Johnson & Johnson (JNJ) knew as early as 2001 the metal-on-metal version of its Pinnacle artificial hips might generate debris that could cause metal poisoning, a lawyer said in the first case over the device to go to trial.
A doctor who consulted with J&J’s DePuy unit on the Pinnacle hip made the company aware in February 2001 that the device would require extensive testing of implant patients to see whether they had metal debris in their bloodstreams, Mark Lanier, a lawyer for a Kathleen Herlihy-Paoli, a Montana woman suing over her hips, said today in his questioning of ex-DePuy President Andrew Ekdahl.
In an internal memo, DePuy officials said Dr. Thomas Schmalzried warned the potential release of metal ions was a “major issue for metal-on-metal hips,” according to Lanier. Ekdahl, now chairman of J&J’s DePuy Synthes unit’s global orthopedics business, denied that officials considered cutting marketing efforts over Schmalzried’s concerns.
Herlihy-Paoli’s suit is the first of more than 6,000 cases over the Pinnacle hips, approved for sale in 2000, 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.
Herlihy-Paoli claims the metal hips’ flawed design produced cobalt and chromium material that leached into her body, causing an infection that required the devices to be surgically removed. She’s seeking damages for pain, suffering and intentional infliction of emotional distress.
Lanier said today that internal files from 2012 showed DePuy officials found the metal Pinnacle hips had a 15 percent failure rate after five years of use. Company officials had expected a failure rate of 5 percent over that time period, he said.
Lanier questioned Ekdahl about whether the company misled the public about the metal-on-metal hips’ durability in a 2007 patient-marketing brochure, which said 99.9 percent of the devices were “still in use after five years.”
“You knew that was a bogus statement,” Lanier said to the executive. “No, it’s not,” Ekdahl responded.
The lawyer produced a string of 2008 e-mails between DePuy executives, who said Schmalzried had reviewed a hip recipient’s case that showed extensive tissue damage tied to the device.
The e-mails, made public in court, recounted that Schmalzried had said the extent of the metal-hip patient’s tissue damage was “alarming and concerning.” DePuy officials said in the e-mails that they planned to tell colleagues to “keep quiet for now” about the case Schmalzried highlighted.
Schmalzried, head of the Joint Replacement Institute at St. Vincent Medical Center in Los Angeles, helped DePuy develop the ASR artificial hip. The doctor testified in an ASR case last year that he’d been paid more than $20 million by DePuy for his work on medical devices like artificial hips.
Lanier also said company files show Dr. John Irving, a Hartford, Connecticut-based orthopedic surgeon, repeatedly contacted DePuy officials to tell them he was seeing high failure rates with Pinnacle metal hips.
In a 2010 letter to Ekdahl, Irving said the wave of problems he’d seen with the metal devices “is an epidemic,” and he considered it to be “borderline unethical to continue to market these products until the issues are elucidated. These products are harming patients.”
Lanier said Irving contacted DePuy again in 2012 to tell officials that one of his Pinnacle patients who’d complained of pain from the inserts had committed suicide because he “was so depressed and thought he would never resolve” the issue.
Under questioning by DePuy’s lawyers, Ekdahl said the company sought to make the Pinnacle metal hips’ risks clear in a 2002 educational brochure created for doctors.
The device maker said it was common knowledge among orthopedic surgeons the metal hips could produce metal ions that showed up in patients’ bloodstreams, Ekdahl testified.