MEMORANDUM OPINION AND ORDER (Daubert Motion re: Robert H. Young, M.D.)
JOSEPH R. GOODWIN, District Judge.
Pending in In re C. R. Bard, Inc., No. 2:10-md-2187, MDL 2187, is the plaintiffs' Daubert Motion to Exclude Opinions and Testimony of Robert H. Young, M.D. [ECF No. 4554]. The Motion is now ripe for consideration because the briefing is complete. As set forth below, the plaintiffs' Motion is GRANTED in part and DENIED in part.
I. Background
These groups of cases reside in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation ("MDL") concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and stress urinary incontinence ("SUI"). In the seven MDLs, there are more than 24,000 cases currently pending, approximately 3,000 of which are in the C. R. Bard, Inc. ("Bard") MDL, MDL No. 2187.
In an effort to manage the massive Bard MDL efficiently and effectively, the court decided to conduct pretrial discovery and motions practice on an individualized basis. To this end, I selected certain cases to become part of a "wave" of cases to be prepared for trial and, if necessary, remanded.
Upon the creation of a wave, I enter a docket control order subjecting each active case in the wave to the same scheduling deadlines, rules regarding motion practice, and limitations on discovery. See, e.g., Pretrial Order ("PTO") # 236, In re C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. 2:10-md-02187, Jan. 27, 2017, https://www.wvsd.uscourts.gov/MDL/2187/orders.html. Included among the discovery rules imposed by the court is the obligation of the parties to file Daubert motions seeking to limit or exclude the testimony of general experts in the main MDL, MDL 2187, and to identify which cases the motion would affect.
Before plunging into the heart of the Motion, I am compelled to comment on the manner in which the parties filed several of their recent general Daubert motions. Rather than file a motion, the parties filed a "Notice" to adopt and incorporate the entirety of a motion filed in a previous wave — sometimes several years old. As such, the grounds upon which the parties challenge the proffered expert are sometimes inapplicable to the cases grouped in Wave 4 or Wave 5. With this in mind, the following analysis involves the parties' efforts to exclude or limit the general opinions and testimony of the experts so identified.
II. Legal Standard
Under Federal Rule of Evidence 702, expert testimony is admissible if it will "help the trier of fact to understand the evidence or to determine a fact in issue." Fed. R. Evid. 702. Furthermore, the expert testimony must be (1) "based upon sufficient facts or data" and (2) "the product of reliable principles and methods" that (3) have been applied reliably "to the facts of the case." Id. A two-part test governs the admissibility of expert testimony. The evidence is admitted if it "rests on a reliable foundation and is relevant." Daubert v. Merrell Dow Pharm., 509 U.S. 579, 597 (1993). The proponent of expert testimony does not have the burden to "prove" anything. However, he or she must "come forward with evidence from which the court can determine that the proffered testimony is properly admissible." Md. Cas. Co. v. Therm-O-Disc, Inc., 137 F.3d 780, 783 (4th Cir. 1998).
The district court is the gatekeeper. It is an important role: "[E]xpert witnesses have the potential to be both powerful and quite misleading"; the court must "ensure that any and all scientific testimony . . . is not only relevant, but reliable." Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Daubert, 509 U.S. at 588, 595; Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999)). I "need not determine that the proffered expert testimony is irrefutable or certainly correct" — "[a]s with all other admissible evidence, expert testimony is subject to testing by `[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof.'" United States v. Moreland, 437 F.3d 424, 431 (4th Cir. 2006) (alteration in original) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at 783 ("All Daubert demands is that the trial judge make a `preliminary assessment' of whether the proffered testimony is both reliable . . . and helpful.").
Daubert mentions specific factors to guide the overall relevance and reliability determinations that apply to all expert evidence. They include (1) whether the particular scientific theory "can be (and has been) tested"; (2) whether the theory "has been subjected to peer review and publication"; (3) the "known or potential rate of error"; (4) the "existence and maintenance of standards controlling the technique's operation"; and (5) whether the technique has achieved "general acceptance" in the relevant scientific or expert community. United States v. Crisp, 324 F.3d 261, 266 (4th Cir. 2003) (quoting Daubert, 509 U.S. at 593-94).
Despite these factors, "[t]he inquiry to be undertaken by the district court is `a flexible one' focusing on the `principles and methodology' employed by the expert, not on the conclusions reached." Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S. at 594-95); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) ("We agree with the Solicitor General that `[t]he factors 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.'" (citation omitted)); see also Crisp, 324 F.3d at 266 (noting "that testing of reliability should be flexible and that Daubert's five factors neither necessarily nor exclusively apply to every expert").
With respect to relevancy, Daubert also explains:
Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful. The consideration has been aptly described by Judge Becker as one of "fit." "Fit" is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes. . . . Rule 702's "helpfulness" standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.
Daubert, 509 U.S. at 591-92 (citations and internal quotation marks omitted).
III. Analysis
In this case, Bard offers Dr. Young to testify as a general expert witness on gynecological surgical pathology issues related to the mesh products that are the subject of this pending litigation. See Notice of Adoption of Prior Daubert Mot. of Robert H. Young, M.D., for Waves 4 & 5, Ex. 1 ("Young Report"), at 4 [ECF No. 4554-1]. Among other things, Dr. Young specializes in the area of diagnostic surgical pathology, with a subspecialty interest in gynecological and urological pathology, and is an active professor of pathology at Harvard Medical School. Id. at 3. In addition to more than 350 peer-reviewed contributions, Dr. Young has co-authored five books. Id. His clinical experience includes prior service as the head of the gynecological and urological pathology units at Massachusetts General Hospital, and he continues to review approximately 6000 pathology cases a year. Id.
The plaintiffs argue that Dr. Young is not qualified to opine generally on four matters: (A) biocompatibility of polypropylene; (B) the adequacy of Bard's testing to determine biocompatibility; (C) pore size; and (D) vaginal mesh contraction and shrinkage. In addition, the plaintiffs challenge the reliability of each of these opinions on the ground that they are unreliable ipse dixit opinions. I will address each argument in turn.
A. Opinions Regarding the Biocompatibility of Polypropylene
As stated in his report, Dr. Young reached the following conclusions:
Polypropylene is biocompatible and commonly used for surgical mesh in the United States. Polypropylene mesh does not degrade and is chemically inert.
See Notice of Adoption of Prior Daubert Mot. of Robert H. Young, M.D., for Waves 4 & 5, Ex. 1 ("Pls.' Br. in Supp."), at 8 [ECF No. 4554-1] (quoting Young Report 7).
The plaintiffs argue that Dr. Young's background in pathology does not qualify him under Federal Rule of Evidence 702 to render an opinion on the biocompatibility of polypropylene, or opine on whether polypropylene mesh does not degrade and is chemically inert. See id. The plaintiffs also challenge the reliability of his opinions that consist entirely of ipse dixit statements.
As it relates to the reliability of Dr. Young's opinions on the biocompatibility of polypropylene, Bard contends that Dr. Young "reviewed pathological slides, compared his observations to published literature, and provided diagnostic interpretations of what he saw." Bard's Opp'n 10. Bard further claims that even a cursory review of Dr. Young's deposition testimony supports such a finding. Id. at 11. I disagree.
During his deposition testimony, counsel for the plaintiffs questioned Dr. Young on the independence of his research.1 Initially, Dr. Young acknowledged that counsel for Bard provided each document cited as supporting scientific literature in his report.2 When asked if he did any independent research to identify relevant literature, Dr. Young admitted that he had not.3 Then, when questioned on his opinions concerning the biocompatibility of polypropylene, Dr. Young stated:
I have concluded based on my being educated as part of this process on this whole area, which I admit before I didn't have much knowledge of — well, much knowledge of, the mesh aspect of it, that is, that polypropylene is — biocompatibility, meaning by that appropriate for usage in the human body, perhaps is the simplest way to put it.
Young Dep. 111:7-13 (emphasis added).
Next, discussing his opinions regarding whether polypropylene mesh degrades, Dr. Young stated:
Q. On Page 7 of your report, Doctor, you write: "I have not seen evidence of polypropylene mesh degrading in the materials made available to me in this matter." . . . . What materials are you referring to in that statement?
A. The pathology slides.
Q. Anything else?
A. No.
. . .
Q. On the next page, Page 8, Doctor, you write: "For
example, polypropylene features have been used clinically for decades and I have reviewed pathology containing sutures." Would you agree with me that polypropylene sutures are not routinely used in the vagina?
A. I think we touched upon this, this morning. I have no knowledge base of any note on the different type of sutures they use in the vagina, outside the vagina. I mean, it's not an area that's of any relevance to my daily practice. So therefore I don't — I have no comment on it other than I'm not an expert on it.
Young Dep. 122:11-19 (emphasis added).
Read together, and in the absence of any objective evidence beyond the conclusory defenses argued by Bard, Dr. Young's opinions regarding the biocompatibility of polypropylene are unreliable, as they appear formulated entirely in the context of this litigation. See Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317-18 (9th Cir. 1995) ("If the proffered expert testimony is not based on independent research, the party proffering it must come forward with other objective, verifiable evidence that the testimony is based on `scientifically valid principles.'"). In sum, after admitting that he does not base his expert testimony on independent research, Dr. Young later acknowledges that his conclusions on the biocompatibility of polypropylene required academic supplementation — which he relied solely on counsel for Bard to supply. Then, Dr. Young concedes that his entire experience with polypropylene mesh derives entirely from seven cases of pathology slides supplied to him during the course of this litigation. When pressed to extrapolate on his methodologies — specifically, his attempt to correlate his observations from the slides provided from the seven explanted mesh devices to his acknowledged pathology qualifications — Dr. Young admits that he cannot state with any scientific certainty how his discussion of polypropylene sutures relates to his conclusions on polypropylene mesh in vivo.
Based on incomplete and therefore unreliable information, Dr. Young's opinions with respect to the biocompatibility of polypropylene, the presence or absence of degradation, and the inertness of polypropylene are EXCLUDED. The plaintiffs' Motion on this point is GRANTED.
B. Qualifications to Opine on the Adequacy of Bard's Testing to Determine Biocompatibility
The plaintiffs next challenge the qualifications of Dr. Young to offer the following opinion:
In the United States, the FDA put out a guidance document for medical companies to follow related specifically to 510(k) submission for surgical meshes. The FDA guidance document recommended the following biocompatibility tests be performed on surgical meshes: cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic/acute toxicity, genotoxicity (if positive, carcinogenicity), implantation, hemolysis, pyrogenicity, subchronic toxicity, and chronic toxicity. My review of the Avaulta Solo, Avaulta Plus, and Align 510(k) documents along with my background, training, and experience revealed that Bard's testing conducted on the mesh products and their predecessors was adequate to determine biocompatibility.
Pls. Br. in Supp. 9 (quoting Young Report 8-9).
According to the plaintiffs, Dr. Young cannot opine on biocompatibility testing because he acknowledged that he has never consulted with the FDA on biocompatibility testing of a medical device and he does not have any academic experience on the biocompatibility of medical devices. Id.
Though not raised by the plaintiffs expressly, I have repeatedly excluded evidence regarding the FDA's section 510(k) clearance process in these MDLs, and will continue to do so in these cases, a position that has been affirmed by the Fourth Circuit. See, e.g., In re C. R. Bard, Inc., 810 F.3d 913, 921-23 (4th Cir. 2016) (upholding the determination that the probative value of evidence related to section 510(k) was substantially outweighed by its possible prejudicial impact under Rule 403). Because the section 510(k) clearance process does not speak directly to safety and efficacy, it is of negligible probative value. See id. at 920 ("[T]he clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value."). Delving into complex and lengthy testimony about regulatory compliance could inflate the perceived importance of compliance and lead jurors "to erroneously conclude that regulatory compliance proved safety." Id. at 922. Accordingly, expert testimony related to the section 510(k) process, including subsequent enforcement actions and discussion of the information Bard did or did not submit in its section 510(k) application, is EXCLUDED.
For the same reasons, insofar as this Motion challenges the FDA-related testimony discussed here, the Motion is GRANTED. In addition to representing inappropriate legal conclusions, such testimony is not helpful to the jury in determining the facts at issue in these cases and runs the risk of misleading the jury and confusing the issues. Furthermore, qualifications to proffer expert testimony on the biocompatibility of polypropylene generally does not render an opinion on the adequacy of certain biocompatibility testing procedures equally qualified. Here, Dr. Young's opinions — aside from his comments on the FDA's guidance documents — are otherwise limited to his "background, training, and experience." Pls. Br. in Supp. 9 (quoting Young Report 8-9).
I FIND that without additional expertise, a pathologist is not qualified to opine on the adequacy of biocompatibility testing based merely on his "general experience as an educated physician." Notice of Adoption of Prior Daubert Mot. of Robert H. Young, M.D., for Waves 4 & 5 Cases, Ex. 2, Ex. D, at 95:11-16 ("Young Dep.") [ECF No. 4554-2]. Accordingly, the plaintiffs' Motion on this point is GRANTED.
C. Qualifications to Opine on the Pore Size of Bard's Mesh Products
The plaintiffs also challenge Dr. Young's qualifications to proffer opinions about pore size and tissue integration. Specifically, the plaintiffs challenge Dr. Young's qualifications to offer the following opinions:
The Avaulta Solo, Avaulta Plus, and Align have primary pore sizes of 1,000 to 1,300 microns. It is generally accepted that the lower limit of pore size for tissue integration is in the order of 50 to 100 microns. Thus, pore sizes ranging above 1000 microns, like the Bard products, are more than sufficient to permit tissue ingrowth with normal wound healing and foreign body reactions. Pore sizes greater than 75 microns allow penetration by macrophages, fibroblasts, blood vessels and collagen fibers. It is generally understood that if pore size is greater than 75 microns, which the Bard products are in all pores, the pore is large enough for adequate tissue integration and will function effectively;
Measuring pore size in mesh products does not have an accepted or established methodology. The 1999 FDA Guidance document does not provide a methodology for how pore size measurements should be conducted. The methodology employed by Bard in measuring pore size was reasonable as it is in line with approaches used in the literature whereby the longest dimensions of the pore are measured; and
The concept of effective pore size is one that was introduced by Muhl et al. in 2008 to describe the dimensions of the pore of a mesh under load. However, there is no direct evidence in the literature that an effective pore size of 1 mm is necessary for the efficacious performance of pelvic meshes or suburethral slings, or that it is a widely recognized or adopted approach to characterize meshes.
Pls. Br. in Supp. 9-10 (citing Young Report 9-12).
The plaintiffs assert that Dr. Young is not qualified to offer these opinions because he acknowledges that he is not an expert in pore size. Id. (citing Young Dep. 145:16-146:1). In Wise v. C. R. Bard, Inc., I assessed a similar argument. No. 2:12cv-01378, 2015 WL 570070, at *4-5 (S.D. W. Va. Feb. 11, 2015). In Wise, the moving party sought the exclusion Dr. Marshall Austin, a pathologist proffered to testify on the gynecologic surgical pathology and cytopathology. The parties raise the same arguments here. Specifically, I stated:
Dr. Austin, however, does not purport to be an expert in pore size, nor is expertise in pore size necessary for him to provide the opinions set forth in his expert report. Rather, Dr. Austin limits his opinions to an explanation of how tissue responds to the pore size of mesh. (See Austin Report [Docket 203-1], at 6 ("[P]ore sizes ranging above 1,000 microns, like the Bard products, are more than sufficient to permit tissue ingrowth with normal wound healing and foreign body reactions."); id. at 10 ("[T]he pore size of the Bard products was adequate for sufficient tissue growth.")). As explained above, Dr. Austin's background and experience in the field of gynecological pathology provide the requisite expertise needed to testify about the reaction between mesh and tissue. He has observed vaginal tissue ingrowth through various mesh products, and he has reviewed numerous publications and studies on how pore size can affect the integration of polypropylene with the surrounding tissue. (See Austin Report [Docket 203-1], at 2-3 ("Throughout my pathology career, I have encountered implanted medical devices in routine specimens submitted for pathologic evaluation, including, for example, pelvic mesh, . . . ."); id. at 6 n.6 (listing the relied-upon literature)). Accordingly, I FIND that he is qualified to testify about the ways in which pore size can affect the biocompatibility of polypropylene.
Id.
Relying in part on Wise, Bard represents that Dr. Young is not offering an opinion on the optimum pore size or the design implications of pore size; rather, Bard states that Dr. Young "simply opined that the pore size [of] Bard's mesh products was large enough to allow for sufficient tissue ingrowth." Notice of Adoption of Bard's Prior Opp'n to Pls.' Mot. to Exclude Ops. & Test. of Robert H. Young, M.D., and Br. in Supp. for Wave 4 & Wave 5 Cases, Ex. B ("Bard's Opp'n"), at 6 [ECF No. 4651-2]. While the parties in this case have not relied on precisely the same arguments, my reasoning and conclusions from Wise still govern. Furthermore, to the extent that there are differences in fact and exhibits, the court does not find them sufficiently material. Particularly in light of Bard's representation, acknowledging certain limitations on the scope of Dr. Young's opinions on pore size, I ADOPT the reasoning articulated in Wise and FIND that Dr. Young is qualified to offer expert testimony on the ways in which pore size can affect the biocompatibility of polypropylene. The plaintiffs' Motion is DENIED on this point.
D. Qualifications to Opine on the Purported Contraction or Shrinkage of Bard's Mesh Products
Next, the plaintiffs assert that the court should preclude Dr. Young from offering opinions related to mesh shrinkage or contracture. Specifically, the plaintiffs challenge Dr. Young's opinion that:
Wound contraction is a normal part of the wound healing process and occurs as part of the evolving granulation tissue phase of the healing response. Generally, wound contraction occurs in large surface wounds and is facilitated by the transient presence of myofibroblasts that have contractile properties. It is important to note that even when contraction occurs, the mesh device itself does not shrink
Pls. Br. in Supp. 11.
The plaintiffs point to extracted statements from his deposition in support of their argument, where Dr. Young testified that he is not an expert on the contraction properties of mesh. Id. at 14 (citing Young Dep. 145:20-146:12). In Wise, I considered the same argument and held that:
This single statement from hundreds of pages of deposition does not overcome Dr. Austin's undeniable expertise as a pathologist. His training and experience in this field equips him to examine tissue and to opine about the tissue's pathology, including its reactions with other present substances, such as mesh. See, e.g., 33 Am. Jur. Trials 467, § 17 (1986) ("Clinical pathology is the area of pathology that deals with testing of various body fluids and excreta in an attempt to correlate changes found in those fluids with the presence and development of disease processes."); id. § 27 ("Upon receipt of the specimen it is necessary to begin a series of steps that will eventually allow the [] pathologist to establish or confirm a diagnosis based on the specific pathology of the tissue.").
Wise, 2015 WL 570070, at *5. Again, to the extent there are differences in fact and exhibits, the court does not find them sufficiently material. I therefore ADOPT the reasoning articulated in Wise and FIND that Dr. Young is qualified to opine on the pathology of mesh explants, which includes an analysis of the foreign body response and how a wound heals around mesh. Any "self-contradiction" or inconsistencies in these opinions can be challenged during cross-examination. See McReynolds v. Sodexho Marriott Servs., Inc., 349 F.Supp.2d 30, 40 (D.D.C. 2004) (stating that the inconsistencies or misstatements in an expert's testimony "go to credibility, rather than Daubert's standard of admissibility"). Accordingly, I DENY the plaintiffs' Motion on this matter.
E. Reliability of Dr. Young's Opinions
As stated above, the plaintiffs challenge the reliability of each of the aforementioned opinions proffered by Dr. Young on the ground that Bard provided all of the literature cited in his report and based on his limited clinical experience working with the mesh products subject in this litigation. Given the limitations conceded by Bard and the exclusion of other opinions as described above, it appears that the remaining narrow scope of testimony Dr. Young is permitted to offer flows naturally from scientific principles regularly encountered in his extensive line of scientific research and technical work. See Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d 426, 434 (6th Cir. 2007). Therefore, except as stated above,4 the plaintiffs' Motion seeking the exclusion of Dr. Young's remaining opinions as unreliable is DENIED.
IV. Conclusion
To summarize, I GRANT in part and DENY in part the plaintiffs' Motion concerning Dr. Young, M.D. [ECF No. 4554], consistent with my reasoning above.
The court >DIRECTS the Clerk to file a copy of this Memorandum Opinion and Order in 2:10-md-2187, and the Bard Wave 4 and Wave 5 cases identified in the Exhibit attached hereto. The court further DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented party.
Exhibit
A
