Arizona Judge Rejects Medtronic Inc.'s Efforts to Dismiss a Lawsuit That Alleges the Company Promoted Off-Label Use of Its Infuse Bone Graft Product, Parker Waichman LLP Reports

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Medtronic sought to have a lawsuit dismissed charging that all the Plaintiff’s claims were preempted by amendments to the Food, Drug and Cosmetic Act, which gives the U.S. Food and Drug Administration wide control over the manufacture and marketing of FDA-approved medical devices. But the judge determined that federal law did not preempt most of the Plaintiff's claims, Parker Waichman LLP reports.

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“The majority of [the Plaintiff’s claims] trace her doctor’s off-label use of Infuse back to Medtronic’s off-label promotion and are therefore not preempted,” the judge wrote in the court documents.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to court documents filed with the U.S. District Court, Arizona, on Aug. 21, 2013, U.S. District Judge G. Murray Snow rejected Medtronic Inc.'s arguments that federal law preempted a lawsuit trial built on claims that the company had promoted the off-label use of its Infuse bone graft product. According to the documents, Medtronic was seeking to have the complaint fully dismissed, alleging that all the Plaintiff’s claims were preempted by medical device amendments to the Food, Drug and Cosmetic Act, which furnishes the U.S. Food and Drug Administration (FDA) with extensive control over the manufacture and marketing of an FDA-approved medical device. (Ramirez v. Medtronic Inc. et al., Case No.:2:13-cv-00512). But Judge Snow found that federal law does not preempt most of the Plaintiff's claims.

“The majority of [the Plaintiff’s claims] trace her doctor’s off-label use of Infuse back to Medtronic’s off-label promotion and are therefore not preempted,” the judge wrote in the court documents.

Parker Waichman LLP 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, while also highlighting potential harm the product can cause.
(*http://annals.org/article.aspx?articleid=1696646; http://annals.org/article.aspx?articleid=1696645)

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 stemming from off-label use of this device, 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

In the 2008 safety alert the FDA also noted 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 yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636
http://www.yourlawyer.com

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Gary Falkowitz
Parker Waichman LLP

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