Product News and Recalls

Unsafe Artificial Hip Marketed after FDA Rejection

The New York Times has reported that Johnson & Johnson marketed an artificial hip overseas after the federal Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.

In addition, the company continued to sell a related model of artificial hip in the U.S. after the FDA rejection, which went on the market because the company used a regulatory loophole that enabled it to avoid a similar safety review

According to the Feb. 14, 2012, New York Times report, the DePuy division of Johnson & Johnson formally recalled the devices in August, 2010, amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.

But in a confidential letter from August of 2009, the F.D.A. informed Johnson & Johnson that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness.

In 2005, DePuy used a regulatory loophole to sell a version of the metal hip implant in the United States without clinical testing, based on the company’s assertion that the implant was similar to one already on the market.

Widespread complaints about the device include patients crippled by tiny particles of metallic debris.

If you received a DePuy Orthopaedics hip implant and are experiencing side-effects, contact Lopez McHugh for a free case evaluation.

See the New York Times report here:

http://www.nytimes.com/2012/02/15/business/hip-implant-the-fda-rejected-was-marketed-abroad.html?pagewanted=1&_r=1&hpw