What is Infuse BMP (Bone Morphogenetic Protein)?
Medtronic Infuse Bone Growth, or Infuse BMP, manufactured by Medtronic, is commonly used in spinal fusion surgeries to promote bone growth. The device is made up of two parts. The first is rhBMP-2, which is a protein that is found in everyone’s body. The second is the carrier for the deliver- a sponge manufactured from bovine (cow) Type 1 collagen. The synthetic protein (rhBMP-2) generates bone growth at the site of implantation and is used in place of the traditional process in which bone is harvested from other parts of the body. The product also requires a third component to be used, the LT Cage (sold separately).
The Infuse Bone Graft was approved by the FDA in 2002 for use in lumbar (lower back) spinal repair surgeries to promote bone growth, including Degenerative Disc Disease (DDD). In spinal operations, it is only approved for anterior surgical approaches, that is, from the front of the patient on no more than one level. However, it is widely used for off-label purposes for other surgical techniques.
Manufacturers have a duty to disclose risks associated with their product. However, according to an investigation conducted by the Journal Sentinel, Medtronic-sponsored studies have largely downplayed the risks associated with off-label uses of Infuse.
According to The Spine Journal, associated risks include: unwanted bone growth (ectopic bone growth), inflammatory reactions, adverse back and leg pain events, radiculitis, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement.
On October 25, 2012, the U.S. Senate Committee on Finance released a report, containing stinging criticisms of how Medtronic marketed Infuse. In response to allegations that Medtronic manipulated data, paid doctors millions of dollars in royalties, and deceived the public as to the safety of Infuse, the Committee ordered Medtronic to release an extensive list of documents pertaining to clinical trials on Infuse BMP. The congressional probe, beginning in June 2011, examined thousands of documents including email communications (both internal and those between physicians and employees) and financial transactions between physicians, “key opinion leaders,” and the company.
The results reported by the Senate on October 25, 2012 were as follows:
- Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic. The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed.
- Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty, and other miscellaneous arrangements.
- An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
- Medtronic officials inserted language into studies that promoted InFuse as a better technique than taking a bone graft from the pelvic bone (autograft technique) by emphasizing the pain of the autograft technique.
- Documents indicate that Medtronic prepared Dr. Hal Mathew’s remarks to the U.S. Food and Drug Administration (FDA) advisory panel meeting prior to InFuse being approved. At the time, Dr. Mathews was a private physician but was hired as a vice president at Medtronic in 2007.
- Medtronic documents show the company unsuccessfully attempted to adopt weaker safety rules for a clinical trial studying InFuse in the cervical spine that would have allowed the company to continue the trial in the event that patients experienced severe swelling in the neck.
If you believe Medtronic’s Infuse Bone Graft has caused your injuries or those of a loved one, please contact us by filling out our online contact form, or call our office for a free consultation. We have been handling dangerous drug and device cases for over 30 years. GoldenbergLaw has the resources and expertise to help you pursue your case.
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Early Litigation Updates:
April Cabana, a California woman who underwent an off-label spinal fusion surgery using Infuse BMP, was allowed to proceed with her lawsuit against Medtronic after a California Judge rejected the company’s motion for summary judgment on August 22, 2012.
Medtronic hoped to use summary judgment to get the case thrown out, arguing that the claim was preempted by federal law. In this case, however, Judge Michael Linfield agreed with Cabana and her attorneys that preemption may not apply if the product was marketed for and used in an off-label manner. Since preemption is one of the principal obstacles that must be overcome before Medtronic can be held accountable, this ruling is reassuring for those who plan to seek compensation for similar injuries.
February 21, 2013: Another state court has ruled in favor of plaintiffs involved in the litigation against Medtronic, the manufacturer of Infuse BMP. Medtronic’s Motion to Dismiss on the grounds of preemption was denied by the District Court of Denver, Colorado.
The case will be allowed to proceed since Judge Herbert L. Stern, III, determined that preemption did not prevent the plaintiffs from seeking a remedy from a state court. Judge Stern asserted that Riegel v. Medtronic, Inc. (2008) did not apply to the lawsuit at hand because the state duties are parallel to, rather than added to, federal requirements.
Much like the ruling in California, this development in Colorado bodes well for other plaintiffs who hope to file cases against Medtronic across the nation. Knowing that preemption is a key hurdle in these cases, it is reassuring to see that another judge has found in favor of those injured by the off-label use of Infuse BMP.
February 6, 2014: Minnesota Judge Laurie Miller denied Medtronic’s motion to dismiss in Lawrence v. Medtronic, allowing the case to proceed to discovery.
GoldenbergLaw has been involved in reviewing and screening thousands of Medtronic Infuse claims. We have the experience, resources and the passion to hold the manufacturer accountable. Our firm was appointed to be one of the Co-Chairs to head up the national AAJ litigation group for Medtronic Infuse cases.
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