06.10.14
Medtronic Inc. has been facing criticism from shareholders who claimed that the Minneapolis, Minn.-based medical device maker underreported side effects for its Infuse bone-growth stimulation product. Two years ago, Medtronic formed an independent committee including a retired Minnesota state court judge and a corporate law professor. The committee reported its conclusions to Medtronic this week—and the company decided not to pursue shareholder claims.
Demands for legal action against current and former officers, directors, employees and physician-consultants were not in the company’s best interest, the committee found, according to a Medtronic filing with the Securities and Exchange Commission.
Medtronic said it would be seeking to dismiss two different consolidated shareholder lawsuits.
Infuse was meant to offer an alternative to painful bone harvesting from other parts of the body to perform a bone graft. However, in 2011, Infuse became the subject of investigations by the U.S. Senate and Department of Justice over off-label use of the product and omissions of safety problems from its clinical trial data. The product drew intense public scrutiny after the influential Spine Journal ran an entire issue criticizing it in June 2011, charging that surgeons who were paid tens of millions of dollars by Medtronic failed to report serious complications such as male sterility, increased risk of cancer, infections, pain and bone dissolution.
Medtronic faces hundred of individual lawsuits over the product. On June 4, one of those suits was dismissed by a Louisiana federal judge on the grounds that the plaintiff did not provide enough evidence to support her claims.
But suits pile on: Just last week, insurer Louisville, Ky.-based Humana Inc. filed a lawsuit against the company accusing it of having falsely represented the product.
Demands for legal action against current and former officers, directors, employees and physician-consultants were not in the company’s best interest, the committee found, according to a Medtronic filing with the Securities and Exchange Commission.
Medtronic said it would be seeking to dismiss two different consolidated shareholder lawsuits.
Infuse was meant to offer an alternative to painful bone harvesting from other parts of the body to perform a bone graft. However, in 2011, Infuse became the subject of investigations by the U.S. Senate and Department of Justice over off-label use of the product and omissions of safety problems from its clinical trial data. The product drew intense public scrutiny after the influential Spine Journal ran an entire issue criticizing it in June 2011, charging that surgeons who were paid tens of millions of dollars by Medtronic failed to report serious complications such as male sterility, increased risk of cancer, infections, pain and bone dissolution.
Medtronic faces hundred of individual lawsuits over the product. On June 4, one of those suits was dismissed by a Louisiana federal judge on the grounds that the plaintiff did not provide enough evidence to support her claims.
But suits pile on: Just last week, insurer Louisville, Ky.-based Humana Inc. filed a lawsuit against the company accusing it of having falsely represented the product.