Long-awaited ruling in Medtronic Infuse lawsuit could have ripple effect on industry

July 10, 2013 by Arezu Sarvestani

Patients attempting to sue Medtronic over the device giant's Infuse bone-growth protein have their eyes on a pending lawsuit that attempts to overcome federal pre-emption laws by tying injury liability to alleged off-label marketing.

Medtronic logo

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.

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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.