Monday, August 13, 2012

Stryker Hip Replacement Lawsuit

Stryker Hip Replacement Lawsuit

Stryker Orthopedics, one of the world’s largest manufacturers of medical devices, recently recalled two of its hip implant systems because of concerns that their metal-on-metal components can cause significant health problems in artificial hip implant recipients. When any medical device product is recalled because it has been shown to fail, because it causes pain and suffering, or because it does not perform as promised, the action opens up its manufacturer to potentially expensive product-liability litigation.

Stryker’s recall of its Rejuvenate and ABG II modular-neck hip stems may have been influenced by dozens of “adverse event reports” the U.S. Food and Drug Administration (FDA) has received concerning the two systems, with patients describing metal toxicity requiring revision surgery.
Stryker Recalls ABG II
ABG II Modular
The recall is expected to lead to another round of lawsuits with Stryker as a defendant. The company, like others that manufacture knee and hip implants, has fought these product liability claims before.

Stryker’s Product Liability Lawsuit History

In 2005, Stryker and other major medical device manufacturers—DePuy, Inc., Smith and Nephew, plc. Biomet Inc., and Zimmer Holdings, Inc. – were cited by the U.S. Department of Justice (DOJ), for unlawful kickbacks to physicians for urging hospitals to buy their respective products.
In November 2007, Stryker and its former outpatient therapy division, Physiotherapy Associates Inc., agreed to pay the United States $16.6 million to settle allegations of false billing to federal health care programs.

In May 2012, the company offered the DOJ $33 million to settle 2010 allegations regarding the improper marketing of a knee device that had not been cleared by the FDA.

For Stryker, this latest round of problems with metal-on-metal systems had hoped to be avoided when the company made a decision not to develop them. While other device companies faced legal woes in the early 2000s because of problems associated with their metal-on-metal ball and socket designs, Stryker made and marketed hip implant systems that featured ceramic cups and metal sockets.
Then those ceramic implants developed problems: patients experiencing squeaking, popping and other noises in the course of normal activity, a potential precursor of prosthesis failure. So Stryker recalled its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cups in January 2008 because of contamination concerns at one of its manufacturing facilities. Predictably, lawsuits followed.

Rejuvenate and ABG II Complications

Stryker is likely to face lawsuits because of problems caused by the metal-on-metal design of its Rejuvenate and ABG II modular-neck hip stems. Unlike one-piece, fixed femoral components, these models have two-part, mix-and-match necks and stems, both of which are made of metal.

Like metal-on-metal ball and socket designs, metal-on-metal femoral pieces can corrode and deteriorate, leaching toxic metal ions into the surrounding tissue, bone and/or bloodstream of implant patients. This metallosis can cause severe repercussions at the implant site including tissue death (necrosis), the formation of pseudotumors, and bone loss (osteolysis), resulting in the need for painful revision surgery.

Additionally, the long-term health effects of the cobalt and chromium alloy used in the Stryker necks, and the titanium that coats the stems, may be extremely deleterious. One British investigation found chromium and cobalt ions from these metals can spread and cause damage to the lymph nodes, spleen, liver and kidneys

No comments:

Post a Comment