Trial Magazine

Bayes v. Biomet, Inc., No. 4:13-cv-00800-SRC (E.D. Mo. Nov. 24, 2020)

Two years after undergoing bilateral hip replacement surgery, Mary Bayes started to feel pain in her left hip. After completing a revision surgery, Bayes’s orthopedic surgeon discovered extensive dead tissue around the hip, likely caused by metallosis—toxic metal poisoning—from her implanted Biomet, Inc., metal-on-metal (MoM) artificial hip. The metal debris destroys tissue cells and also kicks the body’s immune response into overdrive, inadvertently killing surrounding healthy tissue.

Bayes continued to have complications related to the necrotic tissue and elevated levels of metal ions—including six further revision surgeries and 11 dislocations of her hip joint. The same condition also developed in her right hip.

Bayes and her husband filed design defect and failure-to-warn strict liability and negligence claims, among others, against the manufacturer in Missouri federal court. The plaintiffs alleged that the implant design caused metal to grind against metal, leaving debris to migrate into the surrounding tissue at dangerous levels, and that the defendant knew about the risks of the design but marketed it anyway. At an in-person trial during the pandemic, the jury returned a verdict for the plaintiffs, awarding $20 million to Bayes and $1 million to her husband.

“She gave very moving testimony—she didn’t want any money, she just wanted somebody to be able to fix her,” said New Orleans attorney Zachary Wool, one of the plaintiffs’ attorneys and second chair at trial. “There’s literally nothing she can do to stop her hip from dislocating. [It’s] dislocated while sitting in a church pew, while sitting in the bleachers at her grandson’s basketball game, while sitting on the couch and handing her husband the TV remote control. . . . She will have to deal with that the rest of her life.”

The Bayeses also were represented by Darin Schanker (lead trial counsel), J. Chris Elliott, and Melanie Sulkin, all of Denver; Jessica Perez Reynolds of Baton Rouge, La.; and local counsel Jim O’Leary and Michael Quillin of St. Louis.

Even though metal-on-polyethylene implants became the “gold standard” after MoM hip implants fell out of favor in the 1970s, largely due to the known risks, the defendant created a new MoM device line in the 1990s in an attempt to attract new customers and outperform the plastic-based hips on the market. It funneled the implant through the FDA’s accelerated 510(k) clearance process—performing only one small clinical trial in humans with the first iteration of the device and none for the second, third, or fourth iterations.

At trial, the plaintiffs’ theme centered on the defendant’s choice to prioritize profits over patients’ safety and its lack of proper testing. Documents uncovered during discovery showed that the defendant was most concerned with its bottom line and making sure its product entered the market as quickly as possible to grab market share.

“There were no ifs, ands, or buts that money was the motivating factor. The thing that got them to market fastest was cutting out the human trials, even though that’s how you really determine whether your product is fit for its use,” Wool said.

To demonstrate to jurors that the hip implant was not fit for use, the plaintiffs’ team analogized the mechanics of what happened to Bayes to something from everyday life. “If you have a car engine that has no oil, then you’re going to have metal parts grinding on each other and you’ll get metal shavings. And the metal shavings aren’t good. That’s the same concept for MoM hips. Artificial hips are supposed to build up a little layer of fluid like your normal cartilage, but when that doesn’t happen, the metal parts grind against each other,” Wool said.

To break down each element of the complicated science involved and teach it to the jurors, Schanker required his attorneys to put on highly visual displays with their experts. They used the “old-fashioned” ELMO document camera to display visuals and walk through them with their experts—and to hand write charts or summaries during testimony that they used again during closing to refute defense arguments.

Another strategy the attorneys used was to minimize their objections during trial. “We wanted to be the teachers and the truth tellers, so we strategically decided not to object very much. The defense objected continuously, and it looked like they were trying to hide facts from the jury. We made a conscious decision to object only when absolutely necessary, when they had truly crossed the line,” Wool explained.

The defendant also fought discovery “tooth and nail,” forcing protective orders and not timely disclosing potentially game-changing documents. “We have to hold defendants’ feet to the fire when it comes to discovery because we don’t know what we don’t know,” Wool said. “We don’t know what they’re hiding or what they’re not producing. We need to make sure that defendants hold up their end of the discovery bargain. There’s no ‘bad document’ privilege.”

Although defense obstructions may be common in litigation like this, navigating a courtroom set up for social distancing was an unexpected challenge. Wool pointed out that “hip implants are not very large, and it’s extremely difficult if the witness on the stand is trying to show them to jurors who are 60 or 70 feet away in the back of the courtroom behind three panes of plexiglass—but we got there in the end.” And after some time getting used to wearing masks and following COVID-19 protocols, everyone slipped into a relatively normal routine over the three-week trial.

Ultimately, the outcome is one that the attorneys feel medical device manufacturers should pay attention to. “There was no pressing need for MoM hips—zero. The industry was pushing the more expensive, larger profit-margin products,” Wool said. “But now you’ve created a generation of hip patients who have ticking time bombs in their bodies. We really hope that the medical products industry takes note that it cannot rush unnecessary products to the market and put profits before the safety of patients.”

Kate Halloran is the senior associate editor of Trial.