Settlement Good News for Medtronic Infuse Bone Graft Victims

Los Angeles, CALast week Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. A further $140 million is estimated to also settle about 3,800 additional claims, 1,200 of which have been filed and the remainder (2,600) unfiled.

Despite FDA reports of complications over the past four years resulting from the off-label use of Medtronic Inc.’s Infuse Bone Graft, Medtronic is not admitting liability in the settlement, and the company “continues to stand behind INFUSE Bone Graft,” according to a Medtronic statement.

Medtronic must have deep pockets: it paid $210 million in payments and royalties to 13 doctors and two corporations linked to doctors. Then again, its Infuse product, which is also known as BMP-2, has been used in more than one million patients since the FDA approved it more than 10 years ago. The product generated sales of $800 million a year, though the amount has declined since 2011 - when the lawsuits started pouring in.

One cynical attorney believes this settlement is simply the “cost of doing business.” Up to 85 percent of those million people had the bone graft surgery off-label.

Dr. Dan Spengler, a Vanderbilt University orthopedic surgeon, said that with many off-label surgeries, there are going to be problems. He suspected that many of the lawsuits involved patients who experienced excess bone growth that occurred after their off-label surgery.

Many of the lawsuits claim that Medtronic illegally promoted Infuse off-label, i.e., for uses that were not approved by the FDA, through its payments to the spine surgeons. One spine surgeon, Dr. Jeffrey Wang, received an undisclosed $459,500 between 2004 and 2007 from Medtronic, Bone Biologics, FzioMed and the DePuy unit of Johnson & Johnson, according to The Los Angeles Times. Wang is currently being sued for fraud and malpractice for surgeries using the Infuse bone graft. And Dr. Mark Ipsen has a number of lawsuits filed against him, again for using the Medtronic product off-label during surgery. He has been accused of medical malpractice, failure to obtain informed consent and fraud. An estimated 2,300 surgeons have used Medtronic products in the US before any serious side effects were reported.

More lawsuits filed in both federal and state courts are still to be settled, according to Medtronic’s recent financial reports. Attorneys general in California, Illinois, Massachusetts, Oregon and Washington have subpoenaed documents regarding Medtronic's sales and marketing of the product.