Winkelmeyer v. DePuy Orthopedics, Inc.

District Court, W.D. Missouri·Decided March 30, 2023·No. 2:13-cv-04058·Unknown

Opinion

UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

WILLIAM K. WINKELMEYER, M.D., and BRENDA WINKELMEYER,

Plaintiffs,

v. Case No. 2:13-cv-04058-NKL

DEPUY ORTHOPAEDICS, INC.; DEPUY PRODUCTS, INC.; DEPUY SYNTHES, INC.; JOHNSON & JOHNSON, INC.; JOHNSON & JOHNSON SERVICES, INC.; and JOHNSON & JOHNSON INTERNATIONAL,

Defendants.

ORDER Defendants DePuy Orthopaedic, Inc., DePuy Products, Inc., DePuy Synthes, Inc., Johnson & Johnson, Inc., Johnson & Johnson Services, Inc., and Johnson & Johnson International (together, “DePuy”) move to disqualify the expert designated by plaintiffs William K. Winkelmeyer, M.D., and Brenda Winkelmeyer, Stephen Li, Ph.D., from providing expert testimony in this case. Doc. 15. For the reasons discussed below, the motion to disqualify is denied. I. BACKGROUND1 Dr. Li, a polymer chemist, had been one of the scientists at DuPont who invented an

1 In support of its motion, DePuy has submitted the Declaration of an attorney, Kenneth Inskeep, who formerly “had a leadership role in defending the litigation against DePuy and affiliated companies involving the Pinnacle Cup System through the time the consolidated Aoki cases were settled.” In response, Mr. Winkelmeyer has submitted Dr. Li’s affidavit, which states that he does not “recall” Mr. Inskeep’s or any other DePuy lawyer’s sharing any confidential or proprietary DePuy information or any mental impressions or litigation strategy with him. Insofar as Mr. Inskeep’s specific recollections, which include memories refreshed by his notes and other 1 enhanced polyethylene for use as the bearing surface in hip replacements. Dr. Li subsequently was employed in the implant retrieval laboratory of the Hospital for Special Surgery in New York, New York, where (among other things) he studied the performance of components that had been retrieved from patients. Dr. Li also served as lead reviewer on an FDA Advisory Panel that considered the potential down-classification of metal-on-metal devices in August 2001.

In the early 1990s, Mr. Inskeep’s law firm, Barnes & Thornburg, engaged Dr. Li on behalf of DePuy as an expert in cases involving various hip devices, including the ACS and Duraloc cup systems as both a consulting and testifying expert. For a period of time thereafter, Dr. Li was one of DePuy’s principal outside consulting and testifying experts, “particularly on cases involving polyethylene performance.” When “significant litigation . . . involving DePuy’s metal-on-metal (‘MoM’) hip replacement options” “emerged” in 2010, Mr. Inskeep contacted Dr. Li. Dr. Li then advised Mr. Inskeep that a plaintiff’s personal injury firm had approached him to potentially serve as an expert witness in an ASR MoM case against DePuy. Mr. Inskeep responded that, “under the applicable

ethical rules, [he] could not consult with him or discuss MoM hip litigation if he had received any confidential information or performed any substantive consulting with a lawyer representing a Plaintiff.” Dr. Li “confirm[ed] . . . that he had received no confidential information from the lawyer involved, had performed no substantive work, and had informed the lawyer he was declining the proposed engagement . . . .” Mr. Inskeep met with Dr. Li on October 27 and 28, 2010 “to discuss the ASR litigation specifically, but also MoM hips more generally, as [Mr. Inskeep] anticipated [DePuy’s legal

documents, are more precise than those of Dr. Li, the Court credits Mr. Inskeep’s statements. 2 counsel] might also want to use [Dr. Li] as an expert in the litigation involving the DePuy Pinnacle MoM device.” Mr. Inskeep states that “[m]uch of [their] discussion was applicable to both ASR and Pinnacle devices,” but absent from Mr. Inskeep’s declaration is any indication that he communicated to Dr. Li that the consultation would concern MoM Pinnacle devices, the type of device at issue in this case. Mr. Inskeep supplied Dr. Li with “certain medical and scientific journal

articles [Mr. Inskeep] considered important and key regulatory documents.” The subject of their “extensive discussion and detailed analysis” included “MoM devices generally, including the DePuy Pinnacle device (not just the ASR), and [Mr. Inskeep’s] mental impressions and potential strategies for defending MoM cases, and his reactions and thoughts on these topics.”2 Mr. Inskeep states that after this meeting, “it was decided,” though it is not clear by whom, “that the Pinnacle defense team would continue to consult with Dr. Li, and that the ASR defense team would consult with different experts.” There is no suggestion that Dr. Li was included in, or informed of, this decision. Mr. Inskeep was the attorney “principally responsible for dealings with Dr. Li on the

2 More specifically, the topics included: the performance of “first generation” MoM hips; (b) the development and rationale for reintroducing MoM devices in the 2000s; (c) clinical performance data for ASR MoM devices, (d) specific ASR design issues being raised by Plaintiffs, in the literature and identified by defense lawyers, and how the Pinnacle design was different, (e) wear debris from MoM devices and what role if any it plays in various failure modes; (f) factors to consider in evaluating the performance of any particular patient’s MoM device, (g) blood ion levels in MoM patients and their significance from both a product performance and biologic impact perspective, (h) an extensive review of the history of the development of hip replacements and various design and material changes from the 1890s to the present time and the tradeoffs involved in design and material choices, (i) the development over time of lab testing techniques for hip replacement and the associated limitations on what could be studied and known, (j) various FDA positions/actions related to MoM devices, and (i) the state of knowledge when MoM devices were introduced by DePuy regarding the benefits and risks of different bearing surfaces (i.e., various types of polyethylene, metal, and ceramics). 3 Pinnacle litigation.” Mr. Inskeep describes periodic discussions with Dr. Li in 2011 as “follow[-]up on various issues from our 2010 meeting, but focusing on their applicability to the Pinnacle litigation and other matters specific to the Pinnacle litigation.” In addition, the topics discussed between 2010 and 2013 between Mr. Inskeep and Dr. Li were: • respective analysis of new developments and journal articles, • the theories of attack by Plaintiffs,

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Winkelmeyer v. DePuy Orthopedics, Inc., (W.D. Mo. 2023).

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