This week, health care giant, Johnson & Johnson, is set to formally announce its massive and historic $4 billion settlement over thousands of lawsuits and injury reports tied to the DePuy ASR metal-on-metal hip implant device. The accord is meant to resolve thousands of lawsuits, according to three people familiar with the matter.
U.S. District Judge David Katz in Toledo, Ohio, is scheduled to hear the settlement’s terms on November 19th. The terms are scheduled to be presented by plaintiff attorneys and J&J, said the people familiar with the matter. The three people requested anonymity because they were not authorized to speak publicly on the matter, according to Bloomberg.com. Judge Katz scheduled the so-called “open status conference” for early next week court records indicate.
The accord states that J&J will pay no less than $300,000 to each of the 7,500 patients who had to undergo revision surgery for removal of their defective DePuy ASR hip devices, the people told Bloomberg.com. DePuy Orthopaedics is the manufacturer of the ASR and is a J&J unit.
In addition to the $300,000 per plaintiff portion of the settlement, the accord provides other funds to patients who have suffered what are described as “extreme injuries” due to device failure, or to patients who had to undergo long hospital stays following their revision surgeries. The accord also does not bar those who may suffer hip device failure in the future from seeking compensation, the people told Bloomberg.com.
Under the terms of the accord, 94 percent of eligible claimants must sign up for the settlement. Should that figure fail to be reached, J&J can withdraw from the deal, the people told Bloomberg.com. DePuy and J&J face nearly 12,000 lawsuits filed in federal and state courts in Ohio, California, New Jersey, and Illinois; Judge Katz is coordinating the federal litigation.
The historic accord is not capped in terms of its total value, the people familiar with the matter recently told Bloomberg.com, pointing to the settlement’s potential for future compensation. Prior to this accord, J&J lost one trial, won a second trial, and had scheduled seven trials over the DePuy ASRs. The ASR devices were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.
According to Bloomberg.com, the settlement covers the more than 7,500 patients who underwent revision surgery to have their defective DePuy all-metal hip devices removed. The rest of nearly 12,000 claims have been filed by patients who, although they may be experiencing pain tied to the devices, have not yet undergone revision surgery to have the devices removed, according to Bloomberg.com. DePuy spokeswoman, Lorie Gawreluk, declined to comment to Bloomberg.com on the matter.
In August 2010, J&J and DePuy issued a worldwide recall of 93,000 ASR devices. According to internal J&J documents, 37 percent of the devices failed after just 4.6 years; however, in 2012, the failure rate recorded in Australia was higher—44 percent within seven years.
The all-metal devices were marketed as being more durable and longer lasting than prior devices and were touted to provide increased range of motion for at least 20 years. Instead, increasing reports of device failures, injuries, and litigation grew as patients alleged device dislocation, pain, increased blood metal ion levels, and the need to undergo revision surgery, to name just some of the issues recorded.
Those familiar with the matter told Bloomberg.com that this settlement is the largest in the United States involving legal claims brought over a medical device.