Johnson & Johnson Wins First Pinnacle Hip Implant Trial

A Johnson & Johnson unit’s design of a metal-on-metal version of its Pinnacle hip implants isn’t defective, a Dallas jury concluded, ruling against a woman who said the devices poisoned her in the first case of its kind to go to trial.

The ULTAMET artificial hips sold by J&J’s DePuy subsidiary as part of its Pinnacle line of implants had no design defects and the company properly warned patients and doctors about the devices’ risks, jurors in federal court in Dallas concluded yesterday.

More than 6,000 lawsuits have been filed over the Pinnacle hips. The devices weren’t covered by New Brunswick, New Jersey-based J&J’s $2.5 billion settlement of claims last year over another line of artificial hips known as ASRs. In that case, J&J recalled 93,000 implants worldwide in August 2010, saying 12 percent failed within five years.

“A defense verdict in the first bellwether case, tried by Mark Lanier, one of the nation’s premiere plaintiffs’ lawyers, does not augur well for the other 6,000-plus Pinnacle hip cases,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.

The nine-member panel deliberated for more than 12 hours over three days before rejecting Kathleen Herlihy-Paoli’s request for more than $1.5 million in damages over surgeries to remove the artificial hips. The jury included an engineer and a real-estate lawyer.

Ruling Hailed

DePuy officials hailed the jury’s ruling, saying it affirmed the company’s arguments that it properly tested the implants before putting them on the market.

“The evidence showed that ULTAMET Metal-on-Metal was designed to meet the needs of patients and is backed by clinical data showing a track record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain,” Mindy Tinsley, a spokeswoman for the J&J unit, said in an e-mailed statement. She added the company will continue to offer a “vigorous defense” to other suits over the implants.

Herlihy-Paoli, 58, alleged the Pinnacle implants leached cobalt and chromium material into her bloodstream. Those toxins caused an infection that required the devices to be surgically removed, the Montana resident claimed.

Consolidated Cases

The Pinnacle cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges. Kinkeade also presided over Herlihy-Paoli’s eight-week trial.

“It’s the first battle in a long war,” Lanier, 54, said outside the courtroom after the defense verdict was announced. Lanier serves as lead counsel for plaintiffs whose Pinnacle cases have been consolidated before Kinkeade. J&J is the world’s largest healthcare company

Jurors heard testimony that the Pinnacle hips were the template for J&J’s controversial ASR line of hip implants.

The earlier ASR settlement aimed to resolve about 8,000 U.S. suits against DePuy and offered an average of about $250,000 for each surgery, plus related medical costs, officials said when the deal was announced in November 2013.

ASR Accord

J&J agreed to pay as much as $1 billion to insurers who covered the medical costs of removing the recalled ASR hips. Those costs, along with other expenses tied to the drugmaker’s push to resolve hip-implant cases, might drive the agreement’s price tag to more than $4 billion.

The company stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

J&J touted the metal-on-metal implants, first sold in the U.S. in 2000, as a design that would last 20 years and offer greater range of motion.

Herlihy-Paoli, a graphic designer, got two Pinnacle hips in 2009 and quickly began to complain of pain, according to court filings. She had the artificial hips removed in 2011, according to court papers.

Lawyers for the plaintiffs in the Pinnacle cases consolidated before Kinkeade selected Herlihy-Paoli’s case as the first to be tried to gauge juries’ reaction to claims the devices were flawed.

Cobalt, Chromium

Tests prior to the surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream” requiring removal, the woman’s lawyers said in court filings.

During the trial, Lanier argued DePuy officials began a misleading marketing campaign to increase the company’s share of the artificial-hip market while ignoring reports that the devices were failing at alarming rates.

DePuy officials knew the metal-on-metal design of the hips could lead to metal poisoning but continued to push the devices to protect billions in sales, Lanier argued

Richard Sarver, DePuy’s lead lawyer, countered that surgeon error was to blame for Herlihy-Paoli’s ailments and not design flaws. Overwhelming evidence showed the implants were placed in a position that made it “impossible for them to function properly,” Sarver told jurors during closing arguments.

FDA Approval

The FDA approved the metal Pinnacle hips for sale in the U.S., and the J&J unit tested the devices extensively before putting them on the market, Sarver said.

Sarver helped J&J fend off a woman’s claims last year that its ASR hip implants released the same kinds of metal debris that Herlihy-Paoli alleged poisoned her as as a result of having the Pinnacle implants installed.

A state court jury in Chicago rejected Carol Strum’s claims that the ASR, which was based on the Pinnacle implants, was defectively designed.

The Pinnacle case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 12-cv-04975, U.S. District Court, Northern District of Texas (Dallas).

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