| Stryker Biotech, a division of the Kalamazoo Michigan-based medical device manufacturer, has been indicted on making false statements and conspiring to defraud the U.S. Food & Drug Administration (FDA), wire fraud and distributing a misbranded medical device.
Stryker Indictment
According to news reports and a Stryker press release, the U.S. Attorney's Office for the District of Massachusetts has completed an investigation into Stryker's questionable business practices and has returned an indictment charging Stryker Biotech LLC and certain of its current and former employees with wire fraud, conspiracy to defraud the FDA, distribution of a misbranded device and for making false statements to the FDA. If the company is found guilty of the charges, it could be barred from participating in federal and state healthcare programs and face huge fines.
FDA warned Stryker
The FDA has repeatedly warned Stryker Biotech about quality and compliance issues at its Hopkinton, Massachusetts plant which manufacturers OP-1 bone-growth products used in spinal surgery and Calstrux – a bone filler used in conjunction with those products. The warnings accuse the company of falsifying hospital approval documents, having inadequate procedures for clinical studies and for mishandling complaints – the latter of which has plagued Stryker patients for years.
Defective Hip Implant Lawsuits
Hip implant patients have been complaining about defects in Stryker's Trident PSL and Hemispherical Acetabular Cups, a line of hip implants which uses ceramic-on-ceramic components, for years – saying that they experience pain, difficulty in walking, pieces of the ceramic materials breaking off, wearing unevenly and squeaking. Stryker Defective Hip Implant attorneys say that Stryker and Howmedica Osteonics Corporation – who developed, manufactured, marketed and sold the hip implant sold under the name Stryker Trident Ceramic Acetabular System – face hundreds of product liability lawsuits.
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