So far, Medtronic has avoided most personal injury claims under a legal shield known as preemption, which grants immunity to manufacturers of FDA-approved medical devices so long as they are not accused of fraud.
If members of the class action prove that Medtronic fraudulently misrepresented the safety of Infuse, it could open the door for personal injury claims.
The class action was filed by investors who claim Medtronic covered up the side effects of Infuse, which artificially propped up the company’s stock prices. The stock tumbled in 2011, after a series of articles were published in The Spine Journal. Investors allege that Medtronic paid $210 million to a group of doctors who produced research that was favorable to Infuse and downplayed side effects.
Thousands of people have been injured when Infuse was used in “off-label” surgeries that were never evaluated or approved by the FDA. In 2008, the FDA issued a Safety Communication to warn against using Infuse in neck surgery. Dozens of adverse events described patients who had trouble breathing, swallowing, or speaking due to severe swelling in their neck.
Many plaintiffs who were injured by Infuse in “off-label” surgeries have successfully pierced the preemption defense. Earlier this year, Medtronic settled 950 Infuse lawsuits for about $22 million. Medtronic has also set aside $120-140 million to resolve nearly 4,000 additional claims.