Medical device manufacturers could be on the hook for billions of dollars as a result of product liability lawsuits and other costs associated with their metal-on-metal hip replacement systems, which are failing in thousands of people, resulting in severe pain and the need for additional revision surgery.
After they were introduced, metal-on-metal hip implants quickly grew to account for about one-third of the 250,000 hip replacements performed each year in the United States. However, over the past two years, concerns have increased about a risk metal hip replacement complications, resulting in use of the implants dropping to just 5% of the artificial hip market.
Recent research suggests that as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.
According to a report by the New York Times, as many as half a million Americans may have the all-metal hip implants, and a sizeable percentage of them are likely to file a lawsuit after their implants fail.
In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.
At the time of the recall, DePuy and Johnson & Johnson, their parent company, suggested that about 12% of the ASR hip implants will fail within five years. However, more recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.
The New York Times points out that 9%, or 3,500, of those who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit against Johnson & Johnson and DePuy. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is likely to increase.
A recent report by Forbes suggests that DePuy and other manufacturers of similar implants could face $5 billion in legal costs and settlement fees associated with the lawsuits over metal-on-metal hip replacements.