Medical device giant Medtronic PLC has told investors that the company is ready to close the book on one of its biggest and longest-running legal headaches, involving the controversial back-surgery product Infuse.
Infuse includes a genetically engineered protein that causes bones to fuse rapidly after lower back pain surgery. Thousands of patients claim the chemical was used inappropriately, causing permanent, debilitating injuries. In a securities filing Tuesday, Minnesota-run Medtronic revealed that it has reached agreements to settle "substantially all" of the 6,000 actual and threatened Infuse lawsuits.
Medtronic did not release figures for the confidential settlements. The company reported that it set aside $300 million for all of its legal settlements in the fiscal year that ended in April, according to the Securities and Exchange Commission filing.
The company said it is cooperating with attorneys general in five states that have sent subpoenas and document requests for information on how Medtronic studied, marketed and sold Infuse. Late last year Medtronic set aside an undisclosed amount of money "in connection with" the inquiries from attorneys general in California, Illinois, Massachusetts, Oregon and Washington, the Tuesday SEC filing said.
"We continue to cooperate in the State AG inquiries and are hopeful an acceptable resolution can be reached," Medtronic spokesman Eric Epperson said via e-mail Wednesday. Spokespeople with each of the state offices declined to comment.
Medtronic had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. Such a trial could have revealed thousands of pages of sealed internal documents that other plaintiffs could have used in their cases.
Medtronic has always denied the allegations in lawsuits from patients, investors and employees-turned-whistleblowers who claimed over the years that Medtronic promoted sales of Infuse for surgeries that were never proven to be safe and effective uses of the chemical. The company says it strictly follows the law on promotion of medical devices, and it cannot control when doctors use it in unapproved ways, like in pediatric surgery.
The so-called "off-label" use of medical devices is legal because the U.S. Food and Drug Administration regulates only products, not the practice of medicine. Many of the injured patients allege in their lawsuits that they found out about the use of Infuse only after their surgery ended with complications. Some say Medtronic sales reps were present in the operating rooms during their surgeries.