As part of its continuing coverage of the fallout stemming from the August 2010 worldwide DePuy ASR hip recall, on February 22, 2012, the New York Times reported that top executives at Johnson & Johnson (“J&J”) had early knowledge of ASR hip replacement problems associated with its ASR hip system. An internal email sent by a J&J executive to senior management reported that the U.S. Food and Drug Administration (“FDA”) had refused to approve an ASR hip replacement device after reviewing company studies and clinical data evidencing that there were significant ASR hip replacement problems, which required patients to undergo revision surgeries in order to remove the ASR hip system. The email, written by Pamela Plouhar, a vice president of DePuy in August 2009, explained the reasons leading to the FDA’s ASR rejection. The email was sent to three other top executives, including DePuy’s president David Floyd. Floyd resigned as president of DePuy in March 2011, amidst growing criticisms stemming from the DePuy ASR hip system recall, mounting lawsuits and increased scrutiny and media attention because of dangerous ASR hip replacement problems.

Interestingly, at the same time the NYT revealed this damaging email, J&J announced that William C. Weldon, the Chief Executive Officer of J&J during the DePuy debacle, will step down in April 2012. Weldon will be replaced by J&J insider Alex Gorsky.

ASR Hip Replacement Problems Noted By FDA Detailed In Executive’s Email

Plouhar reported that the FDA ASR decision was based on the high rate of ASR hip replacement problems. Specifically, the high rates of early failure of the devices. Additionally, she advised that providing more data to the agency might have little or no impact. “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 wrote. Ms. Plouhar also noted the significance of the letter’s timing. She wrote, “This comes at a time when ASR data from national registries (Australia and the UK) is being closely scrutinized because of higher revision rates.” According to Bernstein Liebhard LLP partner Felecia L. Stern, who is representing clients injured by the defective ASR hip implants, “This email serves as yet further evidence in these cases that DePuy knew there were problems with the ASR long before they issued a recall of the product. To make matters worse, they tried to quietly hide the ASR’s excessive failure rates by telling doctors, patients and investors that they were simply phasing out the device because of declining sales. This is what lawyers call a ‘red hot’ document to use in depositions of J&J executives.”

J&J Continues to Sell ASR Hips Despite FDA ASR Rejection

The internal email indicates that top J&J executives were not only aware that the ASR hip replacement problems were the impetus for the FDA ASR rejection, but that they were clearly informed there was a “downside risk” to conducting additional studies. Significantly, despite the FDA ASR decision, J&J continued to market and sell certain ASR hip implants both abroad and in the United States. Ms. Stern said, “When I think of the number of individuals who received the ASR hip implant in the year between the FDA decision and the recall, I’m infuriated and I’m sure our clients’ implanting surgeons are too.”

ASR Hip Replacement Problems Lead To Worldwide ASR Hip System Recall

In August 2010, J&J finally issued a worldwide ASR hip recall. The recall came after the National Joint Registry of England and Wales released data that 1 out of every 8 patients who received an ASR hip system needed revision surgery within five years of implant. An estimated 93,000 people worldwide were affected by the recall.

ASR Hip System Recall Leads To Hip Replacement Lawsuits

Following the hip replacement recall 2010, litigation over the defective ASR hip implants has surged. Johnson & Johnson is defending over 5,000 hip replacement lawsuits in the United States. If you or a loved one received a DePuy ASR hip system and have experienced ASR hip replacement problems or had to undergo revision surgery, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.

For more information about filing a DePuy ASR lawsuit, depuyasrlawsuit.html contact an attorney at Bernstein Liebhard LLP for a free and confidential case evaluation. Our lawyers have extensive litigation experience, and have recovered billions of dollars for our clients. In addition to being staunch advocates for your claim, our team of ASR hip system lawyers also provides personal attention to guide you through the complex litigation process.

If you received an ASR hip system and experienced ASR hip replacement problems, contact us today to learn more about your legal options.

Published February 23, 2012 by