Amid new skepticism of back pain treatments, one of the largest medical device makers is being sued for a product that brought in close to one billion dollars annually at its peak while increasing risks for patients.
Humana is suing Medtronic, alleging that the Minneapolis-based med tech company manipulated and misrepresented data for its Infuse bone graft, which was eventually used in some one million patients and off-label for many of them.
Made from synthetic bone morphogenetic proteins, the bone graft was approved for lower-back spinal infusions in 2002 and by 2011 was generating sales of $900 million.
But with adverse event reports, especially those from off-label use in upper-back procedures, lawsuits filed by Humana and others have charged that Medtronic concealed significant risks, including infections, neck and throat swelling, and trouble breathing and speaking.
Humana is seeking compensatory damages and punitive damages under the Racketeer Influenced and Corrupt Organizations Act on behalf of claims paid for members who had received surgery with the product and suffered complications.
Medtronic "paid for and sponsored publication of academic and peer-reviewed literature that falsely represented Infuse and (bone morphogenetic protein) as safe and effective for uses not approved by the Food and Drug Administration," wrote Humana's attorney Brandon McGrath in a lawsuit filed in Tennessee federal court.
Medtronic paid approximately $210 million to physician authors of company-sponsored studies from November 1996 through December 2010, and there are emails showing company employees recommending against publishing a complete list of adverse events possibly associated with Infuse in a 2005 Journal of Bone and Joint Surgery article, McGrath wrote.
Those and other articles gave the impression that "adverse events related to the use of Infuse and/or BMP did not exist or were significantly reduced," McGrath argued.
Two independent reviews published last year in the Annals of Internal Medicine concluded that early studies on Infuse tended to underreport risks, and that the synthetic grafts did not appear to produce better outcomes in spine surgeries than traditional grafts from a person's own bones.
While Medtronic continues to defend Infuse and a federal judge in California recently dismissed a suit that was about to go to trial, Medtronic has told investors that it is earmarking $120 million for potential settlement claims.
In 2011 the product became the target shareholder activists accusing management of over-projecting its potential, and in May, the company moved to settle more than 900 product liability lawsuits, agreeing to pay $22 million in a compromise while admitting no wrongdoing.