Medtech giant Medtronic (Fridley, MN) has reported that the number of lawsuits filed against the company over its troubled Infuse spinal graft system now totals about 700 cases, representing about 1000 plaintiffs. And as we reported last month, many of these lawsuits may not be blocked by the Supreme Court decision that device makers cannot be sued for products having FDA approval.
Infuse is Medtronic's tradename for its recombinant bone morphogenic protein-2 (rhBMP-2) product, which stimulates bone growth. It is used during spinal fusion, when a patient’s vertebrae are fused into one piece in an effort to stop back pain. FDA's approval allows its use in one place on the patient's spine.
But it also has been widely reported that as much as 85 percent of the Infuse that Medtronic sold was used in so-called off-label uses, those which FDA has not approved. While off-label uses are legal and not uncommon in the medical device and pharmaceutical industries, most would agree that that is an unusually high percentage. Some of the lawsuits filed allege that Medtronic was engaged in promotion of those off-label uses, which is illegal, and which the company vigorously denies.
Infuse has spelled trouble for Medtronic since its introduction in 2002, and perhaps before. The abuses – alleged and even determined by the United States Senate – committed by the company in the name of Infuse are enough for someone to write a book. These include millions of dollars in payoffs to doctors for positive reviews, underreporting of adverse events, and the drafting of positive reviews by company executives.
The Milwaukee Journal Sentinel reports that “Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product.”
In 2007 The Spine Journal published a report showing that Infuse was associated with an increased risk of adverse events including uncontrolled bone growth, infections, nerve death, bladder issues, an increased risk of cancer, retrograde ejaculation and other issues.
In a statement shared with Qmed, Medtronic states that "[t]he Infuse Bone Graft cases are in the early procedural stages and none have resulted in a finding of liability against Medtronic. There have been a number of rulings on both procedural and substantive grounds, some of which have resulted in dismissal of plaintiff’s claims in their entirety. Many others have substantially limited the claims that will proceed." According to Medtronic, these court decisions have been consistent with conclusions reached by other U.S. courts based on the pre-emption doctrine established in Riegel.
Medtronic spokesperson Cindy Resman explained to Qmed that the court cases are in early procedural stages and none had yet resulted in a finding of liability against Medtronic. "For the claims that remain, we have a number of additional defenses," she says, adding that the company continues to "stand behind Infuse Bone Graft and will vigorously defend it in court."
In 2012 the Senate criticized Medtronic for misleading the public on the safety and efficacy of Infuse. According to the Senate report, Medtronic deliberately hid evidence of negative and adverse events related to the use of its products, among other findings.
Medtronic gave grants to two groups of Yale University researchers in 2011 to conduct independent analyses of Medtronic's own clinical data on over 2000 patients who had undergone surgery with the Infuse device. The results, released in 2013, showed that the Infuse back surgery system provided similar efficacy to existing bone graft systems while carrying higher levels of risk.
Stephen Levy is a contributor to Qmed and MPMN.
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast