By Allison Torres Burtka
Since the DePuy ASR hip implant was recalled last August, hundreds of cases have been consolidated in a multidistrict litigation in federal court and in coordinated proceedings in California state court.
In the MDL in the Northern District of Ohio, which includes about 550 cases, discovery is starting to heat up, said Philadelphia lawyer Thomas Anapol, who is handling about 60 cases. Some depositions have been scheduled. (In re DePuy Orthopaedics, Inc., ASR Hip Implant Prods. Liab. Litig., MDL No. 1:10 md 2197 (N.D. Ohio transferred Dec. 7, 2010).)
And at a hearing on the medical device approval process held last week by the Senate Special Committee on Aging, senators heard from a patient who had had the DePuy ASR implanted and then underwent a second replacement surgery after the recall. The levels of cobalt and chromium in her blood were about 1,000 percent higher than they should be because the ASR released metal debris into her body, she said.
“In my mind, recalls were for dishwashers and cars, not body parts,” said the patient, Katie Korgaokar.
The ASR metal-on-metal implant was recalled after the devices began to fail at high rates, requiring additional hip replacement surgery and causing elevated cobalt and chromium levels. About 93,000 patients had the ASR implant worldwide.
“There’s still a lack of clarity scientifically” about the long-term effect of the cobalt and chromium poisoning, Anapol said, noting that the implants have also caused necrosis of bone and tissue.
The manufacturer had “clear indications that the device was failing at an unacceptably high rate” but did not take action when it should have, Anapol said. “It’s another example of a pharmaceutical manufacturer’s delay in reacting to an evolving problem.” He added that the company “initially blamed surgeons for improper technique.”
Plaintiffs argue that DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson, failed to adequately test the implant and knew about the risks associated with it but kept the problems hidden.
In her testimony before the Senate committee, Korgaokar said that before her implant was recalled, “I thought any medical device that was actually being put into people’s bodies had been extensively tested before it was released to the public.”
Stuart Talley, a Sacramento lawyer who represents Korgaokar, said that most medical devices that get cleared through the FDA’s 510(k) “fast track” process—as the ASR did—are slight modifications of existing devices rather than revolutionary life-saving devices, which are the primary argument for the fast-track process. Before the ASR, “there were lots of hips on the market that worked fine,” he said.
Talley said that depositions of medical device marketing personnel in other litigation have revealed that companies try to release a new device every several months. He likened the practice to Apple periodically releasing a new version of the iPod.
Korgaokar told the committee that she learned her surgeon had received more than $600,000 from DePuy for consulting. “Although I would like to think these payments had no influence on my doctor’s decision to use the ASR, I will always have doubts,” she said.
Korgaokar sued the manufacturer as well as two physicians who developed and marketed the ASR. Her case was filed in February and has been consolidated with the others in California.
Anapol noted that DePuy’s Pinnacle implant—the ASR’s predecessor—also has had a high failure rate but has not yet been recalled. He is handling lawsuits over the Pinnacle as well.