&

Wednesday, November 27, 2013

Estimates for Stryker Hip Recall May Soon Rival Those of DePuy Hip Recall




When consumer health issues such as metal poisoning and metallosis are potential consequences of a recalled metal hip implant, the costs to the manufacturer can be substantial. Stryker Corp, the manufacturer of the recalled Stryker ABGII and Rejuvenate hip implant devices, has increased the original estimates of $190-$390 million to over $1.1 billion for expenses related to the July, 2012 recall. Of course the ultimate cost will depend on a variety of factors, including the number of Stryker lawsuits, the amount of the settlements and the costs of revision surgery and other treatment for victims of the recalled hip implants.

Over 400 lawsuits are pending in a Minnesota Court under U.S. District Judge Donavan Frank, with over 600 more pending in state court in New Jersey. Consolidation of product liability cases is common in order to avoid conflicting pretrial rulings from many different judges as well as to allow sharing of discovery. Johnson & Johnson is estimating over $3 billion in settlement costs for the DePuy ASR metal hip device for the over 10,000 lawsuits filed in response to the recall. With time left for most states under the statute of limitations, it is likely many more Stryker lawsuits will be filed.

Metal poisoning symptoms occur when the hip device suffers corrosion, leading to the generation of microscopic metal ions which enter the bloodstream. Such serious health issues as loss of hearing and vision, memory loss, vertigo, neurological disorders, changes to DNA, the development of pseudo-tumors, cardiovascular problems, renal and thyroid issues, reproductive disorders, gastrointestinal issues and chronic headaches can result. Should the cobalt and chromium ions enter the hip tissue, inflammation, chronic pain and the deterioration of bone and tissue can occur, leading to hip failure and the necessity of revision surgery. At the time of the ABGII and Rejuvenate recall, Stryker stated the risk of fretting, corrosion and the release of metal ion debris at the neck-stem taper junction.

Unlike the traditional one-piece neck and stem, Stryker offered surgeons a variety of neck and stem components of varying angles and lengths which allowed the surgeon to custom-fit the device to the individual patient. Unfortunately, the innovative design which was meant to offer longer implant life and greater freedom of motion failed to live up to expectations. The neck-stem taper junction created friction during periods of activity, and that friction led to dangerous and premature levels of corrosion, despite the use of a ceramic ball rather than a metal ball. 

While there is no United States database which comprehensively tracks hip implants, it is estimated that over 20,000 of the devices were implanted into consumers between FDA approval in 2009 and the time of the recall. Revision surgery, should it become necessary, is considered riskier and more expensive than the original implant surgery, with a considerably longer recovery time. Patients harmed by the recalled Stryker Rejuvenate or ABGII should undergo the necessary testing to determine whether they have dangerous levels of cobalt and chromium in their bloodstream. Legal representation may also be beneficial for those seeking to recover expenses associated with the recalled implants.

No comments:

Post a Comment