J&J Hawked FDA-Banned Hip Replacement Overseas

Product deemed unsafe was still sold overseas, derivative sold in US
By Kevin Spak,  Newser Staff
Posted Feb 15, 2012 1:14 PM CST
J&J Hawked FDA-Banned Hip Replacement Overseas
Johnson & Johnson continued selling a hip replacement overseas after the FDA deemed unsafe here.   (Shutterstock)

Johnson & Johnson continued to sell an ill-designed artificial hip overseas even after the FDA deemed it unsafe—and used a regulatory loophole to sell a related model with the same design issue in the US, the New York Times reports. The FDA sent Johnson & Johnson a non-approval letter on the implants, which were marketed under the name ASR, in August 2009. But Johnson & Johnson never disclosed that letter, instead announcing in November 2009 that it would phase out the ASR over declining sales.

Johnson & Johnson started selling the ASR abroad in 2003, but the FDA demanded more clinical testing to sell it here. In the meantime, the company submitted a variant device through a less-stringent regulatory pathway, while continuing to sell the original device in Europe. Both devices suffered from a faulty, all-metal hip cup. None of this is illegal, but the revelation may hurt Johnson & Johnson in the roughly 5,000 lawsuits it faces over the device, which it formally recalled in August 2010. (Read more Johnson & Johnson stories.)

We use cookies. By Clicking "OK" or any content on this site, you agree to allow cookies to be placed. Read more in our privacy policy.
Get the news faster.
Tap to install our app.
Install the Newser News app
in two easy steps:
1. Tap in your navigation bar.
2. Tap to Add to Home Screen.