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It more or less came out of nowhere, but we’re now watching what’s going on in the Martinez v. Coloplast Corp., No. 2:18-CV-220-JTM-JEM (N.D. Ind.), pelvic mesh case.  Recently, we’ve come across a number of interesting, and generally favorable, Fed. R. Civ. P. 702 expert gatekeeping decisions bearing that caption, as Martinez approaches trial (scheduled for March 21, although the plaintiff has sought a continuance).

Here’s what we have seen:

Decision #1 (in chronological order):  Martinez v. Coloplast Corp., 2022 WL 425206 (N.D. Ind. Feb. 11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.”  Id. at *1.  The defendant sought Pence’s exclusion because “she is not qualified due to her lack of education, experience, or specified knowledge about the regulation of medical devices, specifically the defendants’ mesh.”  Id. at *2.  That’s precisely what this Martinez decision held.  In the medical device field, Pence is to be “view[ed] . . . with skepticism” because her purported expertise is entirely litigation generated:

[Someone] with impressive credentials in a different field also may do research and form an opinion at the request of a party to the litigation.  The court should view that opinion with skepticism. . . .   Someone who attempts to gain knowledge solely for the purpose of litigation should not be considered an expert for purposes of Rule 702.

Id. at *3.

Specifically, Pence’s professional experience is limited to prescription drugs.  “She did not begin working with medical device products until she started her own [litigation] consulting business.”  Id.  She has no professional expertise in:  (1) chemical engineering, (2) polymer science, (3) biocompatibility testing, (4) the plaintiff’s underlying medical condition, (5) device clinical trials, (6) preparing device instructions for use, (7) pelvic mesh research, or (8) pelvic mesh post-market surveillance.  Id.  “None” of her “publications has any connection to “conducting clinical trials for medical devices or post marketing surveillance for medical products.”  Id.  Thus, Pence’s proposed testimony didn’t “fit” this case:

There is no logical connection between her expertise, the issues in the case, and her opinions.  By her own admission, she has had no clinical experience with pelvic mesh devices and has not engaged in research regarding them.  Rather, her only experience with pelvic mesh devices is testifying as a paid expert witness in products liability litigation.  [Plaintiff’s] argument that [her] testimony has been admitted in other cases is not persuasive . . . [since] every case must be decided on its own merits.

Id.  Nor could Pence opine on “the knowledge of the defendants” using internal documents  Id. at *4.  “As a general rule, a document ‘speaks for itself.’  A witness cannot testify about what a document means – that is the function of the jury.”  Id.

Decision #2:  Martinez v. Coloplast Corp., 2022 WL 409638 (N.D. Ind. Feb. 10, 2022), excluded another plaintiff-side recidivist “expert,” Jimmy Mays, a retired chemist.*  “In evaluating the proposed testimony, [under Rule 702] courts also have referred to a ‘fit’ and an ‘intellectual rigor’ requirement.”  Id. at *2.  Mays struck out.

[He] proposes to offer the opinion that the defendants’ mesh implants undergo oxidative degradation. . . .  [He] has come to this opinion without testing his hypotheses on the defendants’ mesh and without examining the defendants’ mesh or the mesh explanted from [plaintiff].  [Plaintiff] argues that [Mays’] testing of the [a different manufacturer’s] mesh, makes up for the fact that he has failed to test his hypotheses on the defendants’ mesh.  But, [he] testified that there are differences between the [other] mesh and the defendants’.

Id. at *3 (citation omitted).

Further, the scientific literature Mays relied on was “debunk[ed].”  Id.  Other recent research offered a plausible rebuttal to [Mays’] criticism, and once again, [he] did not perform any tests of his own.”  Id.  His failure to conduct any testing demonstrated that Mays “did not apply the same ‘intellectual rigor’ to his litigation opinions as he did to his 400 published articles.”  Id. at *4.  Finally:  (1) Mays “misquote[d]” a key article as saying the opposite of what it actually did, id., and (2) like Pence, Mays would could not testify about the supposed knowledge of the defendants.  Id.

Decision #3:  Martinez v. Coloplast Corp., 2022 WL 336811 (N.D. Ind. Feb. 4, 2022), similarly excluded large parts of the opinions of Michael Margolis, M.D., yet another serial mesh testifier.  The problems with Dr. Margolis’ opinions were many.  While he is a practicing pelvic surgeon, he had no product-design-related expertise:

Dr. Margolis has not demonstrated that he has any training or experience that would allow him to reliably testify as to how the design of the [product] is defective. . . .  Dr. Margolis admitted at the hearing that he is neither a biomaterial nor biomechanical expert and that he has not had any training in either field.  He also stated that he never has viewed [this brand of mesh] under a microscope before it was implanted and could not remember whether he has done so once it was removed.

Id. at *3.

Nor did he have anything useful to add about product warnings:

In his deposition, [the implanting surgeon] conceded that he did not review the warnings prior to conducting the implantation surgery.  Given the fact that [the implanter] did not rely on the warnings, and [plaintiff’s] position that Dr. Margolis is unqualified to testify about the adequacy of the warnings on from a regulatory perspective, the court finds that any testimony from Dr. Margolis related to the warnings would not be reliable or relevant.

Id. at *4.

Nor was Dr. Margolis qualified to opine on plaintiff’s future medical needs.  He didn’t do what a doctor would have to do to form such an opinion – actually examine the patient.  “[W]ithout conducting a medical examination, Dr. Margolis cannot determine future medical care” since he “is not in a position to accurately measure the effects that [plaintiff’s] mental health problems have on her alleged physical symptoms.”  Id.

Decision #4:  Martinez v. Coloplast Corp., 2022 WL 336810 (N.D. Ind. Feb. 4, 2022), in which a fourth repeat-player, plaintiff-side purported expert bit the dust − Jerry G. Blaivas, M.D.  This witness had the same basic problem as Pence.  He sought to testify outside his area of professional expertise, urology, based on “articles that [he] has read on surgical meshes” when he never implanted them, but instead (used to) perform non-mesh surgery.  Id. at *2.  Although “undeniably . . . an expert on” non-mesh surgery and related medical conditions, “[t]he defendants did not manufacture [a] sling, and it is not an issue in this case.”  Id. at *4.  Thus, Dr.  Blaivas’ proposed testimony didn’t “fit” the Martinez case:

The proposed testimony of Dr. Blaivas lacks the “fit” requirement of . . . Rule 702.  There is no logical connection between his expertise, the issues in the case, and his opinions.  Additionally, given the area of Dr. Blaivas’ expertise, it is unlikely that he would have accepted [plaintiff] as a patient in his private practice.

Id.  Further, since “it is doubtful that Dr. Blaivas would treat a patient based only on knowledge that he has gained from medical journals,” his opinions, based solely on litigation-related research, lacked the necessary “intellectual rigor.”  Id. (“the ‘intellectual rigor’ of his proposed trial testimony cannot be compared to conclusions he may have drawn in his other professional activities”).

We’ve complained a lot about cases getting the “MDL treatment,” but judges faced with actually trying remand cases can be considerably more muscular in their approach to Rule 702.  That’s four pretty good opinions in the same case since the beginning of this month.  We’ll be on the lookout for more.


*Sorry, Bexis cannot call this Ph.D for hire “Dr. Mays.”  The only true “Dr. Mays” will always be the sainted Dr. Benjamin Mays, who was President of the Atlanta Board of Education when Bexis attended high school there.