Minneapolis, MNPlaintiffs having issues with Medtronic bone graft, and heretofore limited opportunity to launch a Medtronic lawsuit due to pre-emption statutes protecting medical device manufacturers, are finding an alternate pathway to the courts and potential compensation.
In a detailed report, the Star Tribune (7/7/13) of Minneapolis lays out the case for plaintiffs hoping to get around Riegel v. Medtronic, the landmark 2008 case in which the Supreme Court pulled the rug out from under patients attempting to sue device manufacturers for fear state courts could supersede federal regulators.
Instead, attorneys representing plaintiffs allegedly harmed by Medtronic Infuse bone graft are focusing on off-label uses. The latter are uses for the product not approved by the US Food and Drug Administration (FDA), but are otherwise permitted so long as a medical doctor or surgeon is the one pulling the strings and making a determination as to the value and usefulness of Medtronic bone for other uses.
Doctors have the moral, legal, ethical and professional freedom to trump FDA recommendations. A manufacturer, however, is not allowed to promote a product for off-label use. Plaintiff lawyers have accused Medtronic of doing just that - promoting Medtronic off label - and looking to a Senate Finance Committee report, released in December of last year, to back up those claims. According to the Star Tribune, the Committee claims that Medtronic employees, including some who worked in the marketing division, authored, edited and otherwise influenced scholarly articles written by doctors. The latter group, it is alleged, collected $210 million in compensation over a 14-year period from November 1996 through December 2010.
Medtronic issued a statement denying any wrongdoing, and disputed “any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the [Senate] report, or that Medtronic intended to under-report adverse events.”
Medtronic complications have proven to be quite serious for many patients. A genetically engineered protein that promotes the growth of new bone rather than having to harvest bone from the hip, Infuse was allocated little wiggle room in the context of approved uses when the FDA originally gave Infuse the nod.
However, it appears as if Medtronic Infuse bone graft has flourished off label. According to the Star Tribune, federal health statistics reveal that Infuse is used off label 85 percent of the time. Off-label use tends to serve as a scourge for many plaintiffs who allege unwanted, inappropriate or even dangerous bone growth that proved to become a hindrance, a source of pain and a foundation for other negative health issues.
Thus, the issue now being pursued by those in the legal community is whether or not Medtronic influenced scholarly articles directed to doctors that may have helped foster such a substantial growth in off-label use. Jennifer Fuson, a spokesman for the American Association for Justice, said a critical question is who is responsible “if you are injured by a product that was used in a way not approved by the FDA?”
Meanwhile, Professor David Prince of the William Mitchell College of Law said in comments also printed in the Star Tribune that a Medtronic lawsuit brought by a deserving plaintiff is hardly frivolous - especially those which have been tossed out of court due to pre-emption. “The whole area of law certainly doesn’t make sense, especially to consumers,” he said.
“The cases are important.”
Lou Bograd of the Center for Constitutional Litigation said in an interview with the Star Tribune that with eight out of every 10 Medtronic bone graft cases for off-label use, such overwhelming off-label numbers suggest that undue promotion has been undertaken by someone. “[It] defies credibility to say it’s just doctors deciding to do this on their own,” Bograd said. “Medtronic engaged in a false, misleading promotional campaign.”
Medtronic complications have included unwanted bone growth and the potential for cancer risk, according to Dr. Eugene Carragee, editor of The Spine Journal.
A Medtronic lawsuit prefaced upon off-label use is scheduled to be heard by a jury in November, although insiders expect there could be delays.
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