BISNAR | CHASE has learned that even after the U.S. Food and Drug Administration rejected the sale of Depuy Hip Replacements in this country over safety concerns, the health care products giant Johnson & Johnson continued to market the artificial hip in Europe and elsewhere overseas.
During that same period, the company also continued to sell a related model in the U.S. That version passed inspection by using a regulatory loophole not requiring a similar safety review.
It is not known how many people overseas received the replacement hip after the U.S. agency declined approval in 2009, nor the number who received the similar implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that reviewing experts declare was faulty in design.
Amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates, the DePuy orthopedic division of Johnson & Johnson, started citing declining sales as the culprit and began phasing out both models of the defective Dupuy device. The unit is formally known as an "articular surface replacement device", or ASR.
Facing a renewed application process that would probably have taken a year or more, DePuy's receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.
There is no suggestion that Johnson & Johnson ever broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there. The agency can reject approving a device for various reasons, including cases where it is seeking only small amount of added data.
However, the bottom line for both the company and consumers is that the F.D.A.'s rejection may further deepen the company's legal and financial problems surrounding the ASR. The firm recently took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants. The F.D.A. has received thousands of complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. In Britain, the units were all recalled recently as the failure rates skyrocketed.
If you or someone you know had a Depuy hip replacement, contact one of our Depuy lawyers immediately for a free consultation. We are currently representing a number of injured victims who have suffered from failed Depuy hips. To claim your free consultation please call 800.561.4887 or visit BestAttorney.com.
SLS Consulting