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Medtronic Infuse Lawsuit Alleges Fraudulent Misrepresentation

Abingdon, Virginia resident Sandra F. Danna has initiated legal proceedings against Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc., in connection with the serious harm she allegedly sustained following surgical implantation of Infuse bone growth protein.

Filed in the U.S. District Court for the Eastern District of North Carolina on January 19, this Medtronic Infuse lawsuit contends that Ms. Danna suffered debilitating injuries and economic losses due to the defendants’ fraudulent misrepresentation, breach of warranties, defective product design, negligence and failure to warn about the dangers posed by Infuse bone grafts.

Medtronic Infuse lawsuit

In support of her allegations of wrongdoing by the defendants, Danna claims that Infuse suffers from design defects that are exacerbated when utilized in the various “off-label” applications and procedures Medtronic widely touted as being safe, despite not having secured FDA approval for them.

Infuse was granted FDA approval only for use in spinal surgical procedures done in combination with the LT-CAGE device. However, Medtronic has a long history of marketing and selling Infuse apart from the LT-CAGE and promoting its use in areas of the body other than just the lumbar spine.

Allegations of misleading literature regarding Infuse safety

Danna alleges that Medtronic embarked on a systematic process of creating misleading medical literature regarding the safety of Infuse, primarily by commissioning ghostwritten articles and research reports intended to minimize and limit discussion of known risks posed by the product during off-label use.

In a series of journal articles and presentations written and conducted by doctors employed by Medtronic, adverse events relating to these uses of Infuse were concealed, related risks including bone overgrowth at implantation sites were omitted and insufficient information was included regarding appropriate dosages. This pattern of obfuscation, according to Danna, led doctors to perform precisely the type of off-label Infuse implanation surgery she underwent at Pitt County Memorial Hospital in Greenville, NC in October of 2010.

Infuse bone graft complications

Off-label use of the Infuse bone graft has been linked to severe side effects and dangerous complications since the product initially received FDA approval in 2002. Ectopic, or unwanted bone growth in the spinal canal is one of the most serious risks stemming from the use of Infuse, as it can result in nerve impingement responsible for debilitating pain and loss of motor function. Infuse has also been blamed for displacement of implants, chronic back pain, cancer and infection. At least 100 patients thus far have filed suit to recover compensation for injuries sustained following Medtronic Infuse bone graft procedures.

According to her complaint, following her Infuse bone graft procedure, Danna began to experience severe back and leg pain. Imaging studies revealed that she had indeed experienced unconrolled ectopic bone growth near the implantation site as well as impingement of neighboring nerves. In January of 2011, she underwent a revision procedure intended to remove the overgrowth and mitigate the damage. However, Danna’s court filing states that she remains in constant pain, is unable to perform routine household and other tasks, has had to relocate to Virginia in order to live nearer her adult children and is unlikely to be able to return to work.

Proceeding under multiple causes of action including fraudulent misrepresentation, breach of express and implied warranties and strict products liability theories, Danna is seeking compensation for lost earnings, diminution of earning capacity, present and future medical expenses and punitive damages.

This lawsuit represents one of the most recent claims launched by plaintiffs seeking compensation for damages resulting from Infuse bone graft side effects. With litigation pending in relation to both off-label use as well as to FDA-approved applications of the product, the dramatic story of Medtronic and its controversial Infuse bone growth protein continues to play out in jurisdictions across the country.

Reuters, Medtronic to Pay $85 Million to Settle Infuse Lawsuit,