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Blog, Drug & Medical Device
NYT: DePuy Discussed Defective Hip Implants Before Recall
Earlier this week, The New York Times uncovered a 2009 email authored by an executive at DePuy Orthopaedics, a Johnson & Johnson subsidiary, that seems to refute the company’s later claims that it believed its artificial surface replacement (ASR) hip replacement to be safe. The message was sent in August 2009, just days after the Food and Drug Administration confidentially informed DePuy that it would not approve the ASR device. In the email, vice-president Pamela Plouhar explains the reasons for the FDA’s decision to three other top executives, including then president, David Floyd. The New York Times writes that Ms. Plouhar, “reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in ‘significant’ numbers, requiring repeat surgeries for patients.”
Although the ASR implant was denied approval by the FDA, it was sold overseas and was placed in 30,000 patients in the United States before it was officially recalled in 2010. While DePuy’s apparent lack of transparency does not alone constitute a violation of the law, the 2009 email certainly contradicts statements from Johnson & Johnson prior to the recall. After the metal-on-metal hip implants were indeed found to be defective in a number of cases in 2010, the company maintained that its internal studies had demonstrated the safety of the device, and shifted blame onto the doctors and surgeons who were responsible for the implant procedures. The 2009 email, however, proves that DePuy knew the ASR hip implant was unsafe, even when applied by doctors the company hand-picked itself. As The New York Times notes, “DePuy’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it…”
If you are the victim of a defective ASR hip implant, contact Seeger Weiss LLP today. Our experienced defective products attorneys will make sure your case receives the attention you deserve.
For information on the current 2012 Stryker hip implant recall, visit https://www.seegerweiss.com/stryker-hip-recall.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.