February 9, 2015 — The New York Times has highlighted a case report of a woman who was severely injured after an unapproved cutting guide was used during her knee replacement.
Carla Muss-Jacobs, a real estate agent from Oregon, trusted that any device used in her surgery would be safe and effective.
Instead, she says she awoke from surgery in excruciating pain that continued until she contacted another surgeon for revision surgery. In the meantime, she was unable to walk or work, which led her to declare bankruptcy in 2009.
Ms. Muss-Jacobs is not alone in her complaint. According to an investigation by ProPublica, there were 58 reports of “malfunctions” by the end of 2009, but no one knows how many people were injured.
About 18,000 of the OtisMed Cutting Guides were sold from May 2006 to September 2009, generating $27.1 million in sales. The devices were marketed as a way to save time in the operating room and help custom-fit implants to match each patient’s unique anatomy.
However, OtisMed did not seek clearance from the FDA before the cutting guides were sold. Instead, the device-maker tried to pass them off as Class I devices, which are “low-risk,” such as dental floss and band-aids.
When the FDA insisted they were Class III (“high-risk”), OtisMed applied for approval. In 2009, the application was rejected because the company failed to show that the product was safe and effective.
After approval was denied, the CEO insisted on shipping over 200 of the devices to surgeons. After pleading guilty to criminal charges, he now faces up to three years in prison and $300,000 in fines.
The Justice Department also reached an $80 million settlement for civil and criminal charges in December 2014. Prosecutors accused OtisMed of selling unapproved medical device from 2006-2009.
Do I have an OtisMed Knee Lawsuit?
The Schmidt Firm, PLLC is currently accepting OtisMed knee induced injury cases in all 50 states. If you or somebody you know has been injured by a defective knee replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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