Here in MedtronicLand, where reporters, university administrators and even the most progressive legislators march in lockstep with device industry executives, you usually have to look outside the state for news about the latest scandals. A rare exception is today's article by Jim Spencer in the Star Tribune, which reports on a new development with Medtronic's bone-growth product, Infuse. If
Infuse were a drug, rather than a "device," Medtronic would have been in big legal trouble long ago, when the Senate Finance Committee began to uncover evidence of kickbacks and manipulated journal articles. But as Spencer explains:
"Yet for all the claims of poor performance, dangerous outcomes and
shoddy scholarship, Infuse has never been the subject of a
personal-injury trial because of a legal concept called “pre-emption.”
That means federal law takes precedence over state law. The Supreme
Court has extended this premise to say that almost no one can sue for
damages caused by medical devices that received premarket approval from
Yet now there is hope for Infuse victims. Spencer reports that hundreds of new lawsuits are seeking a way around the "pre-emption" obstacle by accusing Medtronic of illegal off-label marketing. A critical case was argued before Hennepin County District
Judge Laurie Miller in May, by Lou Bograd of the Center for Constitutional Litigation and Minneapolis lawyer Stuart Goldenberg. According to the Star Tribune, Goldenberg "represents clients in 35 Infuse cases in Minnesota who will
be affected by Miller’s decision" and says that "hundreds
more” suits might be filed. Miller's decision is expected sometime this summer, Spencer writes.
There is no mention of the University of Minnesota's David Polly in the story, of course. That unpleasant episode has apparently been erased from the Star Tribune archives. But you can still read about it in the Wall Street Journal.
Naturally, the FDA will not comment. Neither will the Department of Justice, which "dropped a criminal investigation of
Medtronic’s off-label promotion of Infuse without explanation in May