Mary Bayes; Philip Bayes v. Biomet, Inc.

United States Court of Appeals
For the Eighth Circuit
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No. 21-2964
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Mary Bayes; Philip Bayes
lllllllllllllllllllllPlaintiffs - Appellees
v.
Biomet, Inc.; Biomet Orthopedics, LLC; Biomet U.S. Reconstruction, LLC;
Biomet Manufacturing LLC, formerly known as Biomet Manufacturing Corp.
lllllllllllllllllllllDefendants - Appellants
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Appeal from United States District Court
for the Eastern District of Missouri - St. Louis
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Submitted: September 21, 2022
Filed: December 14, 2022
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Before SMITH, Chief Judge, KELLY and GRASZ, Circuit Judges.
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SMITH, Chief Judge.
Mary and Philip Bayes sued Biomet, Inc. and associated entities (Biomet) after
Mary Bayes’s M2a Magnum hip implant failed. The M2a Magnum is a large diameter
metal-on-metal hip implant produced by Biomet. Mary argued that the implant caused
irreparable damage to her hip joint and surrounding tissues. A jury awarded Mary $20

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million in damages. The jury awarded an additional $1 million in damages to her
husband Philip for his loss of consortium. Biomet appeals, arguing that (1) the jury’s
verdict was inconsistent, (2) the Bayes failed to establish the required standard of
care, (3) the Bayes failed to show a breach by Biomet, and (4) the damages award was
excessive. We disagree and affirm the judgment of the district court.1
I. Background
Mary Bayes has long suffered from arthritis. A surgeon using the Biomet M2a
Magnum replaced her right hip joint in January 2008 and her left hip joint in April
2008. The M2a Magnum completely replaces the hip joint using an alloy of metals,
including cobalt and chromium for both the ball and the cup of the implant.
In 2010, Mary began experiencing increasing pain in her left hip. X-rays
showed significant bone degeneration in her left hip. Consequently, she underwent
corrective surgery by a new surgeon that replaced the M2a Magnum with a
ceramic-on-plastic hip implant in March 2011. The new surgeon, upon opening the
hip joint, observed severe damage to the joint and surrounding tissue. Metal ions had
permeated the nearby soft tissues, causing severe necrosis. Since this revision
surgery, Mary has suffered 12 dislocations of her left hip. Doctors have performed
seven hip revision surgeries on her. Mary now uses a fully constrained hip
replacement, preventing normal hip function such as sitting in a typical posture.
Mary’s doctors state that continued hip dislocations are highly likely. As a result, she
must markedly limit her life activities to avoid dislocations.
Mary sued Biomet in May 2013. Mary alleged that Biomet negligently
designed the M2a Magnum and was strictly liable for its design, manufacture, and
distribution. The jury trial began October 5, 2020, and lasted 13 days. The court gave
1The Honorable Stephen R. Clark, United States District Judge for the Eastern
District of Missouri.
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two instructions regarding liability. Jury Instruction No. 10 detailed the proof
requirements for “strict liability—product defect.” R. Doc. 362, at 11. These
requirements included that “[t]he M2a Magnum was then in a defective condition
unreasonably dangerous when put to a reasonably anticipated use” and that “the M2a
Magnum was used in a manner reasonably anticipated.” Id. Jury Instruction No. 11
stated the negligence requirements, including that “the M2a Magnum was in a
defective condition unreasonably dangerous” and “Biomet failed to use ordinary care
to design the M2a Magnum to be reasonably safe.” Id. at 12. At the conclusion of the
evidence, Biomet requested a judgment as a matter of law. The district court denied
this motion, concluding that sufficient evidence of causation had been adduced. The
jury found for Biomet on the strict liability claim but for Mary on the negligence
claim, awarding her $20 million.
Biomet then renewed its motion for judgment as a matter of law. Biomet
requested a verdict in its favor, arguing that the jury’s negligence verdict for Mary
was logically inconsistent with and thus irreconcilable with its strict liability verdict
in Biomet’s favor. In the alternative, Biomet requested a new trial or remittitur on
damages. The court denied its motions. The court stated that the verdicts were not
contradictory and that Mary put forward sufficient evidence of breach, causation, and
damages. Biomet timely filed notice of this appeal.
II. Discussion
On appeal, Biomet argues that (1) the verdicts were inconsistent and require
a new trial or directed judgment for Biomet, (2) the plaintiffs failed to establish the
required standard of care for Biomet, (3) the plaintiffs failed to establish a breach by
Biomet, and (4) the damages were excessive and require remittitur or a new trial.
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A. Inconsistent Verdicts
Mary presented strict liability product-defect and negligent design claims to the
jury. Before submitting the case to the jury, the court instructed it on each claim in
Jury Instructions No. 10 and No. 11 respectively.
INSTRUCTION NO. 10.
On Plaintiffs’ claim for strict liability-product defect, your verdict
must be for Mrs. Bayes if you believe:
1. Biomet sold the M2a Magnum in the course of its business,
and
2. the M2a Magnum was then in a defective condition
unreasonably dangerous when put to a reasonably
anticipated use, and
3. the M2a Magnum was used in a manner reasonably
anticipated, and
4. Such defective condition, as existed when the M2a
Magnum was sold, directly caused or directly contributed
to cause damage to Mrs. Bayes.
INSTRUCTION NO. 11
On Plaintiffs’ claim for negligence, your verdict must be for Mrs.
Bayes if you believe:
1. Biomet designed the M2a Magnum, and
2. the M2a Magnum was in a defective condition
unreasonably dangerous, and
3. Biomet failed to use ordinary care to design the M2a
Magnum to be reasonably safe, and
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4. such failure directly caused or directly contributed to
cause Mrs. Bayes to sustain damage.
The phrase “ordinary care” as used in this instruction means that
degree of care that an ordinarily careful person would use under the
same or similar circumstances.
R. Doc. 362, at 11–12.
Following its deliberations, the jury returned a verdict for Biomet on the strict
liability product-defect claim and for Mary on the negligent design claim. Following
the return of the verdict, Biomet argued that the verdict was inconsistent and moved
for a new trial or altered judgment. The district court denied the motion, and Biomet
appeals the district court’s denial of its requested post-trial relief.
Whether a jury verdict is irreconcilably inconsistent is a question of law that
we review de novo. SEC v. Quan, 817 F.3d 583, 589 (8th Cir. 2016). We will
conclude that the district court should have granted a new trial “only if there was ‘no
principled basis upon which to reconcile the jury’s inconsistent findings.’” Top of
Iowa Co-op. v. Schewe, 324 F.3d 627, 633 (8th Cir. 2003) (quoting Bird v. John
Chezik Homerun, Inc., 152 F.3d 1014, 1017 (8th Cir. 1998)).
The jury’s verdict was not contradictory on its face. The strict-liability claim
was defined in Jury Instruction No. 10. The instruction told the jury that two of the
elements of strict liability require proof of reasonably anticipated use. Paragraph two
required that the M2a Magnum be defective when “put to a reasonably anticipated
use.” R. Doc. 362, at 11. Paragraph three required that the M2a Magnum be “used in
a manner reasonably anticipated.” Id. Jury Instruction No. 11, which addressed
negligence, differed. It contained no requirement that the jury find proof of a
reasonably anticipated use.
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Biomet does not dispute the differing proof elements in the two instructions.
Rather, it urges the court to conclude that the element of strict liability requiring proof
of reasonably anticipated use was undisputed and thus functionally stipulated. Biomet
points to the closing arguments. In closing, Mary’s counsel argued, “The M2a
Magnum was used in a manner reasonably anticipated. Well, this is an easy one.”
R. Doc. 357, at 112:9–11. In its closing, Biomet omitted discussion of the element of
reasonably anticipated use. The absence of contrary argument by Biomet did not
create a constructive stipulation obviating the necessity of a jury finding of an
element of Mary’s claim. An assertion of a disputed stipulation requires record
evidence of the stipulation. See Gander v. Livoti, 250 F.3d 606, 610 (8th Cir. 2001)
(“There might have been some tacit agreement at the status conference, but there is
no record of what the parties stipulated to in terms of the facts of this case.
Consequently, we find that there exists no stipulation that would be binding . . . .”).
Without a stipulation, the presence of an essential element of a claim remained
for the fact finder. At trial, Biomet’s strategy focused on potential medical misuse of
the device. It adduced evidence that the surgeon installed Mary’s M2a Magnum
implant outside of the angle recommended by accepted guidelines. Dr. Steven Kurtz,
an expert witness for Biomet, testified that the implantation angle of Mary’s left hip
implant was not in a “biomechanically optimal position.” R. Doc. 345, at 60: 17–20.
Dr. Thomas Fleeter, another Biomet expert witness, testified that the angle of Mary’s
left hip implant was “beyond what was recommended, and that lead to metal-on-metal
wear and metallosis and many of the problems that she has experienced.” R. Doc.
353, at 116: 2–4.
Biomet attempted to persuade the jury that the implant was used beyond what
was reasonably anticipated. A reasonable jury could have agreed. The jury may have
made a principled decision to find negligence but not strict liability after viewing the
evidence. The district court found that the verdicts were not contradictory. We agree.
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B. Standard of Care
Biomet argues that Mary needed to establish the highly technical standard of
care used in the medical device industry. Mary, in turn, responds that she only needed
to establish the standard of care of a reasonably ordinary person, as reflected in Jury
Instruction No. 10. We do not reach the question of which standard of care is
required. Mary supplied sufficient evidence under either standard.
When reviewing a post-verdict motion for judgment as a matter of law, our
analysis reflects our “hesitancy to interfere with a jury verdict.” Bavlsik v. Gen.
Motors, LLC, 870 F.3d 800, 805 (8th Cir. 2017).
[T]he district court must (1) consider the evidence in the light most
favorable to the prevailing party, (2) assume that all conflicts in the
evidence were resolved in favor of the prevailing party, (3) assume as
proved all facts that the prevailing party’s evidence tended to prove, and
(4) give the prevailing party the benefit of all favorable inferences that
may reasonably be drawn from the facts proved.
Ryan Data Exch., Ltd. v. Graco, Inc., 913 F.3d 726, 732–33 (8th Cir. 2019)
(alterations in original) (quoting Washington v. Denney, 900 F.3d 549, 558 (8th Cir.
2018)).
After this, “the court must then deny the motion if reasonable persons could
differ as to the conclusions to be drawn from the evidence.” Id. at 733 (quoting
Denney, 900 F.3d at 558–59). We therefore look to the evidence put forward by
Mary.
Mari Truman, a biomedical engineer with a history of designing orthopedic
devices, testified as an expert witness for Mary. Truman testified that the M2a
Magnum was unreasonably dangerous. She highlighted the increased friction and
wear of metal-on-metal implants like the M2a Magnum. She gave a history of metal-
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on-metal implants and their associated problems. This history included, among other
things, references to a consensus document produced by a substantial number of
biomedical engineers on the standards needed for a new generation of metal-on-metal
hip implants. This consensus discussed the dangers of ion and particle toxicity.
Truman testified that Biomet did not follow the steps recommended by the consensus.
Truman also discussed a letter written to Biomet from an orthopedic surgeon, Dr.
William Hozack. This letter stated Dr. Hozack’s concern that Biomet’s metal-on-
metal hip implants would cause deleterious systemic effects by releasing metal ions.
Further evidence showed that Biomet did not test the M2a Magnum in humans before
bringing it to mass market. See R. Doc. 345, at 133:17–134:7. Biomet’s machine
testing used a standard that was not designed for metal-on-metal implants. See R.
Doc. 348, at 127:16–131:25. Mary’s experts testified that Biomet’s testing did not
replicate the practical conditions of the human body in motion. See R. Doc. 322-1, at
27.
Based on the record before it, the jury could have, in its discretion, believed or
discounted Truman’s testimony in its entirety. Further, the jury could have determined
whether Biomet’s testing procedures met industry standards. If credited by the jury,
this testimony was a sufficient evidentiary basis to conclude that Biomet failed to
meet a reasonable standard of care. When reviewing a renewed motion for a judgment
as a matter of law, “we must resolve credibility issues in favor of the verdict.” United
States v. Spears, 454 F.3d 830, 832 (8th Cir. 2006). Therefore, we credit this
testimony. The district court’s ruling that Mary established a sufficient standard of
care is affirmed.
C. Insufficient Evidence of Breach
Biomet also argues that Mary failed to establish that the M2a Magnum was
defectively designed. In order to recover under Missouri negligent design law, the
plaintiff must show the defendant breached its duty of care in designing the product.
Blevins v. Cushman Motors, 551 S.W.2d 602, 608 (Mo. 1977) (en banc). Biomet
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raises an over-generalized characterization that Mary only put forward evidence that
all metal-on-metal hip implants are defectively designed. It then attempts to defeat
that strawman by arguing that such class-wide criticism does not establish that the
M2a Magnum specifically was defectively designed. Because Mary put forward
evidence that actual choices Biomet made in the specific design of the M2a Magnum
were negligent, this argument fails.
Mary presented the jury with evidence of at least two possible negligent design
choices by Biomet. First, Mary argued that Biomet’s metal-on-metal choice, in
conjunction with the limited testing it received, was negligent. Mari Truman testified
that metal-on-metal implants create harmful metal ions. Biomet contends that this
cannot be a design defect, as it is common to the class of metal-on-metal hip implants.
However, the correct class of comparison is all hip implants, as metal-on-metal is a
specific design choice used in the creation of a hip implant system. Dr. Paul Lux
agreed that this is a problematic choice because “when metal rubs against metal, it
creates particles, ions . . . . And these ions are toxic.” R. Doc. 334, at 55:13–14. The
design choices Biomet made parallel the design choices challenged in Smith v. Brown
& Williamson Tobacco Corp., 275 S.W.3d 748 (Mo. Ct. App. 2008). In that case,
specific design choices in the creation of Kool cigarettes, using menthol and
increasing nicotine levels, increased the probability of harm from the cigarettes. Id.
at 795. Similarly, Mary produced evidence that the design choice to use metal-on-
metal surfaces instead of ceramic or plastic in the M2a Magnum increased the
probability of harm from the implant’s use. The choice of using metal surfaces in the
articulating hip joint is a design that the jury could have fairly judged as reasonable
or negligent.
Second, Mary presented evidence that the choice of the larger implant cup was
negligent. When Mari Truman was asked if the head size of the cup was part of what
made the M2a Magnum defective, she responded, “Yes, it was, . . . those things with
a bigger head just give you more area to have wear . . . and more ions.” R. Doc 330,
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at 104:7–14. Biomet countered that the large head size reduced, not increased, the
levels of ions released, citing a scientific article. See R. Doc 330, at 150:14–20. The
jury was given this competing evidence about the reasonableness of the large femoral
head diameter on the M2a Magnum, and it was within its discretion to weigh this
evidence.
Because the jury had a sufficient evidentiary basis to find a design defect, we
do not overturn its determination. We review the jury’s finding “in the light most
favorable” to its verdict. Borchardt v. State Farm Fire & Cas. Co., 931 F.3d 781, 784
(8th Cir. 2019). Therefore, the decision of the district court is affirmed.
D. Excessive Verdict
Lastly, Biomet argues that the jury verdict of $20 million for Mary was
excessive and that the district court should have granted remittitur. We give great
deference to the judgment of the district court, as “the district court has the benefit of
hearing the testimony and observing the demeanor of the witnesses throughout the
trial.” Bonner v. ISP Techs., Inc., 259 F.3d 924, 932 (8th Cir. 2001). Our standard of
review is for a manifest abuse of discretion. Tedder v. Am. Railcar Indus., Inc., 739
F.3d 1104, 1111 (8th Cir. 2014). Missouri state law governs the adequacy of
damages. Sanford v. Crittenden Mem’l Hosp., 141 F.3d 882, 884 (8th Cir. 1998).
“Although the appropriateness of a new trial is a federal procedural question decided
by reference to federal law, in determining whether a state law claim damage award
is excessive, state case law guides our inquiry.” Id. (citation omitted). Under
Mo. Ann. Stat. § 537.068, a jury verdict is excessive when “the amount of the verdict
exceeds fair and reasonable compensation for plaintiff’s injuries and damages.” The
Missouri Supreme Court instructs courts to look to
(1) loss of income, both present and future; (2) medical expenses; (3)
plaintiff’s age; (4) the nature and extent of plaintiff's injuries; (5)
economic considerations; (6) awards given and approved in comparable
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cases; and (7) the superior opportunity for the jury and the trial court to
evaluate plaintiff's injuries and other damages.
Emery v. Wal-Mart Stores, Inc., 976 S.W.2d 439, 448 (Mo. 1998) (en banc) (per
curiam).
Mary received only non-economic damages. The injuries behind the pain and
suffering damages were undisputedly severe. Mary has undergone seven hip revision
surgeries. None have been able to provide her complete relief. The severe necrosis
of tissue around her left hip joint will permanently prevent proper hip function. Mary
had suffered at least 12 hip dislocations since the installation of the M2a Magnum.
She is highly likely to suffer further dislocations. Routine aspects of daily living, such
as sitting, walking, and sleeping have become sources of fear and discomfort. A
verdict of $20 million is undoubtedly large, but it is not clearly disproportionate to
the severe and irreparable injury Mary has experienced. “Awards for pain and
suffering are often ‘highly subjective and should be committed to the sound discretion
of the jury, especially when the jury is being asked to determine injuries not easily
calculated in economic terms.’” Hudson v. United Sys. of Ark., Inc., 709 F.3d 700,
705 (8th Cir. 2013) (quoting Frazier v. Iowa Beef Processors, Inc., 200 F.3d 1190,
1193 (8th Cir. 2000)).
Awards from similar cases are not out of proportion to the $20 million damages
award. While other awards for metal-on-metal hip implant failures have often been
smaller, other plaintiffs’ injuries have been materially less severe. In Kirschner v.
DePuy Orthopaedics, the plaintiff underwent a single revision surgery and was
awarded $17.5 million in pain and suffering damages. 3:16-cv-01526, 2017 WL
10087150, at *2 (N.D. Tex. Nov. 14, 2017). This award was exclusive of another $28
million of punitive damages awarded. Id. at *3. In Kransky v. Depuy Orthopaedics,
Inc., the jury awarded $8 million to a plaintiff who had undergone a single revision
surgery. No. B249576, 2016 WL 3960033, at *1 (Cal. Ct. App. July 21, 2016). It is
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not incommensurate to award Mary $20 million when she has undergone seven
revision surgeries and has regained only very limited mobility.
Whether $20 million is the correct compensation for a lifetime of hip
dislocations and seven revision surgeries is a difficult question. We defer to the jury’s
judgment in this inquiry and do not usurp the supervision of the district court lightly.
Mary’s damages award was not “plain injustice or a monstrous or shocking result.”
Eich v. Bd. of Regents for Cent. Mo. State Univ., 350 F.3d 752, 763 (8th Cir. 2003)
(internal quotation marks omitted). We affirm the district court’s denial of remittitur
or a new trial.
III. Conclusion
We hold that the district court did not err in denying Biomet’s motions for a
judgment as a matter of law, a new trial, or remittitur. Accordingly, we affirm the
judgment of the district court.
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