Failed Hips Sold Overseas After Being Rejected in US

The NY Times published an article today that claims Johnson & Johnson, the manufacturer of the DePuy ASR XL and DePuy Pinnacle hip devices, sold the unsafe hip devices overseas after the FDA found them to be experiencing a higher than acceptable failure rate among US patients.
According to the Times, “There is no suggestion that Johnson & Johnson 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.”
That’s not really the issue, though. The issue is that the FDA has found safety issues with these hips based on thousands of consumer complaints and physician testimony that the hips aren’t working properly. That’s the issue. It may not be a legal issue but it is surely an ethical one.
Essentially, Johnson & Johnson was willing to sell what is considered in the United States a defective product based on its design (metal-on-metal configuration) in order to make a profit. Sales had been slipping prior to the hip recall and the medical device company saw an opportunity to bolster sales without any regard for the products’ safety.