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Judge Denies Medtronic’s Bid to Dismiss Lawsuit Alleging that the Off-Label Usage of its Infuse Bone Growth Product Caused Disability, Parker Waichman LLP Notes

New York, New York (PRWEB) July 25, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that a Plaintiff's lawsuit alleging that the off-label use of Medtronic’s Infuse bone graft product had caused him to be permanently disabled will proceed. The Judge has denied Medtronic’s bid to have the lawsuit overturned, according to court papers. The suit was filed on Jan. 10, 2013, in the Circuit Court of Cook County, Ill. (Case No.: 2013-L-000305).

According to the Complaint, the Plaintiff had been diagnosed with problems in his cervical spine and, as a result, was given a posterior cervical fusion in 2011. This, the Complaint noted, represented an off-label use of the product because the U.S. Food and Drug Administration (FDA) had not approved Infuse to be used in cervical procedures.

Parker Waichman LLP is reporting that it continues to investigate allegations of people who claim they were harmed by the product. Such allegations are not limited to the off-label use of Medtronic’s Infuse. In fact, two independent studies* published in the June edition of the medical journal Annals of Internal Medicine call into question Infuse’s overall level of effectiveness, as well as highlight potential harm the product can cause.


The two independent studies, overseen by Yale University, reveal important key findings regarding Medtronic’s Infuse product—namely, that there is little, if any, difference in the effectiveness of Infuse over a traditional bone graft. Additionally, Infuse has the potential to cause harmful, if not fatal, side effects, including:

  •     Retrograde ejaculation
  •     Cancer
  •     Pain
  •     Extraneous bone growth.

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.

Infuse was approved by the FDA in 2002, explicitly for use in a single type of spinal surgery that involves fusing together vertebrae in the lower spine, with the surgeon using a frontal approach. But it became widely used off-label—meaning for uses not officially approved by the FDA. On July 8, 2008, the FDA issued a safety alert to warn about the use of Infuse in the upper spine and the neck region after receiving dozens of reports of serious side effects associated with such use of the device. Among the side effects due to off-label use, according to the FDA, are:

  •     Swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck
  •     Difficulty swallowing, breathing or speaking
  •     Nerve damage
  •     Severe dysphagia

The FDA also noted in the 2008 safety alert that, since 2004, it had received nearly 40 reports of complications arising from the off-label use of Infuse in cervical spine fusion. The FDA highlighted the fact that “[w]hen airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomies and, most commonly, second surgeries to drain the surgical site.”

Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. 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 Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636

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