Judge says Medtronic can be sued on charges that it manipulated research and misled doctors about dangers of off-label uses.
A Minnesota man who claims he was injured by Medtronic Inc.’s Infuse bone graft product will be able to sue the company for three charges of fraud and misrepresentation, a Hennepin County district judge has ruled.
Judge Laurie Miller had earlier refused to let the case proceed because of U.S. Supreme Court rulings that usually exclude people injured by federally approved medical devices from suing their makers. But after analyzing more-detailed allegations filed after her initial decision, Miller chose to let the case proceed for three allegations.
The move pushes the case toward a jury that could decide whether Fridley-based Medtronic or its affiliates knowingly downplayed the dangers of Infuse in convincing doctors to use the product in off-label ways, or those that have not been sanctioned by the Food and Drug Administration.
Miller’s decision could have major implications for 32 other Infuse cases already filed in Minnesota and could lead to dozens of new filings in the state and influence hundreds of other cases around the country, a lawyer for plaintiffs Stephen and Barbara Lawrence said Friday.
The Lawrences’ legal team will now be able to interview under oath doctors whom Medtronic paid to do research on Infuse and Medtronic employees who made editorial suggestions for their published findings, said attorney Stuart Goldenberg of Minneapolis.
After that, Medtronic has one more chance to stop a trial by arguing that the information revealed in the interviews does not prove fraud.
In a statement, Medtronic called Miller’s ruling “an early procedural decision in one case and does not change the Court’s prior ruling dismissing as pre-empted all claims other than alleged fraud.”
The company said Miller did not address “other defenses” the company has claimed. As for the decision’s wider impact, Medtronic said it will not determine the outcome of the Lawrence case, nor will it determine the outcome of “any other pending matter.”
“Medtronic will continue to stand behind Infuse bone graft and vigorously defend it in court,” the company said.
Problems with Infuse have sparked a federal investigation and a critical report from the Senate Finance Committee that disclosed $210 million in Medtronic payments to doctors studying Infuse over a 15-year period. The Senate report also found several examples of what investigators believed were Medtronic employees making editorial suggestions to the authors of academic journal articles that played down problems with Infuse and its off-label use. Subsequent retests of several of the Infuse studies showed that the journal reports overstated the safety and effectiveness of procedures.
Miller ruled that a jury could decide if the doctors Medtronic paid were agents of the company. If so, that would link Medtronic to seminars and other teaching episodes that promoted the off-label use of Infuse. Off-label uses produced roughly 90 percent of the $800 million in revenue Medtronic made from Infuse in 2011.
Miller also noted that Stephen Lawrence’s doctor is prepared to testify that Medtronic-affiliated physicians misrepresented to him the safety of using Infuse in non-FDA-approved ways.
Miller rejected Medtronic’s claim that it could not be sued because company representatives never spoke directly to Stephen Lawrence about off-label use of Infuse and Lawrence produced no evidence that they did.
Medtronic’s “position would limit fraud claims to the rare situations where a plaintiff can produce something akin to a deposition transcript to quote allegedly offending statements and to pinpoint the time, date and place each quoted statement was made,” Miller said in dismissing the argument.
Medtronic has avoided trials in many Infuse injury cases by convincing judges that Supreme Court rulings almost always prohibit patients from suing in state courts for malfunctions of FDA-approved devices. But judges in several state courts and at least two federal courts have recently let cases go forward, setting the stage for appeals that most experts expect to end in another Supreme Court case.
Jim Spencer • 202-383-6123