Friday, November 15, 2013

Rumored $4 Billion Settlement in DePuy ASR Reached



Major news outlets are reporting breakthrough in settlement negotiations in the DePuy ASR hip litigation. DePuy, a subsidiary of Johnson & Johnson, is rumored to have agreed in principle to a $4 Billion agreement to settle lawsuits over their metal-on-metal hip product.

Neither the Plaintiff or Defendant leadership committees-nor the Court for that matter-has confirmed these reports.

The reports claim that the settlement will resolve more than 7,500 lawsuits in federal and state courts against J&J. The 7,500 number is an estimate for how many filed lawsuits are for Plaintiffs who have had a revision surgery. That number is important because as of right now, it appears the settlement would only be for those Plaintiffs who have already had a revision surgery, with an average payout of $300,000-$350,000. It is rumored that the agreement does not bar Plaintiffs whose artificial hips fail in the future from seeking compensation from J&J. Of course, there are many different factors to this agreement including those Plaintiffs who cannot have a revision surgery because of their current health conditions.
There is an open court hearing next week in the MDL Court in Ohio, where many people think the settlement will be announced.
The settlement will be the second multibillion-dollar agreement this month for J&J, the world’s largest seller of health-care products. The corporation agreed on November 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of Risperdal and other medicines. I will be posting a blog on that subject in the next few days.
J&J has spent about $993 million on medical costs and informing patients and surgeons about the recall. J&J set aside an undisclosed amount for litigation, which it increased before June 30. See my previous blog posts regarding that subject.
Details of the rumored are sketchy, but it has been reported that 94 percent of eligible claimants must sign up for the settlement or J&J can withdraw from the deal. This is often times referred to as a Defendant’s ‘Opt-out clause’ and is very common in mass tort global settlement agreements.
J&J recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years. About one-third of that number were sold in the United States. The product went on the market in 2003.
J&J had touted the metal-on-metal implants, first sold in the U.S. in 2005, as a new design that would last 20 years and offer greater range of motion. DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the discovery phase of the ongoing litigation showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate. Those documents revealed that internal DePuy projections estimated that it will fail in 40 percent of patients in five years-a rate eight times higher than for many other hip devices. Other documents showed that the head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw.
As failures mounted, patients complained in lawsuits that the metal-on-metal implant caused soft tissue necrosis, pseudo tumors, metalossis, pain and follow-up surgeries known as revisions. They claimed that debris from the chromium and cobalt device caused tissue death and increased metal ions in the bloodstream.
Claims by unrevised Plaintiffs may be handled in a second round of settlements.
The $4 billion settlement will provide compensation to hip patients based on factors including age, extent of injuries and whether they had one or more surgeries to replace defective implants. Typically, a matrix-type grid is used to categorize Plaintiffs based on these factors.
The accord also provides more compensation to hip recipients who suffered “extreme injuries” from the device’s failure, or endured long hospital stays after removal surgeries.
Also reported was that J&J also has agreed to set aside funds to reimburse Medicare and other insurers for claims paid on behalf of hip-implant patients, which could add hundreds of millions of dollars to the value of the settlement.
Of course, any proposed settlement would have to win Court approval.
DePuy continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.


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