MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Marta Villarraga, Ph.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 Opinions and Testimony of Marta Villarraga, Ph.D. [ECF No. 4553]. 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.
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
The plaintiffs seek to exclude certain opinions and testimony of Marta Villarraga, Ph.D., a biomedical engineer that works for Exponent, Inc.
1. Preparation of Expert Report
As a preliminary matter, the plaintiffs discuss the preparation of Dr. Villarraga's expert report. They contend that multiple Exponent employees assisted in the research and writing of it and argue that "Exponent's holistic `team' approach to expert report preparation warrants close scrutiny of Bard's proposed Exponent experts' testimony." Notice of Adoption of Prior Daubert Mot. of Marta Villarraga, Ph.D. for Waves 4 and 5 Cases, Ex. 1 at 6 [ECF No. 4553-1]. According to the plaintiffs, this team method "renders [Dr. Villarraga's] entire report suspect from the outset." Id. Even having made these arguments, the plaintiffs never contend that this method of report preparation is a basis to exclude Dr. Villarraga's opinions entirely. Thus, I need not address such a contention under Daubert standards.
2. Allegedly Non-Expert Lawyer Arguments
Next, the plaintiffs argue that much of Dr. Villarraga's report contains alleged expert opinions that are, in reality, arguments that the lawyers can make. As such, they state that such opinions should be excluded. I have previously analyzed opinions of Dr. Villarraga in another case, and I rule consistently here. "To the extent that the [Dr. Villarraga] purport[s] to simply make arguments that Bard's lawyer's may make, such testimony is not expert opinion and should be excluded. Simply pointing out inconsistencies does not require any `scientific, technical, or other specialized knowledge.'" In re C. R. Bard, Inc., 948 F.Supp.2d 589, 644 (S.D. W. Va. 2013) (citing Fed. R. Evid. 702). However, Dr. Villarraga's "attacks on the plaintiffs' experts' scientific basis for their opinions and their alleged failure to take into account certain testing and clinical experience are admissible."Id.Therefore, I EXCLUDE Dr. Villarraga's opinions to the extent that they "simply make arguments that Bard's lawyers may make." Id.
3. Factual Narratives
The plaintiffs allege that Dr. Villarraga's report contains factual narratives that are improper expert testimony. I incorporate my prior decision concerning this matter here:
I FIND that Liberty Medica Corp. v. Vivendi Universal, S.A. provides the appropriate solution to the situation at hand. 874 F.Supp.2d 169, 174 (S.D.N.Y. 2012). The Southern District of New York in Liberty Media held:
[The expert] will not be permitted to exhaustively recount all of the facts of the case. . . . [The expert] will not be permitted to recount the entire history of Vivendi through the class period. Rather, [the expert] must draw on the facts only as necessary—and in as concise a manner as possible—to support his opinion . . . which is based on his experience in corporate valuations. I decline to parse [the expert]'s report paragraph-by-paragraph to determine where the report turns from expert analysis to factual narrative. Rather, I trust plaintiff's counsel will exercise discretion in allocating trial time and will only present the facts necessary to support [the expert]'s opinion. In the event plaintiffs' counsel fails to exercise appropriate discretion, I will cut off any lengthy factual narrative.
Id. Accordingly, the plaintiffs' motion to exclude factual narratives by the Exponent Experts is GRANTED in part to the extent that they may not seek to offer factual narratives, but DENIED in part to the extent that they may present the bases for their expert opinions in this case.
In re C. R. Bard, Inc., 948 F. Supp. 2d at 646. I adopt my reasoning above and, thus, GRANT in part and DENY in part the plaintiffs' motion as to this matter.
4. Opinions Regarding Biocompatibility Testing and Benchtop Testing
The plaintiffs next argue that Dr. Villarraga's opinions related to Bard's biocompatibility testing and Bard's benchtop testing are unreliable. First, the plaintiffs argue that any opinion based on Bard's biocompatibility testing under ISO 10993 is unreliable. They point out that, for the Avaulta, Bard relied on past biocompatibility testing of another product, the Spermatex, and that Bard conducted lab tests for the Avaulta on only animals and no living humans. If the plaintiffs would like to challenge Dr. Villarraga's opinions in regard to these facts, I FIND that cross-examination is the proper vehicle, rather than a Daubert motion. See Daubert, 509 U.S. at 596 ("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.").
In addition, the plaintiffs argue that Dr. Villarraga's opinions based on benchtop testing are unreliable. Benchtop testing includes mechanical tests, such as tensile testing. Due to this testing's failure to replicate an in vivo environment, I have previously found it to be an unreliable basis for opinions concerning the behavior of mesh in the human body. See In re C.R. Bard, Inc., 948 F.Supp.2d 589, 639 (S.D. W. Va. 2013) (Dr. Brennan); Tyree v. Bos. Sci. Corp., 2014 WL 5320566, No. 2:12-cv-08633, at *29-33 (S.D. W. Va. Oct. 17, 2014) (Dr. Barker). I rule accordingly here. Therefore, I EXCLUDE Dr. Villarraga's testimony to the extent that her opinions based on benchtop testing relate to the mesh's behavior in vivo.
IV. Conclusion
To summarize, I GRANT in part and DENY in part the plaintiffs' motion concerning Dr. Villarraga, Ph.D. [ECF No. 4553] 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"
