MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Peter L. Rosenblatt, 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 Peter L. Rosenblatt, M.D. [ECF No. 4548]. The Motion is now ripe for consideration because the briefing is complete. As set forth below, the plaintiffs' Motion is GRANTED in part, DENIED in part, and RESERVED in part.
I. Background
These 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" and (1) is "based upon sufficient facts or data" and (2) is "the product of reliable principles and methods" which (3) has been reliably applied "to the facts of the case." Fed. R. Evid. 702. 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
The plaintiffs seek to exclude certain opinions and testimony of Dr. Rosenblatt; namely, his opinions: (1) regarding the FDA; (2) that the Avaulta Solo and Align do not shrink; (3) that the Avaulta Solo and Align Instructions for Use adequately warned surgeons; (4) regarding the MSDS; and (5) regarding the AUGS position statement.
1. Testimony Related to the FDA
One particular issue has been a staple in this litigation. A number of the Daubert motions seek to exclude FDA testimony and other regulatory or industry standards testimony. To the extent this Motion raises these issues it is GRANTED in part and RESERVED in part as described below.
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. 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, opinions about Bard's compliance with or violation of the FDA's labeling and adverse event reporting regulations are EXCLUDED. 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. Insofar as this Motion challenges the FDA-related testimony discussed here, the Motion is GRANTED.
Nevertheless, because the nuances of products liability law vary by state, I will refrain from issuing a blanket exclusion on design process and control standards testimony, whether rooted in the FDA or otherwise. Each standard must be assessed for its applicability to the safety questions at issue in this litigation, consistent with state law. I am without sufficient information to make these findings at this time. Accordingly, I RESERVE ruling on such matters until a hearing where the trial judge will have additional context to carefully evaluate the relevance and potential prejudicial impact of specific testimony.
2. Mesh Degradation and Shrinkage of Avaulta Solo and Align Post-Implant
The plaintiffs argue that Dr. Rosenblatt's opinions regarding mesh degradation and shrinkage should be excluded because his methodology is unreliable. In particular, they allege that he based his opinions on scant personal experience. I disagree. An expert may be qualified by "knowledge, skill, experience, training, or education[.]" Fed. R. Evid. 702. "One knowledgeable about a particular subject need not be precisely informed about all details of the issues raised in order to offer an [expert] opinion." Thomas J. Kline, Inc. v. Lorillard, Inc., 878 F.2d 791, 799 (4th Cir. 1989).
Dr. Rosenblatt reported observing the absence of degradation in the Avaulta Solo product in vivo several times both in his practice as an urogynecologist and while viewing excised mesh under a microscope. Notice of Adoption of Prior Daubert Mot. of Peter Rosenblatt, M.D., for Waves 4 & 5 Cases, Ex. 1 (Rosenblatt Report), at 11 [ECF No. 4548-1]. He has used transvaginal mesh to treat POP for over ten years, and has extensive experience with polypropylene mesh. See id. He has also excised polypropylene transvaginal mesh. Notice of Adoption of Prior Daubert Mot. of Peter Rosenblatt, M.D., for Waves 4 & 5 Cases, Ex. 1 (Mem.), at 8 [ECF No. 4548-1]. His professional experience as a lecturer in the field further supports his qualifications to opine on the subject. I therefore FIND that Dr. Rosenblatt is qualified to offer an opinion whether the mesh in question degrades or shrinks.
The plaintiffs also challenge the reliability of Dr. Rosenblatt's opinion that mesh does not degrade or shrink in vivo generally, arguing that his clinical observations are either irrelevant or too small of a sample size to be reliable. Here, Dr. Rosenblatt explicitly states that he relied not only on his knowledge and experience, but also on scientific literature, which are sufficiently reliable methods of forming his particular opinion. Notice of Adoption of Prior Daubert Mot. of Peter Rosenblatt, M.D., for Waves 4 & 5 Cases, Ex. 1 (Rosenblatt Report), at 279, 291. The challenges advanced by the plaintiffs here are more appropriate on crossexamination. Therefore, I FIND Dr. Rosenblatt's clinical experience and review of the scientific literature are sufficiently reliable bases in forming this particular opinion.
3. Opinions Regarding the Instructions for Use ("IFU")
According to the plaintiffs, Dr. Rosenblatt is not qualified to offer expert testimony on the adequacy of an IFU because he was not involved in the drafting of the IFU. Bard, in response, argues that Dr. Rosenblatt is qualified because he is familiar with the products in question and has "read a lot of different IFUs." Notice of Adoption of Bard's Prior Mem. of Law in Opp'n to Pls.' Mot. to Exclude Certain Ops. & Test. of Peter Rosenblatt, M.D., for Wave 4 & Wave 5 Cases, Ex. B, at 12 [ECF No. 4645-2]. I FIND that without additional expertise in the specific area of product warnings, a doctor, such as an urogynecologist, is not qualified to opine on the adequacy of a product warning IFU merely because he is familiar with the products in question in his own practice. Accordingly, the plaintiffs' Motion on this point is GRANTED.
4. Opinions Regarding the Material Safety Data Sheet ("MSDS")
The plaintiffs seek to prevent Dr. Rosenblatt from testifying regarding the utility and interpretation of language contained in the MSDS related to the polypropylene resin in question. Specifically, the plaintiffs take issue with certain language in Dr. Rosenblatt's Report, which states:
I have reviewed the Material Safety Data Sheet cited by the Plaintiffs. I have seen no evidence that there is any scientific basis supporting the medical application caution language in the Material Safety Data Sheet. The MSDS provides no testing, data or literature to support the statements contained in it. The MSDS does not state what, if any, potential risks there are associated with permanent human implantation. I do not review MSDSes for medical devices I use because it is not a source of scientific information that I would use to direct my clinical experience.
Notice of Adoption of Prior Daubert Mot. of Peter Rosenblatt, M.D., for Waves 4 & 5 Cases, Ex. 1 (Rosenblatt Report), at 19-20. In response, Bard contends that Dr. Rosenblatt is qualified to testify on the applicability of MSDSs in general. As I have previously held, whether a particular doctor relies on MSDSs in his practice or not, is not helpful to a jury. The pertinent issue is that the MSDS contained a warning allegedly not heeded by Bard, not whether practicing physicians regularly consult the warnings.
However, Bard argues that Dr. Rosenblatt has certain qualifications that permit him to opine on the scientific reliability of MSDSs. Specifically, Bard argues that Dr. Rosenblatt's experience as an inventor of polypropylene mesh products and his work with engineers qualify him as an expert on the veracity of MSDSs. On the other hand, the plaintiffs argue that he is not qualified to opine on the subject because he is not a chemical engineer or a biomedical engineer. Neither party, however, articulates in any meaningful way why the qualifications they advance establish expertise in this particular area. As such, I am without sufficient information at this time to draw the fine line between qualified and unqualified expert testimony on the scientific reliability of MSDSs. Accordingly, I RESERVE ruling until further testimony may be offered and evaluated firsthand at trial.
5. Opinions Regarding "The American Urogynecologic Society" ("AUGS")
Last, the plaintiffs seek to exclude Dr. Rosenblatt's references to AUGS's organizational position statement. As I indicated previously during these MDLs, position statements are not expert opinions. Huskey v. Ethicon, Inc., 29 F.Supp.3d 691, 731-32 (S.D. W. Va. 2014). Dr. Rosenblatt is not using his "scientific, technical, or other specialized knowledge" in making these statements. Fed. R. Evid. 702. Therefore, I will not address the admissibility of this testimony here and RESERVE this ruling for trial.
IV. Conclusion
To summarize, I GRANT in part, DENY in part, and RESERVE in part the plaintiffs' Motion concerning Dr. Rosenblatt, M.D. [ECF No. 4548], consistent with my reasoning above.
The court DIRECTS the Clerk to file a copy of this Memorandum Opinion and Order in 2:12-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
