Medical Device Manufacturer Settles Criminal and Civil Charges for $80 Million
OtisMed, the maker of the OtisKnee surgical knee replacement guide, has pleaded guilty in federal court in New Jersey for selling an adulterated medical device. The defective product manufacturer has also agreed to pay $80 million to settle other outstanding criminal and civil charges that it put the health and safety of patients at risk as it defrauded doctors by the thousands about the safety and efficacy of its product.
Guilty of Selling an Unapproved Medical Device
OtisMed began selling its OtisKnee cutting guide to surgeons back in 2006, before it even had applied to the FDA for approval of the device. Although the guide is used by surgeons in the performance of knee replacement surgeries, OtisMed in its application to the FDA classified the OtisKnee as a Class I medical device, a category suitable for products with the lowest risk to patient safety, such as bandages, enema kits and surgical gloves. The FDA therefore did not evaluate OtisMed’s claims very closely…at first.
OtisMed sold about 18,000 OtisKnees between 2006 and 2009, when it was finally considered and rejected by the FDA for failing to meet the agency’s standards for safety and effectiveness. Even after their application was denied, OtisMed continued to ship over 200 OtisKnee devices. At this point, a whistleblower stepped forward and alerted the authorities, leading to the civil and criminal charges and the multi-million dollar settlement.
Compensation is Available for Botched Knee Surgeries
Knee replacement surgeries are among the most common elective surgery procedures in the country, and about 10% of the more than half a million surgeries performed every year are replacement surgeries of previously-implanted artificial joints. Knee surgeries come with a lengthy and painful recovery period, and a revision surgery to correct an improper procedure can be particularly traumatic and debilitating. If you suffered from a knee surgery in West Virginia that may have involved the use of a faulty medical device or other medical error, we want to hear from you. Contact the Bayless Law Firm for a free evaluation of your case.