(Reuters) – Medical equipment maker Medtronic Inc said Tuesday an independent committee had investigated shareholder claims that it had underreported side effects of its Infuse bone-growth stimulation product and it would not be pursuing those claims.
Demands for legal action against current and former officers, directors, employees and physician-consultants were not in the company’s best interest, the panel found, according to a Medtronic filing with the Securities and Exchange Commission.
The committee, formed two years ago, included a retired Minnesota state court judge and a corporate law professor. It reported on its conclusions to the company’s board of directors on May 30, Medtronic said.
Medtronic said it would be seeking to dismiss two different consolidated shareholder lawsuits.
Infuse was once hailed as a major advance in spinal fusion surgery, offering an alternative to painful bone harvesting from other parts of the body to perform a bone graft.
But 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.
Just last week, insurer Humana Inc said it had filed a lawsuit against the company accusing it of having falsely represented the product. (Reporting by Caroline Humer; Editing byBernadette Baum)
