An August 2009 internal e-mail from DePuy Orthopaedics, Inc.’s vice president confirms that Johnson & Johnson and its subsidiary (DePuy Orthopaedics, Inc.) were well aware of the FDA’s refusal to approve the metal-on-metal ASR hip replacement and resurfacing systems a year prior to issuing the now-famous recall. In August of 2010, Johnson & Johnson and DePuy recalled both the ASR XL Acetabular System and the ASR Hip Resurfacing System, after data revealed that both DePuy ASR hip replacement products have excessively high failure rates. Both companies now face thousands of lawsuits from patients that received these implants. Recently, thousands of documents were produced and released under seal in the multidistrict litigation (MDL), one of which is an e-mail from DePuy Orthopaedics vice president, Pamela Plouhar.
In Ms. Plouhar’s August 2009 email to other DePuy Orthopaedics executives and the company’s president, she outlines the FDA’s reasons for refusing to approve the ASR systems in America. According to the e-mail, Ms. Plouhar reported how the device had not met FDA approval standards and that a major issue was the high rate of premature failure in the clinical trials. These statistics came from clinical trials where DePuy hand-picked the surgeons implanting the devices. Despite that sort of control over the testing, the results still came back with an abnormally high early failure rate. According to Ms. Plouhar’s e-mail, there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”
Ms. Plouhar also cautioned her fellow executives that additional testing may not change the FDA’s stance and that it would likely take years to come up with additional clinical testing data. The e-mail also referenced the high failure rates coming out of Australia and the UK. This e-mail establishes that Johnson & Johnson and DePuy Orthopaedics, Inc. were aware of dangerous safety issues with the ASR systems at least a year prior to issuing the world-wide recall of the devices. This appears to severely undercut DePuy’s argument that the high failure rates were due to improper placement by surgeons during implantation. It is estimated that some 30,000 patients in the United States received the flawed implants. What is underdetermined at this point is how many of these patients received the implants after DePuy was aware of the abnormally high failure rate in its devices.