After FDA rejection, NJ company sold defective product overseas
About 10 years ago, DePuy Orthopaedics, a unit of New Jersey-based Johnson & Johnson, began selling a medical device called the articular surface replacement, or ASR, overseas. DePuy soon sought approval of the product by the U.S. Food and Drug Administration. Because it involved a process that had not been used for hip replacements in the U.S., the FDA refused to issue an approval, directing DePuy to put the medical device through additional clinical trials.
DePuy complied and began gathering additional data on the ASR. In the meantime, however, it took two actions that were decidedly less compliant. First, it continued to sell the ASR overseas, despite the FDA rejection and questions about the device’s safety and efficacy. Second, it sought and was granted FDA approval for a similar hip replacement product without conducting thorough testing. This would ultimately result in thousands of injuries, illnesses, and product liability lawsuits filed against the New Jersey company.
The second hip replacement product received an immediate approval from the FDA under the agency’s 501(k) program. This requires the FDA to approve any device that is similar to a previously approved device.
However, the ASR soon proved to be dangerous and defective, with patients reporting injuries and ailments that resulted from the metal parts of the hip joint rubbing against one another and causing metal byproducts to be released into the bloodstream. Johnson & Johnson ultimately recalled all of the products in 2010, and is currently facing some 5,000 personal injury lawsuits from patients who were injured by the devices.
It is unknown how many people were injured by the ASR devices internationally. The FDA has no requirement that companies notify agencies in other countries of an FDA rejection, which allowed the devices to be sold in those countries even after they were recalled in the U.S.
Source: New York Times, “Hip Implant U.S. Rejected Was Sold Overseas,” Barry Meier, Feb. 14, 2012