Medtronic Infuse Injury Lawsuit Not Preempted, Maryland Appeals Court RulesOct 9, 2014
The Court of Special Appeals in Maryland ruled that a lawsuit over the off-label use of Medtronic Infuse bone graft is not preempted by federal law, according to Law360. When faced with allegations of injury due to Infuse, Medtronic has often relied on preemption as a legal strategy.
The court decided that although preemption applies to cases that focus on approved uses of Infuse, allegations of off-label marketing are not preempted by the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. “Insofar as Medtronic’s alleged misrepresentations consist of false statements of material fact in the context of off-label promotion, outside the scope of the safe harbor, a state-law misrepresentation claim would parallel the FDCA prohibitions on off-label marketing.” the court stated. “To that extent, therefore, a state-law misrepresentation claim would not impose any requirements different from or in addition to those imposed under federal law.”
The court noted that after a year of investigation, the Senate Committee on Finance found that Medtronic employees were “shaping” medical studies by giving “significant” payments to consulting doctors through royalties and fees.
The suit was filed on behalf of a man suffered serious complications, allegedly due to the misrepresentations Medtronic made about Infuse. After undergoing spinal fusion in 2007 to treat back pain, the man allegedly suffered unwanted bone growth that forced him to undergo a second surgery in 2010. In 2011, he discovered two potentially-cancerous nodules in his lungs. The man also alleges that a sales representative had overseen the off-label insertion of Infuse.
The lawsuit alleges that Medtronic illegally marketed Infuse for uses not approved by the FDA. The man alleges serious injuries occurred because Infuse was inserted off-label through the back of his body, while the product is only FDA-approved for insertion through the front of the body.. He suffered unwanted bone growth that led to a subsequent second surgery in 2010, the suit alleges. Medtronic should have warned that Infuse should only be inserted in an anterior manner. The lawsuit alleges that Medtronic knew of Infuse's cancer risks.
Medtronic allegedly engaged in off-label marketing of Infuse due to “financial incentives”. In 2010, off-label use of products accounted for roughly 85 percent of the company's sales, according to the suit.