A whistle-blower lawsuit alleging that some of the nation's top spine surgeons accepted kickbacks for promoting a Medtronic Inc. spine surgery product was dismissed Friday by a federal judge in Massachusetts.
The 2007 suit was filed by Jacqueline Kay Poteet and Bobbie Vaden, former employees with Medtronic's Memphis-based spine business. Named as defendants were 120 leading spine surgeons across the country, including nine in the Twin Cities, and 18 medical device distributors.
The complaint alleges the surgeons were paid consulting fees totaling $8 million in 2006 to promote a Medtronic product called Infuse for use in "off-label" ways not approved by the Food and Drug Administration (FDA).
But Judge Richard Stearns rejected those claims in an 18-page decision, ruling the allegations did not constitute a whistle-blower suit. He also blocked a motion by the two women to file an amended complaint.
Infuse is a bioengineered product commonly used in spine surgery to promote bone growth between vertebrae. But the blockbuster product is widely used by surgeons off-label -- a practice that is legal, but not recommended by the FDA.
The FDA warned doctors last July against using Infuse in neck surgeries because the product is only approved for use in the lower back.
After Poteet filed her complaint in U.S. District Court for the District of Massachusetts, the government declined to intervene and grant it official whistle-blower status -- where plaintiffs are given a portion of any cash settlement.
Despite the government's decision, the civil suit continued in federal court. In December, Poteet moved to dismiss 80 of the original defendants, including Drs. Stanley Skinner and Amir Mehbod from the Twin Cities.
The local doctors remaining in the complaint that was dismissed Friday were Timothy Garvey, Francis Denis, Joseph Perra, Manuel Pinto, James Schwender, Ensor Transfeldt and David Polly.
"I talked to a number of them today, and they're all very pleased that they prevailed and that the case has finally been dismissed," said John Lundquist, a Minneapolis attorney who represented the physicians.
Andrew Carr, a Memphis attorney who represents Poteet and Vaden, could not be reached for comment Friday.
The Boston lawsuit was the third complaint filed in recent years involving Medtronic's spine devices. In 2006, the company agreed to pay $40 million to settle a whistle-blower case filed in federal court in Tennesee. The suit alleged the company illegally marketed its spine products, but the company admitted no wrongdoing in the settlement.
Poteet filed a previous whistle-blower lawsuit in Tennessee federal court, alleging that illegal kickbacks were granted to doctors, including travel junkets and sham consulting and royalty agreements. The government declined to intervene in that case, which was dismissed.
Medtronic spokeswoman Marybeth Thorsgaard said in a statement Friday, "The court's decision to dismiss Ms. Poteet's case against physicians and distributors is a welcome reaffirmation of the rule against whistle-blowers seeking to profit through copycat lawsuits." (Medtronic was not named in the suit as a defendant.)
"My clients are relieved they don't have the specter of this case hanging over them, which would inhibit their research and publishing," Lundquist said. "I think it's important so that the products can continue to be developed and improved" with their work.
Medtronic still faces a U.S. Justice Department investigation into off-label use of Infuse.
Janet Moore • 612-673-7752
