Rejection by the United States Food and Drug Administration was not enough to stop one company from selling a product outside the U.S. The well-known company Johnson & Johnson continued to sell its defective DePuy hip implant overseas, including in Europe, despite the FDA ban on the sale of this device in the United States because of safety concerns. Because regulations overseas can differ significantly from those in the United States, the company can say that it operated fully within the law.
The rejection letter from the FDA came in 2009 and it is still unclear how many people received the artificial hip, or ALR, since the rejection. The company also continued to sell a related product both in the United States and overseas that got onto the market because of a regulatory loophole. The two products consisted of an all-metal hip socket, and both were on the market for a combined total of eight years. During that time, 93,000 people received the hip implant, one third of them in the United States.
Sales overseas did not last very long as problems with the device began to surface. The company recalled both devices in August of 2000 due to reports of a large number of problems with the devices. In March of 2000, FDA records showed that the company had received around 300 complaints about the device, citing that those who had the device implanted needed to undergo a replacement surgery not long after.
One cannot help but wonder if Johnson & Johnson really thought that the product would cause fewer problems for patients overseas than it did for those in the U.S. And one can only hope that this matter will lead more medical device companies to prioritize patients' safety and well-being.
Source: New York Times, "Hip Implant U.S. Rejected Was Sold Overseas," by Barry Meier, Feb. 14, 2012.