The American Association for Justice (AAJ), a plaintiff lawyers industry group, is asking the Food and Drug Administration (FDA) to prevent makers of metal-on-metal hip implants from using a proposed change in the medical device approval process to protect them against liability claims. Tens of thousands of lawsuits have been filed against manufacturers of all-metal artificial hips after the devices showed a higher than expected failure rate and in some cases began corroding inside the bodies of patients, endangering their health.
Traditional hip replacement systems are made with ceramic or plastic parts. But in more recent years, artificial joint manufacturers have offered all metal implants designed to be more durable and last longer than traditional implants. Because the metal-on-metal hip implants were similar in design to traditional artificial hips, they were approved without clinical studies that documented their safety and efficacy.
That approval process came under fire in 2010, when DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recalled one of its metal-on-metal hip replacement systems because of premature failures. The metal in the devices was also linked to a type of blood poisoning known as metallosis. An estimated 93,000 people worldwide are affected by the recall.
In January, the FDA issued a proposed rule that would require manufacturers to provide more clinical tests that show the safety of the devices in order to continue selling the devices or to introduce new ones to the market. In April, the American Association for Justice sent a letter to the FDA supporting its proposal to require more testing on medical devices. However, the group expressed concern that when a device is approved through premarket approval, consumers could lose their ability to sue the manufacturer of the device in court over alleged injuries.
The organization is asking the FDA to include language in its final rule that would prevent makers of medical devices from trying to use premarket approval retroactively to protect them from personal injury lawsuits that originated before the new rule goes into effect.
The FDA declined to comment on the association’s request. However, the agency plans to finalize the proposed order within a year, at which time the medical device makers would have 90 days to submit data on clinical trials showing their products’ safety and efficacy.
Source: Thomson Reuters