A bone cement injection into the spine sounds like a procedure straight out of a horror movie. For some unfortunate patients, however, bone cement and its resulting problems are a reality. The federal government has conducted a criminal investigation into bone cement, and civil litigation may also be possible. If you and your family would like to discuss your legal options, speak with a New York personal injury lawyer who has expertise in medical device cases.
What is Bone Cement?
Bone cement, known by the product names Norian XR and Norian SRS, is a product which uniquely turns into bone when injected into the human skeleton. However, the U.S. Food and Drug Administration (FDA) had warned the product manufacturer to not use the bone cement in certain types of spinal surgeries. The company proceeded with clinical trials anyway. During trials for the product, the company promoted the Norian product for treatment of vertebral compression fractures. Patients undergoing surgery for this type of fracture are typically older patients and seniors.
When doctors injected bone cement into patients’ spines during surgeries for vertebral compression fractures, at least five patients died. Some families were surprised and horrified to learn about the unlawful use of bone cement after the U.S. Department of Health and Human Services and the FDA investigated the Norian clinical trials.
Legal Consequences of Bone Cement Trials
The FDA conducted a criminal investigation into Snythes, Inc., the U.S. branch of a multinational medical device company, and its clinical trials of the Norian product. The U.S. Attorney’s Office accused the company of running illegal clinical trials in violation of federal laws. In November 2011, several corporate executives received prison sentences and will be required to pay fines as a result of their unlawful activities. All four executives had pled guilty to misdemeanor charges related to the bone cement product. In addition, Norian Corporation, a subsidiary of Snythes, pled guilty to impeding the FDA’s functions and to committing crimes against the United States.
Do you have a medical horror story of your own? Would you like to know if medical device litigation is a possibility? An experienced attorney can assess your potential claim and help to develop a plan for legal action. Contact Gerowitz Libo & Korek, P.C., New York personal injury lawyers, at 800-529-9997 for a free consultation.