Infuse bone-growth protein lawsuits are starting to pile up for Medtronic

Infuse lawsuits pile up for Medtronic | Legal News (MassDevice)

A Florida woman is the latest in what’s sure to be a long line of plaintiffs filing personal injury lawsuits against Medtronic Inc. over its controversial Infuse bone morphogenetic protein.

Personal injury lawsuits over its controversial Infuse bone-growth protein are beginning to pile up for Medtronic Inc. (NYSE:MDT), after theSpine Journal revealed serious concerns about the device’s safety this summer.

In June, the journal took the unprecedented step of devoting an entire issue to the Infuse controversy. Its investigation found problems with 13 studies by MDT-sponsored physicians, all of which downplayed or omitted the rates of adverse events associated with the protein, known as recombinant human bone morphogenetic protein-2.

Although the furor ignited by the study eventually died down on Wall Street (where analysts warned of a possible 3-cent-per-share dip in overall profits), Medtronic and Infuse are under intense scrutiny elsewhere. The U.S. Justice Dept. and the U.S. Senate are each conducting probes into the bone morphogenetic compound and its Fridley, Minn.-based maker’s marketing practices.

Now Jennifer English is the latest in what’s likely to become a long line of plaintiffs to file personal injury suits against the Fridley, Minn.-based medical device colossus. The of Lake Worth, Fla., woman was implanted with an Infuse device in August 2007, according to court documents. But the rhBMP-2 embedded in the device allegedly caused ectopic bone growth that compressed nerves and required two revision surgeries to remove the out-of-control bone growth.

“I trusted Medtronic with my life,” English said in prepared remarks. “It is disappointing to find out Medtronic is not looking out for the best interests of the patient, but for own its financial interests.”
English’s complaint accuses Medtronic of fraudulently misrepresenting the device’s risks and of improperly promoting and marketing Infuse for off-label uses, according to documents filed with the U.S. District Court for Southern Florida.

Medtronic spokesman Steve Cragle told MassDevice in July that the company hasn’t “heard any feedback from our customers that they are reducing their expected use.” Infuse, Cragle told us, is a “physician-pull product,” meaning that Medtronic reps don’t actively promote it and aren’t compensated for any Infuse sales.

“So it’s up to the physician to determine when to use our product,” Cragle wrote in an email.

Medtronic pulls down between $700 million and $750 million from Infuse alone, analysts estimate.