Thursday, March 28, 2013

Order Establishing Multi-County Litigation in Stryker Rejuvenate and ABGII Hip Implant Recall Issued from NJ Supreme Court

On January 15th, the New Jersey Superior Court issued an order which established a multi-county litigation regarding hip replacement lawsuits for the recalled Stryker Rejuvenate and ABGII. Judge Brian R. Martinotti will preside over the litigation in the Bergen County Superior Court. Stryker recalled two of its hip implant devices on July 6, 2012, only three months following the Urgent Field Safety Notice sent to surgeons and hospitals in April of 2012. 

In that notification, Stryker stated health risks associated with the ABGII and the Rejuvenate, including corrosion and fretting. The stem of the Rejuvenate and ABGII are titanium-coated while the neck components are constructed of cobalt and chromium.When fretting or corrosion occur tiny shards of cobalt and chromium can shear away from the implant, lodging in nearby tissue or entering into the bloodstream. This in turn can result in inflammation, pain, bone loss, tissue degradation or death, loosening or dislocation of the hip joint and the necessity for revision surgery. Pseudo-tumors can also form, requiring surgery to remove them. Symptoms of metal toxicity may also be evident.

The recall of the Stryker Rejuvenate and ABGII hip implants involved over 20,000 implants and, according to Reuters, is expected to cost the company nearly $400 million dollars. The impending lawsuits as well as revision surgery costs, blood tests, MRIs and X-rays will all take their part of that amount. Stryker advises those implant recipients who have experienced swelling or pain at the hip joint—and even those who have not yet experienced symptoms—to seek the advice of their physician and undergo blood tests and image screening. Thus far 81 lawsuits against Stryker have been filed in the New Jersey multi-county litigation. A conference regarding the recall litigation took place on March 19, 2013.

All-metal hip implants were intended to last considerably longer than their ceramic and polyethylene predecessors, however relatively soon after recipients were implanted with metal-on-metal implants adverse reports began pouring in. Rather than the anticipated 12-20 years the all-metal implants were expected to last, revision surgeries were required after only three, four and five years.  In fact, depending on the manufacturer and model of the metal implant, failure rate can reach 40-60% within the first five years. When patients engage in physical activities, the metal implant parts rub against one another, releasing metal ions into the body. Metal toxicity can result in cardiovascular, renal, thyroid and gastrointestinal disorders, hearing and vision disturbances, anxiety, depression, memory loss, vertigo, skin issues, pseudo-tumors and disruption of DNA.

It is unknown at this point whether the number of lawsuits against Stryker will reach the level of those leveled at DePuy and Johnson & Johnson who have had nearly 10,000 suits filed regarding the DePuy ASR hip implant since its recall in 2010. The first DePuy case concluded in a California Court recently resulting in a settlement of over $8 million dollars for the plaintiff. The results of this first case are considered extremely important for all the cases to come, including the Stryker Rejuvenate and ABGII lawsuits.

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