 |
| Medtronic's Infuse bone growth spinal implant--Courtesy of Medtronic |
Medtronic ($MDT) has failed to prevent another lawsuit involving its Infuse bone growth spinal implant from advancing. It's an ominous sign as the Minnesota device giant gears up for a growing number of related cases that are working their way through the court system.
A Minnesota judge in Hennepin County District Court ruled that a patient who claims Infuse harmed him can sue Medtronic for three charges involving fraud and misrepresentation, according to the Star Tribune. Previously, Judge Laurie Miller supported U.S. Supreme Court precedent, which the article explained usually stops patients from suing medical device manufacturers over FDA-approved devices if state rules differ or are in addition to those federal standards.
The judge mulled the issue further and decided to let the case advance on the fraud and misrepresentation charges after considering some of the more detailed allegations, according to the story.
Medtronic issued a statement to the newspaper that downplayed the development, noting that the ruling was only "an early procedural decision in one case" and that it didn't change anything else that the judge already determined was preempted by U.S. Supreme Court precedent. Medtronic also said the ruling doesn't affect the particular plaintiff's case (Stephen and Barbara Lawrence) nor other lawsuits ramping up for trial.
Medtronic still stands behind Infuse and will "vigorously defend it in court," according to the company statement cited in the story.
As the Star Tribune reported, at least 32 additional Infuse cases are already in play in Minnesota. Hundreds more are pending nationally. Even more lawsuits might be filed now, considering that the judge's decision finds a way around the U.S. Supreme Court precedent issue.
It is also the second major legal decision in recent weeks that hands Medtronic an Infuse-related defeat. At the end of January, a California appeals court ruled in favor of an Infuse plaintiff by overturning a lower court decision that had determined federal regulations preempt state rules regarding product liability. But as Mass Device reported, the plaintiff's appeal success revolved around the argument, in part, that Medtronic was at fault for promoting its off-label use. Doctors are allowed to use a product for off-label treatment options, but the nuance here is the focus on Medtronic actively promoting that use, even though it may have known the risks.
Similarly, a U.S. District Judge ruled in August that another Infuse patient's lawsuit could move forward because she alleged that Medtronic's off-label promotion of Infuse caused her injury.
Beyond legal issues, Infuse has been a drag on Medtronic's revenue even as it has otherwise excelled in most other areas these days. In addition to the growing number of patient lawsuits, a major Yale University review of multiple trials found in 2013 that Infuse works about on par with traditional bone grafts but carries added risks of everything from cancer to sterility and other side effects. Medtronic has also denied allegations in the past that it manipulated Infuse data to boost sales, and that it paid "consulting fees" to medical authors in return for focusing more on Infuse benefits and underreporting adverse events, allegations that Spine Journal reported in 2011.
- here's the Star Tribune story
- check out the recent MassDevice piece