Milwaukee, WIAlmost 1,000 patients have sued Medtronic over its Infuse bone graft product use off-label. And attorneys predict more Medtronic lawsuits are on the horizon, according to the medical device maker’s recent financial reports.
Medtronic doesn’t need a crystal ball to speculate more legal woes. Experts and investigators (and a few sleuths from the Milwaukee Journal Sentinel) questioned the company’s sales and marketing practices shortly after the Infuse bone graft was approved in 2002: they discovered doctors received millions of dollars in royalties from Medtronic for other spine products. And two years ago there was a scathing investigation by the U.S. Senate Committee on Finance after a group of spine surgeons called earlier research into the product “biased and corrupted” by the financial ties between Medtronic and medical researchers.
It was discovered that Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to one orthopedic surgeon, University of Wisconsin’s Thomas Zdeblick, who co-authored a series of papers about the product.
And last year two independent reports found that Infuse offered little benefit over conventional spine surgery. Instead, it may be linked to serious harm, including cancer and a complication that can cause sterility in men. The product can also cause the growth of unwanted bone.
But Medtronic is still in denial. Despite about 700 lawsuits filed involving about 1,000 people over Infuse in state and federal courts, a Medtronic spokesperson said, “Looking ahead, the Company expects continued scientific and clinical research scrutiny focused on the safety and efficacy of Infuse in realworld, clinical experience.”
It also said that “Certain law firms have advised the Company that they may bring a large number of similar claims against the Company in the future.” According to MedPage Today, Medtronic stands by its Infuse product and “will vigorously defend it in court.” The company told MedPage that cases are in their early stages, and none have yet led to any rulings against Medtronic. While some cases have been dismissed, “others are limited in scope but proceeding.”
Current Medtronic litigation
Just last month a Minnesota judge ruled that one such case can proceed. A Medtronic patient who claimed the Infuse injured him can sue Medtronic for three charges involving fraud and misrepresentation. Also, in February a Florida federal judge remanded a case claiming that Medtronic improperly marketed its Infuse bone-grafting device for off-label uses. The judge found that the plaintiffs have pled viable claims against the non-diverse sales representative defendant.
In California, an appeals court in January 2014 ruled in favor of an Infuse plaintiff by overturning a lower court decision that had determined federal regulations preempt state rules regarding product liability. The plaintiff argued that Medtronic is at fault for promoting Infuse’s off-label use even though it allegedly may have known the risks.
And in August 2013, a U.S. District judge accepted a claim from an Infuse bone graft patient that Medtronic’s off-label promotion injured her. She is going forward with her Medtronic lawsuit.
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