Complaint Names Close to 100 Plaintiffs Who Allege Medtronic Purposefully Promoted Off-Label Uses of Infuse Bone GraftOct 3, 2013
A Complaint names 98 plaintiffs in a lawsuit filed this week against Medtronic Inc. over the device maker’s long history of supporting and promoting the off-label use of its Infuse bone graft product.
The complaint, which alleges that the plaintiffs incurred serious and permanent damages as a result of the “off-label” use of the Infuse Bone Graft and LT-Cage device, was filed on Oct. 1 at the 22nd Circuit Court in St. Louis, Missouri. Off-label use means using a product in ways not approved by the U.S. Food and Drug Administration (FDA)when it first allowed a product on the market.
Infuse has been touted by Medtronic as a solution to the reduction of pain and complications associated with treating degenerative disc disease by eliminating the need for a second surgery to harvest bone from a patient's hip for transplantation to the spine. The Infuse Bone Graft consists of a solution to stimulate bone formation; it contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) soaked into an absorbable collagen sponge designed to dissipate. The solution-soaked sponge goes inside the LT-Cage, which is designed to stabilize the spine during fusion.
The U.S. Food and Drug Administration (FDA) approved Medtronic’s Infuse in 2002 for one use only: spinal surgery on the lower back in which the surgeon enters the patient through the front. Despite this, the agency was receiving alarming news about the use of Infuse on the upper, or cervical, spine; in response, the FDA sent out a July 1, 2008, notification to highlight that Infuse was not approved for use on the upper spine. The notification warned that, when used in cervical spinal fusions, the Infuse Bone Graft had been associated with serious complications – including:
- Excessive swelling in the neck
- Compressed airways
- Difficulty breathing
- Problems swallowing
- Nerve damage
The Complaint further alleges that, in order to tap expand the potential of Infuse in the face of the FDA approval’s limitations, Medtronic “devised a well-financed and extensive scheme to promote and market Infuse for non-approved, off-label uses,” that would make use of “fraudulent pretenses, representations and concealments of material facts.”
The Complaint refers to the June 2011 issue of The Spine Journal, which was entirely devoted to Medtronic – the first time in the publication’s history that it devoted itself to one topic – disclosed that Medtronic-paid researchers had failed to report serious potential complications stemming from use of Infuse bone graft; in addition, Medtronic paid these researchers hundreds of millions of dollars, something not disclosed to the public until much later.
The U.S. Senate Finance Committee also took issue with most of the initial Medtronic-supported Infuse research used to promote the product, as reported by Bloomberg Businessweek last year. Doctors and researchers who authored at least 11 medical journal reports about Infuse were paid approximately $210 million in royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to Infuse side effects, as well as to promote off-label use.
Medtronic approached Yale University researchers to do a thorough independent study in response to the allegations made by The Spine Journal. Published on June 18, 2013, in the medical journal Annals of Internal Medicine, were two studies that served up the key findings that:
- There is no difference between using Infuse and a traditional bone graft
- The initial Medtronic Infuse research was biased
- There is a small, increased risk of developing cancer or, in men, retrograde ejaculation, a cause of male infertility
The Medtronic lawsuit was filed by Parker Waichman LLP, Lanier Law Firm, based in Houston, Texas; Neblett, Beard & Arsenault, in Alexandria, La.; The Drakulich Firm, APLC, in San Diego, Cal.; and Holland, Groves, Schneller & Stolze LLO, in St. Louis, Mo.