Is Medtronic's Infuse vulnerable to new lawsuits?
A number of legal obstacles have prevented patients alleging that Medtronic's ($MDT) Infuse bone growth product has harmed them from suing the company. But plaintiffs' attorneys believe they've found a sound argument that could allow hundreds of suits to go forward.
It could come down to a case before Judge Laurie Miller in Hennepin County District Court in Minnesota, where a decision on whether a number of lawsuits will be allowed to move forward is expected later this summer.
As the Star Tribune reports, Infuse-related lawsuits haven't moved forward in large part because of the Supreme Court. In 2008, it ruled that patients generally aren't allowed to sue manufacturers for alleged damages caused by medical devices for which the FDA has already granted premarket approval. (The concept is known as "pre-emption.") But attorneys are now arguing that the Infuse cases must go forward because many involve "off-label" uses not approved by the FDA, according to the story.
Doctors' use of devices in off-label treatments is legal. But federal law prohibits companies from promoting or advocating off-label uses. And Medtronic may be vulnerable in the case of Infuse because it has been used off-label 85% of the time, according to federal health statistics cited in the story--a number that some see as unusually high. And so the Hennepin County case, if the court rules in favor of the plaintiffs, could propel hundreds of other lawsuits across the country against Medtronic.
Medtronic issued a statement to the Star Tribune denying any wrongdoing and said any suggestion that it improperly influenced or authored previous studies on Infuse in order to minimize negative results is incorrect. The company also denies it has promoted off-label Infuse uses.
But Infuse-related problems for the company are mounting. Last month, two independent reviews of 17 trials involving over 2,000 patients concluded that the Infuse spinal implant performed no better than traditional bone grafts. Their finding also determined that Infuse carried a higher risk of side effects including cancer and sterility.
And that conclusion adds to the provocative Spine Journal report that started the controversy in 2011. The publication alleged that Medtronic paid hundreds of millions in consulting fees to study authors in exchange for focusing more on Infuse-related benefits and less on adverse events. A subsequent Senate investigation determined that Medtronic manipulated Infuse data to help propel Infuse sales. Medtronic has vehemently denied both allegations.
- read the Star Tribune story
Studies: Medtronic's Infuse offers mild benefit, significant risk
Senate report rules Medtronic improperly shaped bone growth data
Analyst: Infuse fallout could lead to Medtronic selling spine biz