Medtronic Inc’s motion to dismiss a product liability and medical malpractice lawsuit was denied by an Illinois state court judge recently. The lawsuit is over Infuse, an off-label bone graft manufactured by Medtronic Inc. The plaintiff, Karl Sanda, is suing Medtronic for negligence, strict liability, breach of warranty and willful and wanton conduct. Additionally, the lawsuit charges Northwestern Memorial Hospital, Northwestern Orthopedic Institute LLC and Dr. Mark T. Nolden with negligence claims.
Sanda experienced severe complications after initial and additional surgery and is now permanently disabled.
Although the U.S. Food and Drug Administration (FDA) approved Infuse for use in spinal fusion on the lower spine and for specific dental procedures, it was not approved for use in the cervical spine, which was where Sanda’s surgery occurred. In 2008, the FDA warned that the product could cause serious side effects and injures when used in cervical spine fusion surgeries, including swelling of the neck, difficulty breathing, constricted airways, swallowing difficulties and even nerve damage. Recent studies indicate that Infuse has even been linked to more severe injuries, including male sterility, infections and cancer.
Last October, the U.S. Senate Finance Committee found Infuse’s research to be suspect. Their investigation showed that Medtronic paid $210 million in royalties, consulting fees and other forms of compensation to doctors who co-authored company research studies of Infuse. Senate investigators claim that Medtronic manipulated data in order to minimize the side effects and injuries from Infuse.
To redeem the company’s reputation and its product, Medtronic funded an independent study of Infuse. Two research teams determined Infuse offered no significant benefit over grafted bone taken from the patient’s own body.
It will be interesting to see how this lawsuit unfolds. Here is yet another glaring example of how major medical equipment companies will do whatever it takes to sell their products, including falsifying or manipulating data and having no regard for patients’ well-being.
If you or someone you know suffered injuries from Infuse, please call us for a complementary and confidential consultation – You may have a claim and may be due compensation. You are under no obligation to use our services. Call us today at 214-526-7900, or submit the short case review form on the right.