J&J Unit Ran ‘Amok’ Marketing Pinnacle Hips, Jury Is Told

Sep 03, 2014 5:28 pm ET

(Updates with details on ASR settlement starting in eighth paragraph.)

Sept. 3 (Bloomberg) -- Johnson & Johnson’s bid to convince doctors the metal-on-metal version of its Pinnacle hip implants were safe amounted to “marketing run amok,” a lawyer told jurors in the first case over the devices to go to trial.

J&J’s DePuy unit ignored signs the Pinnacle hips suffered from design flaws and assured doctors the metal devices worked “99.9 percent of the time,” Mark Lanier, a lawyer for a Montana woman who sued after complications forced her to have the device removed, told jurors today in Dallas federal court on the first day of trial of her lawsuit.

“They didn’t tell people they were basically guinea pigs,” Lanier said in opening statements.

Lanier’s client, 58-year-old Kathleen Herlihy-Paoli, claims the metal hips made by J&J, the world’s largest health-care company, leeched cobalt and chromium material into her bloodstream, causing an infection that required the devices to be surgically removed.

Herlihy-Paoli’s suit is the first of more than 6,000 cases over the Pinnacle hips, first sold in 2005, to be weighed by a jury. The devices weren’t covered by 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 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years.

The cases have been consolidated before U.S. District Judge Ed Kinkeade for pretrial information exchanges. Kinkeade is presiding over Herlihy-Paoli’s trial.

‘Smokescreen’ Complaint

J&J’s lawyer, Richard Sarver, said in his opening statement that Herlihy-Paoli’s ailments were caused by the position of the hips in her body and weren’t tied to design flaws.

Herlihy-Paoli’s complaint about the device maker’s marketing was a “smokescreen,” Sarver said, adding that Lanier exaggerated the company’s marketing efforts in a bid “to make you mad.”

The earlier 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 drive the agreement’s total cost beyond $4 billion, Tobias said last year.

Sales Halted

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 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 graphic designer, got two Pinnacle hips in 2009 and quickly began to complain of pain from the devices, according to court filings. She had the artificial hips removed in 2011, the filings show.

Tests prior to the surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream,” the woman’s lawyers said in court filings. The cobalt and chromium levels caused an infection that required the removal of the device, according to her complaint.

“Tests indicated that Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal,” the filings said.

Lanier told jurors today evidence will show DePuy researchers knew the design of the metal-on-metal hips couldn’t meet the company’s own safety standards. “Depuy just didn’t tell anybody,” the lawyer said.

‘Utter Nonsense’

J&J officials said in a statement prior to trial the metal hips were “thoroughly tested” and “closely monitored” for design defects and the company properly marketed the devices.

Lanier’s assertion that J&J put profit over patient safety by marketing flawed hips was “utter and complete nonsense,” Sarver added.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 12- cv-3590, U.S. District Court, Northern District of Texas (Dallas).