A recently uncovered email circulated within Johnson & Johnson’s DePuy Orthopaedics medical device unit sheds new light on what DePuy executives knew and when they knew it. In August 2009, a vice-president of DePuy Orthopaedics wrote an email to senior J & J management notifying them that the FDA had refused to approve DePuy ASR hip because of “significant” numbers of premature failures. This is interesting news because the email message directly contradicts statements made by DePuy and J&J about the artificial hip assembly that would subsequently be recalled in 2010.
DePuy Vice President Pamela Plouhar wrote the email to senior managers after the FDA confidentially informed DePuy that it would not approve the hip implant because DePuy’s own studies showed a “significant number of revisions in the ASR group,” compared to “very few in the control group.”
The device that was disapproved by the U.S. FDA was sold overseas, including Australia and U.K., but DePuy used a regulatory loophole to market and sell a companion version in the U.S. This device was used on some 30,000 patients in the U.S. and over 90,000 patients worldwide. Both the U.S. and overseas versions of the implant shared the same critical component that experts claim is flawed in design.
According to internal DePuy emails, in September, 2009, just weeks after the FDA’s decision and Plouhar’s email, DePuy executives decided that the ASR implant was not viable and the program was scrapped. This decision was announced in November, 2009.
Despite large numbers of documented failures and these recently uncovered internal Johnson & Johnson continued to claim the ASR hip system was safe and that their internal studies refuted studies that the design of the implant was flawed. It is now evident that neither of these assertions was true.
A New England Journal of Medicine study found that metal-on-metal hips failed at 3 times the rate of other artificial hips. The MOM hip problems have gotten so bad, the FDA ordered an in-depth study of the systems by artificial hip manufacturers.
Metal-on-metal hips include the DePuy ASR SL Acetabular Head System, DePuy ASR Hip Resurfacing System, DePuy Pinnacle artificial hip systems, as well as certain artificial hips manufactured by Stryker, Biomet and Zimmer.
Remarkably, most medical devices recalled by the FDA in recent years because of deaths or life-threatening problems were approved under less stringent regulations that did not require human testing — meaning the devices were never tested in human patients before being implanted into hundreds of thousands of people.
Making matters worse, not only are these devices not properly tested, but the hip manufacturers pay doctors to actively promote the defective products. DePuy paid more than $80 million to doctors across the country to promote, research, and consult on DePuy's defective hips.
Metal-on-metal hips may also be linked to certain cancers. The metal-on-metal construction of the DePuy ASR artificial hip permits grinding and allows metal particles to contaminate the surrounding tissue. These metal particles — cobalt and chromium — enter the blood stream and can be distributed to other areas of the body.
[More on the DePuy Hip Recall]
- Hip Maker Discussed Failures [Barry Beier at NYT]
(c) Copyright 2012 Brett A. Emison
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.