How Does FDA Approval Affect Product Liability Lawsuits?


There have been some recent court decisions that limit or bar state law tort claims for injuries from products or drugs that previously received FDA approval.  But that is an evolving area of the law, and each potential case must be reviewed by a products liability attorney to determine its merit.  For example, Stryker’s Rejuvenate and ABG II modular hip implants were approved by the FDA in June 2008. But the approval process was through the FDA’s 510(k) Premarket Notification Process. Under this program, a drug or medical device can be offered to the public without having to undergo clinical trials, if it can be shown that the product is substantially similar to a product that has already received FDA approval. In both cases, Stryker’s newer systems were approved because they were similar to other previously approved systems.  

Under this type of approval process, Stryker was relieved of the burden of testing and proving the products were safe in advance.  They were only required to conduct post-market surveillance.  Problems in 510(k) devices can only be found after they have been implanted in patients.  So patients who believed they were being implanted with fully tested and approved products, were actually the guinea pigs in the testing process itself.

Medical device manufacturers and drug companies are ethically and legally responsible for designing safe products. They must also warn consumers about products that are unsafe in sufficient time to prevent harm and/or device failure. When manufacturers neglect these responsibilities, victims can sue for compensation.  Patients who have had Rejuvenate or ABG II hip stem components implanted should contact a product liability attorney to see if they are eligible for monetary compensation.