Metal Hip Device Implant Sold in EU After Rejected in U.S.
February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip overseas even after it was rejected for sale in the U.S.
Two related versions of the metal-on-metal hip, DePuy ASR were implanted in about 93,000 patients worldwide with about one-third in the U.S. DePuy sold the implant overseas in 2003 while DePuy won approval to sell another version of the ASR in the states under the 510(k) approval process because it was similar to a version of hip implants already sold. No clinical trials were required.
The revelation brings into question the credibility of Johnson & Johnson and why it continued to sell a related model of the ASR metal hip. Both models of artificial hip contained an all-metal socket that was found to send chips of metal into the patient causing a toxic reaction. By August 2010 both models of DePuy hips were recalled after reports showed they were failing at an alarming rate.
The European Union is generally thought to have lower standards for medical device approval, and Johnson & Johnson did not break the law in failing to alert regulators there that the US had rejected approval of the device. J & J has taken a $3 billion charge anticipating the cost of lawsuits from about 5,000 injured patients. A former gymnast turned spokeswoman for DePuy in the UK has joined in the lawsuit after the metal hip left her in crippling pain. Background story here.
What remains secret is the 13-page rejection letter from the FDA to Johnson & Johnson. While lawyers have obtained a copy, it has reportedly been sealed by the court. Revelations of its contents could damage the Johnson & Johnson brand and reputation, says one lawyer.
Johnson & Johnson had long defended articular surface replacement device blaming any failure on the quality of the surgeons who implanted the hip cup.
The DePuy debacle was not bad for everyone. A former J & J DePuy sales executive, Michael Mahoney was promoted and named to be president of Boston Scientific last October. Background story here.
The New York Times story is here.