After lengthy legal battle, Iowa woman gets to keep $3.5 million jury awarded for defective hip implant

Just short of a decade after she first filed suit, an Iowa woman who had to have her hip replaced twice can keep the $3.5 million jury verdict she won from the manufacturer of the first device, a federal court has ruled.

Her suit was one of thousands nationwide, though only a limited number went to trial.

Fort Dodge resident Lori Nicholson underwent a hip replacement surgery in 2007, but four years later learned the original implant had failed and she would need another surgery.

Nicholson in 2013 sued Biomet Inc., the manufacturer of the M2a Magnum hip replacement, for defective design. The case went to trial in 2020, and the jury awarded her $3.55 million.

On August 24, the Eighth U.S. Circuit Court of Appeals affirmed that verdict and rejected Biomet's request for a new trial. The court found evidence supported Nicholson's claim that Biomet rushed the untested device to market despite multiple warnings it might not be safe for patients.

Biomet, now known as Zimmer Biomet, after a 2015 acquisition, and its attorneys did not respond to messages requesting comment. A 2014 Reuters piece about settlements of other cases said that Biomet maintained that "the injuries, losses and damages were not due to its hip implants."

Lawsuit: defective implant shed metal particles into woman's body

As summarized by the appellate court, Nicholson's left hip was replaced in 2007 with an M2a Magnum joint made by Biomet. Four years later, she returned to her original surgeon with complaints of pain and a cyst on her hip.

In most hip implants, one or both parts of the joint are made of ceramic or plastic. For the M2a, though, both the ball and the socket are made of metal. Nicholson's surgeon determined that the metal-on-metal wear was releasing metal ions into her body, contributing both to the loosening of the replacement joint and the cyst. A test found that Nicholson's blood had six times the normal level of chromium in it.

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Nicholson had a second surgery to replace her first implant with a metal-on-plastic joint, and her condition improved. She then sued the company. A court dismissed some claims, including allegations Biomet had provided inadequate warnings and instructions, but allowed her claim for defective design to go before a jury.

When the case finally went to trial, the jury found the M2a Magnum's design had caused Nicholson's injuries, and awarded $1.05 million in compensatory damages. It added $2.5 million in punitive damages, finding Biomet's actions constituted "willful and wanton reckless disregard" for the safety and rights of patients.

Nearly 3,000 lawsuits nationwide

Nicholson isn't the only M2a Magnum recipient to report problems with the device. Since 2012, a federal judge in Indiana, where Zimmer Biomet is headquartered, has been overseeing a docket of nearly 3,000 filed around the country bringing product liability claims related to the replacement hips.

More than 90% of those plaintiffs accepted a settlement offer Biomet made in 2014. Consumer advocacy group Drugwatch said those settlements amounted to about $200,000 per case, subject to some reductions. The several hundred cases that didn't settle, including Nicholson's, were remanded to federal courts in their home states for trial. According to Drugwatch, at least 190 cases remained pending as of July 2019.

Among those plaintiffs were at least three Iowans, including Nicholson. Court records show the other two Iowa cases were settled separately in 2020 and 2021.

In another case that did go to trial, a Missouri jury in November 2020 awarded $21 million to a woman who'd had both hips replaced with M2a Magnum implants.

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The M2a is classified as a total hip replacement implant. The U.S. Food and Drug Administration says that no metal-on-metal total hip replacement systems are approved for marketing in the U.S., although some patients received such implants prior to 2016. The agency has approved two metal-on-metal hip resurfacing implants, which replace a smaller portion of the patient's natural hip joint. Neither is made by Zimmer Biomet.

The FDA warns that metal-on-metal implants can cause a variety of symptoms, including joint pain, swelling and numbness, as well as symptoms affecting the skin, kidneys, heart and thyroid and nervous systems.

Emails: company feared more testing would harm sales

After the 2020 trial, Biomet asked the court to order a new trial or grant it judgment notwithstanding the verdict. The trial judge denied both motions, and the company appealed.

Much of the most recent opinion concerns different evidentiary rulings made by the trial judge, with the appellate court finding in each case that the judge had been correct, or that any error would not likely have swayed the outcome of the case.

But Biomet also argued that the evidence at trial should not have supported punitive damages, because the company provided legal warnings and disclaimers with the Magnum devices. The court found that argument meritless, and described in detail evidence from trial showing that Biomet ignored warnings the metal-on-metal hip joints might not be safe.

The jury heard that an earlier generation of metal-on-metal devices was considered a "failed system," and that several experts urged the company to conduct testing on the second generation of implants to see if they were safer before releasing them commercially.

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Also introduced at trial were internal Biomet emails, including one from an administrator telling employees to "not accept delays" on projects critical to the company's bottom line, and another email responding to a doctor suggesting further testing, in which a Biomet official said the resulting data "could be (sic) sales to a halt."

"It is reasonable to conclude that, despite known dangers of past metal-on-metal designs and advisement to conduct testing before releasing the M2a Magnum device, Biomet willfully and wantonly disregarded other peoples’ safety" by releasing the device without long-term clinical trials, the appellate court found.

Devin Kelly, one of Nicholson's attorneys, said after the recent ruling that the multiple surgeries and side effects related to the failed implant had a "significant impact" on his client's daily life.

"We were elated the jury ruled in her favor and recognized that pain and impact and held the defendants accountable for their product that should never have been put inside Ms. Nicholson in the first place," he said in an email. "And now we’re very grateful the Eighth Circuit respected the hard work that the district court and the jury did in this case and affirmed the jury’s decision."

William Morris covers courts for the Des Moines Register. He can be contacted at wrmorris2@registermedia.com, 715-573-8166 or on Twitter at @DMRMorris.

This article originally appeared on Des Moines Register: Iowa woman's defective hip implant jury verdict upheld by 8th Circuit