Olszeski v. Ethicon Women's Health & Urology

• Decision Date: 13 April 2022
• Docket Number: 5:19CV1787
• Parties: JANE OLSZESKI, Plaintiff, v. ETHICON WOMEN'S HEALTH AND UROLOGY, et al., Defendants.
• Court: U.S. District Court — Northern District of Ohio

JANE OLSZESKI, Plaintiff, v. ETHICON WOMEN'S HEALTH AND UROLOGY, et al., Defendants.

No. 5:19CV1787

United States District Court, N.D. Ohio, Eastern Division

April 13, 2022

MEMORANDUM OF OPINION AND ORDER (GENERAL OPINIONS)

[RESOLVING ECF NOS. 135, 137, AND 143]

Benita Y. Pearson, United States District Judge

Pending are Plaintiff's and Defendants Ethicon, Inc. and Johnson & Johnson's motions to strike report and/or exclude testimony of an expert witness (general opinions) (ECF Nos 135, 137, and 143). The Court has been advised, having reviewed the record, the parties' briefs, and the applicable law.

I. Background

The background set forth in the Memorandum of Opinion and Order (ECF No. 301) is incorporated by reference herein.

II.

The Federal Rules of Evidence, and specifically Rule 702, “assign to the trial judge the task of ensuring that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand.” Daubert v. Merrill Dow Pharm., Inc., 509 U.S. 579, 597 (1993). Rule 702 governs the admissibility of expert testimony and codifies the Supreme Court's holdings in Daubert and Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999). Expert testimony is admissible only if (1) the testimony is based on sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the expert has reliably applied the principles and methods to the facts of the case. Fed.R.Evid. 702. The proponent of the expert testimony has the burden of establishing by a preponderance of the evidence that the proposed testimony satisfies those standards. See Fed.R.Evid. 702 advisory committee's note (2000); Daubert, 509 U.S. at 592 n.10. Expert testimony is not admissible “is the exception rather than the rule.” In re Scrap Metal Antitrust Litig., 527 F.3d 517, 530 (6th Cir. 2008) (quoting Fed.R.Evid. 702 advisory committee's note (2000)).

Furthermore, Daubert analysis includes consideration of Fed.R.Evid. 403. Daubert, 509 U.S. at 595. Therefore, courts in the Sixth Circuit employ a four prong test to determine the admissibility of expert opinions: “(1) that the witness, a qualified expert, (2) was testifying to a proper subject, (3) which conformed to a generally accepted explanatory theory, and (4) the probative value of the testimony outweighed its prejudicial effect.” United States v. Smithers, 212 F.3d 306, 312 (6th Cir. 2000) (citing United States v. Green, 548 F.2d 1261 (6th Cir.1977)).

III. ECF No. 137 - Shelby Thames, Ph.D.

Dr. Thames is a polymer chemist with a Ph.D. in organic chemistry and Defendants' material scientist in the case at bar. He served as a general expert during the MDL, in which he offered several opinions in defense of Ethicon's PROLENE-based meshes used by Ethicon to manufacture its SUI devices, including the TVT-O device that allegedly injured Plaintiff. He opines that it does not degrade after implantation into the human body. ECF No. 137-16 is his General Report. Dr. Thames's general opinion is that “Ethicon's Prolene material used in its mesh products does not undergo meaningful or harmful degradation in vivo.” ECF No. 137-16 at PageID #: [6]. ECF No. 137-19 is his case-specific report. The motion requests that the Court limit Dr. Thames' general and case-specific opinions. Sections A (the PROLENE used in Defendants' SUI mesh products undergoes in vivo degradation) and C (Dr. Thames cannot determine PROLENE's “toughness” from the tensile testing data collected from year 7 of Dan Burkley's dog study) of that motion are challenges to general opinions of Dr. Thames. Only these general portions will be addressed in this opinion.

A.

According to Plaintiff, Defendants have already admitted under oath through their 30(b)(6) corporate witness in the MDL, Dr. Thomas Barbolt, that the PROLENE used in their SUI mesh products undergoes in vivo degradation. Dr. Barbolt testified as follows at his trial deposition:

Q. . . . Is it Ethicon's position that the antioxidants in the polypropylene Prolene fibers in TVT can leach from the fibers?

MR. THOMAS: Object to the form of the question.

THE WITNESS: Yes.

* * *

Q. And could you explain to the ladies and gentlemen of the jury what we mean by “leach”?

A. Leaching means the movement of substances from an implant into the surrounding tissue.

* * * Q. So you would agree as a spokesperson -- as a 30(b)(6) person for Ethicon that the surface of polymer fibers, including the polypropylene fibers in TVT, can crack?

MR. THOMAS: Object to the form of the question.

THE WITNESS: Yes.

* * *

Q. Despite the antioxidants being added to the Prolene sutures, in two of the Prolene sutures in the study, the surface layer was cracked, correct?

MR. THOMAS: Object to the form of the question.

THE WITNESS: Two revealed cracking, yes.

BY MR. THORNBURGH:

Q. And you aren't suggesting to the ladies and gentlemen of the jury that those cracks were anything other than the Prolene polypropylene, are you?

A. No, I am not suggesting that, and that's not reflected in this report.

Q. You would agree that the surface layer that's cracked here is the polypropylene surface layer, correct?

MR. THOMAS: Object to the form of the question.

THE WITNESS: In reading the report, it says that -- that's what I would conclude.

* * *

Q. And that's Ethicon's position as you -- as the spokesperson for Ethicon, it's Ethicon's position that degradation, surface degradation, can occur, correct?

MR. THOMAS: Object to the form of the question.

THE WITNESS: Yes.

BY MR. THORNBURGH:

Q. And this was known well in advance of this statement that the material is not absorbed, nor is it subject to degradation, correct?

A. Yes. This is from 1992.

Deposition of Thomas A. Barbolt, Ph.D. (ECF No. 137-15) at PageID #: [360:20-25, 361:2-6, 385:14-20, 396:2-23, 409:2-13] (emphasis added). Plaintiff contends this binding testimony shows that PROLENE undergoes in vivo surface degradation and that Defendants knew this several years prior to disseminating misinformation to physicians in its labeling that erroneously claims that PROLENE does not degrade. Plaintiff argues Defendants should be precluded from providing new evidence or testimony through Dr. Thames that contradicts the testimony provided by the designated 30(b)(6) corporate witness. SeeRainey v. American Forest & Paper Ass'n. Inc., 26 F.Supp.2d 82, 94 (D.D.C. 1998).

In response, Defendants argue Dr. Thames's opinions are not barred by the Fed. R Civ. P. 30(b)(6) deposition testimony of Dr. Barbolt. According to Defendants, a full reading of Dr. Barbolt's testimony shows he does not admit Prolene degrades in vivo, and instead refers to subjective observations of surface cracking having no significance to the claims of degradation. He explains these observations are not the same as objective assessments necessary to establish Prolene meaningfully degrades in vivo. For example:

Q. Are you telling the ladies and gentlemen of the jury that when the outer surface of the polypropylene fibers crack and peel away from the surface, that that is not degradation?

MR. THOMAS: Object to the form of the question.

THE WITNESS: I am telling listeners that the key endpoint of adverse effects of degradation are molecular weight and tensile strength, both quantitative measures, not subjective assessments of surface changes, but quantitative measures that hold great weight and suggest that there's no degradation to the Prolene fiber in terms that are significant.

ECF No. 137-15 at PageID #: [373:24-374:12]; see also [448:19-449:16] (explaining that a study reported “no evidence of degradation that's meaningful.”). Defendants assert the opinions of Dr. Thames are consistent with Dr. Barbolt's testimony, and simply go a step further and shows that the cracked material is protein and not degraded mesh. See, e.g., ECF No. 137-16 at PageID #: [10] (“there are those who allege Prolene's structural changes in vivo are sufficient to affect property/device function loss. However, this tenet is not founded on factual, reliable and repeatable scientific data of which I am aware. It is my opinion, supported by extensive and repeatable experimental data, that such proponents have historically, and erroneously, identified adsorbed protein coatings on the implant surface as polypropylene; they are mistaken.”).

This prong of the motion is denied. See Pitlyk v. Ethicon, Inc., No. 20-cv-00886-SRB, slip op. at 2 (E.D. Mo. July 7, 2021) (“The motion is DENIED insofar as the Court finds that Defendant Ethicon is not bound by the admissions of its Federal Rule of Civil Procedure 30(b)(6) witness Dr. Thomas Barbolt, and DENIED insofar as the Court will not exclude Dr. Thames's opinions that contradict the testimony of Dr. Thomas Barbolt.”); Mason v. Ethicon, Inc., No. 6:20-cv-1078-RBD-DCI, 2021 WL 2580165, at *3 (M.D. Fla. June 10, 2021) (“Assuming Dr. Thames' testimony contradicts the testimony of Defendants' 30(b)(6) witness, this is an insufficient basis to preclude Dr. Thames' opinion.”).

B.

Next, Plaintiff argues Dr. Thames cannot determine PROLENE's “toughness” from the tensile testing data collected from year 7 of the dog study.^[1] Dr. Thames opines “[t]aken in totality, Burkley's physical property/toughness data validates toughness ‘improvement' after the initial implantation, and confirms no meaningful loss in molecular weight.” ECF No. 137-16 at PageID #: [9].

According to Defendants, Dr. Thames has a scientific basis for finding that the dog study showed “toughness” in Prolene increased and that demonstrates no degradation. Defendants maintain Plaintiff's argument is virtually identical to the argument in Plaintiffs' Wave 2 Motion in the MDL. In adopting its Wave 1 Thames Order, the MDL rejected this argument and denied plai...