Filing a Lawsuit after Suffering Complications from Medtronic Infuse Bone Graft


May 14, 2012     By Estey & Bomberger, LLP

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The Medtronic Infuse Bone Graft has been implanted into thousands of patients for spinal fusion surgery. Although the medical device was approved for only one purpose, analysts estimate that as much as 85.2 percent of Infuse use was for off-label purposes.
Since 2002 until 2008, when the FDA finally issued a warning against off-label Infuse treatments in the cervical spine, approximately 680,000 units had been sold, meaning thousands had received these dangerous off-label Medtronic Infuse spinal fusion surgeries. Patients who have been seriously injured as a result of an unapproved Infuse procedure may be entitled to recover compensation for their injuries.

Risks and Benefits of the Medtronic Infuse Bone Graft

The Infuse Bone Graft uses a bioengineered bone protein called recombinant bone morphogenetic protein-2 (rhbmp-2). Because the implant uses a synthetic bone graft, the Infuse eliminates the need to harvest bone graft from the patient, simplifying the spinal fusion treatment into one surgery. However, there are risks associated with the rhbmp-2. Even the studies conducted by Medtronic sponsored researchers found that as many as 70 percent of their patients developed ectopic bone growth during the clinical trials. In addition, independent researchers have found a number of serious side effects associated with the Infuse Bone Graft that were either not mentioned or downplayed by the medical literature written by surgeons with financial ties to Medtronic. Some of the risks associated with the Medtronic bone fusion treatment include:

• Uncontrollable bone growth;
• Male sterility (retrograde ejaculation);
• Nerve damage;
• Respiratory problems;
• Cancer;
• Paralysis;
• Higher rate of fatality.

Allegations Filed against Medtronic

In recent months, there have been a number of lawsuits filed by patients who have been developed severe complications after an Infuse Bone Graft treatment. In the lawsuits that have been filed, Medtronic faces many allegations, such as:

Illegally promoting off-label use of the Infuse Bone Graft.
Downplaying the serious risks associated with the product.
Giving financial incentives for doctors to use the Infuse Bone Graft.

Seeking Justice against Medtronic

The billion-dollar medical device manufacturer is currently under investigation by the U.S. Department of Justice and the Senate Finance Committee regarding the millions of dollars Medtronic gave to doctors who were involved in the clinical testing of the Infuse or published medical journal articles that failed to link the product to dangerous complications. If you have suffered serious health problems after an Infuse Bone Graft treatment, contact a professional Medtronic Infuse Bone Graft lawyer today to determine your eligibility to file a lawsuit.

ABOUT THE AUTHOR: Mike Bomberger
As a founding partner at Estey & Bomberger, Mike Bomberger has successfully defended numerous claimants against large corporations like Medtronic. If you have any questions regarding a potential medical device injury claim, please contact Estey & Bomberger for a free consultation.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.