MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Matthew Clark, 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 Certain General Opinions and Testimony of Matthew Clark, M.D. [ECF No. 4540]. 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. 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 general opinions and testimony of Matthew Clark, M.D. Dr. Clark is an urogynecologist. The plaintiffs argue that the court ought to preclude Dr. Clark from offering opinions on mesh shrinkage, polypropylene degradation, the polypropylene MSDS, and position statements. Under my discretion, I will address such arguments under the Daubert standards as I see fit.
1. Opinions Regarding Mesh Shrinkage
The plaintiffs argue that Dr. Clark's opinions regarding mesh shrinkage should be excluded because his methodology is unreliable. In particular, they allege that he based his opinions merely on personal experience and little scientific literature. 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. Clark's clinical experience includes thousands of procedures involving transvaginal mesh, and his professional experience includes lecturing and teaching on the subject of sling and prolapse mesh products. Further, Dr. Clark cites relevant studies to support his opinion that the mesh in question does not shrink. I therefore FIND that Dr. Clark is qualified to offer the opinion that the mesh in question does not shrink.
Next, the plaintiffs challenge the reliability of Dr. Clark's opinion. According to the plaintiffs, Dr. Clark's opinion is contrary to generally accepted scientific phenomenon, inconsistent with the very studies he cites, and contrary to Bard's internal documents. The challenges advanced by the plaintiffs here, however, are more appropriate on cross-examination. Therefore, I FIND that Dr. Clark's clinical experience and review of the scientific literature are sufficiently reliable bases in forming this particular opinion.
2. Opinions on Degradation of Polypropylene
The plaintiffs also challenge Dr. Clark's opinion that polypropylene mesh does not degrade in the human body. In particular, they take issue with the following statement from Dr. Clark's expert report:
[A]lthough I have reviewed the medical application caution language included in the Marlex HGX-030-01 MSDS, I am not aware of any medical literature or scientific information to support the theory [polypropylene] is not suitable for permanent implant in humans or that it degrades as a result of either oxygen or peroxides in the body or intraoperative contact, however minimal, with Betadine.
Notice of Adoption of Prior Daubert Mot. of Matthew Clark, M.D. for Waves 4 & 5 Cases, Ex. 1 (Clark Report), at 33 [ECF No. 4540-1]. In sum, the plaintiffs argue that this opinion is unreliable because some of Dr. Clark's reliance materials and multiple scientific studies refute his conclusion.
The plaintiffs' arguments here do not assist me in my Daubert analysis. I am to determine whether the methodology used by Dr. Clark in developing his opinions was reliable. The plaintiffs, instead, focus their arguments on why Dr. Clark's ultimate conclusion—that degradation does not occur—is wrong according to other sources. However, under Daubert, the court is not to decide whether an opinion is scientifically correct; it is to evaluate the method a proffered expert uses in reaching that opinion. Daubert, 509 U.S. at 595 ("The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate."). If the plaintiffs wish to challenge the content of Dr. Clark's conclusion regarding degradation, they may do so on cross-examination.
Moreover, the plaintiffs' argument that Dr. Clark is unreliable because he failed to account for this contrary literature is unavailing. In arguing this, the plaintiffs refer to parts of my Daubert opinion in Tyree concerning Dr. Margolis. See Tyree v. Bos. Sci. Corp., 2014 WL 5320566, No. 2:12-cv-08633, at *7 (S.D. W. Va. Oct. 17, 2014). In Tyree, the challenging party cited to particular portions of Dr. Margolis's deposition testimony where he was asked about specific studies contrary to his opinion and, then, dismissed them in a conclusory manner without a scientific basis. Here, the plaintiffs point to no such testimony. The mere statement in Dr. Clark's report that he is "not aware of any medical literature or scientific information to support the theory that [polypropylene] . . . degrades" is hardly equivalent.
Therefore, the plaintiffs' Motion with respect to this matter is DENIED.
3. Opinions Regarding the MSDS
The plaintiffs next seek to exclude Dr. Clark's opinions on the polypropylene MSDS. They take issue with the following passage of Dr. Clark's report:
[Polypropylene] is composed of raw materials that are extruded in the thin filaments woven into the final mesh product. Because the resin is altered in the process of manufacturing, my focus as a surgeon has been on the biocompatibility of the final product rather than the raw material. In particular, I have never asked a manufacturer of medical devices for information regarding the substance of an MSDS, which I understand is regulated by the Occupational Safety & Health Administration (OSHA) and used to ensure workplace safety where raw materials are being used. Nor would I expect a manufacturer to provide me with the MSDS, which has proven to be misleading and harmful in understanding the properties of the manufactured device. Prior to being shown the MSDS listed in my reliance list, I had never before examined an MSDS in the course of my practice.
Notice of Adoption of Prior Daubert Mot. of Matthew Clark, M.D. for Waves 4 & 5 Cases, Ex. 1 (Clark Report), at 33. In particular, the plaintiffs challenge his opinions that the MSDS is a workplace safety regulation merely applying to raw materials and that he does not use MSDSs in his medical practice.
In Tyree, I stated the following in excluding the testimony of a proffered safety, health, and training expert:
Although I believe that the warning provided in the MSDS is relevant, I do not believe an expert is required to discuss MSDSs generally or the issue of whether polypropylene requires an MSDS because of its hazardous nature. A narrative review of the history and development of MSDSs and who uses them in the field is not helpful to the jury. The pertinent issue is that the MSDS contained a warning (Medical Application Caution) allegedly not heeded by BSC, not that an MSDS itself existed. This warning from the supplier could have taken any form.
Tyree, 2014 WL 5320566, at *63. To the extent that Dr. Clark's opinions are a mere general discussion of MSDSs, those opinions are EXCLUDED. The plaintiffs' Motion is GRANTED to the extent that Dr. Clark's opinions run counter to my ruling above in Tyree.
The plaintiffs also argue that his statement, "I had never before examined an MSDS in the course of my practice[,]" is unhelpful to a jury and irrelevant. Notice of Adoption of Prior Daubert Mot. of Matthew Clark, M.D. for Waves 4 & 5 Cases, Ex. B, at 33. I agree with the plaintiffs that this is not an expert opinion. Dr. Clark is merely stating what he does in his practice. Thus, I need not address its relevancy under Daubert.
In its response, Bard contends that Dr. Clark must be permitted to opine on the medical community's standard practice with regard to use of MSDSs in order to refute the plaintiffs' general position in certain cases that Bard should have provided the MSDS, or at least the information contained therein, to physicians. Notice of Adoption of Bard's Prior Mem. of Law in Opp'n to Pls.' Mot. to Exclude Certain General Ops. & Test. of Matthew Clark, M.D. for Waves 4 & 5 Cases, Ex. 1 (Clark Report), at 16-17 [ECF No. 4638-2]. However, I do not read the above contested sentence to disclose such an opinion. I will not address the admissibility of this nonexpert testimony here.
4. Opinions Regarding the AUGS/SUFU Position Statement
Last, the plaintiffs seek to exclude Dr. Clark's references to organizational statements, including those of the American Urogynecological Society ("AUGS") and the Society for Female Urology and Urodynamics ("SUFU"). 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. Clark 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. Matthew Clark, M.D. [ECF No. 4540], 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
