Two reports released in 2013, both published in the Annals of Internal Medicine, indicated that the genetically engineered Infuse product has “little benefit beyond standard treatment and could expose patients to harm.” One report went further, stating that previously published studies were biased and they were little more than “infomercials” for medical device companies. Both reviews also mentioned a possible cancer risk with the product.
Medtronic’s Infuse Bone Graft was initially approved by the FDA in 2002 to be used only for an Anterior Lumbar Interbody Fusion (“ALIF”) surgical procedure, involving a single-level fusion in the L4-S1 region of the lumbar spine. Then the agency approved its use in some fusion surgeries in the lower back only, as well as for some oral and dental uses.
Fast forward a decade, and almost 85 percent of the Infuse bone graft sales involve various “other” (i.e., mainly “off-label”) surgeries.
In 2011, off-label use of Infuse by physicians comprised nearly 90 percent of sales. That year was busy for Medtronic. In June, the company announced it had received an inquiry from the U.S. Senate requesting information related to the Infuse Bone Graft product.
Five days later, The Spine Journal published a damning article about the Infuse product and physicians, saying that “Doctors who received millions of dollars from Medtronic systematically failed to reveal serious complications linked to the company’s lucrative back surgery product, Infuse.” Incredibly, the authors of the study at one time promoted the product.
“We find ourselves at a precarious intersection of professionalism, morality, and public safety,” stated a Spine Journal editorial published along with the study. “We work under a burden of suspicion that new technology research and publication is simply a ‘broken system’ as currently practiced.”
By August, Medtronic announced it would publicly release Infuse Bone Graft data for Yale University researchers to conduct a review. Also that month, Medtronic stocks declined from over $43 in May 2011 to $30.41 per share on August 10, 2011.
Medtronic investors lawsuit
A lawsuit was filed in the U.S. District Court for the District of Minnesota on behalf of Medtronic investors, alleging violations of Federal Securities Laws by Medtronic, Inc. in connection with certain allegedly false and misleading statements that were made between December 8, 2010 and August 3, 2011. The lawsuit alleges that between these dates Medtronic issued false and misleading statements to the investing public regarding the use of the Infuse Bone Graft product.
As reported by Medtronic, its total revenue rose from over $15.39 billion for the 53-week period that ended on April 27, 2012 to $16.59 billion for the 52-week period that ended on April 26, 2013. Although shares of Medtronic rose, the lawsuit says that, due to a result of the allegedly false statements, Medtronic’s stock traded at artificially inflated prices.
The use of Infuse by surgeons fell significantly in the past few years. At one time, annual sales of Infuse were close to $1 billion, but slid to $528 million during the 12-month period ending in April 2013.
Are physicians less easily swayed by the Infuse product now that Medtronic lawsuits have been filed?
Medtronic off-label lawsuits
In 2009, Christina Ramirez had spinal surgery using an off-label posterior approach with the Infuse bone graft that went horribly wrong. She filed a Medtronic personal injury lawsuit. Ramirez claims Medtronic promoted the Infuse Bone Graft for use off-label and it promoted such uses through journals, media, sales representatives and by paying leading physicians.
In August 2013, Judge G. Murray Snow of the United States District Court for the District of Arizona ruled on a motion to dismiss in the case of Ramirez v. Medtronic, Case 2:13-cv-00512-GMS. The court found that “While permitting health care providers to use devices in ways other than those anticipated by the FDA, the FDA prohibits device manufacturers from promoting the off-label use of their product. By engaging in off-label promotion, the manufacturer may misbrand a device.” Further, the court said, “When Medtronic allegedly violated federal law by engaging in off-label promotion that damaged the Plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies.”
This decision means that the claims of design defect, failure to warn, fraud and misrepresentation were not preempted.
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On December 3, Judge Ortrie D. Smith of the U.S. District Court for the Western District of Missouri found that the surgeon was not fraudulently joined and that the case does not arise under federal law. Judge Smith said the claims against Medtronic Inc. and the surgeon do not “turn on substantial questions of federal law.” The Medtronic lawsuit has been remanded back to state court.
As well as linking the Infuse bone graft to cancer, a number of researchers have associated the Infuse bone graft procedures with male sterility, urinary problems, ectopic bone growth, infection and bone degeneration. More lawsuits are likely on the horizon.