King v. DePuy Orthopaedics Inc.

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Michael King, et al., Plaintiffs, v. DePuy Orthopaedics Incorporated, et al., Defendants.

No. CV-23-00196-PHX-SMB

United States District Court, D. Arizona

August 31, 2023

ORDER

Susan M. Brnovich United States District Judge

Pending before the Court are several motions: Defendants' Motion to Exclude, In Part, The Opinions And Testimony of David Kessler, M.D. (Doc. 64); Defendants' Motion to Exclude In Part, The Opinions and Testimony of William R. Evans M.D., P.A. (Doc. 62); Defendants' Motion To Exclude, In Part, The Expert Opinions And Testimony Of Minette E Drumwright (Doc. 61); and Defendants' Motion and Memorandum Of Law In Support Of Motion To Disqualify Plaintiffs' Expert Stephen Li (Doc. 30). Oral argument was held on August 28, 2023. After consideration of the documents, oral argument and relevant case law, the Court will grant some of the motions and deny others as discussed below.

I. BACKGROUND

This case arose out of the installation of an allegedly defective “metal-on-metal” hip replacement manufactured, marketed, and sold by Defendants. This hip replacement is known as the Pinnacle Acetabular Cup System (hereinafter “device”). The device is used to replace diseased hip joints and was intended to remedy conditions such as osteoarthirits, rheumatoid arthritis, avascular necrosis, or fracture. It also sought to provide patients with pain-free natural motion over a longer period of time than other hip replacement devices.

The device is composed of four components: “the metal femoral stem, which is inserted inside the femur bone; the metal femoral head (or ball), which connects to the top of the stem; the metal acetabular cup or shell (socket), which attaches to the pelvis; and the liner, which sits inside the acetabular cup.” (Doc. 17 at 7.) The acetabular cup is made of titanium, while the liner is made of either plastic, ceramic, or cobalt-chromium, depending on the patient. This case involves an implant with a cobalt-chromium lining and is referred to as a metal-on-metal (“MoM”) device. The MoM description designates devices containing the cobalt-chromium liner because “both articulating surfaces-the femoral head (ball) and the acetabulum liner (socket)-are comprised of cobalt-chromium metal.” (Id.)

Plaintiffs allege that due to the friction between these two components, cobaltchromium metal particles are released. The resulting particles accumulate in the patient's surrounding tissue and end up in the patient's bloodstream. This in turn can lead to metallosis, biological toxicity, pseudotumors, infection, inflammation, and an early and high failure rate of the device. (Id. at 6.) Plaintiffs also allege that the metal components corrode inside the body, leading to many of the same ailments. (Id. at 10.)

On June 28, 2010, Plaintiff Michael King underwent a total hip arthroplasty procedure in Mesa, Arizona and had a MoM device implanted in his left hip. After the procedure, Plaintiff alleges that the friction between the cobalt-chromium components caused metal ions and particles to be released into his blood, tissue, and bone surrounding the implant, resulting in severe pain, discomfort, and inflammation. Due to these symptoms, Plaintiff underwent a second surgery to replace the device on January 10, 2014.

Plaintiffs filed suit alleging negligence, strict liability, fraud, negligent misrepresentation, and breach of warranty claims. (See Doc. 17.) In addition, Mr. King's wife, Deborah King, filed a loss of consortium claim. (See id.) The case was initially filed in the United States District Court for the Northern District of Texas as part of the multi- district litigation against Defendants coordinated out of that District. This case was not selected as one of the bellwether cases. See In re: DePuy Orthopaedics, Inc., MDL Docket No. 3:11-MD-2244-K, 2016 WL 6271474, at *1 (N.D. Tex. Jan. 5, 2016). Therefore, it was consolidated for purposes of discovery and pretrial matters. See id.; 28 U.S.C. § 1407. Litigation continued in the bellwether cases, resulting in substantial fact and expert discovery. This case was transferred to the District of Arizona on December 30, 2022. (Doc. 41.)

Before the Court now are Defendants' Motions to exclude, in part, the opinions and testimony of three of Plaintiffs' expert witnesses-Minette E. Drumright, Ph.D. (Doc. 61), William Evans, M.D., P.A. (Doc. 62), and David Kessler, M.D. (Doc. 64.) These Motions address the qualifications of these experts and the reliability and relevance of the opinions to be proffered. Defendants also filed a Motion to Disqualify one of Plaintiffs' expert witnesses, Stephen Li, M.D. (Doc. 30.) The parties jointly requested to hear this Motion to Disqualify at the scheduled hearing on the other Motions, and the Court agreed. (Docs. 96; 97.) The Court will address each of these Motions below.

II. LEGAL STANDARD

A party seeking to present an expert's testimony carries the burden establishing that testimony's admissibility. Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007). Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) govern the admissibility of such testimony. Rule 702 states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. Daubert entrusts courts to act as gatekeepers tasked with excluding unreliable expert testimony. 509 U.S. at 597; see also Elosu v. Middlefork Ranch Inc., 26 F.4th 1017, 1024 (9th Cir. 2022) (“Rule 702 tasks a district court judge with ensuring that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand.”) (cleaned up).

Expert testimony is admissible only if it is relevant and reliable. Daubert, 509 U.S. at 589. Expert testimony is “relevant” if it fits the facts of the case and logically advances “a material aspect of the proposing party's case.” Daubert v. Merrell Dow Pharms., Inc. (Daubert II), 43 F.3d 1311, 1315 (9th Cir. 1995). Expert testimony is “reliable” if the expert's opinion is reliably based in the “knowledge and experience of the relevant discipline.” Alaska Rent-A-Car, Inc. v. Avis Budget Grp., Inc., 738 F.3d 960, 969 (9th Cir. 2013) (quoting Primiano v. Cook, 598 F.3d 558, 565 (9th Cir. 2010)). To assess reliability, courts may consider “(1) whether the theory can be and has been tested, (2) whether the theory has been peer reviewed and published, (3) what the theory's known or potential error rate is, and (4) whether the theory enjoys general acceptance in the applicable scientific community.” Murray v. S. Route Mar. SA, 870 F.3d 915, 922 (9th Cir. 2017). Courts have great discretion in determining whether Daubert's specific factors are “reasonable measures of reliability in a particular case.” McClure v. State Farm Life Ins. Co., 341 F.R.D. 242, 256 (D. Ariz. 2022) (citing Kuhmo Tire Co. v. Carmichael, 526 U.S. 137, 153 (1999)). Unlike challenges to an expert opinion's relevancy or reliability, challenges to the “correctness” of an opinion go to its weight, not its admissibility. Messick v. Novartis Pharm. Corp., 747 F.3d 1193, 1199 (9th Cir. 2014).

III. DISCUSSION

A. David Kessler, M.D.

Dr. Kessler is a physician and lawyer. He received his M.D. from Harvard Medical School in 1979 and his J.D. from the University of Chicago Law School in 1978. He served as Commissioner of the United States Food and Drug Administration from 1990 to 1997. Dr. Kessler also taught food and drug law at Columbia University, testified before Congress on the federal regulations of drugs and medical devices, and published numerous articles in legal, medical, and scientific journals on the federal regulation of drugs and medical devices. Additionally, he serves on the boards of two pharmaceutical companies.

Defendants do not move to preclude Dr. Kessler's testimony altogether. Rather, they seek to preclude his testimony in areas that are not the subject of proper expert testimony and his opinion of the risk of systemic illness from metal wear debris. Defendants further claim that Dr. Kessler's opinions include improper legal conclusions and that his opinions about DePuy's ethical responsibilities and knowledge comprise improper expert testimony.

Defendants argue that Dr. Kessler should be precluded from testifying as to his opinion about DePuy's duty to warn. Defendants point to several places in Dr. Kessler's expert report where he opines that DePuy failed to adequately warn of risks associated with revision due to metallosis or had a duty to warn about that risk. Defendants contend that these opinions amount to an improper legal conclusion. “[A]n expert cannot testify to a matter of law amounting to a legal conclusion.” United States v. Tamman, 782 F.3d 543, 552 (9th Cir. 2015). Plaintiffs point out that an opinion that touches on legal issues is not necessarily precluded. Plaintiffs argue that Dr. Kessler's opinions will not encroach on the Court's role in instructing the jury on the law.

To prove a strict products liability claim based on failure to warn, a plaintiff must prove “that the manufacturer had a duty to warn of the product's dangerous propensities and that the lack of an adequate warning made the product defective and unreasonably dangerous.” Watts v Medicis Pharm. Corp., 365 P.3d 944, 948 (Ariz. 2016). The Court finds that...