to the tips." (Jarrell Dep. at 185:20-187:5.) Dr. Jarrell based this opinion on his "inspection and handling of the exemplar Mirena" during which time he observed "relatively sharp edges." (Jarrell Report at 18.) Dr. Jarrell relied primarily upon his own senses to determine the Mirena was "sharp" and compared it to itself, not to other IUDs (or even to other Mirenas to potentially argue that one Mirena in particular was sharper than others). This is not scientific and does not amount to reliable expert testimony. See In re C.R. Bard, Inc., 948 F.Supp.2d at 604-05 (general causation opinion precluded when it was "based on nothing more than [the expert's] personal, unscientific observation and opinion that `it's obvious' that mesh arms are sharp and can serrate or tear nerves" and finding such testimony to be "the type of subjective, conclusory approach that cannot reasonably be assessed for reliability and that Rule 702 is designed to exclude") (internal quotation marks omitted); In re Rezulin, 309 F.Supp.2d at 544 (finding that allowing experts "to tender purely subjective views in the guise of expert opinions" would "border on the absurd"). Dr. Jarrell admitted at his deposition that individuals' opinions as to whether the Mirena feels sharp could differ. (Jarrell Dep. at 188:12-20.) Dr. Jarrell was also unable to cite support, peer-reviewed or otherwise, that backs his theory that the Mirena IUD is sharp. (Jarrell Dep. at 184:22-185:2.) Dr. Jarrell's methodology is devoid of objective standards that can be tested by others. Dr. Jarrell's experiment has not been peer-reviewed or recreated in any other testing. See Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. It cannot be recreated or reviewed because he provides no standards by which he measured sharpness. Further, it was prepared solely for litigation, which by itself does not warrant exclusion, but weighs against reliability of an expert's testimony. See In re Rezulin, 369 F.Supp.2d at 420 (courts may consider "whether an expert's opinion was developed for litigation," in addition to the four Daubert factors).
Plaintiffs try to salvage Dr. Jarrell's opinions by pointing out that Dr. Jarrell performed "tactile analysis and evaluation" and "direct observation," which they argue are "generally accepted methods used by experts in [Dr. Jarrell's] field." (Ps' Jarrell Opp. 13-14.) The quoted language apparently refers to Dr. Jarrell touching and looking at the Mirena, something the jury is capable of doing itself.
Dr. Jarrell also gives an opinion that the "Mirena design has generally flexible arms" but that they "become very stiff when loaded in constrained conditions," which "causes the device to become very rigid at the tips, allowing the device to transfer high forces and pressures to the tissues in response to uterine contractions leading to tissue necrosis, embedment and in some instances, perforation and migration." (Jarrell Report at 22.) Dr. Jarrell described a "constrained condition" as corresponding to the top of the Mirena arms contacting the top of the fundus (the top portion of the uterus opposite the cervix) and the tips of the arms contacting the adjacent uterine surface. (Id.) Although Dr. Jarrell says the Mirena has "generally flexible arms," he says that in a constrained position the arms are unable to flex and became much stiffer. (Id.) To measure the forces they transfer to uterine tissue in that position, he tested a Mirena in laboratory equipment apparently intended to mimic the uterus. (Id. at 10-11, 22.) Dr. Jarrell used double-sided tape to affix the tips of the Mirena's arms to an "abutting block" across the top of the arms to apply pressure to the Mirena and hold it in place. (Id. at 11; Jarrell Dep. at 234: 2-14.)
Dr. Jarrell's constrained testing conditions do not reliably replicate the conditions inside a woman's uterus, and therefore render his methodology and the conclusions he draws from it unreliable. Dr. Jarrell admitted at his deposition that he did not have any basis to suggest that the way the Mirena became rigid in his experiment occurs in vivo (inside a human being). (Jarrell Dep. at 228:23-229:2, 318:10-14.)
Similarly, Dr. Jarrell's manual pressure plate testing, which he utilized to get a "numerical value" for the forces that the Mirena's arms could resist, (Jarrell Dep. at 223:20-224:19), also does not satisfactorily replicate conditions inside a uterus as it appears Dr. Jarrell held the Mirena and pushed it against the pressure plate.
Defendants also criticize Dr. Jarrell's report and proposed testimony because his mechanical test has not been tested by others, let alone peer reviewed, and he does not cite other support for his methodology or conclusions. (Ds' Jarrell Mem. 13-14.) Although peer-review and studies supporting a methodology are not always necessary, see Kumho Tire Co., 526 U.S. at 156, 119 S.Ct. 1167, here these factors, when added to the unreliability of Dr. Jarrell's in vitro mechanical testing, further weaken the reliability of Dr. Jarrell's experiment. See Daubert, 509 U.S. at 593, 113 S.Ct. 2786. Plaintiffs' broad claims that engineers are qualified to opine generally on mechanisms and their citation to the Reference Manual on Scientific Evidence are unavailing. See McClain, 401 F.3d at 1244 (finding expert testimony speculative and inadmissible when based upon "broad principles of pharmacology"); Moore v. Ashland Chem. Inc., 151 F.3d 269, 276 (5th Cir.1998) ("The expert's assurances that he has utilized generally accepted scientific methodology
In addition, Defendants argue that Dr. Jarrell's report and testimony are unreliable because his mechanical testing amounted to an ad hoc test with no written protocol. (Ds' Jarrell Mem. 14-15.) Although not necessarily dispositive, the fact that Dr. Jarrell did not have a written protocol prior to testing the Mirena, (Jarrell Dep. at 56:13-17) — he apparently created it after the fact, a short time before his deposition, (id. at 133:25-134:22) — again weighs against admissibility. See Hall v. Bos. Sci. Corp., No. 12-CV-8186, 2015 WL 868907, at *12 (S.D.W.Va. Feb. 27, 2015) (noting expert's "failure to adhere to testing standards or a written protocol" in finding methodology unreliable). Dr. Jarrell's mechanical testing of the Mirena is not sufficiently reliable to withstand Daubert scrutiny, and he may not opine on this topic.
Without his force calculations, Dr. Jarrell cannot opine that Mirena transfers enough force to cause pressure wounds. Putting that aside, however, there are other problems with his proposed pressure-wound testimony.
Dr. Jarrell opines that "[s]ustained pressures between human tissues and rigid objects can lead to the rapid development of pressure wounds" and that "[t]he rigidity and geometry at the tips of the Mirena and pressures generated by uterine contractions are sufficient to cause rapid degradation to soft tissues." (Jarrell Report at 24.) He also finds that "[a]n inflammatory response and foreign body reaction occurs when polyethylene (and silicone polymers) come in contact with compromised tissues and during embedment and migration," which "enhances damage and breakdown of surrounding tissues and accelerates erosion and perforation of tissues, enhancing the potential for migration." (Id. at 29.) Dr. Jarrell, albeit a qualified and impressive engineer, is not qualified to opine on pressure wounds in the uterus based on studies and patent filings he has read. (Id. at 29-32). In his report, to support his pressure wound opinion, Dr. Jarrell quotes portions of a study "evaluat[ing] uterine and serum concentrations of LNG," (id. at 29), a patent filing by Bayer stating the shape of an IUD should have "
Furthermore, because Dr. Jarrell had never heard of perforation before being contacted about this case, it is safe to say his theory of IUD perforation was created for purposes of this litigation. (Jarrell Dep. at 85:5-8.) Although a methodology or experiment that is created for litigation does not automatically require exclusion, such an origin is a factor in assessing reliability. See In re Rezulin, 369 F.Supp.2d at 420 (listing whether an expert's opinion was developed for litigation as factor for consideration in Daubert analysis); see also Amorgianos, 137 F.Supp.2d at 190-91 (excluding experts after finding that they had not "tested [the] hypothesis in any way or subjected it to peer review. Instead, plaintiff's experts have aired their hypothesis only in the courtroom and have elected not to share their ideas on this subject with their peers in the medical and industrial hygienic communities."). Here, Dr. Jarrell had very limited experience and exposure to IUDs prior to this litigation, and drafted his report based upon at least one important study (Goldstuck, see supra note 14) that he received from Plaintiffs' counsel and of which he had not heard before being retained. (Jarrell Dep. at 266:1-11.) This is not the level of academic rigor that would be expected of an engineer or doctor in the field. In addition, Dr. Jarrell's pressure wound hypothesis has not been tested or peer reviewed, (Id. at 295:19-296:3), and Dr. Jarrell does not point to any convincing evidence of acceptance within the scientific community. See Golod, 964 F.Supp. at 860 (excluding an expert because his theory did "not constitute `scientific knowledge' within the meaning of Daubert. Instead, it is, at most, scientifically-grounded speculation: an untested and potentially untestable hypothesis.").
Plaintiffs argue in their Opposition that the Zakin study
Dr. Jarrell's reliance on animal studies, without a sound basis for extrapolating these studies to human uteruses, is another example where his conclusions do not "flow reliably from the premises." In re Rezulin, 369 F.Supp.2d at 426. Although animal studies can be reliable bases for expert opinions on humans if there is a scientific basis for such extrapolations, see In re Fosamax, 645 F.Supp.2d at 186-87, in this instance Dr. Jarrell could not articulate why these studies were the appropriate foundation for his pressure wound opinion, (Jarrell Dep. at 294:712). In fact, Dr. Jarrell copied and pasted portions of studies to support his opinion without any analysis, except that he put certain sections in bold font. (Jarrell Report at 27-29.) Further, the animal studies involved sustained pressure for hours, (Jarrell Dep. at 263:14-9, 297:13-16), contrary to uterine contractions, which are measured in seconds, (id. at 263:9-13, 297:17-22). There are just too many gaps between Dr. Jarrell's analysis and the conclusions he draws to permit him to testify under Daubert. See Joiner, 522 U.S. at 144-45, 118 S.Ct. 512. Dr. Jarrell may not offer opinions on the relative sharpness of Mirena, his mechanical testing hypothesis or his pressure wound and necrosis theories.
Defendants seek to exclude any opinions Dr. Jarrell might offer regarding alleged manufacturing defects. (Ds' Jarrell Mem. 24-25.) At his deposition, Dr. Jarrell offered an opinion that he found a 70 micron misalignment in the Mirena he tested, which he claimed exceeded the
Because, as discussed above, Dr. Jarrell is unqualified to testify about his opinion regarding the effects of LNG on the uterus, and the rest of his opinions are unreliable, his testimony would not be helpful to a jury.
Accordingly, Defendants' motion to exclude the testimony of Dr. Jarrell is GRANTED.
Defendants move to exclude the expert testimony of Susan Wray, Ph.D. on the ground that Dr. Wray lacks the qualifications to opine on whether a Mirena can perforate a uterus unrelated to insertion, on the mechanism by which this could occur, and on the adequacy of the Mirena label. (Memorandum of Law in Support of Defendants' Motion to Exclude the Testimony of Susan Wray, Ph.D. ("Ds' Wray Mem."), (Doc. 2692), 1-2.) Defendants argue that Dr. Wray's general causation opinion should be excluded because it is unreliable, in that it contains analytical gaps and is grounded on insufficient data, and that her mechanism opinion should be excluded because it is based only on her own say-so and lacks an objective basis. (Id. at 2.) For the reasons stated below, Defendants' motion is GRANTED.
Dr. Wray opines, based on her expertise and a review of scientific literature, that "contractions of the myometrium [the muscular middle layer of the uterus] can cause the transport of the Mirena device through the uterine wall into the peritoneal cavity and beyond (e.g. bladder, bowel)." (Wray Report at 3.) In addition, Dr. Wray opines that these contractions of the myometrium are able to transport a Mirena through the uterine wall without there having been any injury to the uterine wall during insertion. (Id.) It is Dr. Wray's view that the force of contractions alone are sufficient to cause a Mirena to migrate out of the uterus. (Id.) As part of her mechanism opinions, Dr. Wray also opines that "[i]n women with smaller than average width of their uterine cavity, adolescents and/or the nulliparous [those who have never had children] ... disproportion between their uterus and the device size (32mm) ... will lead to pressure
Dr. Wray is a professor of physiology at the University of Liverpool, where she served as departmental chair from 2004 to 2008. (Wray Report at 1.) From 2008 to 2013, Dr. Wray was the Director of the Centre for Better Births at Liverpool Women's Hospital, and since 2015 she has served as the co-Director of the Harris-Wellbeing of Women Centre for Preterm Birth Research. (Id.) As a scientist, Dr. Wray has focused her research on women, neonatal health and physiology, and she has worked with clinicians on issues related to uterine contractions. (Id.) Defendants argue that Dr. Wray is not qualified to opine on general causation or the mechanism by which a Mirena can perforate a uterus unrelated to insertion because she is not a medical doctor and has no expertise in contraception or IUDs. (Ds' Wray Mem. 4-5.) At her deposition, Dr. Wray admitted to not having conducted any research on contraception, (Wray Dep. at 37:9-11), authored publications on contraceptives, (id. at 37:12-14), or personally examined, tested or even handled a Mirena, (id. at 43:9-11, 44:9-11).
While it is a close question, given her lack of familiarity with contraceptives in general, Mirena in particular, the effect of LNG on the uterus or clinical evaluation of patient symptoms, Dr. Wray is an expert on uterine physiology, particularly the myometrium and uterine contractions, (id. at 29:22-30:8; Declaration of Diogenes P. Kekatos in Opposition to Defendants' Motion to Exclude the Testimony of Susan Wray, Ph.D. ("Kekatos Wray Decl."), (Doc. 2781), Ex. B, Wray Report app. A, Curriculum Vitae of Susan Wray ("Wray CV"), at 19), which gives her sufficient qualification to opine on a mechanism by which uterine contractions might cause a Mirena IUD to migrate outside the uterus after proper placement at insertion. See Hilaire, 54 F.Supp.3d at 236 ("An expert need not be precluded `from testifying merely because he or she does not possess experience tailored to the precise product or process that is the subject matter of the dispute.'") (quoting Yaccarino v. Motor Coach Indus., Inc., No. 03-CV-4527, 2006 WL 5230033, at *9 (E.D.N.Y. Sept. 29, 2006)); In re Zyprexa, 489 F.Supp.2d at 282 ("If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.") (citing Stagl, 117 F.3d at 80); Lappe, 857 F.Supp. at 226 ("In a product liability action, an expert witness is not strictly confined to his area of practice, but may testify concerning related applications; a lack of specialization affects the weight of the opinion, not its admissibility."). Dr. Wray's expertise in uterine anatomy, especially the myometrium, is a closely related topic to migration of IUDs, and therefore qualifies her to give a mechanism opinion.
Defendants also claim that Dr. Wray is unqualified to use case reports
Defendants additionally argue that Dr. Wray is not qualified to opine on the adequacy of Mirena's label because this is not within her area of expertise. Dr. Wray's experience as a physiologist and as an expert on the myometrium do not enable to her opine on the adequacy of the Mirena label; Dr. Wray even admitted that she is not qualified to offer an opinion on pharmaceutical labeling in the United States. (Wray Dep. at 66:10-17.) Plaintiffs do not argue otherwise. She will thus be precluded from testifying on the adequacy of the Mirena label.
In order to satisfy the admissibility standards set forth in Rule 702 and Daubert, the expert must not only be qualified, but his or her testimony must also be reliable. See Fed. R. Evid. 702 (testimony must be based on "sufficient facts or data" and "the product of reliable principles and methods"); Daubert, 509 U.S. at 590, 113 S.Ct. 2786 ("Proposed testimony must be supported by appropriate validation — i.e., good grounds, based on what is known. In short, the requirement that an expert's testimony pertain to scientific knowledge establishes a standard of evidentiary reliability.") (internal quotation marks omitted). Dr. Wray's testimony does not satisfy any of the four factors listed in Daubert to assist district courts in considering whether a proffered opinion has sufficient indicia of reliability. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. Her theory of secondary perforation has not been tested, and therefore has no known error rate. (Wray Dep. at 368:1-12.) Her conclusions have not been subject to peer review; there is no evidence that she has published her work in journals or elsewhere, or that she even gave any thought to secondary perforation of IUDs before being retained in this case. (Id. at 49:17-50:13.) Her theory has not been generally accepted in the scientific
Dr. Wray's contention that it is "undisputed" that secondary perforation occurs, without confronting scientific literature that refutes this notion, casts doubt upon the reliability of her opinions. See In re Rezulin, 369 F.Supp.2d at 425 ("[I]f the relevant scientific literature contains evidence tending to refute the expert's theory and the expert does not acknowledge or account for that evidence, the expert's opinion is unreliable."). An expert who "discusse[s] only the evidence that [she] believed would advance the plaintiffs' position," does not exhibit "`the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.'" Id. at 426 (quoting Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. 1167). Dr. Wray does not discuss any contradictory evidence, and instead took the occurrence of secondary perforation — the existence of which is the major dispute of this litigation — as a given.
Like Dr. Young, Dr. Wray came up with a plausible hypothetical mechanism by which secondary perforation could occur. (See Wray Report at 2 ("I have been asked to consider the mechanisms whereby the Mirena IUS perforates the uterus."); Wray Dep. at 50:8-13 ("[W]ith regard to IUDs specifically ... you first heard the term secondary perforation in the course of your — you said preparation for your report in this case? [Dr. Wray:] Yes."); id. at 109:12-22 (Dr. Wray has not conducted testing to validate her mechanism opinion); id. at 200:10-13 ("plausible" that strong uterine activity will move IUD through uterine wall); id. at 370:14-16 (secondary perforation is "plausible mechanism for what occurred there").)
Dr. Wray also does not explain in her deposition or report why Mirena's effects on the endometrium would necessarily impact the risk of perforation of the myometrium, nor could she identify a theory to support her claim. (Wray Report at 13; Wray Dep. at 328:23-330:15.) In addition, Dr. Wray takes an immense analytical leap, without adequately explaining the reasoning or methodology behind it, when she points to uterine activity ushering menstrual flow down to the cervix or sperm up to the fallopian tube as support for the notion that a Mirena could be transported through the uterine wall. (Wray Report at 13-14.) While these are examples of "myometrial activity transporting things beyond the uterus," (id.), she provides no reason to think that the movement of bodily fluids through anatomical pathways toward anatomical openings would shed any light on whether a plastic object could penetrate the muscular myometrium in the absence of any preexisting damage to that wall. This obvious analytical gap undermines the reliability of Dr. Wray's opinions. See Joiner, 522 U.S. at 146, 118 S.Ct. 512.
Apart from the issues identified above, Defendants also challenge Dr. Wray's use of the sources on which she purports to rely. In addition to relying upon her experience and expertise related to the myometrium and the uterus, Dr. Wray cites articles and multiple case reports to support her conclusion that a Mirena IUD is capable of secondary perforation. Case reports are generally disfavored by courts as evidence of causation because they merely describe "`reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group; [they] do not isolate and exclude potentially alternative causes; and [they] do not investigate or explain the mechanism of causation.'" Siharath v. Sandoz Pharm. Corp., 131 F.Supp.2d 1347, 1361 (N.D.Ga.2001) (quoting Casey v. Ohio Med. Prods., 877 F.Supp. 1380, 1385 (N.D.Cal. 1995)), aff'd sub nom. Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002); see In re Rezulin, 369 F.Supp.2d at 406 ("The difficulty with case reports ... is distinguishing between association and causation. Simply because a patient exposed to a particular substance exhibited a set of symptoms does not mean that it was the substance that caused the symptoms.").
Although some courts have found case reports to be sufficiently reliable indicators of causation when they exist in large quantities, see Bee v. Novartis Pharm. Corp., 18 F.Supp.3d 268, 304-05 (E.D.N.Y.2014); In re Fosamax, 645 F.Supp.2d at 184-85, that is not the case here. Unlike In re Fosamax, in which the court noted there were "hundreds of published case reports," 645 F.Supp.2d at 184, Dr. Wray cites a total of 95 supporting authorities, a fraction of which are case reports. (Kekatos Wray Decl. Ex. B app. B.) Moreover, unlike the situations in Bee and In re Fosamax, where the case reports found an association between a particular disease and a particular drug, several of the case reports Dr. Wray cites acknowledge the possibility that perforation occurred at insertion but was only detected later when
An example of this gap appears in the Chen article,
Indeed, some of the other publications, including controlled studies, on which Dr. Wray relies undermine her theory. See In re Accutane, 2009 WL 2496444, at *2 ("[W]hen an expert relies on studies of others, he must not exceed the limitations the authors themselves place on the study. That is, he must not draw overreaching conclusions."). Dr. Wray cites the Boortz article
Dr. Wray's reliance on the 1991 Tang study
Similarly, Dr. Wray's citations for the proposition that "uterine peristalsis"
Several other of Dr. Wray's opinions are not grounded in any scientific literature. For example, Dr. Wray could not identify a study for the proposition that inserting a Mirena into women with smaller uterine cavities, adolescents and/or nulliparous women leads to pressure on the uterine lining and erosion of it over time. (Wray
Dr. Wray similarly lacks support for the proposition that because of decreased estrogen availability in the myometrium, Mirena "may produce a myometrium that is contractile but less extensive and hence weakened and more prone to perforations, despite initial correct and non-damaging insertion of the device." (Wray Report at 25-26.) Dr. Wray could not identify any studies or other objective support for this opinion. (Wray Dep. at 362:17-363:19.) Dr. Wray based her conclusion on what she would expect to happen, but although she is an expert on the myometrium, she is not an expert on contraceptives, let along LNG-releasing IUDs, or their effects. (Id. at 37:9-18, 42:20-22, 45:5-7, 45:16-46:6.) This does not pass muster under Daubert. See McClain, 401 F.3d at 1244. Dr. Wray also lacks support for her assertion that Mirena's effects on the endometrium and myometrium "build up over months and years." (Wray Report at 19.) She does not cite any sources in her report, and at her deposition she could not point to a study. (Wray Dep. at 203:1-10, 206:1-8.) This speculation does not have sufficient indicia of reliability.
Furthermore, Dr. Wray was asked at her deposition to identify specific published case reports that ruled out damage to the uterine wall during insertion, as well as peer-reviewed publications stating that changes in the endometrium influence the risk of perforation of the myometrium. (Wray Dep. at 391:4-392:16.) Dr. Wray could not give examples during her deposition, and Plaintiffs did not mention any in their papers.
Plaintiffs respond to Defendants' arguments relating to lack of citation and adequate support for Dr. Wray's opinions by pointing to the 95 sources Dr. Wray cites in her report. (Ps' Wray Opp. 11, 13, 15-16.) Quantity does not equal reliability. Plaintiffs fail to show how these articles reliably substantiate Dr. Wray's views. Apart from the case reports and studies discussed above, which do not reliably bolster Dr. Wray's opinions, Plaintiffs do not offer other reliable sources on which Dr. Wray based her conclusions. Plaintiffs cite some articles that are not helpful, and do not address the substantive arguments put forth by Defendants regarding certain publications.
Finally, Dr. Wray had not heard of secondary perforation prior to being consulted in connection with this litigation, another indication that her opinions lack the reliability to be admissible. See Eghnayem, 57 F.Supp.3d at 670 (concern that testimony is litigation-driven has "a role in applying Daubert"); In re Rezulin, 369 F.Supp.2d at 420 (courts have considered "whether an expert's opinion was developed for litigation," in addition to the four Daubert factors, in assessing reliability); Awad v. Merck & Co., 99 F.Supp.2d 301, 304 (S.D.N.Y.1999) ("[A] significant consideration is whether research was conducted independently or for the sole purpose of litigation."), aff'd sub nom. Washburn v. Merck & Co., 213 F.3d 627 (2d Cir.2000). Dr. Wray acknowledged at her deposition that the first time she heard of secondary perforation was after being retained as an expert in this litigation. (Wray Dep. at 50:8-13.) This is but another factor that demonstrates Dr. Wray's opinion is not sufficiently reliable under Daubert and would not stand up in a scientific setting.
Because Dr. Wray's opinions do not have sufficient indicia of reliability to pass muster under Daubert, they would not be helpful to a jury.
For the reasons stated above, Defendants' motion to exclude the testimony of Susan Wray, Ph.D. is GRANTED.
Defendants move to exclude the opinion of Dr. Strassberg, who has offered a specific causation opinion for Hayes. Defendants argue that Dr. Strassberg's opinions are not reliable because they do not have a reliable foundation and are not based on sufficient facts and data. (Memorandum of Law in Support of Defendants' Motion to Exclude the Testimony of Richard Strassberg, M.D. ("Ds' Strassberg Mem."), (Doc. 2689), 3-4.) For the reasons stated below, the Court finds Dr. Strassberg's opinion lacking the indicia of reliability required under Daubert, and therefore Defendants' motion to preclude him from testifying is GRANTED.
Dr. Strassberg offers five opinions in this three page report. First, Dr. Strassberg opines that Ms. Hayes was an appropriate candidate for Mirena. Second, he states that the insertion of Ms. Hayes' Mirena was done within accepted medical standards and in compliance with the product's label and instructions for use. Third, Dr. Strassberg opines that there is no reason to believe that perforation occurred at the time Ms. Hayes' Mirena was inserted. Fourth, Dr. Strassberg states there is no reason to believe that the care and treatment provided to Ms. Hayes by the healthcare professionals involved in the insertion or removal of her Mirena deviated from accepted medical standards. Fifth, Dr. Strassberg concludes that after being properly placed, the Mirena subsequently perforated Ms. Hayes' uterus. (Cook Strassberg Decl. Ex. A, Case Specific Expert Report of Richard Strassberg ("Strassberg Report"), at 1-2.) Defendants move to preclude Dr. Strassberg's testimony in its entirety, but their arguments address only his third and fifth opinions, so the Court will do the same.
Dr. Strassberg is an Assistant Professor in the Department of Obstetrics and Gynecology at the University of Miami School of Medicine. (Strassberg Report at 2.) He has also practiced as a clinician at several hospitals. (Id.) Dr. Strassberg has served as Chairman of the OB/GYN Department and of OB Complications at South Miami Hospital. (Id.) He has practiced as a clinical instructor and has served as President of the Miami Obstetrical-Gynecological Society. (Id.) Because of his clinical experience related to obstetrics, gynecology and family planning, Dr. Strassberg is qualified to give an opinion as to whether Ms. Hayes' Mirena perforated her uterus at the time of insertion or later. Nonetheless, Rule 702 and Daubert require that in addition to an expert being qualified, the expert's testimony must also be reliable. Daubert, 509 U.S. at 590, 113 S.Ct. 2786.
Defendants argue that Dr. Strassberg's expert testimony should be excluded because it lacks a required foundational predicate — a general causation opinion. (Ds' Strassberg Mem. 4-6.) As discussed in connection with Dr. Young, in the absence of evidence of general causation, evidence of specific causation is "irrelevant." In re Rezulin, 441 F.Supp.2d at 578. The court in In re Rezulin in 2005 held that "a physician must have some reliable basis for believing that a particular substance is capable of causing the injury in question in relevant circumstances before concluding that the substance caused that injury in a particular case." 369 F.Supp.2d at 438. Plaintiffs attempt to challenge this proposition by distinguishing the procedural posture of a different In re Rezulin decision, 441 F.Supp.2d 567, from 2006, but they do not address the 2005 decision that contained the language quoted above, nor do they seem to seriously quarrel with the proposition that a specific causation expert must show general causation or rely on a reliable general causation opinion. (Plaintiffs' Memorandum of Law in Opposition to Defendants' Motion to Exclude the Testimony of Richard Strassberg, M.D. ("Ps' Strassberg Opp."), (Doc. 2778), 5-6.) Rather, they point out that Ms. Hayes intends to rely on other experts for a general causation opinion. (Id. at 6.) But the problem is that Dr. Strassberg has not relied on those experts in forming his opinion that the Mirena caused Ms. Hayes' injuries subsequent and unrelated to insertion, (Strassberg Dep. at 41:20-42:14), nor
Apart from lacking a general causation predicate for his specific causation opinion, Dr. Strassberg's report and proposed testimony do not have sufficient indicia of reliability. Dr. Strassberg's expert report consists of one page listing his opinions, one page listing his qualifications, and one page describing Ms. Hayes' medical records followed by a restatement of the same opinions listed on the first page. (Strassberg Report at 1-3.) Although Dr. Strassberg is a qualified OB/GYN, his expert opinion in this instance consists of nothing more than conclusory statements, which fails under Rule 702 or Daubert. See Hilaire, 54 F.Supp.3d at 244 (finding expert report lacking sufficient detail for court to consider reliability and "consist[ing] primarily of conclusory statements").
Dr. Strassberg's report does not cite any publications or medical literature in support of his opinions, and he acknowledged at his deposition that he did not review any medical literature in reaching them. (Strassberg Dep. at 164:24-165:2.) Moreover, based on his report, the court cannot determine what caused Dr. Strassberg to formulate his opinions.
Dr. Strassberg fared little better during his deposition. He attempted to explain his analysis by saying that he based his opinion that perforation did not occur at insertion on the inserting doctor's experience, a note from the doctor describing the procedure as uncomplicated, the threads of the Mirena being visible after insertion, and post-insertion examination and a September 29, 2011 ultrasound. (Strassberg Dep. at 222:5-18, 228:8-229:4.) Nonetheless, when asked specifically how he determined the perforation occurred after insertion, Dr. Strassberg merely said: "My opinion, just what I said there, that the IUD was properly placed and subsequently became a perforation. I don't know how that happened or when it happened, but ... my opinion is that the perforation wasn't caused by the provider at the time of insertion." (Id. at 224:24-225:6.) Dr. Strassberg is to be commended for his candor in admitting that he does not know when or how the perforation occurred, but that admission shows his report and testimony to be unreliable. See R.F.M.A.S., Inc. v. So, 748 F.Supp.2d 244, 248-49 (S.D.N.Y.2010) ("Expert testimony that is merely `subjective belief or unsupported speculation' should be excluded.") (quoting Daubert, 509 U.S. at 590, 113 S.Ct. 2786).
In addition, there are flaws with each of the bases on which Dr. Strassberg rests his opinion that perforation did not occur at insertion. First, Dr. Strassberg's reliance on the years of experience of the inserting physician amounts to speculation. He cites nothing to support his implication that experienced doctors never inadvertently perforate the uterus upon insertion, and common sense suggests the opposite, even if perhaps the likelihood of such an event occurring may be higher with a newer practitioner. The conclusion that Dr. Robboy did not perforate Ms. Hayes' uterus because he is experienced is speculation based solely on Dr. Strassberg's ipse dixit. See Joiner, 522 U.S. at 146, 118 S.Ct. 512.
Second, that no complications were noted is, by Dr. Strassberg's own account, unsurprising, given that Ms. Hayes was under sedation during the insertion of her Mirena and would not have felt any pain if a perforation occurred. (Strassberg Dep. at 179:2-12.) Likewise, the inserting doctor's belief that the Mirena was properly placed is not a reliable basis for concluding that no perforation occurred upon insertion. No responsible professional would conclude the insertion procedure in the belief that the Mirena was in the wrong position, and yet nobody disputes that it sometimes is. Accordingly Dr. Strassberg's reliance on the fact that the insertion procedure seemed to be uneventful to indicate that perforation did not occur at insertion is flawed.
Third, Dr. Strassberg's reliance on the threads of the Mirena being visible after insertion does not, by his own account, support his conclusions. Although visible threads can be an indicator of proper placement, Dr. Strassberg admitted that the visibility of the threads does not mean that a perforation did not occur and that he could not rely on the visibility of the threads in September 2011 to conclude that the Mirena was properly placed in February. (Strassberg Dep. at 191:5-21, 230:11-15.)
Finally, while not conclusive, the unreliability of Dr. Strassberg's opinion is underscored by the fact that he did not consider alternative factors that may have caused perforation. Although an expert need not rule out every alternative in forming an opinion, "[a] factor that courts have considered in Daubert analyses is whether an expert has accounted adequately for obvious alternative explanations," which is "appropriate because any theory that fails to explain information that otherwise would tend to cast doubt on that theory is inherently suspect." In re Rezulin, 369 F.Supp.2d at 425; see In re Fosamax Prods. Liab. Litig., 924 F.Supp.2d 477, 493 (S.D.N.Y.2013) ("`While an expert need not rule out every potential cause in order to satisfy Daubert [sic], the expert's testimony must at least address obvious alternative causes and provide a reasonable explanation for dismissing specific alternate factors identified by the defendant.'") (quoting Israel, 2006 WL 3196956, at *5).
Dr. Strassberg, however, did not rule out obvious possible alternatives. Ms. Hayes had a separate procedure immediately before her Mirena was inserted during which the physician inserted a cannula (tube) and a sharp object (a curette) into her uterus. (Strassberg Dep. at 174:222, 176:14-20.) By his own account this procedure could have perforated the uterus or damaged the myometrium, (id. at 177:1-5; see id. at 62:1-3), yet Dr. Strassberg did not even consider or offer an explanation for dismissing this potential alternative cause of perforation, (id. at 217:17-19).
Dr. Strassberg's opinions do not have a reliable foundation because they are not based on any theory of general causation and are unreliable, and would therefore not be useful to a jury.
For the reasons stated above, Defendants' motion to exclude the testimony of Dr. Strassberg is GRANTED as to his opinions: (1) that there is no reason to believe that perforation occurred at the time Ms. Hayes' Mirena was inserted; and (2) that after being properly placed, the Mirena subsequently perforated Ms. Hayes' uterus. The Court expresses no view on whether the remainder of Dr. Strassberg's opinions would be relevant or admissible in the absence of the excluded opinions.
Plaintiffs move to exclude the proposed testimony of Defendants' regulatory experts, Dr. David Feigal, M.D., M.P.H. and Dr. Dena Hixon, M.D.
Plaintiffs move to exclude the proposed expert testimony of David Feigal, M.D., M.P.H. Plaintiffs argue that Dr. Feigal's opinions are duplicative of those put forth by Dr. Hixon. In addition, Plaintiffs argue that Dr. Feigal is not qualified to give an opinion on the adequacy of the Mirena label, has an insufficient basis to opine on the FDA's willingness to accept different perforation warnings for Mirena, should not be allowed to opine on Bayer's compliance with standards, including FDA regulations, and should not be allowed to opine on the FDA's state of mind. For the reasons stated below, Plaintiffs' motion to preclude Dr. Feigal's testimony is GRANTED in part and DENIED in part.
In his expert report, Dr. Feigal opines on the adequacy of the Mirena label. He concludes that the Mirena label's warnings were "scientifically accurate, concise and adequate to alert physicians" to the risk of perforation. (Declaration of Diogenes P. Kekatos in Support of Plaintiffs' Motion to Exclude Expert Opinion of Dr. David Feigal ("Kekatos Feigal Decl."), (Doc. 2726), Ex. 5, Regulatory Expert Report of David W. Feigal, Jr., M.D., M.P.H. ("Feigal Report"), at 34.) He finds that the essential risk information regarding perforation has always been present in the label, and that
Plaintiffs argue that Dr. Feigal's testimony should be excluded because it is duplicative of Dr. Hixon's. I need not decide whether admitting Dr. Feigal's testimony would be "needlessly ... cumulative" pursuant to Rule 403 because Defendants have said they will only be introducing evidence from one of their regulatory experts at any given trial. (Defendants' Memorandum of Law in Opposition to Plaintiffs' Motion to Exclude the Proposed Testimony of David Feigal, Jr., M.D., M.P.H. ("Ds' Feigal Opp."), (Doc. 2797), 7-8.) Plaintiffs' motion with respect to the cumulative nature of Dr. Feigal's testimony is therefore denied as moot.
Dr. Feigal is board certified in Internal Medicine and has a Master's Degree in Public Health in epidemiology and biostatistics. (Feigal Report at 1.) From 1992 to 2004, Dr. Feigal held senior positions at the FDA. (Id. at 2.) From 1992 to 1997, he held positions in the FDA's Center for Drug Evaluation and Research ("CDER"), where he had authority to "approve investigational studies of new drugs," halt studies for safety reasons, approve "new indications for approved drugs," approve manufacturing methods, and take compliance actions — all with respect to anti-viral or anti-infective drugs. (Id.) In these positions, Dr. Feigal was "responsible for the evaluation of safety and efficacy of new drugs, including the approval process and continuing oversight of the safety and effectiveness of those drugs after approval." (Id. at 3.) From 1997 to 1999, Dr. Feigal served as the Medical Deputy Director of the Center for Biologics Evaluation and Research, where he was responsible for medical issues associated with blood, vaccines and therapeutic proteins. (Id. at 2.) From 1999 to 2004, Dr. Feigal was the Director of the Center for Devices and Radiological Health ("CDRH"), which is responsible for the approval of new medical devices, (id.), including contraceptive devices, (Declaration of Christopher J. Cook in Support of Defendants' Opposition to Plaintiffs' Motion to Exclude Proposed Testimony of David W. Feigal, M.D., M.P.H. ("Cook Feigal Decl."), (Doc. 2798), Ex. 2, Deposition of David Feigal ("Feigal Dep."), at 37:2-4). He was also a member of the WHO Task Force on Contraceptive Methods. (Id. at 36:19-37:1.) Dr. Feigal is familiar with "the process and criteria utilized by FDA in assessing safety and efficacy, pharmaceutical product labeling and pharmaceutical manufacturing quality," and he "participated directly in that process for years." (Feigal Report at 3.) Dr. Feigal was also responsible for reviewing and approving changes to product labels, although none involving IUDs. (Feigal Dep. at 66:5-67:5.)
After his tenure at the FDA, Dr. Feigal taught and participated in research grants at Arizona State University, where he is currently an adjunct professor in the School of Law. (Feigal Report at 3.) Dr. Feigal has also held senior positions in two
Plaintiffs do not dispute that Dr. Feigal is qualified to offer opinions regarding the regulatory workings of the FDA. (Memorandum of Law in Support of Plaintiffs' Motion to Exclude the Testimony of Dr. David Feigal ("Ps' Feigal Mem."), (Doc. 2725), 4.) They do argue, however, that because he has never prescribed, inserted, or otherwise worked closely with Mirenas or other IUDs, he is not qualified to opine on the adequacy of the Mirena label. (Id. at 12-14.) Plaintiffs also argue that Dr. Feigal acquired any relevant expertise related to IUDs solely in connection with this litigation. (Id. at 12.) Defendants argue that Dr. Feigal does have relevant experience in contraception and counseling patients about the risks and benefits of IUDs, and that his experience at the FDA, including reviewing and evaluating regulatory requirements, makes him qualified to opine on the adequacy of the Mirena label. (Ds' Feigal Opp. 8-12.)
Plaintiffs' arguments for precluding Dr. Feigal's testimony fail in the context of a regulatory expert opining on the adequacy of a label. Although Dr. Feigal is not an OB/GYN, nor has he prescribed or inserted IUDs, he has had some experience with contraception over the course of his career. (Feigal Dep. at 17:20-18:8, 19:11-20:13, 40:1-15.) In addition, Dr. Feigal is opining on the adequacy of the Mirena label from a regulatory perspective — a field in which he is qualified — which means he does not need to have equally specialized knowledge in a particular medical field. See In re Depakote, No. 14-CV-847, 2015 WL 4775868, at *7 (S.D.Ill. Feb. 13, 2015) ("[Expert's] opinions as to the adequacy of the warning fall within her expertise since she has been involved with the reviewing, drafting, and interpretation of drug safety data, and regulation or approval of product labeling for prescription drugs."); Hilaire, 54 F.Supp.3d at 236 ("An expert need not be precluded `from testifying merely because he or she does not possess experience tailored to the precise product or process that is the subject matter of the dispute.'") (quoting Yaccarino, 2006 WL 5230033, at *9); In re Zyprexa, 489 F.Supp.2d at 282 (expert with education and experience in closely related field permitted to testify). Critiques of Dr. Feigal's expertise in this regard go to the weight of his testimony, not its admissibility. See Lemmon v. Wyeth, LLC, No. 04-CV-1302, 2012 WL 2848161, at *10 (E.D.Mo. July 11, 2012) ("These witnesses have specialized knowledge of the regulatory procedures, pharmaceutical labeling, FDA standards and practice, governmental statutes and regulations, pharmaceutical industry customs and practices, administrative rules, internal policies, and other factors that can assist the trier of fact in determining the adequacy of Defendants' label warnings. Defendants' challenge to the testimony of these experts goes more to the weight, rather than the admissibility, of the evidence."); Lappe, 857 F.Supp. at 226 (expert may testify as to related applications and lack of specialization goes to weight, not admissibility).
The Depakote decision is helpful. There the court found that an expert who was not a medical doctor, and therefore could not prescribe drugs, was qualified to opine on the adequacy of a drug label because her opinions did not "necessarily center on the prescribing physician's subjective interpretation of the ... label." In re Depakote, 2015 WL 4775868, at *7 (finding that the expert's "opinions [were] based on her knowledge of the federal regulations
In re Celexa & Lexapro Prods. Liab. Litig., MDL No. 1736, 2013 WL 791784, at *4 (E.D.Mo. Mar. 4, 2013), is also illuminating. In that case, the defendants argued that one of plaintiffs' experts was not qualified to offer an expert opinion "because his job at the FDA did not include drafting warning labels or statistics, and he ha[d] no specific experience with antidepressants or suicidality." Id. The court found these arguments "meritless" because "the combination of [the expert's] qualifications and his extensive experience and training in both the public and private sectors regarding regulatory compliance and safety issues provide[d] him with specialized knowledge that [would] assist a jury at trial." Id. Although the defendants, like Plaintiffs here, "ma[de] much out of the fact that [the expert did] not have any prior experience with antidepressants and suicidality specifically," this did not prevent the court from admitting the expert's opinions. Id. The court noted that the expert relied on another expert's report regarding background information, but the second expert was also not a medical doctor. Id. Dr. Feigal was able to rely upon his medical training, some familiarity with contraception, and extensive experience in connection with FDA regulations, in order to opine on the adequacy of the Mirena label from a regulatory perspective.
Dr. Feigal is not, however, qualified to testify on the existence (or not) of the phenomenon of secondary perforation, nor is he qualified to opine that mentioning post-insertion migration in the Mirena warning would not have given healthcare providers useful information.
Plaintiffs argue that Dr. Feigal should not be allowed to offer opinions related to the FDA's willingness to accept different perforation warnings for Mirena, because he failed to consider or analyze the label for Progestasert, another progestin-releasing IUD on the market before Mirena, (Kekatos Feigal Decl. Ex. 8), to which the FDA referred in recommending warnings for Mirena, (id. Ex. 7), and because he is speculating that the FDA would not have accepted a stronger label. (Ps' Feigal Mem. 14-17.)
Dr. Feigal's failure to analyze the Progestasert label goes to the weight, not the admissibility, of his testimony. The FDA's Medical Review for Mirena does contain the sentence, "Recommended warnings include the warnings that are currently on the USA labels for the other two USA-approved IUDs," (Kekatos Feigal Decl. Ex. 7, at 6), and the product information for Progestasert does contain the sentence,
In connection with Dr. Feigal's opinion that the FDA would not have approved a Mirena label with wording that Plaintiffs believe should have been included, Dr. Feigal will not be permitted to testify as to what type of label the FDA would or would not have ultimately accepted or rejected. This is impermissible speculation as to the state of mind of the FDA. See Kruszka v. Novartis Pharm. Corp., 28 F.Supp.3d 920, 931 (D.Minn. 2014) ("[The experts] may not proffer an opinion relating to what individuals ... with the FDA thought with respect to certain documents or about their motivations."); Deutsch, 768 F.Supp.2d at 442 (testimony on "intent, motives, or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise") (internal quotation marks omitted). Nonetheless, he may testify as to what the FDA did, and what it said, based on the documents he reviewed. Dr. Feigal based his opinion on documents that reflect communications between Bayer and the FDA, exchanged during multiple label approval processes spanning several years. (Feigal Report at 20-27.) Dr. Feigal may opine on these documents, including what they mean, and on commentary provided by the FDA in connection with added and stricken language in the label. See Kruszka, 28 F.Supp.3d at 931 (finding that expert testimony on what the FDA and pharmaceutical company "actually did, rather than thought, [is] properly within the scope of admissible testimony," and allowing expert testimony on the reasonableness of defendant's interactions with FDA and compliance with FDA regulations); see also In re Levaquin Prods. Liab. Litig., No. 08-CV-5742, 2011 WL 6888533, at *2 (D.Minn. Dec. 29, 2011) (expert permitted to testify as to FDA's intent only in instances where intent was "clearly indicated in public documents").
Although experts cannot "supplant the role of counsel in making argument at trial, and the role of the jury in interpreting the evidence," In re Rezulin, 309 F.Supp.2d at 541, and while generally "an expert's testimony on issues of law is inadmissible," Bilzerian, 926 F.2d at 1294, courts admit expert testimony regarding companies' compliance with FDA regulations, see, e.g., Wells v. Allergan, Inc., No. 12-CV-973, 2013 WL 7208221, at *1 (W.D.Okla. Feb. 4, 2013) (finding expert testimony about FDA regulations would not "usurp" the role of the trial judge); In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 09-MD-2100, 2011 WL 6302287, at *25 (S.D.Ill.Dec. 16, 2011) (discussing FDA regulations and finding that "[t]o the extent [the expert] does offer legal conclusions, the Court finds that [the expert's] testimony is permissible because of the complex nature of the process and procedures and the jury needs assistance understanding it. [The expert's] testimony will assist the trier of fact in understanding the federal regulations, and the jury will be instructed that that the Court, not [the expert] nor any other witness, will instruct the jury on the law in this case."); In re Fosamax, 645 F.Supp.2d at 191 (denying motion to preclude expert from "testifying about general FDA regulatory requirements and procedures or offering an opinion as to [the pharmaceutical company's] compliance therewith"); Pfizer, 461 F.Supp.2d at 278-79 (finding admissible expert testimony regarding pharmaceutical company's "compli[ance] with the FDA's statutory and regulatory requirements").
Admitting expert testimony in this context makes sense given the complicated nature of FDA regulations, and it would be helpful to the jury to have an expert explain this complex regulatory process. See In re Fosamax, 645 F.Supp.2d at 191 ("A lay jury cannot be expected to understand the complex regulatory framework that informs the standard of care in the pharmaceutical industry. [The expert's] assessment of the reasonableness of [the pharmaceutical company's] conduct in light of her experience and her understanding of FDA regulations will be helpful to the jury."). Moreover, as was the case in the Fosamax MDL, this case is "not governed by federal regulations but by state law theories of negligence and strict liability." Id. at 191 n. 16. Expert testimony regarding Bayer's compliance with FDA regulations therefore will not usurp the Court's role in explaining the law to the jury, but will assist the jury in determining whether Bayer "acted as a reasonably prudent pharmaceutical manufacturer." Id. The parties' should propose an instruction making clear that the jury must determine the outcome based on the law as I give it to them, not on the legal views of a witness. See id. Furthermore, "[c]ross-examination and competing expert testimony ... will ensure that the jury carefully weighs [this expert's] testimony." Id. at 191. Plaintiffs' motion with respect to Dr. Feigal's opinions in connection with Bayer's compliance with FDA regulatory standards is thus denied.
Dr. Feigal's opinions concerning the complicated regulatory framework of the FDA, the process by which the FDA approves
For the reasons stated above, Plaintiffs' motion to exclude the testimony of Dr. Feigal is therefore GRANTED in part and DENIED in part.
Plaintiffs move to exclude the proposed testimony of Defendants' regulatory expert, Dr. Dena Hixon. Plaintiffs argue that Dr. Hixon did not properly disclose the basis of her opinions or the facts she considered as required by Federal Rule of Civil Procedure 26(a)(2)(B)(i), and should therefore be excluded from testifying pursuant to Federal Rule of Civil Procedure 37(c)(1). (Memorandum of Law in Support of Plaintiffs' Motion to Exclude Proposed Testimony of Dena R. Hixon, M.D. ("Ps' Hixon Mem."), (Doc. 2706), 13-16.) Plaintiffs additionally argue that Dr. Hixon's testimony should be excluded under Federal Rule of Evidence 403,
Dr. Hixon opines generally on the role of the FDA and the regulatory framework in connection with approving new drugs and labeling. (Hixon Report at 4-12.) Dr. Hixon concludes, based on her experience as an OB/GYN and as an officer at
Dr. Hixon is a licensed medical doctor who completed residencies in Family Practice and in Obstetrics and Gynecology and is board-certified by the American Board of Obstetrics and Gynecology. (Hixon Report at 1.) Dr. Hixon has 13 years of clinical OB/GYN experience, which included inserting a small number of IUDs. (Id.; Cook Hixon Decl. Ex. 2, Deposition of Dena Hixon ("Hixon Dep."), at 23:5-14.) For almost 13 years after her clinical practice, Dr. Hixon was a Medical Officer in the FDA's Center for Drug Evaluation and Research, during which time she served as a primary reviewer and team leader in the Division of Reproductive and Urologic Drug Products at the Office of New Drugs. (Hixon Report at 1.) Dr. Hixon reviewed and evaluated information regarding the safety and efficacy of women's reproductive health products, including IUDs with a drug releasing component, and other contraceptives. (Id.) In addition, Dr. Hixon reviewed "postmarketing labeling proposals, safety reports, and supplemental applications for new indications and/or for labeling changes." (Id.) Dr. Hixon was also involved with the regulatory review of Mirena for a period of months in 2000 when its initial labeling was considered. (Hixon Dep. at 59:18-60:16.) Dr. Hixon's work as an OB/GYN and her experience and training as an officer at the FDA qualify her to opine on the regulatory implications surrounding Mirena and its original and subsequent labels. Plaintiffs do not argue that Dr. Hixon is unqualified to offer her opinions, except in connection with her opinion regarding the FDA's willingness to accept different perforation warnings.
Plaintiffs argue that Dr. Hixon is not qualified to opine on the FDA's willingness to accept alternative warning labels for Mirena because she was not aware of certain discussions that took place between the Defendants and the FDA about the perforation warning, she was not "in the driver's seat" in connection with "Changes Being Effected" (the term used to describe the situation where manufacturers add or strengthen warnings), she had little knowledge about perforation warnings for other IUDs, and she did not know the FDA's
Plaintiffs argue that Dr. Hixon's testimony should be excluded in its entirety because she has not adequately disclosed the bases for her opinions or the facts that she considered in forming her opinions, in violation of Federal Rule of Civil Procedure 26(a)(2)(B)(i). (Ps' Hixon Mem. 13-14.) Plaintiffs argue that because Dr. Hixon refused to discuss conversations that took place at the FDA regarding Mirena, including her own conversations in connection with the pre-marketing regulatory review of Mirena, and because Dr. Hixon failed to name individuals who were involved in these discussions, Defendants have violated Rule 26, and therefore Dr. Hixon's testimony should be excluded as a sanction pursuant to Federal Rule of Civil Procedure 37(c)(1).
Rule 26(a)(2)(B) requires that an expert's report contain, among other things, "a complete statement of all opinions the witness will express and the basis and reasons for them" and "the facts or data considered by the witness in forming" his or her opinions. "[T]he courts have embraced an objective test that defines `considered' [in Rule 26(a)(2)(B)(ii)] as anything received, reviewed, read, or authored by the expert, before or in connection with the forming of his opinion, if the subject matter relates to the facts or opinions expressed." Euclid Chem. Co. v. Vector Corrosion Techs., Inc., No. 05-CV-80, 2007 WL 1560277, at *4 (N.D.Ohio May 29, 2007) (footnotes omitted). Under Rule 37(c)(1), "[i]f a party fails to provide information or identify a witness as required by Rule 26(a) ... the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless." "Rule 37 is self-executing" and "the non-disclosing party has the burden to demonstrate that the failure to disclose was substantially justified or that the failure was harmless." Atkins v. Cty. of Orange, 372 F.Supp.2d 377, 395-96 (S.D.N.Y.2005), aff'd on other grounds sub nom. Bellotto v. Cty. of Orange, 248 Fed.Appx. 232 (2d Cir.2007). The Court has "wide discretion to impose sanctions, including severe sanctions, under [Rule 37]." Design Strategy, Inc. v. Davis, 469 F.3d 284, 294 (2d Cir.2006).
According to her report, Dr. Hixon based her opinions on her "knowledge of the FDA regulations, policies and procedures, as well as [her] own training and clinical experience as an obstetrician gynecologist providing women's health care and [her] experience at FDA as a medical officer and regulatory reviewer of Mirena, other IUDs, and other contraceptive products." (Hixon Report at 42.) Throughout her report she cites to a number of documents, including communications between Bayer and the FDA from the time of the initial review of Mirena and after, to support her opinions regarding the adequacy of Mirena's label and Bayer's post-marketing actions. The only relevant bases of her opinions that Dr. Hixon could possibly be withholding relate to the time period when she was actively a member of the team reviewing the Mirena label; she refused to name individuals or disclose specific conversations related to this particular review. (Hixon Dep. at 58:6-15.) I find no ground, therefore, to exclude under Rule 37(c) any of Dr. Hixon's testimony relating to the regulatory framework of the FDA or to Bayer's actions and the label change that occurred after Dr. Hixon was no longer a part of the team working on Mirena. I will only consider whether proposed testimony by Dr. Hixon that could be based on her work as a regulatory reviewer of Mirena should be precluded under Rule 37(c) for the alleged Rule 26 violation.
Although Defendants argue that Dr. Hixon is not basing her testimony on her personal recollections regarding the Mirena labeling process, Plaintiffs are correct that (as Dr. Hixon conceded, (Hixon Dep. at 134:23-135:2)) it would be impossible for a witness to divorce herself from her memories about what occurred during a project in which she was an active participant and segregate that information from the documentary record in forming her opinions. Moreover, Dr. Hixon states in her report that she based her opinions, at least in part, on her experience as a "regulatory reviewer of Mirena." (Hixon Report at 42.) In addition, she conceded that "there are some details of [her] involvement with Mirena at FDA that [she was] aware of but [could not] testify to," (Hixon Dep. at 53:8-12), and while she maintains that her opinions were based on the records, she admitted that she "remember[ed] what [she] remember[ed]" and that her "experiences at FDA with the product" would likely "bleed into" her opinions, (id. at 54:3-5, 15-20). Further, "even if the expert avers under oath that he did not actually consider certain materials in forming his opinion, that will not control," and instead courts apply an "objective test" that defines "considered" as any facts or data on the subject matter learned by the expert at any time before rendering her opinion. Euclid Chem. Co., 2007 WL 1560277, at *3-4. Although in her report Dr. Hixon does not cite to specific conversations
Allowing Dr. Hixon to testify without having fully disclosed the bases for her opinions is harmful to Plaintiffs because they cannot effectively cross-examine her. See Fid. Nat'l Title Ins. Co. of N.Y. v. Intercounty Nat'l Title Ins. Co., 412 F.3d 745, 751 (7th Cir.2005) (expert must disclose materials reviewed "even if in the end he does not rely on them in formulating his expert opinion, because such materials often contain effective ammunition for cross-examination"). During her deposition, Dr. Hixon refused to discuss "who said what or who did what" during the FDA review process, (Hixon Dep. at 134:4-6), yet she stated that she "remember[ed] discussions that the remainder of the information in the label [apart from the stricken language regarding reports of IUD migration after insertion] includ[ed] not only the perforation warning but throughout the label was adequate to warn about the risk of perforation," and that "the term `migration' was not well-defined and it was not felt to add to the inserter's understanding of perforation and how to manage it," (Hixon Dep. at 138:1-19). Plaintiffs' inability to cross-examine Dr. Hixon regarding, or find other witnesses to, these discussions is not harmless. Moreover, a jury would likely afford Dr. Hixon's testimony added credence because she was present during the FDA's Mirena review and would be perceived as having inside information. Allowing her to testify without allowing Plaintiffs an effective cross-examination would be harmful because Plaintiffs would not be able to undermine this added credibility.
Nor have Defendants shown the failure to disclose to be substantially justified. Dr. Hixon's personal unwillingness to divulge names of individuals involved in the regulatory review of Mirena or specific discussions that took place may be justified in light of her duty of confidentiality to the FDA.
Further, I find that the probative value of Dr. Hixon's testimony about events involving the FDA when she was reviewing Mirena is substantially outweighed by a danger of unfair prejudice." See Fed. R. Evid. 403. "`Expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it,'" Price v. Fox Entm't Grp., Inc., 499 F.Supp.2d 382, 387 (S.D.N.Y.2007) (quoting Daubert, 509 U.S. at 595, 113 S.Ct. 2786), and in connection with Dr. Hixon's testimony, Plaintiffs cannot (as discussed above) effectively cross-examine her or dissipate the aura of credibility from her "insider" testimony. See United States v. Deutsch, 987 F.2d 878, 884 (2d Cir.1993) ("[T]he probative value of this evidence is lessened by the inability of the other party to cross-examine."); Gill v. Arab Bank, PLC, 893 F.Supp.2d 523, 541-42 (E.D.N.Y.2012) (expert testimony excluded where "[m]uch, if not all, of [the expert's] testimony [was] based on facts developed through confidential... investigations" and the opposing party was unable to adequately cross-examine).
Dr. Hixon's testimony relating to the FDA's review of Mirena's NDA in 2000 is thus excluded pursuant to Rule 37(c)(1) and in any event is also inadmissible under Rule 403.
Plaintiffs additionally argue that Dr. Hixon's testimony should also be excluded under Rule 702 and Daubert because her testimony is not sufficiently reliable.
As discussed in greater detail in connection with Dr. Feigal, expert testimony related to a company's or agency's state of mind, motives or intent is impermissible. See In re Rezulin, 309 F.Supp.2d at 546. Dr. Hixon is not allowed to opine on an entity's intent or state of mind that is not "clearly indicated in public documents." In re Levaquin, 2011 WL 6888533, at *2. Dr. Hixon will be permitted to testify to the same extent as Dr. Feigal. She may explain and opine on documents or communications between Bayer and the FDA and on public filings relating to Mirena (except to the extent I have already limited her admissible testimony under Rule 37(c) and Rule 403).
In her report, Dr. Hixon wrote that the "FDA would not accept the words `most often' in the Mirena perforation warning" in 2008. (Hixon Report at 41). Dr. Hixon may describe what language the FDA struck, what it said regarding why it struck that language, and what recommendations it made for Defendants to consider, but it will go too far (and is unnecessary) to say the FDA at that time "would not accept" that language under any circumstances. That the FDA "recommend[ed]" against using non-specific terms and suggested that Defendants "[c]onsider either
Dr. Hixon opines that Bayer's conduct comported with FDA rules and regulations. Dr. Hixon's thirteen years of experience working at the FDA qualify her to opine on the FDA's regulatory framework and Bayer's compliance therewith. As previously discussed in connection with Dr. Feigal, courts have consistently found that expert testimony regarding FDA regulations and a company's compliance under that regulatory scheme is admissible. See, e.g., Wells, 2013 WL 7208221, at *1; In re Yasmin & YAZ, 2011 WL 6302287, at *25; In re Fosamax, 645 F.Supp.2d at 191; Pfizer, 461 F.Supp.2d at 278-79. Furthermore, in this case, as in Fosamax, the ultimate issues a jury will decide relate to state law claims of strict liability and negligence, not FDA regulatory violations. See In re Fosamax, 645 F.Supp.2d at 191 n. 16. For these reasons, the Court will (as discussed below) permit Plaintiffs' expert to offer opinions that Defendants did not comply with FDA requirements, and Dr. Hixon's testimony regarding Bayer's compliance with FDA regulations is likewise admissible.
Like that of Dr. Feigal (and Plaintiffs' expert Dr. Parisian), Dr. Hixon's testimony — to the extent that it is otherwise admissible — is helpful to the trier of fact because of the complex nature of the FDA framework. Expert testimony from a regulatory expert on complicated schemes like the FDA's statutory framework, as well as opinions on the adequacy of a drug's label and the reasonableness of a pharmaceutical company's conduct, are useful in assisting the trier of fact. See In re Depakote, 2015 WL 4775868, at *8; In re Zicam, 2011 WL 798898, at *22.
For the reasons stated above, Plaintiffs' motion to preclude Dr. Hixon's testimony is GRANTED in part and DENIED in part.
Defendants move to exclude the proposed testimony of Suzanne Parisian, M.D. Defendants argue that Dr. Parisian is not qualified to opine on causation and other scientific issues related to Mirena, foreign regulatory issues, and potential alternative designs. (Memorandum of Law in Support of Defendants' Motion to Exclude the Testimony of Suzanne Parisian, M.D. ("Ds' Parisian Mem."), (Doc. 2686), 5-11.) Defendants also argue that Dr. Parisian's narrative of the regulatory history involving Mirena is not a proper subject of expert testimony, that Dr. Parisian offers improper legal conclusions that Bayer violated the Food, Drug, and Cosmetic Act ("FDCA") and related regulations, and that Dr. Parisian improperly speculates about Bayer's and the FDA's knowledge, motives and state of mind. (Id. at 11-15.)
Dr. Parisian provides four opinions: (1) that the manufacturer of a drug, not the FDA, is responsible for ensuring the drug's safety and the adequacy of the drug's label and warnings, (Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of Suzanne Parisian, M.D. ("Cook Parisian Decl."), (Doc. 2687), Ex. B, Expert Report of Suzanne Parisian, M.D. ("Parisian Report"), at 14-28); (2) that Defendants had access to information to support a label change reflecting the risk of migration as a result of perforation unrelated to insertion, (id. at 28-62); (3) that Defendants' pharmacovigilance techniques for monitoring the safety of Mirena were flawed and failed to adequately address the reported post-market risks, (id. at 62-75); and (4) that Bayer failed to consider and implement safer alternative designs for Mirena, (id. at 75-78).
Dr. Parisian has previously practiced medicine as a general practitioner, emergency physician and pathologist, and is currently licensed to practice medicine in Arizona and Virginia, although she has not treated a live patient since 1988 and has not practiced pathology since the 1990s. (Parisian Report at 6; Cook Parisian Decl. Ex. A, Deposition of Suzanne Parisian ("Parisian Dep."), at 49:5-15.) From 1991 to 1995, Dr. Parisian was a Commissioned Officer in the United States Public Health Service, and was assigned to the Center for Devices and Radiological Health at the FDA, where she served as a medical officer in the Office of Health Affairs from 1991 to 1993 and Chief Medical Officer in the Office of Device Evaluation from 1993 to 1995. (Parisian Report at 6-7.) Dr. Parisian "helped broadly cover both pre-market evaluation and post-market compliance issues, with an emphasis on post-market issues for products sold in the United States." (Id. at 7.)
Dr. Parisian was responsible for reviewing adverse event reports ("AERs") submitted by manufacturers, product recalls, labeling, and communications from manufacturers to physicians and the public regarding the performance of FDA-regulated products. (Id.) She also assisted in authoring FDA-issued Safety Alerts and was responsible for publicity in connection with causes of injury, issues with the performance of devices, and risks to public health. (Id.) After leaving the FDA in 1995, Dr. Parisian founded a consulting firm specializing in matters involving the FDA, the regulation of medical products, and public health. (Id. at 10.) As president of the company, Dr. Parisian helps, among other things, to design and market new medical products, "present marketing applications to FDA," and "draft product labeling." (Id.) She has authored a graduate-level textbook and lectured to the industry on the FDA, and she has served as an expert, primarily for plaintiffs. (Id.; Parisian Dep. at 23:7-29:5.)
Defendants argue that Dr. Parisian lacks the expertise to opine on medical causation related to Plaintiffs' theory of secondary perforation — that a Mirena can migrate out of the uterus unrelated to insertion — and other scientific issues related to the Mirena IUD. (Ds' Parisian Mem. 6-10.) Dr. Parisian is a medical doctor, but she has no expertise or special skills related to the uterus or IUDs, nor is she a gynecologist. (Parisian Dep. at 49:21-50:9, 103:24-104:23.) Because she does not have specialized expertise in this area, she
Although seemingly more regulatory in nature, Dr. Parisian's testimony related to "causal association" — as this term is used pursuant to 21 C.F.R. § 201.57(c)(6)(i)
Dr. Parisian will not be allowed to opine on foreign regulatory issues. Dr. Parisian is admittedly not an expert in the laws of foreign jurisdictions, and therefore is not qualified to testify on those subjects. (Parisian Dep. at 124:23-126:8.) There is no reason to believe that the regulatory framework of Canada or Germany is similar to the FDA's system. Moreover, Dr. Parisian's report and proposed testimony in this area is a recitation of reports and regulatory actions, with little or no analysis, which is not proper expert testimony because it is not helpful to the trier of fact. See In re Trasylol Prods. Liab. Litig., 709 F.Supp.2d 1323, 1336 (S.D.Fla.2010) (finding Dr. Parisian's testimony on "foreign regulatory matters" inadmissible); In re Rezulin, 309 F.Supp.2d at 553 (finding that plaintiffs' experts are not "appropriate vehicles" for introduction of evidence related to foreign regulatory actions because subject of that testimony is a lay matter). If Plaintiffs wish to submit evidence to show that Bayer was on notice of adverse events they may do so, if the evidence proves to be otherwise admissible, but not through Dr. Parisian. And if Dr. Parisian wants to refer to the fact of a particular foreign regulatory action as evidence of information available to Defendants on the basis of which a regulatory obligation in the U.S. was triggered, she may do so. But she may neither summarize foreign regulatory history nor imply that an action required abroad was necessarily required in the U.S. Defendants' motion to preclude
Dr. Parisian is also not qualified to opine on potential alternative, safer designs for Mirena, including the Skyla IUD or an IUD described in a patent application.
Defendants argue that Dr. Parisian's testimony of Mirena's regulatory history is an impermissible narrative or regurgitation of facts. In her report, Dr. Parisian writes at length about the regulatory history of Mirena and internal communications among Bayer personnel and between Bayer and the FDA. (See, e.g., Parisian Report at 32-33, 35, 43-44.) To the extent Dr. Parisian "is simply rehashing otherwise admissible evidence about which [she] has no personal knowledge, such evidence — taken on its own — is inadmissible." Highland Capital Mgmt., L.P. v. Schneider, 379 F.Supp.2d 461, 468-69 (S.D.N.Y. 2005); see In re Rezulin, 309 F.Supp.2d at 551 (excluding expert testimony on historical and regulatory background of drug that is just as easily understood by jury if submitted through percipient witness). Dr. Parisian may rely upon the regulatory history of Mirena, as well as documents reflecting communications between Bayer and the FDA and internal Bayer communications, in forming her regulatory opinions, but she may not present these documents to the jury with no analysis or merely "read, selectively quote from, or `regurgitate' the evidence." In re Fosamax, 645 F.Supp.2d at 192 (quoting In re Prempro Prods. Liab. Litig., 554 F.Supp.2d 871, 880, 886 (E.D.Ark.2008), aff'd in relevant part, 586 F.3d 547 (8th Cir.2009)). Defendants' motion with respect to Dr. Parisian's narrative testimony is granted insofar as she merely repeats facts, as opposed to using documents and background to opine on the FDA, the adequacy of Mirena's label and the reasonableness of Bayer's conduct pursuant to FDA regulations.
Dr. Parisian's experience as an officer at the FDA qualifies her to opine on the background of the FDA, its functions, and the FDA's regulatory framework. See Lemons v. Novartis Pharm. Corp., 849 F.Supp.2d 608, 614 (W.D.N.C.2012) (allowing Dr. Parisian to testify on "the role, process, and function of FDA and the responsibilities of pharmaceutical drug sponsors"). As is the case with Defendants' regulatory experts Drs. Feigal and Hixon, this type of expert testimony on the complex FDA framework is helpful to a jury. Defendants argue, however, that Dr. Parisian should be excluded from testifying that Bayer violated the FDCA and related regulations. (Ds' Parisian Mem. 12-13.) The Court finds Defendants' arguments unpersuasive.
As discussed in more detail with respect to Dr. Feigal, although generally experts
Defendants also seek to preclude Dr. Parisian from testifying as to the state of mind, knowledge or motives of Bayer and the FDA. (Ds' Parisian Mem. 13-15.) Defendants are correct that an expert's testimony on the "intent, motives or states of mind of corporations, regulatory agencies and others" is inadmissible. In re Rezulin, 309 F.Supp.3d at 546. Plaintiffs contend, however, that Dr. Parisian will not offer opinions regarding Bayer's motive, intent or state of mind and that she simply relies on internal company documents in forming her opinion that Bayer did not comply with its duties in accordance with regulatory requirements. (Ps' Parisian Opp. 12-14.) In her report, however, Dr. Parisian seems to impermissibly speculate on Bayer's or the FDA's state of mind or intent. For example, on page 33 of her report, Dr. Parisian writes, "[T]he `project lead' seemed concerned about maintaining timelines rather than taking the time necessary for addressing the safety of the United States Mirena user and providing an adequate label." Dr. Parisian has no expertise in divining the concerns or motives of others, and may not opine on such topics. See In re Trasylol, 709 F.Supp.2d at 1346. To the extent Plaintiffs want the jury to draw inferences about intent or motive from Defendants' statements, that is a matter for argument. Nonetheless, Dr. Parisian may opine on what documents in Bayer's possession said — in other words, on what Bayer "knew" in the sense of what information was in its possession — or on the FDA's or Bayer's intent to the extent it is "clearly indicated in public documents." In re Levaquin, 2011 WL 6888533, at *2. She may also opine on what the FDA would have done in a typical situation when presented with a set of facts.
Defendants argue that Dr. Parisian did not use a reliable methodology to reach her opinions regarding the adequacy of the Mirena label and Bayer's pharmacovigilance policies. (Ds' Parisian Mem. 15-24.) Defendants, however, attempt to force Dr. Parisian's opinions into the four-factor mold set forth by Daubert that governs scientific expert opinions but is not applicable to a non-scientific regulatory expert. See Kumho Tire Co., 526 U.S. at 150, 119 S.Ct. 1167 ("[F]actors identified in Daubert may or may not be pertinent in assessing reliability, depending on the nature of the issue, the expert's particular expertise, and the subject of his testimony.") (internal quotation marks omitted); id. at 156, 119 S.Ct. 1167 ("[N]o one denies that an expert might draw a conclusion from a set of observations based on extensive and specialized experience."); In re Fosamax, 645 F.Supp.2d at 190 ("An expert is permitted to draw a conclusion from a set of observations based on extensive and specialized experience."). None of the four factors listed in Daubert apply to Dr. Parisian, which makes sense because she is not purporting to be a scientist giving a scientific opinion. See Pritchett v. I-Flow Corp., No. 09-CV-2433, 2012 WL 1059948, at *8 (D.Colo. Mar. 28, 2012) (finding that Dr. Parisian's opinions were not "manifestly scientific in nature"). Her regulatory opinions are based upon her training and experience, as well as a review of "pertinent portions of the regulatory filings," In re Fosamax, 645 F.Supp.2d at 190-91, and Bayer's internal documents, which is the same methodology she would have employed as an officer at the FDA, see Forman v. Novartis Pharm. Corp., 794 F.Supp.2d 382, 384 (E.D.N.Y. 2011) (finding Dr. Parisian's reliance on regulatory filings, internal documents and medical literature sufficiently reliable to opine on the reasonableness of the pharmaceutical company's conduct with respect to the FDA). This is permitted under Daubert.
Defendants argue that Dr. Parisian used an unreliable methodology to reach her conclusions about Mirena's labeling and that her opinions are based on unreliable and speculative data. (Ds' Parisian Mem. 16-23.) As discussed above, Dr. Parisian has relied on her training and experience at the FDA to form her opinions regarding the adequacy of the Mirena label, which is a reliable methodology. See In re Fosamax, 645 F.Supp.2d at 190-91; see also
Defendants also argue that Dr. Parisian's third opinion on pharmacovigilance
As discussed above and in the discussion relating to Drs. Feigal and Hixon, Dr. Parisian's testimony regarding the complex FDA regulatory framework, Bayer's
For the reasons stated above, Defendants' motion to exclude the testimony of Dr. Parisian is GRANTED in part and DENIED in part.
Defendants move to exclude the proposed testimony of Plaintiffs' epidemiological expert, April Zambelli-Weiner. As a threshold matter, Defendants contend that the EURAS
Dr. Zambelli-Weiner gives six opinions in her expert report, all related to the EURAS study: (1) information was available to Bayer before the design and implementation of the EURAS study that secondary perforation was a serious safety signal warranting further investigation; (2) the EURAS study suffered from methodological limitations that compromised the internal and external validity of the study and limits the inferences that can be drawn from it, including perforation rates; (3) the EURAS study was not properly designed to detect perforations over the lifecycle of Mirena with a high degree of sensitivity or to discriminate between primary and secondary perforation; (4) the EURAS study was not designed to advance the understanding of mechanisms of insertion-related and non-insertion-related perforation; (5) the EURAS extension was underpowered from its inception to test perforation rates of Mirena compared to copper IUDs within a reasonable margin; and (6) despite its methodological limitations, the EURAS study provides evidence that Mirena use is associated with a significantly increased risk of perforation compared to copper IUDs. (Cook Zambelli-Weiner Decl. Ex. A, General Expert Report of Dr. April Zambelli-Weiner, Ph.D. ("Zambelli-Weiner Report"), at 2.)
Dr. Zambelli-Weiner has a Bachelor's degree in Chemistry and English, a
Defendants argue as a threshold matter that all of Dr. Zambelli-Weiner's opinions regarding the EURAS study are irrelevant pursuant to Federal Rule of Evidence 401 because the opinions do not advance Plaintiffs' claims in this litigation. (Ds' Zambelli-Weiner Mem. 1 n.1.) Defendants are correct that expert testimony must be relevant to be admissible, United States v. Khan, 787 F.2d 28, 34 (2d Cir.1986), but in this case both parties mention and seem to be relying, to some extent, on the results of the EURAS study. If neither Plaintiffs nor Defendants choose to rely upon the EURAS study, Dr. Zambelli-Weiner's testimony will be moot. To the extent it is mentioned, however, Dr. Zambelli-Weiner will be allowed to opine on the study, with the limitations on her proposed testimony discussed below.
Dr. Zambelli-Weiner is not qualified to opine on general causation or a mechanism for secondary perforation. During her deposition, Dr. Zambelli-Weiner stated both that she is not qualified to opine on a mechanism of secondary perforation and that she does not intend to offer an opinion on general causation. (Cook Zambelli-Weiner Decl. Ex. B, Deposition of April Zambelli-Weiner ("Zambelli-Weiner Dep."), at 90:10-14; 333:22-334:9.) Plaintiffs argue that Dr. Zambelli-Weiner is not offering such opinions, but that she is opining, "based upon a review of case reports, adverse event data and relevant scientific and medical literature," that there was information available to indicate that a number of IUD users experience perforations unrelated to insertion. (Plaintiffs' Memorandum of Law in Opposition to Defendants' Motion to Exclude the Testimony of April Zambelli-Weiner, Ph.D. ("Ps' Zambelli-Weiner Opp."), (Doc. 2784), 5.)
Dr. Zambelli-Weiner is not permitted to opine on how, why or whether secondary perforation occurs, which Dr. Zambelli-Weiner concedes are not opinions she intends to offer. (Zambelli-Weiner Dep. at 90:10-14.) Nonetheless, Dr. Zambelli-Weiner is qualified and will be permitted to opine from an epidemiological perspective, based on information available when the EURAS study was being designed and implemented, that a well-designed study should have taken the possibility of secondary perforation into account. "Epidemiology
Defendants further argue that Dr. Zambelli-Weiner's opinion that the time from insertion to the detection of perforation is a "surrogate measure of secondary perforation" is inadmissible. (Ds' Zambelli-Weiner Mem. 7-9.) The Court agrees that Dr. Zambelli-Weiner does not base this opinion on a reliable methodology. She bases what she described as this "logical concept" on nothing more than her conjecture that the temporal lag between insertion and detection suggests that the perforation occurs later. (Zambelli-Weiner Dep. at 144:11-145:8.) This type of speculative testimony based only on Dr. Zambelli-Weiner's say-so is impermissible. See Joiner, 522 U.S. at 146, 118 S.Ct. 512 ("[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert."). Plaintiffs are correct that an expert is often qualified to opine in a related field, and an epidemiologist does not need to be an expert in a particular field to analyze the data or studies showing a relationship between a drug and a disease. See Deutsch, 768 F.Supp.2d at 455. In this instance, however, Dr. Zambelli-Weiner is not basing her opinions on an analysis of data or studies, but rather on what she describes as a "logical concept," which does not pass muster under Rule 702 or Daubert. If her opinion is based on simple common sense, it is not helpful; the jury does not need expert opinion because its common sense will suffice. And if the jury needs expert opinion because common sense will not suffice, it must come from an expert who is applying her expertise. Dr. Zambelli-Weiner is not doing so where she attributes her opinion to simple logic rather than any application of principles of epidemiology.
Defendants move to exclude Dr. Zambelli-Weiner's opinions on the efficacy of diagnostic imaging in detecting uterine perforation. (Ds' Zambelli-Weiner Mem. 9-13.) Dr. Zambelli-Weiner criticized the
Moreover, Bayer's argument that Dr. Zambelli-Weiner fails to meet the four Daubert factors is not persuasive. Dr. Zambelli-Weiner is not offering a scientific opinion; she is opining that had diagnostic imaging — a general method used to evaluate patients in studies — been used in EURAS, the study would have produced more "robust, actionable results." (Zambelli-Weiner Report at 18.) The Daubert factors are not appropriate in every context. See Kumho Tire Co., 526 U.S. at 150, 119 S.Ct. 1167 ("[F]actors identified in Daubert may or may not be pertinent in assessing reliability...."); UMG Recordings, Inc. v. Lindor, 531 F.Supp.2d 453, 457 (E.D.N.Y.2007) ("The Daubert factors... were intended as suggestions, and are not appropriate for every type of expert testimony.") (citing Daubert, 509 U.S. at 593, 113 S.Ct. 2786). Dr. Zambelli-Weiner may not, however, opine that including an imaging protocol in EURAS would have shown a specific value of perforation rates, in this case "=2/1000 insertions." (Zambelli-Weiner Report at 18.) Dr. Zambelli-Weiner does not adequately explain why the results of one study that she cites in her report, (id.), would necessarily be the results had there been more imaging in EURAS, and during her deposition she declined to "wed[] [herself] to a particular number," (Zambelli-Weiner Dep. at 268:12-17). Dr. Zambelli-Weiner thus can opine generally on how imaging might affect a study like EURAS, but she may not opine on a particular statistic that would have resulted because she has provided no basis, other than her own say-so, as for why that specific number would result (and also backed away from that number). See Golod, 964 F.Supp. at 861 ("[T]he courtroom is not the place for scientific guesswork, even of the most inspired sort. Law lags science; it does not lead it.'") (quoting Rosen, 78 F.3d at 319) (alteration in original).
Defendants argue that Dr. Zambelli-Weiner is not qualified to render pharmacovigilance opinions and that those opinions are not reliable. (Ds' Zambelli-Weiner Mem. 13-18.) Plaintiffs concede that Dr. Zambelli-Weiner is "not a pharmacovigilance expert and will offer no opinions related to such processes," but argue that she is an "expert on the collection, analysis and interpretation of data" and should
In addition to being outside the scope of her expertise, Dr. Zambelli-Weiner's opinions relating to the adequacy of Bayer's pharmacovigilance efforts are not based on a sound methodology. Much of her opinions consist of her interpretations of internal Bayer documents, including emails, which in her view reflect confusion over internal coding. (Zambelli-Weiner Report at 8-14; Zambelli-Weiner Dep. at 219:8-20.) Dr. Zambelli-Weiner does not have any special expertise that gives her particular insight into these emails or what was going on at Bayer at the time, nor can she "read minds." In re Fosamax, 645 F.Supp.2d at 192. It is impermissible for experts to opine on the state of mind or motives of corporations or regulatory bodies. In re Rezulin, 309 F.Supp.2d at 546. Dr. Zambelli-Weiner admitted that she did not know how Bayer analyzed perforation events it received in connection with Mirena, (Zambelli-Weiner Dep. at 206:11-207:7), which makes her testimony on this point speculative and unhelpful to a jury. See In re Fosamax, 645 F.Supp.2d at 194 (excluding opinion by expert as lacking foundation "because he d[id] not know what types of animal testing [the pharmaceutical company] conducted with Fosamax"). Defendants' motion with respect to an opinion on the adequacy of Bayer's pharmacovigilance by Dr. Zambelli-Weiner is granted, but she can testify as to what an epidemiologist trying to design a good study would do with the information that Bayer had. She may not evaluate Bayer's internal coding system or its pharmacovigilance but can explain what, epidemiologically speaking, one should do when one has data like what Bayer had in its possession at the time.
Dr. Zambelli-Weiner may not opine on broad, undefined obligations that she believes Bayer failed to follow. (See, e.g., Zambelli-Weiner Report at 10 ("Bayer had an obligation to monitor potential safety issues and to investigate them further."); id. ("[S]afety signals should have spurred further investigation in well-designed studies even in the absence of regulatory involvement.").) Dr. Zambelli-Weiner does not seem to be basing her opinions of Bayer's obligations on any objective factors. She is not qualified to opine on — nor does she purport to use — FDA or any other objective standards, and we are left with a vague notion that in her personal opinion Bayer's conduct was inadequate. This is impermissible expert testimony. See In re Rezulin, 309 F.Supp.2d at 543 (experts' opinions "concerning purported ethical standards [were] based on their
Dr. Zambelli-Weiner will not be allowed to opine on the adequacy of the Mirena label. Plaintiffs state that Dr. Zambelli-Weiner will not be offering any such opinion, but argue she should be permitted to testify on the content of the label as it "relates to the correlation between the Mirena label and design of the EURAS study." (Ps' Zambelli-Weiner Opp. 16.) It is not clear what testimony Plaintiffs are attempting to describe. In her report, in any event, Dr. Zambelli-Weiner writes that "[c]ertain aspects of the MIRENA® label appear to be questioned by case reports in the literature," which seems to be an opinion on the inadequacy of the label. (Zambelli-Weiner Report at 7.) Dr. Zambelli-Weiner is not qualified to offer an opinion on Mirena's label as she is not a medical doctor, clinician or regulatory expert, and acknowledged that she is not an expert on labeling. (Zambelli-Weiner Dep. at 38:16-18, 162:14-24, 164:1-8.) Defendants' motion with respect to opinions on labeling is granted.
Defendants argue that Dr. Zambelli-Weiner's proposed testimony regarding the German regulatory equivalent of the FDA, the Federal Institute for Drugs and Medical Devices ("BfArM"), and Bayer's interactions with BfArM, should be excluded. (Ds' Zambelli-Weiner Mem. 21-24.) For example, in her report, Dr. Zambelli-Weiner mentions that "BfArM also sought some insight into the mechanism of IUD related uterine perforations" and referred to "BfArM concerns" that "Bayer did not investigate." (Zambelli-Weiner Report at 7.) As discussed in connection with Dr. Parisian, experts are not the "appropriate vehicles" to introduce evidence regarding foreign regulatory actions, In re Rezulin, 309 F.Supp.3d at 553, unless perhaps the expert has specialized expertise in a foreign regulatory body and its requirements. Dr. Zambelli-Weiner has no such expertise. She admitted that she is not a regulatory expert. (Zambelli-Weiner Dep. at 377:23-24.) Moreover, Dr. Zambelli-Weiner cannot opine on the state of mind of BfArM, because any such testimony would be purely speculative and is impermissible. See In re Rezulin, 309 F.Supp.3d at 546; In re Fosamax, 645 F.Supp.2d at 192.
In addition, Dr. Zambelli-Weiner's testimony regarding foreign regulators is excluded under Federal Rule of Evidence 403 because its probative value is substantially outweighed by its likelihood of confusing the jury.
Despite the limitations set forth above, Dr. Zambelli-Weiner's testimony regarding the EURAS study, including her description of what it did and did not test and her criticisms of it, based on her training and experience as an epidemiologist, would be helpful to a jury. Dr. Zambelli-Weiner may therefore offer opinions regarding the breadth and scope of the EURAS study, and what she believes are shortcomings of the study and its findings. She is qualified to render these opinions, which are both reliable and relevant, if the parties discuss the EURAS study. If Defendants disagree with Dr. Zambelli-Weiner's conclusions regarding the study, they can cross-examine her or offer contradictory testimony.
For the reasons stated above, Defendants' motion to preclude the testimony of Dr. Zambelli-Weiner is GRANTED in part and DENIED in part.
For the foregoing reasons, Defendants' and Plaintiffs' motions are granted to the extent set forth above and otherwise denied. Specifically:
The Clerk of Court is respectfully requested to terminate the pending motions (13-MD-2434 Docs. 2679, 2685, 2688, 2691, 2694, 2697, 2702, 2705 and 2724 and 13-MC-2434 Docs. 134, 140, 143, 146, 149 and 152).
(Wray Dep. at 287:22-288:10.) This does not show that Dr. Wray confronted or distinguished contradictory evidence regarding the existence of secondary perforation. Instead it seems to indicate that she merely acknowledged the existence of primary perforation. Moreover, Dr. Wray also stated during her deposition that although "[you] look[ ] at both sides when you're forming your opinion," "I wasn't spending a lot of time trying to think of reasons why my opinion might not be reasonable once I've reached my opinion." (Id. at 101:9-13.)
