April 1, 2014 was the deadline for 8,000 hip replacement patients suing Johnson & Johnson’s DePuy unit over its recalled ASR metal-on-metal hip implant to opt-in or opt-out of a $4 billion settlement offered by the medical device manufacturer.
Thousands of hip replacement patients have sued DePuy for complications allegedly caused by the recalled ASR hip implant, including:
• Failure of the metal on metal hip implant requiring early replacement surgery
• Dislocated hip
• Leaking of toxic substances chromium and cobalt into the surrounding tissue or the bloodstream from the hip implant
• Degenerative Heart Disease Cardiomyopathy
• Loss of bone strength or structure causing bone fractures
• Death of tissue surrounding the implant
• Non-cancerous tumors around the hip implant
Flawed Device Gets FDA Fast Track Approval
The DePuy ASR metal-on-metal hip implant, fashioned from copper, chrome alloys, chromium or cobalt, contains no rubber, silicone or non-metal components, was supposed to be safer than traditional hip replacement systems, and was approved by the United States Food and Drug Administration (FDA) in 2005 without having undergone clinical trials. Instead, it has proved to be the “most flawed ever.”
Risks with Repeat Hip Implant Surgeries
When ASR metal-on-metal hip implants rub together they release metal ions into the surrounding tissue and blood stream, causing not just pain but also the potential for metal poisoning. The hip implant must then be removed and replaced.
According to DePuy’s own data, 12 percent (one in eight) of patients who received an ASR implant required corrective surgery less than five years after implant, due to failure of the device. The average time for a non-metal hip implant follow-up procedure is 15 to 20 years after implantation.
Every additional surgery involving the hip joint increases the chances of serious complications, including:
• Blood clots
• Bone loss
• Nerve damage
Repeat surgery also causes additional pain, rehabilitation time, and expense.
DePuy Offers Settlement While Denying Wrongdoing
After receiving complaints for years, DePuy only recently removed the ASR devices from the market. Denying any wrongdoing, officials from DePuy said that the company phased out sales of the ASR for commercial reasons, not because of any safety issues.
While denying fault, in the recent lawsuit DePuy agreed to offer a $4 billion settlement to resolve the 8,000 cases. Each individual plaintiff would receive between $300,000 and $350,000 if the settlement is approved. If 94% of the plaintiffs do not opt-in for the settlement offer, DePuy will withdraw it, and plaintiffs would then need to file individually, taking on the drug giant one-on-one in court.