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Details of the DePuy ASR artificial hip settlement were officially released yesterday during a hearing involving lawyers and judges involved in litigation across the country.  To date, there have been nearly 8,600 cases filed in the federal MDL with additional cases filed in state courts across the country.  This massive litigation involves approximately 12,000 plaintiffs.

There have been many leaks and rumors surrounding the settlement in the years and months leading up to its final approval.  Because of the various rumors and confusion surrounding the settlement, I’ll attempt to answer some basic questions.

What devices are covered by the settlement?

This settlement resolves claims involving the DePuy ASR Acetabular hip system or the DePuy ASR hip resurfacing system.  Other defective hip claims – including DePuy Pinnacle hip systems and artificial hips manufactured by Wright, Biomet, Stryker, or  Zimmer – are not included in the DePuy ASR settlement.

Who is eligible for the settlement?

Plaintiffs are eligible to participate in the settlement if they are either U.S. citizens or U.S. residents and had surgery to replace a DePuy ASR hip implanted for more than 180 days with the revision surgery occurring on or before August 31, 2013 either in the United States or at a U.S. Military hospital abroad.

Patients having a replacement surgery after August 31, 2013 (or not all) are not eligible to participate in this settlement.

How is the settlement structured?

The settlement is structured in multiple parts.  Part A provides the “base” award.  Under the Part A base award, qualified patients will receive $250,000 subject to limited potential reductions for factors that include smoking, BMI, ASR as a revision device, length of use, and death unrelated to the revision surgery.

Some plaintiffs may be eligible for an additional award under Part B of the settlement agreement.  Part B supplemental awards will be made to plaintiffs who can demonstrate extraordinary injuries related to the removal of their ASR hip device.  Qualifying extraordinary injuries include, for example, plaintiffs who required multiple hip surgeries following their ASR implant or re-revision surgeries; bilateral ASR implants (implants for both the right and left hip); serious or catastrophic medical events such as death, heart attack, stroke, DVT, dislocation, foot drop, or infection either during revision surgery or caused by the revision.  Plaintiffs will also have an opportunity to present “special circumstances” to the settlement administrators if they believe such circumstances warrant a supplemental award.

In addition to Part A and Part B, DePuy has also assumed responsibility for any outstanding medical bills or liens by health care providers or insurance companies directly associated with a compensable revision surgery.  This means that, in addition to the $250,000 Part A payment and any Part B supplement payment, DePuy will also pay any outstanding bills related to the costs of the revision surgery.

Plaintiffs wishing to participate in the settlement must register by January 6, 2014.  Submission of all claims packages and documentation must occur on or before April 1, 2014.

What about plaintiff’s without a revision?

Unfortunately, patients not having a revision surgery by August 31, 2013 will not be eligible for this settlement.  Approximately 1/3 of the plaintiffs (4,000 out of 12,000 plaintiffs) in the DePuy ASR litigation are non-revision patients.  Patients without revisions will retain all of their legal rights and their claims remain preserved.  Plaintiff attorneys continue to work to resolve the claims of plaintiffs without revisions surgery.  It is important to note that the decision to have a revision is a medical one; not a legal decision.  The decision to have revision surgery should be made in consultation with a physician.

How will settlement money be distributed?

Plaintiffs and DePuy have engaged a third party settlement administrator – BrownGreer – to oversee the settlement.  BrownGreer has established a web site with more information about the settlement, which should be up and running by Friday, November 22, 2013.  BrownGreer will serve as the first level of claim determination.  If you are unhappy with BrownGreer’s determination of your claim, then you can appeal your claim to a panel of special masters who serve as a second level of review.  The special masters are retired judge Marina Cordemus, retired judge John Trotter, and mediator Cathy Yanni.  In addition, Judge James McMonigle has been appointed Chief Claims Administrator and will have final authority in approving or rejecting submitted claims.

When will plaintiffs receive settlement money?

No payments will be made to any plaintiff until DePuy has decided whether or not it will exercise its “walk away” rights.  These “walk away” rights permit DePuy to reject the settlement if an insufficient number of plaintiffs participate in the settlement program.  Reports suggest that DePuy may exercise these “walk away” rights if less than 94% of eligible plaintiffs participate in the settlement program.

The enrollment deadline for participating plaintiffs will be April 1, 2014.

BrownGreer has committed to review all Part A (“base”) claims within 90 days after the enrollment deadline.  It’s important to note that the claims review process will be a “first in, first out” process.  The earlier a plaintiff enrolls, the earlier the plaintiff will receive his or her settlement proceeds.

First payments will be come after DePuy has determined whether or not it will exercise its “walk away” rights.  DePuy must made its “walk away” decision on or before June 1, 2014.

Once BrownGreer has issued its initial report of plaintiffs whose claims are ready to be paid, DePuy will fund the escrow agent to play the approved claims within 15 business days.

How did the settlement come about?

The settlement came about after three years of litigation involving a substantial amount of work and expense by all parties involved.  DePuy produced and plaintiffs reviewed approximately 80 million pages of documents.  Plaintiffs deposed 60 DePuy and 3rd party employees across the world – including England, Ireland, California, Indiana, New Jersey, and more.  Each side consulted and retained a substantial number of experts – including physicians, scientists, chemists, metallurgists, etc.  The parties litigated two jury trials to verdict and prepared a number of additional cases for trial.

Should plaintiffs participate in the settlement?

That will be the key issue arising out of the settlement agreement.  My staff and I have been reviewing the reports and terms of the settlement as they have become available and will have a number of serious discussions with our DePuy ASR clients.  Ultimately, this decision will be the individual plaintiffs’ decision, but only after careful consideration of the full settlement terms with their attorney.

What is wrong with the DePuy ASR artificial hip?

The DePuy ASR artificial hip is defective because its metal-on-metal design resulted in an abnormally high failure rate and permitted toxic metals to be leached into the body as particles were ground away from the device.  DePuy’s internal estimates suggested that more than 1/3 of patients receiving an ASR hip replacement would need a revision surgery within 5 years.  Despite that knowledge, DePuy executives decided in 2009 to phase out – but sell off – ASR inventories to unsuspecting patients after the FDA asked the company for additional safety data and voiced safety concerns about the “high concentration of metal ions” in patients receiving the implant.

What about other metal-on-metal hips?

While this settlement only involves the DePuy ASR metal-on-metal hip systems, the problem does not stop with the particular device.  All metal-on-metal hips suffer from the same basic design flaw that permits toxic metals to be ground away from the device and to contaminate the body tissue surrounding the implant.  The New England Journal of Medicine found that metal-on-metal artificial hips failed at 3-times the rate of other artificial hip implants.  There are a number of additional lawsuits involving DePuy’s Pinnacle artificial hip device as well as other manufacturers including Biomet, Stryker, Wright, and Zimmer.

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© Copyright 2013 Brett A. Emison

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