Nicholson v. Biomet, Inc.

• Decision Date: 24 August 2022
• Docket Number: 21-2263
• Citation: 46 F.4th 757
• Parties: Lori NICHOLSON, Plaintiff - Appellee Willis William Nicholson, Plaintiff v. BIOMET, INC.; Biomet Orthopedics, LLC ; Biomet Manufacturing LLC, formerly known as Biomet Manufacturing Corp.; Biomet U.S. Reconstruction, LLC, Defendants - Appellants
• Court: U.S. Court of Appeals — Eighth Circuit

46 F.4th 757

Lori NICHOLSON, Plaintiff - AppelleeWillis William Nicholson, Plaintiff

v.BIOMET, INC.; Biomet Orthopedics, LLC ; Biomet Manufacturing LLC, formerly known as Biomet Manufacturing Corp.; Biomet U.S. Reconstruction, LLC, Defendants - Appellants

No. 21-2263

United States Court of Appeals, Eighth Circuit.

Submitted: April 13, 2022

Filed: August 24, 2022

Counsel who presented argument on behalf of the appellants and appeared on the appellants brief was Aaron Daniel Van Oort, of Minneapolis, MN. The following attorney(s) appeared on the appellants brief; Joseph Michael Price, of Minneapolis, MN., Bruce Gregory Jones, of Minneapolis, MN., Thomas James Joensen, of Des Moines, IA., Stephanie Anne Koltookian, of Des Moines, IA., Bryan D. Pasciak, of Chicago, IL., Thomas Kus, of Fort Wayne, IN.

Counsel who presented argument on behalf of the appellee and appeared on the appellee brief was Bryan S. Gowdy, of Jacksonville, FL. The following attorney(s) appeared on the appellee brief; Jeffrey L. Haberman, of Fort Lauderdale, FL., Dimitrios A. Peteves, of Jacksonville, FL.

Before SMITH, Chief Judge, WOLLMAN and GRASZ, Circuit Judges.

GRASZ, Circuit Judge.

This products liability case arises out of the multidistrict litigation¹ ("MDL") proceedings regarding Biomet's M2a Magnum hip-replacement device. After experiencing complications from a hip replacement surgery using the M2a Magnum, Lori Nicholson sued Biomet, Inc., Biomet Orthopedics, LLC, Biomet Manufacturing LLC, and Biomet U.S. Reconstruction, LLC (collectively, "Biomet"), alleging multiple claims, including defective design. A jury ultimately found in Nicholson's favor, concluding the M2a Magnum was defectively designed. The jury also awarded Nicholson punitive damages. Biomet moved for a new trial and renewed its motion for judgment as a matter of law, but the district court² denied these motions. For the reasons set forth below, we affirm.

I. Background

Nicholson's left hip was replaced in 2007 with Biomet's M2a Magnum—a large metal-on-metal articulation total hip replacement device. About four years later, Nicholson returned to her surgeon, Dr. Emile Li, with hip pain and a cyst at the crease of her left hip. Dr. Li determined Nicholson's symptoms were caused by the M2a Magnum's loosening and migration. Dr. Li attributed the cyst and migration to metal-on-metal wear and the release of metal ions. Dr. Li tested Nicholson's chromium and cobalt levels through a blood draw and discovered Nicholson's chromium level was six times the normal rate. Dr. Li diagnosed Nicholson with metallosis—deposition of metal debris into bodily fluids and tissue—and concluded the M2a Magnum had failed. Dr. Li recommended Nicholson have a revision surgery to replace the metal-on-metal M2a Magnum with a metal-on-polyethylene ("metal-on-poly") device. Dr. Li performed Nicholson's revision surgery months later without complication, and Nicholson's condition improved.

Nicholson later sued Biomet, asserting multiple claims—including one for defective design.³ Nicholson also sought punitive damages, alleging Biomet knew the M2a Magnum's metal-on-metal design was defective yet continued to design, manufacture, and market the device with a conscious and deliberate disregard for the rights and safety of consumers. Biomet moved for summary judgment on all claims. The district court granted summary judgment in favor of Biomet on all claims except for Nicholson's defective design and punitive damages claims. Among the claims on which the district court awarded summary judgment to Biomet was a product liability claim based on a failure to warn. The district court held the warnings and instructions for the device were adequate as a matter of law.

The case proceeded to a jury trial on the defective design claim and punitive damages. The jury found for Nicholson, finding the alleged design defect of the M2a Magnum caused Nicholson's injuries, and awarded $1,050,000 in compensatory damages. The jury further found Biomet's conduct constituted a willful and wanton reckless disregard for the rights and safety of consumers and awarded Nicholson $2,500,000 in punitive damages.

Biomet then filed two post-trial motions. First, Biomet moved for a new trial claiming the district court erred in admitting evidence and refusing to give appropriate jury instructions. Second, Biomet moved for judgment as a matter of law on Nicholson's defective design claim and on Nicholson's request for punitive damages. The district court denied both motions. Biomet now appeals the district court's denial of these post-trial motions.

II. Analysis

A. Biomet Was Not Denied a Fair Trial

Biomet claims the district court erred in denying its motion for a new trial. Specifically, Biomet argues it is entitled to a new trial because the district court erroneously: (1) admitted testimony relying on post-2007 data regarding the performance of metal-on-metal devices while refusing to allow Biomet to introduce evidence of the M2a Magnum's performance in 2007; (2) failed to instruct the jury on its previous ruling that the M2a Magnum's warnings were adequate as a matter of law; and (3) admitted certain testimony from Nicholson's experts.

We review the district court's denial of a new trial for abuse of discretion. Bank of Am., N.A. v. JB Hanna, LLC , 766 F.3d 841, 851 (8th Cir. 2014). When a motion for new trial is based on evidentiary rulings or jury instructions, "we will not reverse the district court in the absence of ‘a clear and prejudicial abuse of discretion.’ " SEC v. Cap. Sols. Monthly Income Fund, LP , 818 F.3d 346, 353 (8th Cir. 2016) (quoting White v. McKinley , 605 F.3d 525, 533 (8th Cir. 2010) ); accord Vaidyanathan v. Seagate US LLC , 691 F.3d 972, 976 (8th Cir. 2012). In other words, "[a] new trial is necessary only when the errors misled the jury or had a probable effect on a jury's verdict." Vaidyanathan , 691 F.3d at 978 (quoting Slidell, Inc. v. Millennium Inorganic Chems., Inc. , 460 F.3d 1047, 1054 (8th Cir. 2006) ).

1. Post-2007 Evidence and the M2a Magnum's Performance

Biomet first argues a new trial is needed because the district court erroneously permitted Nicholson to introduce evidence regarding post-2007 data on the performance of metal-on-metal devices while it forbade evidence of the M2a Magnum's performance. Biomet sought to introduce evidence that, on the week of Nicholson's surgery in 2007, the MAUDE database⁴ —a government database housing medical device reports—showed only one complaint of the M2a Magnum's loosening out of approximately 25,000 devices sold. The district court excluded Biomet's evidence, along with any evidence of gross data from either side on failure rates, because the data's probative value did not outweigh the danger of misleading the jury. The district court, however, allowed post-2007 evidence relating to causation issues.

At trial, Nicholson's experts Mari Truman and Dr. John Cuckler testified that metal-on-metal devices had higher rates of revision surgery than metal-on-poly devices because metal-on-metal devices have a higher risk of causing damage.⁵ These experts used post-2007 data and academic research to reach their conclusions. In response, Biomet sought to elicit testimony from Dr. Li explaining that, out of the 200 M2a Magnums he had used in surgery, Nicholson's was the only revision he performed. Biomet also sought to introduce evidence of post-market surveillance data up to 2016 showing the M2a Magnum performed almost identically to metal-on-poly devices and performed substantially better than other metal-on-metal devices. The district court excluded this evidence and upheld its rulings in denying Biomet's motion for a new trial.

a. The MAUDE Data

Biomet argues the district court abused its discretion by excluding its MAUDE data. Biomet argues this evidence was relevant because it "powerfully supported the reasonableness of Biomet's conduct in designing and selling the M2a Magnum in 2007." Biomet also argues the district court erred in excluding the evidence based on relevancy because critiques concerning the data's meaning and value "are more appropriately directed to the weight, rather than the admissibility of this evidence." Tillman v. C.R. Bard, Inc. , 96 F. Supp. 3d 1307, 1332 (M.D. Fla. 2015).

Even if we assume the district court erred in excluding the MAUDE data, it is unlikely the data would have substantially swayed the jury. See Russell v. Anderson , 966 F.3d 711, 729 (8th Cir. 2020) (holding this court will not disturb the verdict unless "it is likely that the jury would have been substantially swayed by the wrongly excluded testimony if it had been admitted") (quoting Hall v. Arthur , 141 F.3d 844, 849 (8th Cir. 1998) ). The jury was tasked with determining whether Biomet's M2a Magnum design was defective. Nicholson presented evidence that Biomet knew of the foreseeable risks of using metal-on-metal devices and that reasonable alternative designs (metal-on-poly) would have reduced those foreseeable risks. See Restatement (Third) of Torts: Prods. Liab. § 2(b) (defining defective design); see also Wright v. Brooke Grp. Ltd. , 652 N.W.2d 159, 169 (Iowa 2002) (adopting sections 1 and 2 of the Restatement (Third) of Torts: Products Liability for product defect cases). The MAUDE data suggesting the M2a Magnum's success in 2007 does not refute any of Nicholson's evidence. Success of the M2a Magnum does not mean the design did not have foreseeable risks and that those risks could not have been prevented with an alternative design. We thus hold that any alleged error in excluding the MAUDE data was harmless. See White , 605 F.3d at 533 (holding reversal is necessary only if "there is no reasonable assurance the jury would have reached the same" verdict had the excluded evidence been admitted) (quoting Wilson v. City of Des Moines , 442 F.3d 637, 641 (8th Cir. 2006) ).

b. Testimony Relying on Post-2007 Data

Next, Biomet argues the district court erred in admitting...