Federal pre-emption statutes have thus far stalled personal injury complaints over Medtronic’s (NYSE:MDT) troubled Infuse bone-growth protein, but new lawsuits may find their way to trial by claiming that the medtech titan is liable for injuries because it engaged in off-label marketing.
Such a complaint is pending before Minnesota Hennepin County District Judge Laurie Miller. A ruling is expected this summer, and the decision could have a ripple effect that reaches beyond Medtronic. If Miller rules against Medtronic, the decision could set a precedent that would have major implications for the way courts judge liability of medical device companies, possibly twisting a 5-year-old precedent that also involved a lawsuit against Medtronic.
In 2008 the U.S. Supreme Court ruled that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. The decision has helped block lawsuits against many medtech companies, including some Infuse complaints, but the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.
Lawyers representing patients with complaints against Medtronic may stake their arguments on allegations the the medical device company illegally marketed the Infuse product for uses that were not explicitly cleared by the FDA, the Star Tribune reported.
Medtronic in 2002 won limited approval to market Infuse for use in the lower spine, but other "off-label" uses make up about 85% of Infuse use, according to the Tribune. Physicians are free to use approved medical devices in off-label ways, but the manufacturers are prohibited from promoting those types of practices. Prior lawsuits have accused Medtronic of illegally marketing Infuse for use in the neck, but a years-long criminal and civil investigation closed in May 2012 without finding evidence of wrongdoing.
Ultimately, the new complaints may hinge on a matter of who is liable when a patient is injured by a product that is used in a way other than what has been specified by the FDA, American Assn. for Justice spokesperson Jennifer Fuson told the paper. For lawyers representing patients, the high amount of off-label use is a sign that Medtronic encouraged off-label use.
Minnesota lawyers Lou Bograd and Stuart Goldenberg of the Center for Constitutional Litigation are representing the plaintiff in the lawsuit before Judge Miller, as well as 35 other Infuse patient injury complaints. Thus far decisions in lower courts and gone both ways, and the case is likely to land Medtronic back in the Supreme Court.
The controversy over the Infuse product, which recently included a shareholder lawsuit accusing Medtronic and its leadership of misleading investors, blew up over the summer of 2011 when the Spine Journal dedicated its entire June issue (PDF) to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.
The journal’s investigation concluded that 13 studies (published by authors who collectively received millions from Medtronic) downplayed or omitted entirely evidence of safety risks from Infuse. The actual rate of "frequent and occasionally catastrophic complications" associated with the product was between "10% to 50% depending on approach."
The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks. In the fall of 2012 a U.S. Senate report blasted Medtronic over its handling of the Infuse product, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company "vigorously" denied.
