On August 26, 2010, DePuy Orthopaedics, Inc. (DePuy), a division of Johnson & Johnson, issued a voluntary recall of the DePuy ASR™ XL Acetabular System and ASR Hip Resurfacing Device – a total hip replacement system. It involves not only the replacement of the joint (ball and socket), but also the “neck” of the femur. A rod coming off of the artificial neck is inserted into the shaft of the femur. During clinical trials, more fractures than expected were occurring at the femur neck. The Food and Drug Administration (FDA) had approved the ASR Acetabular System in 2005, but through a 501(k) approval process, which allowed DePuy to bundle an unapproved implant into an existing design and sell a device with minimal testing. Although it was never approved by the FDA, doctors could choose to implant the ASR Resurfacing Device in what is referred to as an “off label” use. The U.S. has no national reporting database, and nobody tracks such implants. As a result, doctors were unaware of problems with the ASR Hip Implant.
Late last year, DePuy reached an agreement to settle an estimated 8,000 hip implant products liability claims for approximately $2.475 billion. The settlement was announced at a November 19, 2013 hearing before the Honorable David A. Katz, presiding judge over the federal Multi-District Litigation (MDL) pending in the Northern District of Ohio. However, the settlement is not limited to the federal MDL, but is also accessible to plaintiffs in the coordinated ASR Hip lawsuits in New Jersey, California, Illinois, and Maryland.
The DePuy settlement program does have limitations on who may participate, namely the requirement that the claimant had to have undergone a revision surgery on or before August 31, 2013. The program provides for a base award of $250,000 to each claimant, subject to certain reductions related to factors such as tobacco use and body mass index. Claimants may also be entitled to a supplemental “Part B” award if they had bilateral revisions, re-revisions, or complications arising out of a revision.
From a subrogation perspective, however, the most interesting and refreshing feature of the program is that DePuy has agreed to handle lien claims separately from the claimants’ monetary awards. Not all liens are “qualified liens” under the agreement. DePuy has limited its lien resolution obligation to liens directly related to compensable revision surgeries and medical expenses incurred for treatment related to the reasons for the recall of the implants. DePuy’s protocol for resolving the lien claims has not yet been made public.
Now is a crucial time. The enrollment deadline for eligible plaintiffs is April 1, 2014. As part of the enrollment process, claimants are required to submit a form identifying all claimed liens along with any supports and correspondences they have received from the lienholders. While claims administration procedure mandates that claimants must update and supplement that information as needed, whether that obligation extends beyond the April 1 deadline, and whether the claimants will comply, is not certain. Therefore, it is absolutely imperative that subrogation professionals with potential liens related to DePuy ASR Hip Implants submit their claims to the proper plaintiffs’ attorneys or to unrepresented claimants, as soon as possible.
If you have any questions regarding this article or subrogation in general, please contact Timothy Mentkowski at [email protected].