(Updates with comment on cancer risks in 10th paragraph.)
Sept. 2 (Bloomberg) -- Johnson & Johnson, which set aside $2.5 billion last year to resolve claims that 8,000 of its artificial hips were defective, faces a new round of lawsuits over another line of hip implants blamed for poisoning patients.
J&J’s DePuy unit is starting its first trial of allegations that the metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. The cobalt-and-chromium material caused an infection that forced Kathleen Herlihy-Paoli to have her artificial hips surgically removed, she said in court filings.
Jury selection began today in Herlihy-Paoli’s suit, the first of more than 6,000 cases over the devices to be weighed by a jury. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges. Kinkeade will preside over Herlihy-Paoli’s trial.
“The first trials in any of these consolidated litigations set the tone for the following cases,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in an interview. “If J&J loses the first couple of these Pinnacle trials, they better start seriously thinking about coming up with a settlement similar to what they signed off on for the ASR hips.”
J&J said studies have shown the Pinnacle Ultamet line of devices restores mobility and reduces pain for patients in need of hip replacement.
“We are confident the evidence presented at trial will show the company acted appropriately and responsibly in the development, testing and marketing” of the Pinnacle hips, Mindy Tinsley, a DePuy spokeswoman, said in an e-mailed statement.
The Pinnacle line wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices caused dislocations, pain and required surgical removal. Some patients also said chromium and cobalt debris from the metal-on-metal ASR hips caused tissue death and increased metal ions in the blood.
J&J, the world’s largest health-care company, recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years. Internal J&J documents showed 37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.
A 2012 British study also raised questions about whether recipients of metal-on-metal hips faced an increased risk of bladder and kidney cancer and genetic damage.
Tinsley noted the British Orthopaedic Association has said “there is no verified evidence that having a metal-on-metal hip replacement increases cancer risk.”
The ASR settlement was designed to resolve about 8,000 U.S. suits against DePuy and offered an average of about $250,000 for each surgery, as well as covering related medical costs, officials said when the deal was announced in November 2013.
J&J, based in New Brunswick, New Jersey, agreed to pay as much as $1 billion to insurers who covered the medical costs of removing the recalled ASR hips. Those funds, along with other expenses tied to the drugmaker’s push to resolve the hip-implant cases, will probably drive the accord’s total cost beyond $4 billion, Tobias said last year.
J&J 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 had touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion.
Herlihy-Paoli, a 58-year-old graphic designer from Montana, got two Pinnacle hips in 2009 and soon began to complain of pain from the devices, according to court filings. She had the artificial hips removed in 2011, according to the filings.
Tests before the removal surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream,” she said in court filings. “Tests indicated that Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal,” she said.
Once surgeons removed Herlihy-Paoli’s left hip, they “discovered the implant had turned black with metallosis,” according to the filings.
DePuy officials misled patients and their doctors about the safety of the artificial hips and sponsored a “nationwide satellite telecast to physicians all over the country to tout the advantages of the Pinnacle Device, including representations of the benefits of metal-on-metal hip replacements,” her lawyers said in court filings.
Herlihy-Paoli is seeking damages for physical injuries connected with the hip-removal surgeries, loss of earnings and other compensatory damages. She’s also asking for damages for intentional infliction of emotional distress over the company’s aggressive marketing of the hips.
“In their continued marketing of the Pinnacle devices in spite of known deficiencies and defects, defendants’ actions were beyond all bounds of decency, were atrocious and of a kind utterly intolerable in a civilized society,” the graphic artist said in court papers.
If jurors find DePuy officials’ mishandling of the devices warrants punitive damages, an expert hired by Herlihy-Paoli’s lawyers has said the panel could consider ordering the company to pay as much as $5.78 billion as punishment, according to court filings.
J&J said Herlihy-Paoli’s expert is unreliable because he used flawed methodologies to come up with his punitive-damage findings.
Jurors also should reject Herlihy-Paoli’s emotional- distress claims because she can’t show DePuy engaged in “intentional conduct” to harm her in designing the hips or marketing the devices, J&J said in court papers.
The Pinnacle hips were “thoroughly tested over more than a decade” and J&J officials have “closely monitored” the devices’ performance over time, said Tinsley, the DePuy spokeswoman.
Herlihy-Paoli is represented in the case by Mark Lanier, a plaintiffs’ lawyer in Houston who persuaded a federal jury in Louisiana last year to order Takeda Pharmaceutical Co. and Eli Lilly & Co. to pay a combined $9 billion in punitive damages over their handling of the Actos diabetes drug.
Lanier also won the first Vioxx verdict against Merck & Co. in 2005, persuading a state court jury in Texas to award $253 million to the family of a marathoner who had a fatal heart attack after taking the recalled painkiller.
“This is a very dangerous case for J&J,” said Erik Gordon, a professor at the University of Michigan’s business and law schools who teaches classes about how drugs are developed and regulated in the U.S.
“They could be facing huge damages here and it will be easy for the plaintiffs’ lawyers to scare the jury with talk of metal poisoning and increased cancer risks,” he said.
The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11- cv-3590, U.S. District Court, Northern District of Texas (Dallas).