“Defendants also aided and facilitated hospitals and physicians in obtaining payments from Humana through false statements and fraudulent omissions and concealment to obtain insurance payouts where Infuse and/or BMP was used. Humana would not have paid for Infuse if it had known the true facts regarding the uses of Infuse and/or BMP or the risks and efficacy of such uses” says the lawsuit. The Spine Journal’s June issue in 2011 was devoted exclusively to the adverse events being seen with the use of Infuse including an increased risk of cancer and male sterility, among other side effects. The action accuses Medtronic of RICO violations – Racketeer Influence & Corrupt Organizations- which can be leveled if a company allegedly lies to the public, conceals adverse events and changes the complication rates to make the product look less dangerous as part of a deliberate, deceitful campaign. Senate report blasted Medtronic over its handling of the Infuse product, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company "vigorously" denied.Medtronics’ world headquarters in Minnesota. A shareholder lawsuit accused Medtronic and its leadership of misleading investors about its prospects for Infuse, and the ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks.
The Spine Journal dedicated its entire June issue (PDF) that year to problems with the BMP-2 bone-growth protein in off-label procedures and cited problems with some of the Medtronic-sponsored research behind Infuse. The controversy over the Infuse product, a bone morphogenetic protein that stimulates bone growth, erupted during the summer of 2011. A years-long federal investigation into Medtronic’s practices closed in May 2012 without finding evidence of wrongdoing. The Infuse lawsuits generally accuse Medtronic of illegally marketing the product for uses not approved by the FDA.
#Infuse lawsuits plus
Medtronic said it expects to take a $120 million to $140 million charge during its fiscal 4th quarter, which closed in April, accounting for the $22 million deal announced today plus enough to cover the estimated settlement of the remaining 3,800 claims. More lawsuits could be in store, with law firms telling Medtronic they may bring "a large number" of similar suits for roughly 2,600 more potential claimants, according to the release.
#Infuse lawsuits trial
The 1st Infuse lawsuit slated for trial ended in Medtronic’s favor when a California judge granted its motion for summary judgment, according to the release. Medtronic said it stands behind Infuse, saying it’s been used in more than 1 million patients, and pledged to "vigorously defend the product and company actions in the remaining cases." There are about 750 lawsuits pending in state and federal courts, involving about 1,200 patients, according to a press release. Medtronic (NYSE: MDT) said today that it agreed to pay $22 million to settle an estimated 950 lawsuits filed over its controversial Infuse bone graft product, admitting to no wrongdoing in what it termed a "compromise" of disputed claims.
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