FDA Called on to Investigate DePuy Hip ImplantAug 29, 2013
Attorneys for thousands of alleged victims of defective metal hip implants made by Johnson & Johnson subsidiary DePuy Orthopaedics Inc. informed the U.S. Food and Drug Administration (FDA) that the medical device maker had broken federal law by hiding experts’ misgivings about the implants. The agency was called on to investigate.
In a letter to the agency, attorneys shared testimony that they say shows DePuy breached federal reporting requirements between 2006 and 2010 by failing to alert the FDA to evidence that its ASR XL implants were unsafe. The testimony, previously sealed under protective court orders, is now part of the public record following two bellwether personal-injury trials, Law360 reports.
In their letter, the attorneys requested “an immediate and thorough investigation,” according to Law360. “We believe almost all of these injuries would have been avoided had DePuy complied with the reporting requirements and informed your agency about the adverse events and concerns about the safety of the ASR which came to the company’s attention.”
Law360 reports that DePuy marketing executives allegedly assumed responsibility for investigating complaints about the hips, despite their obvious conflict of interest and lack of qualifications. “[I]t appears that many adverse events were not reported to the FDA or were not timely reported,” the letter says.
DePuy sold more than 33,000 ASR implants for patients undergoing total hip replacements before it recalled the hip system in 2010. DePuy now projects that 37 percent of the implants will fail prematurely, but other estimates have put the rate at over 60 percent, according to Law360. More than 11,000 patients have sued DePuy.
The DePuy lawsuits generally allege that the metal-on-metal hips degrade prematurely and shed toxic metal debris inside patients' bodies, causing pain and necessitating revision surgeries to remove and replace the implants. Revision surgery is often more complicated and risky than the initial hip replacement procedure because many patients suffered bone loss and damage to surrounding tissue from the initial surgery.
DePuy lost the first case to go to trial. In March a California state jury, finding the implant's design faulty and DePuy as having acted negligently, ordered the company to pay $8.3 million in compensatory damages to a retired prison guard.