Medtronic Infuse bone cement
Approved in 2002 for use in spinal fusion surgery, Medtronic’s Infuse bone cement at one point had annual sales of nearly $1 billion. But the bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems.
Critics say that Fridley, Minn.–based Medtronic not only downplayed the product’s risks but also promoted it for off-label use.
By mid-2017, Medtronic had settled lawsuits from most of the 6,000 people claiming that Infuse bone graft had injured them, according to the company’s most recent annual report. The company announced in March 2018 that a shareholder lawsuit brought over Infuse was over; the U.S. Supreme Court declined to review the case.