J&J hip recall: Internal emails detail FDA’s non-approvable letter (MassDevice)
Uncovered internal emails from Johnson & Johnson subsidiary DePuy Orthopaedics highlight the company’s decisions to abandon a PMA bid for the now-defunct ASR hip resurfacing implants amid “a significant number of revisions” during clinical trials.
A newly uncovered Johnson & Johnson email may pose problems for the health care giant in the ongoing lawsuits over defunct hip implants made by subsidiary DePuy Orthopaedics.
DePuy has insisted that the recalled ASR metal-on-metal hip resurfacing implants had failed due to improper positioning during surgery, but those arguments may lose some of their luster in light of an internal email from 2009 in which a company employee notes “a significant number of revisions” associated with the device in clinical trials.
The email, written by DePuy executive Pam Plouhar, outlines the FDA’s decision not to grant pre-market approval to the ASR implant and notes the higher of corrective surgeries required by patients who received the device compared to a control group, according to a report by the New York Times.
While the FDA non-approval letter remains confidential, Plouhar explains in her email that “the FDA took issue with several aspects of the pooled clinical data,” especially concerned that “there have been a significant number of revisions within the ASR group (both in the IDE and in the OUS study) as opposed to very few in the control group.”
“The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority with additional downside risk,” Plouhar added. “This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates.”
At the time, Australian regulators were urging DePuy to withdraw the devices from the market or be forced off, according to the Times.
J&J withdrew its PMA application shortly thereafter, a decision which the company has publicly said was driven by lackluster sales and a softening market.
“At the same time that the company received this FDA letter, market demand for hip resurfacing was declining rapidly,” DePuy said in a statement released this week. “DePuy chose not to move forward with gathering additional data based on the declining demand for hip resurfacing. This was purely a business decision for the U.S. market.”
The ASR implants had already been on the market overseas since 2003, and continued to sell in the European Union and other countries for another year after the abandoned FDA bid.
Soon after withdrawing the PMA application, DePuy announced plans to phase out the ASR implants amid declining sales. About a year later, in August 2010, the company issued a global recall of the ASR resurfacing implants, as well as a related ASR cup, due to a high rate of revision surgeries required to correct or remove defective implants.
The devices have been used on about 93,000 patients worldwide, according to DePuy, which is currently mired in a multi-district lawsuit under an Ohio federal court.