MEMORANDUM OPINION AND ORDER (Daubert Motion re: James Anderson, Ph.D., M.D.)
JOSEPH R. GOODWIN, District Judge.
Pending in In re C. R. Bard, Inc. 2:10-md-2187, MDL 2187, is the plaintiffs' Daubert motion1 to Exclude Certain Opinions and Testimony of James Anderson, Ph.D., M.D. [ECF No. 4538]. 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 is 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 29,000 cases currently pending, approximately 3,000 of which are in the C. R. Bard, Inc. 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 the instant Daubert motions. Nearly all of the identified motions before the court are presented on the docket as a "Notice," wherein a party adopts and incorporates 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. As I have previously lamented, recycling expert testimony, objections, and the court's prior rulings, creates the perfect storm of obfuscation. The parties' practice of adopting and incorporating dated materials only compounds the issue as the briefing suffers from antiquation. With this in mind, the following analysis involve 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 (alteration in original)); 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
Bard offers Dr. James Anderson to opine on the biocompatibility of, and pathological responses to, implantable materials and devices. The plaintiffs seek to preclude Dr. Anderson from offering opinions concerning six topics: (1) specific causation for plaintiffs for whom he reviewed no pathology; (2) surface oxidation of polypropylene in vivo; (3) FDA regulatory process; (4) credibility of plaintiffs' experts; (5) the Material Safety Data Sheet ("MSDS") for Marlex polypropylene; and (6) the American Urogynecologic Society (AUGS) and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) position statement on midurethral slings.
As discussed below, the plaintiffs' motion to exclude certain opinions expressed by Dr. Anderson is GRANTED in part and DENIED in part.
1. Specific Causation
As noted above, the docket reflects several of the Daubert motions pending before the court as a "Notice," wherein a party adopts and incorporates by reference the Daubert Motion and Reply Brief filed against the same expert in prior Bard, MDL 2187, wave cases. Certain aspects of these reinstituted Daubert motions are irrelevant or inapplicable to Bard Wave 4 or Wave 5 cases. Here, the parties' dispute pertaining to specific causation concerned other multidistrict litigation plaintiffs. The motion is therefore DENIED as moot on this point.
2. Surface Oxidation
Dr. Anderson advances the opinion that surface oxidation with respect to polypropylene implants does not occur in vivo. The plaintiffs seek the exclusion of this opinion as redundant and duplicative of Dr. Maureen Reitman's, another expert Bard intends to proffer. See Notice of Adoption of Prior Daubert Mot. of James Anderson, Ph.D. for Waves 4 and 5 Cases, Ex. 1 at 10 (citing Eberli v. Cirrus Design Corp., 615 F.Supp.2d 1357, 1364 (S.D. Fla. 2009) (stating that an expert "must make some findings and not merely regurgitate another expert's opinion")) [ECF No. 4538-1].
In support of their position, the plaintiffs infer the absence of individuality and of a credible methodology by noting the dichotomy between the opinions Dr. Anderson expresses currently, and the position concerning surface oxidation of polypropylene mesh materials in vivo he took previously in —. Dr. Anderson testified as follows:
Q: And Doctor, you would agree that—you had testified before that surface oxidation occurs with respect to polypropylene implants in vivo.
A: Yes.
Q: Is that true?
A: Yes, I—that was my opinion in — and now my opinion has changed because we have more additional information regarding the possibility of that process.
Q: Okay. So you no longer believe that surface oxidation occurs to polypropylene in vivo.
A: As it relates to the polypropylene utilized in the mesh materials, that's correct, I no longer believe that. . . .
Q: Is your current opinion, or new opinion, about the surface oxidation of polypropylene in vivo, is that solely based on your reviewing of Reitman's expert report and any exhibits attached to that report?
A: That's correct.
Q: Are there any articles that you're relying upon to support your current opinion with respect to surface oxidation of polypropylene in vivo?
A: No.
Id. at 8-9 (citing Anderson Dep. 605:24-608:10).
This acknowledgement alone, however, does not serve as an admission that his conclusions mirror Dr. Reitman's, nor does it render Dr. Anderson's testimony unhelpful. Rather, it appears from the record that Dr. Anderson merely relies on the testing performed by Dr. Reitman in forming his opinion.
Q: Okay. So why is it that you have chosen to accept Dr. Reitman's study and results and reject Dr. Brennan's study and results?
A: Well, based upon my knowledge and experience as an organic chemist, dimethyl sulfoxide is, as I said, a universal solvent; and then secondly, the Fourier transform infrared spectroscopy was consistent with removal of the protein because protein peaks were not seen in that, and only — excuse me. Protein peaks were seen in that evaluation, but no — no oxidation peaks of the polypropylene. So I felt that that was — I felt that that was sufficient. I cannot speculate regarding Dr. Brennan's method because I don't — I don't recall it.
See Notice of Adoption of Bard's Prior Opposition to Pls.' Mot. to Exclude Certain Ops. & Test. of James Anderson, Ph.D., M.D., & Br. in Supp. for Waves 4 and 5 Cases, Ex. B at 13 (citing Anderson Dep. 610:25-611:15) [ECF No. 4638-2]. In other words, the plaintiffs have not demonstrated that Dr. Anderson's acknowledgement that he relied upon the testing performed by Dr. Reitman in forming his current opinion serves as an admission that his opinion mirrors that proffered by Dr. Reitman.
The plaintiffs neither cite Dr. Reitman's conclusions to compare to Dr. Anderson's, nor point to anything in the record that permits such an inference. SeeBuck v. Ford Motor Co., 810 F.Supp.2d 815, 844 (N.D. Ohio 2011) ("[T]he process of analyzing assembled data while using experience to interpret the data is not illicit; an expert need not actively conduct his or her own tests to have a valid methodology.") (citing Clark v. Takata Corp., 192 F.3d 750, 758 (7th Cir. 1999) (holding that either "hands on testing" or "review of experimental, statistical, or other scientific data generated by others in the field" may suffice as a reasonable methodology upon which to base an opinion)); see also Bouygues Telecom, S.A. v. Tekelec, 472 F.Supp.2d 722, 729-30 (E.D.N.C. 2007) (citing Westfield Ins. Co. v. Harris, 134 F.3d 608, 613 (4th Cir.1998) (reversing district court's exclusion of an expert report even where an estimated ninety percent of the report was derived from another investigator's work where such reliance was of the type reasonably relied upon by experts in that field); McReynolds v. Dodexho Marriot Servs. Inc., 349 F.Supp.2d 30, 37 (D.D.C. 2004) (allowing expert testimony which relied in part on the work of others, where expert was able to review for error and independently verify the analysis); see also Ohio Envt'l Dev. Ltd. P'ship v. Envirotest Sys. Corp., 478 F.Supp.2d 963, 976 (N.D. Ohio 2007) (holding that "an expert's testimony may be formulated by the use of the facts, data and conclusions of other experts")).
The plaintiffs can explore a challenge regarding perceived changes to his testimony over time on 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"). Therefore, the plaintiffs' motion is DENIED on this point.
3. FDA 510(k) Clearance
Many of the Daubert motions filed in this MDL raise the same or similar objections. One particular issue has been a staple in this litigation, so I find it best to discuss it in connection with every expert. 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., 81 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 any Daubert motion in this case challenges the FDA-related testimony discussed here, the motions are GRANTED.
4. The Credibility of Plaintiffs' Experts
The plaintiffs also seek the exclusion of certain statements made by Dr. Anderson concerning Dr. Klosterhalfen's credibility, an expert certain plaintiffs intend to proffer, believing such criticisms are beyond a permissible critique. Bard concedes the issue in response, stating that Dr. Anderson will not provide opinions regarding the credibility of Dr. Klosterhalfen. Insofar as Dr. Anderson's testimony usurps the province of a jury to determine a witness's credibility, the parties agree that such statements are EXCLUDED. However, statements by one expert assessing or analyzing another expert's substantive testimony or the reliability of their opinions are permissible.
5. The Material Safety Data Sheet for Marlex HGX-030-01
Bard concedes that Dr. Anderson will not on direct examine proffer any opinions about the MSDS. Therefore, the plaintiffs' objections to Dr. Anderson's opinions regarding the MSDS in question are DENIED as moot.
6. AUGS/SUFU Position Statements
The plaintiffs' objections to Dr. Anderson's opinions on the AUGS/SUFU position statements are DENIED as moot, given that Bard has agreed that Dr. Anderson will not offer any testimony about the AUGS/SUFU position statement.
IV. Conclusion
To summarize, I GRANT in part, DENY in part, and DENY as moot in part the plaintiffs' motion concerning Dr. James Anderson, Ph.D., M.D. [ECF No. 4538] 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 "1"
