Has Stryker Been Fined Over Its Knee Replacement Cutting Guides?
As we have reported previously in our blog, our firm has been involved in Stryker litigation, including lawsuits over defective hip implants manufactured by the company.
Recently, Reuters reported Stryker has been ordered to pay the U.S. government $80 million to settle criminal and civil charges that one of its subsidiaries sold devices used in knee replacement surgery without gaining approval from the U.S. Food and Drug Administration.
According to Reuters, OtisMed Corp and its CEO Charlie Chi, 45, pleaded guilty to selling unapproved medical devices in federal court. The company was ordered to pay a fine of $34.4 million, criminal forfeiture of $5.16 million and a civil settlement of $40 million.
Additionally, the news outlet reported that Chi is scheduled to be sentenced March 18, 2015. According to Reuters, OtisKnee sold about 18,000 cutting guides, designed to help surgeons make accurate bone cuts in knee replacement surgeries, between May 2006 and September 2009, prior to receiving FDA approval.
“Companies and individuals put the public health at risk by not complying with FDA regulatory requirements for the pre-market review of medical devices,” Philip J. Walsky, acting director of the FDA’s Office of Criminal Investigations, said in a statement.
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All medical devices must be reviewed for defects and companies that avoid regulations could put out defective products, which can lead to injuries.
Some of other high-profile implants that have been linked to injuries include:
- DePuy ASR XL Acetabular System
- DePuy ASR Hip Resurfacing System
- Biomet M2A Magnum
- Stryker CerviCore cervical implants
- Stryker FlexiCore lumbar spine implants
If you have developed complications due to a defective medical device listed above or have concerns about any product, our attorneys are here for you.
Zoll & Kranz, LLC – Defective Medical Drug and Device Lawyers
ZK’s Tidbit: An estimated 719,000 knee replacement procedures are performed in the U.S. each year.