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Bograd argued this point to Hennepin County District Judge Laurie Miller in May in what could become an influential case nationally.
Minneapolis lawyer Stuart Goldenberg, Bograd’s co-counsel, represents clients in 35 Infuse cases in Minnesota who will be affected by Miller’s decision. Goldenberg said he has “hundreds more” suits that might be filed.
In the Hennepin County case, Medtronic’s lawyers denied off-label promotion of Infuse and argued that none of the 35 Minnesota plaintiffs has the right to sue.
“Many [cases] have already been dismissed based on the pre-emption doctrine established in Riegel,” Medtronic said in its statement to the Star Tribune. “We have a number of defenses for these cases, including pre-emption, and will stand behind our product and vigorously defend it in court.”
Miller’s decision is expected this summer. It will add to a handful of conflicting lower-court opinions that almost everyone believes will eventually end in a Supreme Court decision.
Prince also believes the issue “cries out for federal legislation.”
“Off-label promotion is prohibited by federal law, but state law could also prohibit it,” he said. In that case, a personal injury law suit might be allowed to go forward. But the courts have thus far “confused this by going off in all directions.”
On June 18, a two-year, $2.5 million Medtronic-funded comprehensive re-analysis of all past Infuse research showed that the bone growth product did not perform as well and had more adverse effects than Medtronic-sponsored researchers had said.
The only use of Infuse that has received FDA approval is to implant it through the front of an adult’s body to help recovery from lower-back spinal fusion surgery and then only if the bone growth factor is constrained in a specific brand of cage.
Otherwise, studies show that unwanted and potentially dangerous bone growth can occur and cancer risks may arise, said Dr. Eugene Carragee, editor of the Spine Journal. Carragee devoted the June 2011 issue to a scathing critique of the Infuse research that Medtronic sponsored.
Carragee said he took on Medtronic because its sponsored research results differed so markedly from research the company did not pay for and because of Medtronic’s influence on the content of scholarly articles.
Still, that may not rise to the level of off-label promotion.
“Manufacturers can send representatives to medical conferences and say, ‘Doctors A, B and C used the device in this way,’ ” said Prince. Doctors can also write about off-label device use in scholarly journals. “That’s not considered promotion.”
Ron Goldman could be the first lawyer in the country to actually get an Infuse off-label-promotion case before a jury. The Los Angeles attorney persuaded a judge there to let his client go to trial. The case is set for November, although Goldman expects a delay.
“Underlying all the legal mumbo jumbo,” he said, “we have people who are severely injured.”
Jim Spencer • 202-383-6123