Johnson & Johnson and its DePuy Orthopaedics division may be setting themselves up for many more lawsuits over metal-on-metal hip replacements, The New York Times reports. That's because the company apparently kept selling the ASR product in Europe and elsewhere internationally, even as the FDA declined in 2009 to approve its sale after a review of J&J's safety studies.
J&J/DePuy issued a voluntary, massive global recall of two versions of the product in 2010 that affected more than 90,000 patients, after reports of too many patients whose hip replacements failed prematurely. The company also blamed sales declines. But after the FDA decision and before the recall, sales of the product continued internationally. Sales proceeded in the U.S. with a similar model that had gained approval through the 510(k) process that helped avoid a related safety review and additional clinical testing, the NYT notes.
As the article points out, none of the company's actions were illegal. The FDA's approval process is designed to be confidential, and the European and other international regulatory gantlets allowed the product to reach the marketplace, after all. But here's where the legal liability may increase: The FDA told J&J in a confidential letter that the international safety data it used to try to gain U.S. approval wasn't enough to determine if the implant was both safe and effective, and regulators urged more clinical tests. And J&J appears to have not discussed the FDA non-approvable letter publicly while it was still selling the hip replacements overseas, and product complaints grew. A DePuy spokesperson told the NYT that the company had received the FDA letter but would not confirm whether DePuy talked about FDA concerns with the international medical community, patients, investors or regulators.
With this in mind, J&J/DePuy risks many more lawsuits, the NYT predicts. In January, J&J took a $3 billion charge to cover anticipated recall-related legal and medical expenses. About 5,000 lawsuits (and counting?) are pending, according to the article.
- here's the NYT article