A July 1, 2008 FDA notification highlighted the fact that Infuse had been approved by the agency in 2002 for use in fusing damaged vertebrae in the lower spine; Infuse was not approved for use on the upper, or cervical, spine.
New York, NY (PRWEB) October 03, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, working with 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., on Oct. 1 filed with the 22nd Circuit Court in St. Louis, Missouri, a Complaint that names 98 Plaintiffs in a lawsuit against Defendants Medtronic Inc., Medtronic Sofamor Danek USA, Inc. and 100 John Does, or those whose name is not yet known (Lucas Gayer et al v. Medtronic Inc., et al, Case No. 1322-CC09531). The lawsuit is in response to the device maker’s alleged long history of supporting and promoting off-label uses (meaning uses not approved by the U.S. Food and Drug Administration (FDA)) for its Infuse bone graft product.
According to a Sept. 22, 2010 Medtronic post on the company’s website, Infuse is positioned as a way to reduce the pain and complications associated with treating degenerative disc disease (DDD) 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.
According to the Complaint, the Plaintiffs incurred serious and permanent damages allegedly as a result of the “off-label” use of the Infuse Bone Graft and LT-Cage device. A July 1, 2008 U.S. Food and Drug Administration (FDA) notification highlighted the fact that Infuse had been approved by the agency in 2002 for use in fusing damaged vertebrae in the lower spine; Infuse was not approved for use on the upper, or cervical, spine, where it would, in fact, become widely used, according to an Oct. 25, 2012, Bloomberg Businessweek report. The July 1 FDA 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 and nerve damage.
The Complaint further alleges that, in order to tap into the potential of the upper-back market, 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 articles in the June 2011 issue of The Spine Journal which alleged that Medtronic-paid researchers had failed to report serious potential complications stemming from use of Infuse bone graft products in spinal surgery. The Spine Journal articles also alleged that these researchers were paid hundreds of millions of dollars by Medtronic and that these payments were never disclosed to the public until much later.
The Oct. 25, 2012, Bloomberg Businessweek report revealed that the U.S. Senate Finance Committee had also found problems with most of the initial Medtronic-supported Infuse research used to promote the product. The article alleged that 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 after The Spine Journal issue devoted to Infuse was released. Published on June 18, 2013, in the medical journal Annals of Internal Medicine, the two studies* offered several key findings, namely that there is no difference between using Infuse and a traditional bone graft; that the initial Medtronic Infuse research was biased, and that there is a small, increased risk of developing cancer or, in men, retrograde ejaculation, a cause of male infertility.
Parker Waichman LLP is currently offering free legal consultations to victims of injuries allegedly caused by Medtronic Infuse Bone Graft. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse, please contact their office by visiting the firm's Medtronic Infuse injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney