Although hundreds of patients implanted with Medtronic’s Infuse spinal bone graft device have suffered serious complications, not a single lawsuit has made it court. That may change, however, if the plaintiffs of hundreds of potential new lawsuits find a way around the legal concept of “pre-emption.”
New lawsuits accuse Medtronic of illegally promoting non-FDA-approved uses of its Infuse spinal bone graft device.
According to an article published on the Star Tribune’s website, hundreds of new lawsuits will try to sidestep pre-emption by accusing the world’s largest medical device maker of illegally promoting uses of Infuse that differ from those already approved by the FDA. According to experts, if this most recent allegation is upheld and makes it to court, the wave of lawsuits and resulting settlements against Medtronic could signal a new era in liability for the entire medical device industry.
“The cases are important,” David Prince, a professor at the William Mitchell College of Law, said to the Tribune. “The whole area of law certainly doesn’t make sense, especially to consumers.”
So far, pre-emption—when federal law takes precedence over state law—has protected many medical device makers from liability as long as the device in question received premarket approval from the FDA. In regard to the allegations against Medtronic, a judge would be required to throw out any Infuse case before a jury could hear evidence. This provision is based on a landmark 2008 case in which the Supreme Court generally forbade patients from suing medical device manufacturers because that “would let state courts trump federal regulators” who are responsible for reviewing clinical test results that decide which devices get released to the market.
The recent allegations made against Medtronic could certainly be viewed as startling. Although the FDA approved limited use of the Infuse bone growth device in 2002, it warned doctors in 2008 about “life-threatening complications” from unapproved applications. In 2011 and 2012, the Spine Journal and the U.S. Senate Finance Committee, respectively, criticized Medtronic after they allegedly paid doctors hundreds of millions of dollars for writing scholarly articles about the Infuse, articles that were allegedly altered later on to downplay the serious risks associated with the device.
According to a 2012 Senate Finance Committee report, Medtronic employees “wrote, edited and otherwise influenced” the content in scholarly articles about the Infuse written by doctors who were collectively paid more than $200 million by the device maker between 1996 and 2010.
‘It defies credibility to say it’s just doctors deciding to do this on their own. Medtronic engaged in a false, misleading promotional campaign.’
“The editing of the journal articles and large payments to the authors of those articles,” according to Senate Finance Committee Chairman Max Baucus, “raises troubling questions about whether Medtronic crossed the line regarding off-label promotion of Infuse.”
This evidence, as well as the “overwhelming off-label use” of Infuse, according to Lou Bograd of the Center for Constitutional Litigation, certainly suggests Medtronic illegally promoted their product.
“[It] defies credibility to say it’s just doctors deciding to do this on their own,” Bograd told The Tribune. “Medtronic engaged in a false, misleading promotional campaign.”
While the FDA has yet to say whether they’ve investigated the promotion of Infuse, they did make a general statement regarding the promotion of unapproved uses of any medical device, saying, “Promotional materials are unlawful if they promote an unapproved use for the product; contain claims relating to the dosing, safety or effectiveness of the product that are inconsistent with the approved labeling; or if they lack a fair and balance presentation of information, i.e., of benefits and risks.”
According to adverse event reports, Infuse has caused patient complications such as infections, cysts, male infertility and death. According to the Spine Journal, up to half of the patients implanted with Infuse suffered some sort of adverse event, particularly when the device was used after cervical spine fusions, a procedure for which the device was not FDA-approved. To date, the only federally-approved use of Infuse is for it to be implanted “through the front of an adult’s body to help recovery from lower-back spinal fusion surgery.”