In the recent tempest of news swirling around DePuy Orthopedics, Inc’s hip replacement recall, most media outlets have overlooked an FDA warning letter issued only days before the DePuy Hip Recalls began. The letter was sent on August 19, 2010 from FDA representative Timothy A. Ulatowski to David Floyd, president of DePuy Orthopedics, Inc.
The letter warned DePuy to discontinue marketing and selling its TruMatch Personalized Solutions System and Corail Hip System in the U.S. due to violations of the law. The letter reported that DePuy had not received prior approval for the ways they were marketing both of the devices. TruMatch is a knee replacement device and Corail is part of a hip replacement system.
Neither the Trumatch nor the Corail products have been recalled. The letter issued underscores a larger problem that appears to be widespread in the U.S. health care system.
The questionable actions on the part of DePuy have led to multiple DePuy ASR Class Action Lawsuits involving patients from the U.S. and abroad. The main allegations being made in the DePuy Hip Class Action cases is that the company knew about the high failure rate of its devices for years before taking action to fix the device or remove it from markets around the world.
An Irish Times article reported that DePuy has not yet admitted liability or negligence in the hip recall cases. Lawyers and patients will likely be awarded compensation for replacement surgeries, “However, this does not include redress for the pain, anxiety and suffering experienced by patients who have been implanted with a faulty system and may now need to under go surgery again,” the Irish Times reported.
Reddan, Fiona. (September 14, 2010) “Hip recall: what happens next?” Retrieved on September 20, 2010 from the Irish Times.
Ulatowski, Timothy A. (August 19, 2010) “DePuy Orthopedics, Inc. 8/19/10 Warning Letter.” Retrieved on September 20, 2010 from the Food and Drug Administration.