Medtronic Dealt Legal Setback over Infuse LawsuitsMedtronic Dealt Legal Setback over Infuse Lawsuits

Medtronic appears to have been dealt a legal setback in its efforts to use a U.S. Supreme Court decision to protect itself against lawsuits related to its Infuse bone growth system.The Fridley, MN-based medical device giant had argued that it was protected because of a years-old Supreme Court ruling that patients can't sue medical device manufacturers for alleged damages that are caused by devices that have already received premarket approval from the FDA. But a local judge in Minneapolis has decided that some of a Minnesota man's allegations about Infuse injuries can proceed, the Star Tribune of Minneapolis reports.Here's how the Star Tribune described the decision of Laurie Miller, a Hennepin County district judge, in the lawsuit filed by Stephen and Barbara Lawrence:

Medtronic told the newspaper that the decision was an early procedural decision in one case. But the Lawrences' lawyer thinks Miller's decision could influence hundreds of Infuse-related lawsuits filed around the country.In the end, the Supreme Court might have to rule again to clear up the matter.Lawyers for injured patients have argued that the cases need to go forward since many were caused by off-label uses. FDA regulators do not control off-label uses of medical devices. While this practice is legal, federal law prohibits manufacturers from advocating or promoting these non-approved uses.Since the Infuse product by Medtronic has been used most of the time in an off-label way, plaintiffs may have grounds for patient injury lawsuits to move forward.