throbber
United States Court of Appeals
`For the Eighth Circuit
`___________________________
`
`No. 21-2263
`___________________________
`
`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
`____________
`
`Appeal from United States District Court
`for the Northern District of Iowa
`____________
`
`Submitted: April 13, 2022
`Filed: August 24, 2022
`____________
`
`
`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
`
`1The Judicial Panel on Multidistrict Litigation transferred products liability
`
`cases concerning Biomet’s M2a Magnum to the United States District Court for the
`Northern District of Indiana. In re Biomet M2a Magnum Hip Implant Prod. Liab.
`Litig., 896 F. Supp. 2d 1339, 1340–41 (J.P.M.L. 2012). The United States District
`Court for the Northern District of Indiana then transferred Nicholson’s case to the
`Northern District of Iowa.
`
`
`2The Honorable C.J. Williams, United States District Judge for the Northern
`District of Iowa.
`
`
`
`-2-
`
`

`

`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
`
`
`3Nicholson’s defective design claim is governed by Iowa law. Adams v.
`
`Toyota Motor Corp., 867 F.3d 903, 916 (8th Cir. 2017) (“State law governs the
`substance of . . . diversity-based products liability actions.”) (alteration in original)
`(quoting Pritchett v. Cottrell, Inc., 512 F.3d 1057, 1063 (8th Cir. 2008)); see also
`Complaint, ECF No. 1 at 2, Nicholson v. Biomet, Inc, No. 3:18-cv-03057 (N.D. Iowa
`2021) (claiming federal jurisdiction under 28 U.S.C. § 1332).
`-3-
`
`
`
`

`

`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
`-4-
`
`
`
`

`

`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
`
`4The MAUDE database houses medical device reports submitted to the United
`
`States Food and Drug Administration (“FDA”) by mandatory reporters
`(manufacturers, importers, and device user facilities) and voluntary reporters such
`as health care professionals, patients, and consumers. FDA, Medical Device
`Reporting (MDR): How to Report Medical Device Problems, https://www.fda.gov/
`medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-
`medical-device-problems (last visited Aug. 8, 2022); see also 21 C.F.R. § 803.1(a)
`(establishing requirements for medical device reporting).
`
`
`5The district court also allowed Dr. George Kantor to testify about the number
`of revision surgeries he has performed on patients with second generation metal-on-
`metal hips. Biomet did not object to this testimony at trial but now argues the district
`court erroneously admitted this testimony. Accordingly, we review the district
`court’s admission of Dr. Kantor’s number of revision surgeries for plain error. See
`Dixon v. Crete Med. Clinic, P.C., 498 F.3d 837, 849–50 (8th Cir. 2007). Assuming
`for the sake of argument the admission of this testimony was plain error, the
`testimony did not prejudice Biomet’s substantial rights. We therefore reject
`Biomet’s argument.
`
`
`
`-5-
`
`

`

`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
`-6-
`
`
`
`

`

`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 testimony relying on
`post-2007 data on metal-on-metal devices. Biomet argues Nicholson should not
`“have been allowed to present evidence showing how the M2a Magnum performed
`and compared with products after 2007, since Biomet could not reasonably have
`known about or acted on that information” at the time of Nicholson’s surgery.
`Biomet is correct in that post-2007 data was inadmissible to show the M2a Magnum
`product was defectively designed. Biomet cannot be held liable for not acting on
`the post-2007 revision-rate data on the M2a Magnum at the time of Nicholson’s
`surgery in 2007. See Restatement (Third) of Torts: Prods. Liab. § 2(b) cmt. d (“If
`such a design could have been practically adopted at the time of sale and if the
`omission of such a design rendered the product not reasonably safe, the plaintiff
`establishes [design] defect[.]” (emphasis added)).
`
`But the post-2007 revision-rate data was admissible to prove causation—that
`is, the M2a Magnum’s metal-on-metal design caused Nicholson’s injury. Under
`Iowa law,
`
`
`[A] plaintiff seeking to recover damages on the basis of a design defect
`must prove “the foreseeable risks of harm posed by the product could
`have been reduced or avoided by the adoption of a reasonable
`alternative design by the seller or other distributor, or a predecessor in
`the commercial chain of distribution, and the omission of the alternative
`design renders the product not reasonably safe.”
`
`
`Wright, 652 N.W.2d at 169 (quoting and adopting Restatement (Third) of Torts:
`Prods. Liab. § 2(b)). The plaintiff must also show the defective design caused the
`plaintiff’s injury. Huber v. Watson, 568 N.W.2d 787, 790 (Iowa 1997) (“In products
`
`
`
`-7-
`
`

`

`liability, the plaintiff must prove his or her injuries were proximately caused by an
`item manufactured or supplied by the defendant.”).
`
`Here, Truman’s and Dr. Cuckler’s testimonies—relying on post-2007 data—
`suggesting metal-on-metal devices had higher revision rates went toward proving
`causation. Their testimony was limited to data concerning revision rates based on
`patients’ adverse biologic reactions to the metal-on-metal device. Thus, the
`evidence was probative of whether the M2a Magnum caused Nicholson’s
`complained-of injuries—hip implant failure based on loosening of the device, a
`pseudo cyst consistent with metal-on-metal wear, and increased chromium levels.
`
`Further, the danger of prejudice did not substantially outweigh the evidence’s
`probative value given the district court’s limiting instructions explaining that post-
`2007 evidence could only be used for purposes of causation. See Fed. R. Evid. 403;
`United States v. Howard, 977 F.3d 671, 676 (8th Cir. 2020), cert. denied, 142 S. Ct.
`123 (2021) (holding a limiting instruction “diminished the prejudicial effect of the
`evidence”). The district court explicitly warned the jury it “can’t use [post-2007]
`evidence to try to determine whether [Biomet] should have known about the results
`of [studies] that clearly occurred before—or after the implant.” Given the evidence’s
`probative value establishing causation and the district court’s limiting instructions,
`we will not disturb the jury’s verdict because of the admission of this evidence.
`
`
`c. Dr. Li’s Revisions and M2a Magnum’s Post-Market Data
`
`
`
`Biomet also argues the district court erred by precluding Biomet from offering
`fair rebuttal. Biomet argues that Dr. Li’s revision testimony and the M2a Magnum’s
`post-market data should have been admitted—even if the evidence was not
`originally admissible—because Nicholson’s expert testimony “opened the door.”
`We disagree.
`
`“The doctrine of opening the door allows a party to explore otherwise
`inadmissible evidence on cross-examination when the opposing party has made
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`

`

`unfair prejudicial use of related evidence on direct examination.” Valadez v. Watkins
`Motor Lines, Inc., 758 F.3d 975, 981 (8th Cir. 2014) (quoting United States v.
`Midkiff, 614 F.3d 431, 442 (8th Cir. 2010)). “But the door is not opened to all
`similar, inadmissible evidence.” Id. The evidence introduced must be in response
`to something elicited during the opposing party’s evidence. Id. In other words, it
`must actually rebut the initial testimony. See Hamilton v. Nix, 809 F.2d 463, 469
`(8th Cir. 1987).
`
`The evidence Biomet sought to introduce was not related to Nicholson’s
`expert testimony relying on post-2007 data. Nicholson’s expert testimony relying
`on post-2007 data established that metal-on-metal devices are known to cause the
`type of injuries suffered by Nicholson. As the district court made abundantly clear
`in its limiting instructions, the evidence was only admissible for the purpose of
`causation. Biomet’s proffered evidence did not speak to causation. Dr. Li’s history
`of revision surgery on patients with the M2a Magnum device and post-market data
`of the M2a Magnum do not rebut Nicholson’s claim that metal-on-metal devices
`cause the injuries at issue here. Thus, because Biomet’s proffered evidence does not
`speak to causation, the district court did not abuse its discretion in excluding this
`evidence.
`
`
`2. Expert Testimony
`
`
`
`Biomet also argues the district court abused its discretion in allowing
`Nicholson’s experts—specifically, Truman and Dr. Kantor—to testify on issues they
`were not qualified to address. Biomet argues the testimony given by the experts was
`outside their scope of expertise and unfairly prejudicial, warranting a new trial. For
`the following reasons, we disagree.
`
`
`a. Truman’s Testimony
`
`
`
`Biomet argues the district court erroneously allowed Truman, a biomedical
`engineer, to testify as to the causal relationship between metal ions produced by the
`-9-
`
`
`
`

`

`M2a Magnum device and adverse biologic reactions in patients. Before trial, the
`MDL court held that Truman “can’t testify as an expert on the clinical effects of
`metal ions” because she was not qualified to do so. But at trial, Truman testified
`that medical reports and literature reported adverse reactions caused by metal ions
`produced from metal-on-metal devices. This included testimony about the medical
`impact of metal ions in the body.
`
`
`Biomet argues Truman’s testimony was inadmissible under Federal Rule of
`Evidence 703 because it went beyond the scope of her expertise. Indeed, under Rule
`703, “[a] scientist, however well credentialed [she] may be, is not permitted to be
`the mouthpiece of a scientist in a different specialty.” Dura Auto. Sys. of Ind., Inc.
`v. CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002). Rule 703 does, however, allow
`experts to offer “an opinion on facts or data in the case that the expert has been made
`aware of or personally observed . . . [i]f experts in the particular field would
`reasonably rely on those kinds of facts or data in forming an opinion on the
`subject[.]” Fed. R. Evid. 703.
`
`
`The district court did not err in admitting Truman’s testimony because her
`testimony was limited to her opinion on the design of the M2a Magnum. Truman
`did not testify as to whether metal ions caused certain clinical effects. Instead, she
`relied on medical experts’ opinions about the clinical effects of metal ions to draw
`her conclusion as to whether the M2a Magnum was defective in its design.
`Biomedical engineers, such as Truman herself, unquestionably rely on such data
`from medical experts when designing medical devices compatible with the human
`body. Thus, Truman correctly used medical reports and literature as contemplated
`by Rule 703 to support her opinion as a biomedical engineer on the design of the
`M2a Magnum.
`
`If any of Truman’s testimony inadvertently touched on the causation of
`adverse medical reactions, any danger of prejudice was mitigated by the district
`court’s limiting instructions. The district court gave several limiting instructions
`explaining Truman did not have personal knowledge of metal ions and how metal
`-10-
`
`
`
`

`

`ions affect the body. The district court also explained that Truman was using expert
`reports to form her opinion on the M2a Magnum’s design. Given that these
`instructions effectively addressed Biomet’s concerns about Truman’s testimony
`being mistaken for that of a medical expert, it is hard to imagine that any alleged
`error in admitting the testimony prejudicially influenced the outcome of the trial.
`See United States v. Bassett, 762 F.3d 681, 688 (8th Cir. 2014) (“[A] proper limiting
`instruction serves as a protection against unfair prejudice.”) (alteration in original)
`(quoting United States v. Cockerham, 417 F.3d 919, 921 (8th Cir.2005)). For this
`reason, we hold the district court did not abuse its discretion in admitting Truman’s
`testimony.
`
`
`b. Dr. Kantor’s Testimony
`
`
`Biomet next argues the district court abused its discretion in allowing Dr.
`
`Kantor, an orthopedic surgeon, to testify on the ethics or criminality of introducing
`the M2a Magnum without first conducting clinical testing. Biomet also takes issue
`with Nicholson’s attorney’s comments regarding Dr. Kantor’s testimony during
`closing arguments.
`
`
`At trial, the district court permitted Dr. Kantor to give his opinion on the
`dangerousness of marketing a product without clinical testing—despite Biomet’s
`objections. The MDL court had precluded testimony from Dr. Kantor on the
`sufficiency of Biomet’s testing and clinical studies. The MDL court concluded Dr.
`Kantor’s opinion was not reliable on this topic based on Dr. Kantor’s admitting he
`had only looked at some of Biomet’s testing. Yet at trial, the district court admitted
`the following testimony:
`
`[Nicholson]:
`
`the
`to
`is your opinion with respect
`What
`dangerousness of marketing a product without
`doing clinical testing?
`
`
`[Dr. Kantor]:
`
`
`
`I think it’s unethical. I think it borders on criminal
`behavior, if you know that that—if you know that
`-11-
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`

`

`that material can be deleterious and harmful to
`patients, including—including the life of patients,
`because of
`the complications related
`to
`the
`introduction—reintroduction of a failed material.
`
`
`Then, during closing argument, Nicholson’s counsel reiterated Dr. Kantor’s
`
`testimony, but directed it toward Biomet’s testing specifically:
`
`
`[Nicholson]:
`
`
`[Biomet]:
`
`
`[The Court]:
`
`[Nicholson]:
`
`Dr. Kantor said that what was done was unethical
`and borderline criminal. Those are very strong—
`
`I’m going to object to that, Your Honor. I think that
`was stricken.
`
`Yeah, it was not. My recollection is that came in.
`
`Yeah. Those are very strong words, very strong
`words from a doctor, talking about a medical device
`company. And, obviously, he has very strong
`feelings, and that came through in spades.
`
`
`
`Even if the district court erroneously admitted Dr. Kantor’s testimony and
`Nicholson’s counsel’s statement during closing arguments, Biomet fails to show the
`errors “prejudicially influenced the outcome of the trial.” Coterel v. Dorel Juv. Grp.,
`Inc., 827 F.3d 804, 807 (8th Cir. 2016) (quoting Regions Bank v. BMW North Am.,
`Inc., 406 F.3d 978, 980 (8th Cir. 2005)). “To determine whether the evidentiary
`errors . . . prejudicially influenced the outcome of the case, we look to the jury’s
`verdict.” Id. at 808 (quoting Qualley v. Clo–Tex Int’l, Inc., 212 F.3d 1123, 1131 (8th
`Cir. 2000)). Here, the jury was asked to determine whether Biomet’s M2a Magnum
`product was defective in design. While the ethical or criminal nature of Biomet’s
`conduct is irrelevant to Nicholson’s defective design claim under Iowa law, see
`Wright, 652 N.W.2d at 169, the jury was clearly instructed on the proper elements
`of defective design, see Interstate Fin. Corp. v. Iowa City, 149 N.W.2d 308, 313
`(Iowa 1967) (holding proper instructions cured trial court’s erroneous admission of
`testimony), and Biomet can only offer speculation that the jury improperly
`
`
`
`-12-
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`

`

`considered Dr. Kantor’s testimony as to the ethical or criminal nature of Biomet’s
`conduct. “Speculation, however, is not a sufficient basis for finding [the appellants’]
`substantial rights were affected, and we will not set aside the jury’s verdict in this
`case.” Coterel, 827 F.3d at 808 (alteration in original) (quoting Regions Bank, 406
`F.3d at 981).
`
`
`To the extent Biomet claims the alleged errors prejudicially influenced the
`jury’s award of punitive damages, we also find this unpersuasive. Given the
`evidence of Biomet’s willful and wanton disregard for safety detailed below, we
`cannot say the evidence complained of was so prejudicial a new trial would likely
`produce a different result. See Parkhurst v. Belt, 567 F.3d 995, 1003 (8th Cir. 2009)
`(holding evidentiary error would have been harmless because overwhelming
`evidence supported verdict).
`
`
`3. Jury Instructions
`
`
`Biomet next argues that the district court erroneously refused to instruct the
`jury that the district court had previously found the M2a Magnum’s warnings and
`instructions were adequate as a matter of law. Biomet proposed two jury instructions
`on this point. The district court initially agreed to give these instructions but
`ultimately excluded them, finding the adequacy of the M2a Magnum’s warnings and
`instructions were irrelevant.
`
`
`a. The District Court Did Not Abuse Its Discretion
`
`
`
`Biomet argues the district court abused its discretion in failing to instruct the
`jury that the M2a Magnum’s instructions and warnings were adequate as a matter of
`law. Biomet argues the omission of this instruction was erroneous because the
`“instructions and warnings accompanying the product” are expressly listed in Iowa
`Civil Jury Instruction 1000.4 as a factor to consider in assessing “whether a product
`was reasonably safe.” Nicholson admits warnings and instructions are listed as a
`
`
`
`-13-
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`

`factor on which the court could have instructed the jury.6 But Nicholson maintains
`the district court was not required to include this factor because the evidence and
`issues presented to the jury did not involve the adequacy of the M2a Magnum’s
`warnings and instructions. We agree.
`
`Biomet simply failed to produce evidence at trial that its warnings or
`instructions for the M2a Magnum created a defense to Nicholson’s design defect
`claim. The district court possesses a broad discretion in instructing the jury. While
`the district court’s jury instructions “must fairly and adequately represent the law of
`the forum state,” it is “not required to instruct on issues that do not find support in
`the record.” McCoy v. Augusta Fiberglass Coatings, Inc., 593 F.3d 737, 744 (8th
`Cir. 2010) (quoting Brown v. Sandals Resorts Int’l., 284 F.3d 949, 953 (8th Cir.
`2002)). Here, the trial record is void of any attempt by Biomet to suggest the M2a
`Magnum’s warnings and instructions negated Nicholson’s claim that a reasonable
`alternative design existed.
`
`
`Biomet argues it cannot be faulted for not introducing evidence of M2a
`Magnum’s warnings or instructions at trial because the district court had already
`
`
`6Iowa Civil Jury Instruction 1000.2 lays out what is required to prove a
`
`defective design claim. Relevant here, a plaintiff must prove that the product was
`defective at the time it left defendant’s control by showing “[a] reasonable
`alternative safer design could have been practically adopted at the time of sale or
`distribution,” “[t]he alternative design would have reduced or avoided the
`foreseeable risks of harm posed by the product,” and “[t]he omission of the
`alternative design renders the product not reasonably safe.” Iowa Civ. Jury Instr.
`1000.2 (propositions 4–6) (formatting altered). Instruction 1000.4 then provides
`instructions for determining whether an alternative design is reasonable and whether
`the omission of the alternative design renders the product not reasonably safe. Iowa
`Civ. Jury Instr. 1000.4 (“Concerning propositions 4, 5, and 6 of Instruction No.
`[1000.2], you may consider the following factors . . . .”). The instructions provide a
`non-exhaustive list of factors to consider. See Iowa Civ. Jury Instr. 1000.4
`(providing at the end of the factor list: “Any other factor shown by the evidence
`bearing on this question”). One factor listed is “[t]he instructions and warnings
`accompanying the product.” Id. (formatting altered).
`-14-
`
`
`
`

`

`concluded they were legally sufficient. But the district court’s summary judgment
`ruling concluded the M2a Magnum’s warnings and instructions were legally
`sufficient in the context of Nicholson’s failure to warn claim.7 This ruling has no
`bearing on whether the M2a Magnum’s warnings and instructions prove an
`alternative design was unreasonable or would not have prevented the foreseeable
`risks it posed. Minding the district court’s broad discretion in formulating its jury
`instructions, we affirm the district court’s decision to not instruct the jury on the
`sufficiency of the M2a Magnum’s warnings and instructions.
`
`
`B. Punitive Damages
`
`
`
`Lastly, Biomet argues the district court erred in denying its motion for
`judgment as a matter of law on the issue of punitive damages. We review the district
`court’s denial of a motion for judgment as a matter of law de novo and consider the
`evidence in the light most favorable to the jury’s verdict. Procknow v. Curry, 826
`F.3d 1009, 1013 (8th Cir. 2016). “Judgment as a matter of law is only appropriate
`when no reasonable jury could have found for the nonmoving party.” Monohon v.
`BNSF Ry. Co., 17 F.4th 773, 780 (8th Cir. 2021) (quoting Southern Wine & Spirits
`of Nev. v. Mountain Valley Spring Co., 646 F.3d 526, 533 (8th Cir. 2011)).
`Accordingly, we give high deference to the jury’s verdict, drawing all reasonable
`
`
`7Nicholson’s failure to warn claim was a separate and distinct cause of action
`
`from its design defect claim. Under Iowa law, a plaintiff can claim a product is
`defective based on a manufacturing defect, a defective design, or that the product is
`defective because of inadequate instructions or warnings. See Restatement (Third)
`of Torts: Prods. Liab. § 2. These are treated as separate claims with separate
`standards of liability. See Wright, 652 N.W.2d at 168. To establish a failure to warn
`claim, a plaintiff must show that a product “is defective because of inadequate
`instructions or warnings when the foreseeable risks of harm posed by the product
`could have been reduced or avoided by the provision of reasonable instructions or
`warnings.” Restatement (Third) of Torts: Prods. Liab. § 2(c). Here, the district court
`granted summary judgment on Nicholson’s failure to warn claim because it found
`the M2a Magnum’s warnings and instructions warned consumers of the foreseeable
`risks that materialized with Nicholson here.
`-15-
`
`
`
`

`

`inferences in favor of the verdict. Gruttemeyer v. Transit Auth., 31 F.4th 638, 646
`(8th Cir. 2022).
`
`Under Iowa Code § 668A.1(1)(a), punitive damages are appropriate when a
`plaintiff proves by a “preponderance of clear, convincing, and satisfactory evidence,
`the conduct of the defendant from which the claim arose constituted willful and
`wanton disregard for the rights or safety of another.” Iowa law defines “willful and
`wanton” conduct as “an act of an unreasonable character in disregard of a known or
`obvious risk that was so great as to make it highly probable that harm will follow,
`and which thus is usually accompanied by a conscious indifference to the
`consequences.” Mercer v. Pittway Corp., 616 N.W.2d 602, 617 (Iowa 2000)
`(quoting Fell v. Kewanee Farm Equip. Co., 457 N.W.2d 911, 919 (Iowa 1990)).
`Thus, Nicholson bore the burden of proving, by a preponderance of clear,
`convincing, and satisfactory evidence, that Biomet acted with a willful and wanton
`disregard of safety in designing the M2a Magnum.
`
`Viewing the evidence in the light most favorable to the verdict, the district
`court did not err in denying Biomet’s motion for judgment as a matter of law on
`punitive damages. At trial, Nicholson introduced evidence suggesting Biomet
`should have tested the M2a Magnum device before introducing it to the market but
`failed to do so. For example, Truman testified that a consensus document from a
`metal-on-metal conference suggested conducting clinical trials monitoring the
`metal-on-metal wear and ion measurements in the body. Truman also testified that
`Dr. Hozack, an orthopedic surgeon who B

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