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Lawsuit Allegations and Plaintiffs Suing Stryker
With the widespread problems experienced with its recalled Rejuvenate and ABG II hip implants, thousands of patients are suing Stryker Orthopaedics. Plaintiffs allege that Stryker was negligent in failing to properly test the devices, which were cleared through the FDA’s 510(k) program. That failure allegedly led to the release of a defective product that, once implanted, shed toxic metal particles into the tissue surrounding the hip, causing a range of side effects including dislocation, bone loss and chronic pain. Many patients continue to suffer permanent side effects even after revision surgery.
Plaintiffs also accuse Stryker of misleading the public about the benefits and effectiveness of its implants. The company claimed the Rejuvenate and ABG II were more durable than other implant designs, and touted the versatility of their modular design, which made the devices suitable for a wide range of patients, including younger patients with active lifestyles.
Lawsuits against Stryker remain in the early stages. Stryker settled in December 2013 with four plaintiffs whose cases were selected from those consolidated in New Jersey state courts. Two other cases failed to reach an agreement in mediation. Terms of the settlements were not disclosed, and further cases remain in negotiation.
Regulatory filings submitted by the company last October estimated the cost of the recall and litigation to be as high as $1.13 billion, double the $660 million estimated in a previous filing. Those numbers also didn’t take into account payments to third-party insurance companies. Stryker spent over $510 million in 2013 on related costs.