Massive $4 Billion DePuy ASR Settlement to be Announced by J&J

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johnson-and-jonson-settlementJohnson & Johnson is scheduled to formally announce its historic $4 billion settlement over the DePuy ASR metal-on-metal hip implant device. According to three people who are familiar with the matter, the accord is meant to resolve thousands of lawsuits.

U.S. District Judge David Katz in Toledo, Ohio, will hear the terms of the device—presented by plaintiff attorneys and J&J—on November 19th, said people familiar with the matter. The three people asked for anonymity as they were not authorized to speak publicly about the settlement, according to Bloomberg.com. Judge Katz scheduled the so-called “open status conference,” court records indicate.

According to the accord, J&J will pay no less than $300,000 to each of the 7,500 patients who underwent revision surgery to have their defective DePuy ASR hip devices removed, the three told Bloomberg.com. DePuy Orthopaedics is the manufacturer of the ASR and is a unit of J&J.

The accord also provides other funds to patients who have suffered what the accord  described as “extreme injuries” over device failure, as well as to patients who endured long hospital stays following their revision surgeries. The accord does not bar people who may potentially suffer future hip device failure from seeking compensation, the people told Bloomberg.com.

Also under the terms of the accord, 94 percent of eligible claimants must sign up for the settlement. Should 94 percent fail to sign on, J&J may withdraw from the deal, the people told Bloomberg.com. DePuy and J&J are facing nearly 12,000 lawsuits, which have been filed in federal and state courts in Ohio, California, New Jersey, and Illinois; Judge Katz is coordinating the federal litigation.

The massive accord is not capped as to its total value, the three also recently told Bloomberg.com, noting the settlement’s potential for future compensation. To date, J&J has lost one trial and won a second trial; J&J had also scheduled seven trials over the DePuy ASRs. The ASRs were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.

The settlement covers more than 7,500 patients who underwent revision surgery to have their defective DePuy all-metal hip devices removed, according to Bloomberg.com. The rest of the nearly 12,000 claims were filed by patients who, although they allege pain associated with their devices, have not yet had those devices removed, according to Bloomberg.com. DePuy spokeswoman, Lorie Gawreluk, declined to comment on the matter.

In August 2010, J&J and DePuy announced a global recall of 93,000 ASR devices. According to internal J&J documents, 37 percent of the devices had failed after just about 4.6 years; however, in 2012, the failure rate recorded in Australia—44 percent within seven years—was higher.

The metal-on-metal devices were touted as being more durable and longer lasting than their predecessors and promised increased range of motion for at least 20 years. Increasing reports revealed the opposite—device failures, injuries, and litigation. Patients alleged device dislocation, pain, increased blood metal ion levels, and the need to undergo revision surgery, a much more complex, painful, and costly procedure when compared to original device implantation.

The three familiar with the matter told Bloomberg.com that the settlement is the largest in the United States involving legal claims brought over a medical device.