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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.
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:
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.
Source: http://www.reuters.com/article/2014/12/08/us-health-stryker-idUSKBN0JM24K20141208
Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
A serious injury can have life-altering results.
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A serious injury can have life-altering results.
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