Published: May 6, 2014
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
Image from MedPageToday.com
Medtronic said it will pay $22 million to settle about 1,000 legal claims related to its spine surgery product known as Infuse, and it is setting aside up to $140 million for an even larger number of expected claims.
The payment announced Tuesday is the latest chapter in a medical saga played out over more than a decade that became a symbol of how conflicts of interest in medicine can adversely affect the health of patients.
Infuse includes the biologic drug, BMP-2, which was approved by the FDA in 2002 as an alternative to conventional spinal fusion, which normally would require harvesting a small amount of bone from the patient’s hip.
It became a near blockbuster product reaching sales of about $800 million annually and, to date, has been implanted in more than one million people worldwide.
Shortly after its approval, a small group of prominent spine surgeons began co-authoring papers in medical journals that failed to link the product a several serious complications, including cancer, the growth of unwanted bone and a complication that can cause sterility in men.
Those papers were the subject of several Journal Sentinel/MedPage Today investigative reports.
That also led to an unprecedented review and rebuke of the Infuse papers by a group of reform-minded doctors who published their findings in 2011 in the Spine Journal.
At the same time, the U.S. Senate Committee on Finance, prompted in part by the Journal Sentinel/MedPage Today stories, investigated the issue and in 2012 issued a report saying that Medtronic marketing employees secretly were involved in drafting and editing favorable articles about Infuse while the company paid millions to the surgeons whose names lent weight to the studies.
The company’s undisclosed manipulation of information about the genetically engineered product included overstating its benefits and downplaying concerns about serious complications, the Senate report said.
Over the course of 15 years, Medtronic paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors.
Many of the lawsuits allege that Medtronic, through its payments to the spine surgeons, illegally promoted Infuse for uses for which it was not approved by the FDA.
“It certainly seemed to many of us to be promotion in a medical or scientific sense,” said Eugene Carragee, MD, the Stanford University spine surgeon who headed the 2011 Spine Journal review of Infuse. “Whether that is promotion legally is unclear.”
Dan Spengler, MD, a professor of orthopedic surgery at Vanderbilt University Medical Center, said it was good that Medtronic was recognizing its problems with Infuse and agreeing to help people who were harmed.
“It’s a step in the right direction,” Spengler said.
In a press release issued Tuesday, Medtronic said it was paying out $22 million to resolve the claims of about 950 people.
It said about 750 filed cases brought by 1,200 people remain pending in various U.S. courts. Most of those are in early procedural stages, the company said.
In addition, the company said it expects law firms to bring another 2,600 claims.
It is taking a special charge of $120 million to $140 million in its recently completed fourth quarter to cover those potential costs, which includes the $22 million.
“This agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic,” the company said. “The company continues to stand behind Infuse Bone Graft … and will vigorously defend the product and company actions in the remaining cases.”
Just how many more cases are brought remains to be seen.
Bijan Esfandiari, a Los Angeles attorney who is involved in about 15 Infuse cases, none which are a part of the $22 million settlement, said it is in Medtronic’s interest to resolve the cases.
“When it is all said and done, I would estimate 5,000 total Infuse cases,” he said.