Today’s case is Bayes v. Biomet, https://ecf.ca8.uscourts.gov/opndir/22/12/212964P.pdf (8th Cir., No. 21-2964, 9/21/2022), a lawsuit against the manufacturer of a failed metal-on-metal hip replacement. The trial court instructed the jury on two theories of recovery: strict liability and negligent design. The outcome was unusual – at least, it seems unusual to me. As the Eighth Circuit Court of Appeals explained,
The jury found for [defendant] Biomet on the strict liability claim but for [plaintiff] Mary on the negligence claim…. Biomet then [moved] 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. The court denied [the motion]. The court stated that the verdicts were not contradictory and that Mary [had] put forward sufficient evidence of breach, causation, and damages…. [W]e affirm the judgment of the district court.
Before discussing the case, a brief history of metal-on-metal hip replacement devices seems in order:
While metal-on-polyethylene (MoP) bearings are currently the most widely implanted prosthesis, recently, metal-on-metal (MoM) bearings have come under the spotlight amid evidence of higher than expected revision rates. Since 2008, it has become evident from national joint registry data that hip replacements and resurfacings with MoM bearing surfaces have significantly higher revision rates compared to those with MoP…. The increased revision rates of MoM hip replacements are thought to relate to adverse reactions to metal debris released from the bearing surface as the implant wears. These reactions cause soft tissue changes in the surrounding tissues…[which] can be locally destructive to nearby muscle and bone…. (“Metal-on-Metal Hip Arthroplasty: A Review of Adverse Reactions and Patient Management,” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598667/.)
In 2010, DePuy became the first company to recall an MoM prosthesis, followed by Stryker in 2012, then by others. These were manufacturer-initiated recalls, because FDA-initiated recalls would have been much more expensive for the manufacturers – though as it turned out, there were no FDA-initiated recalls. Instead, the FDA began the slow notice-and-comment process in 2013, and its new rule didn’t become effective until 2016:
In January 2013, the FDA published a proposed order to allow for notice and comment regarding the FDA’s recommendation to change the requirements for all metal-on-metal (MoM) total hip implants from premarket notification to premarket approval, the most stringent regulatory category of the FDA's oversight for medical devices. [T]he requirement for filing premarket approval was effective in May 2016. Since that time, all manufacturers of MoM total hip implants are required to stop marketing their devices and submit premarket approvals…. Premarket approval is based on a determination by the FDA that the application contains sufficient valid scientific evidence to reasonably assure that the device is safe and effective for its intended use…. To date, there are no FDA-approved metal-on-metal total hip replacement devices marketed for use in the US…. (https://www.fda.gov/medical-devices/implants-and-prosthetics/metal-metal-hip-implants -- Emphasis added.)
Beginning in 2008, thousands of lawsuits, consolidated into multiple MDLs, have been filed against the manufacturers of MoM hip replacement implants, and thousands have been settled, often in large group settlements. But the industry is still litigating a lot of these cases, including (until the Eighth Circuit’s recent decision) Bayes v. Biomet.
In 2008, plaintiff Mary Bayes had bilateral total hip replacements. The surgeon used the Biomet M2a Magnum, an MoM device. The Eighth Circuit’s opinion summarizes what happened next:
In 2010, Mary began experiencing increasing pain in her left hip. X-rays showed significant bone degeneration…. [A] new surgeon…replaced the M2a Magnum with a ceramic-on-plastic hip implant in March 2011. [Upon] opening the hip joint, [he] 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…[has had] seven hip revision surgeries…[and] now uses a fully constrained hip replacement, preventing normal hip function…. [C]ontinued hip dislocations are highly likely. As a result, she must markedly limit her life activities to avoid dislocations.
First, the court addressed Biomet’s argument that the verdicts – for the defendant on strict liability, for the plaintiff on negligent design – were irreconcilably contradictory. Biomet’s trial strategy had focused heavily on a key element of strict liability – that the product must have been used in a reasonably anticipated manner. In other words, it blamed the surgeon for the bad outcome:
[Biomet] 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.” Dr. Thomas Fleeter, another Biomet expert witness, testified that the angle of Mary’s left hip implant was “beyond what was recommended, and that led to metal-on-metal wear and metallosis and many of the problems that she has experienced.”
However, as the court of appeals explained, this testimony was irrelevant to the issue of negligent design:
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.” Paragraph three required that the M2a Magnum be “used in a manner reasonably anticipated.” Jury Instruction No. 11, which addressed negligence, differed. It contained no requirement that the jury find proof of a reasonably anticipated use. (Emphasis added.)
It seems likely that the jury credited the expert testimony about improper placement of the prosthesis and therefore found for the defendant on strict liability. This did not preclude a verdict for the plaintiff on negligence, which requires proof that the product was defective and unreasonably dangerous, breach of the standard of care, and causation – but not proof of use in a reasonably anticipated manner.
Next, Biomet argued that the plaintiff had failed to establish the standard of care. The rejected this argument by summarizing the testimony of the plaintiff’s expert:
Mari Truman, a biomedical engineer with a history of designing orthopedic devices…testified that the M2a Magnum was unreasonably dangerous. She highlighted the increased friction and wear of metal-on-metal implants…. She gave a history of metal-on-metal implants and their associated problems. This history included…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…. [In addition,] Biomet’s machine testing used a standard that was not designed for metal-on-metal implants…[and] Biomet’s testing did not replicate the practical conditions of the human body in motion…. If credited by the jury, this testimony was a sufficient evidentiary basis to conclude that Biomet failed to meet a reasonable standard of care.
Finally,
Biomet 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.
…. 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.”… [Thus, there was] 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…. 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. Therefore, the decision of the district court is affirmed. (Citation omitted.)
Back in the late 70s when I was a rookie plaintiffs’ lawyer, my firm handled a number of Dalkon Shield cases. For anyone not familiar with that particular IUD, read https://www.britannica.com/science/Dalkon-Shield for the horrifying details. I used to say that the Dalkon Shield could be the worst medical device ever foisted on American womanhood. (This was before pelvic mesh came along to compete for the title.) It never occurred to me that the devastation wreaked by the Dalkon Shield was not limited to the United States. Per the Britannica article just cited, “The A.H. Robins Company stopped selling the device in 1974, and manufacturing ceased in 1976. In the United States more than 2 million devices had been sold; total global sales were around 4.5 million in 80 countries.” (Emphasis added.) These days, I know better, and I think it’s fair to say that the metal-on-metal hip implant might well be one of the worst medical devices ever foisted on humanity at large.
