The class action was filed by investors who allege that Medtronic covered up side effects of Infuse and made $210 million in payments to doctors who produced favorable research between 1996 and 2010.
Investors allege that the scheme artificially propped up share prices, which tumbled in 2011 after an exposé was published in The Spine Journal.
If the plaintiffs can prove that Medtronic deliberately misled investors about safety issues associated with Infuse, the company may be found guilty of fraud. Until now, Medtronic has avoided most personal injury claims under a legal shield known as pre-emption (immunity), which limits lawsuits against manufacturers of FDA-approved devices without allegations of fraud.
Federal judges have thrown out the preemption defense in many lawsuits involving “off-label” use of Infuse. In May 2014, Medtronic announced a $22 million settlement involving 950 Infuse lawsuits. They also announced plans to hold $120-140 million to settle another 3,800 claims.
Infuse is a bone graft implant that contains a bioengineered human bone-growth protein, which stimulates bones to grow together. Thousands of people have been injured when doctors used Infuse “off-label,” for uses that were never evaluated in clinical trials or approved by the FDA. In 2008, the FDA issued a Safety Communication after receiving dozens of injury reports when Infuse was used in the neck. Some patients had problems swallowing, breathing, or speaking due to severe swelling in the neck.