Johnson & Johnson's DePuy medical device division reportedly sold a model of an artificial metal-on-metal hip overseas even though the Food and Drug Administration had rejected its sale in the United States. The hip replacement joint has since been recalled worldwide.

Knowledgeable lawyers in California and elsewhere know those sales weren't illegal, but they also know that the decision to go ahead with them despite the F.D.A.'s rejection potentially exposes the company to deeper legal and financial troubles from individuals with legitimate personal injury claims.

The joint in question was marketed under the name ASR. That stands for articular surface replacement. According to court records, there are currently about 5,000 lawsuits pending over alleged problems with the devices. Some of them involve patients who claim they've been crippled by tissue-eroding shards of metallic debris that sloughed off from the ball and cup joints.

Additionally questionable is the fact that DuPuy continued selling a similar type model in the United States. It did that under what legal experts say is a regulatory loophole that allows a critical implant device to be brought to market without clinical safety trials if it happens to resemble a previously approved device already in use. Experts say both the U.S. model and the one sold overseas incorporated the same faulty all-metal hip socket and cup.

Unknown is just how many people may have received these hip joints between the time the F.D.A. rejected the design in August 2009 and DuPuy formally recalled them in August 2010. What is known is that about 31,000 patients in the U.S. alone received them. Another 60,000 people overseas received them.

As noted earlier, no claim has surfaced that any laws were broken, but there are questions about whether the DuPuy ever bothered to publicize the fact that the FDA had disapproved the joints. A lawyer who specializes in F.D.A. regulation says companies typically do disclose such information if it might affect earnings. Still, there are no rules requiring it.

Source: The New York Times, "Hip Implant U.S. Rejected Was Sold Overseas," Barry Meier, Feb. 14, 2012