MEMORANDUM OPINION AND ORDER

(Daubert Motion re: Donna-Bea Tillman, Ph.D., M/P.A., FRAPS)

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 Donna-Bea Tillman, Ph.D., M/P.A., FRAPS [ECF No. 4549]. The motion is now ripe for consideration because the briefing is complete. As set forth below, the plaintiffs' motion is GRANTED.

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:

Daubert, 509 U.S. at 591-92 (citations and internal quotation marks omitted).

III. Analysis

Bard seeks to offer Dr. Bea Tillman as an expert witness in the field of biomedical engineering and to testify regarding Bard's compliance with regulatory and industry standards. The plaintiffs seek to exclude Dr. Tillman from offering any opinion regarding: (1) the FDA's clearance process and (2) the Material Safety Data Sheet for the Marlex HGX-030-01 polypropylene used in the Avaulta and Align products.

1. FDA Clearance Process

As noted above, I have repeatedly excluded evidence regarding the FDA's clearance process. I ADOPT those findings here and insofar as any Daubert motion in this case challenges the FDA-related testimony discussed here, and the motion is GRANTED on this point.

2. Opinion Regarding the MSDS Sheet

In response to the plaintiffs' motion, Bard represents that Dr. Tillman "focuses her opinions on whether Bard's use of polypropylene . . . resin, notwithstanding the disclaimer contained in the MSDS, was consistent with applicable FDA regulations." Notice of Adoption of Bard's Prior Memo. of Law in Opp'n to Pls. Mot. Exclude Ops. & Test. of Donna-Bea Tillman, Ph.D., M/P.A., FRAPS for Wave 4 & Wave 5 Cases, Ex. B at 9 (emphasis added) [ECF No. 4646-2]. In doing so, Bard cabins the testimony of Dr. Tillman within the purview of this court's decision to exclude testimony related to FDA compliance in this case insofar as a Daubert motion challenges it. Having done so, the plaintiffs' motion on this point is GRANTED.

IV. Conclusion

To summarize, I GRANT the plaintiffs' motion concerning Dr. Donna Bea Tillman, Ph.D., M/P.A., FRAPS [ECF No. 4549] 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"