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Class Action Status Approved for Medtronic Infuse Shareholder Lawsuit

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A Medtronic Infuse shareholder lawsuit was just granted class action status by a Minnesota federal judge. The shareholder group alleges that Medtronic Inc.’s stock value dropped over Medtronic’s off-label promoting of its Infuse spinal graft product. Cleared by the U.S. Food & Drug Administration (FDA), in 2002, Medtronic Infuse is a bone growth product approved for use in one type of spine surgery (anterior approach lumbar fusion), Infuse was ultimately approved for two different types of dental surgery. In 2008, the FDA warned Infuse and similar bone growth products had been linked to serious problems when used off-label in spinal procedures. That same year, Medtronic disclosed that the U.S. Justice Department was investigating possible off-label promotion of Infuse. Yesterday, U.S. District Judge Paul Magnuson issued a ruling that the class in this case would include any people or entities who/that purchased or acquired Medtronic Inc. stock between November 2006 and November 2008 and were damaged by that Medtronic stock purchase, said Law 360. The investors—the Minneapolis Firefighters’ Relief Association and other institutional investors—have alleged in an amended complaint, filed in August 2009, that Medtronic intentionally advanced Infuse off-label and also neglected to release information that the Infuse system’s revenues were, for the most part, derived from these off-label, unapproved uses, Law 360 wrote. Medtronic objected, arguing that plaintiffs’ counsel was not adequate and that witness statements were misrepresented; however, Judge Magnuson found that Medtronic’s opposition was both insufficient and premature and that if plaintiffs made representations, that “remained to be seen,” according to Law 360. “Defendants’ entire opposition to the motion for class certification focuses on these mostly innocuous differences between what the amended complaint says and what the witnesses now say more than three years later,” he said, Law 360 reported. “It may be that the depositions of these witnesses will reveal that what defendants say is true: Plaintiffs’ counsel misinterpreted what the witnesses told them,” Judge Magnuson said. “But without the benefit of deposition testimony, the court cannot and will not make that assumption about an officer of the court,” the judge added, said Law 360. Judge Matheson also rejected the company’s opposition to how the class was defined, saying that Medtronic did not point to cases in which a possibly too-broad class was grounds for certification denial, explained Law 360, which also wrote that the judge declined to strip the lead plaintiff from the class. The judge also ruled that opposition to the certification motion was not in the proper context for Medtronic’s claim that plaintiffs’ council representation was inefficient, said Law 360. Meanwhile, Medtronic, just disclosed that the California Attorney General issued a subpoena to it this October as part

of an investigation into Infuse. The product is also being investigated by a U.S. Senate Committee. Among other things, Medtronic has been accused of downplaying significant side effects linked to Infuse in clincial trials for the device. Just last month, renowned researcher warned that Infuse may be linked with increased cancer risks.

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