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Category : ASR Acetabular Cups

NYT: DePuy Discussed Defective Hip Implants Before Recall

February 23rd, 2012

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 and retribution you deserve.

For information on the current 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.

FDA Issues Another Warning to DePuy

January 24th, 2012

In a warning letter published last week, the Food and Drug Administration announced that fourteen types of devices sold by DePuy Orthopaedics Inc. lacked necessary approval. The letter, sent by Steven D. Silverman, director of the office of compliance, was the result of a near month-long inspection of the Warsaw, Indiana-based company. The inspection also found that DePuy’s quality system did not comply with FDA requirements.

DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, has been the subject of significant FDA attention in the past. In 2010, the FDA released another warning letter regarding the manufacturer’s defective hip replacements, the ASR Hip Resurfacing System and the ASR XL Acetabular Cups System. These “metal on metal” hip replacements released dangerous metal shavings in patients, often leading to debilitating pain and other health complications. DePuy recalled the hip implants in 2010, and since then, Seeger Weiss LLP has been working with victims to restore their health and recover compensation for their suffering. If you have been affected by the DePuy ASR hip replacement recall, contact Seeger Weiss today. One of our experienced attorneys will review your case for free.

For information on the 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.

Johnson & Johnson and DePuy Orthopaedics Recall Defective Hip Replacements

August 30th, 2010

On August 26, 2010, DePuy Orthopaedics, Inc. a subsidiary of Johnson and Johnson recalled both its ASR acetabular cups used in hip replacement arthroplasty and total hip replacements. The Johnson and Johnson recall comes more than two years after the Food and Drug Administration began receiving complaints and follows a determination that the failure rate for both ASR acetabular cups was more than 12%.

The ASR acetabular cups are a metal-on-metal device, a design that according to the New York Times, is coming under increasing scrutiny due to the potential for generating large amounts of metal debris during normal wear and tear. Such debris can negatively impact soft tissue and evolve into a health issue for some patients.

DePuy’s ASR cup, was approved for use in 2005 by the FDA but “was cleared through a regulatory pathway that did not require it to undergo clinical trials,” reports the New York Times.

Are you a victim?

Don’t wait. If you think you have had your hip replaced using DePuy’s ASR acetabular cups, contact Seeger Weiss today. Our experienced defective hip replacement attorneys can immediately assist you and discuss your legal options.

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