Lawsuit Against Medtronic Inc. Will Proceed, as Judge Rejects Device Maker's Preemption Arguments to Have Medtronic Infuse Case Dismissed, Parker Waichman LLP Reports
Medtronic sought to have an entire lawsuit dismissed on the grounds that the medical device amendments to the Food, Drug and Cosmetic Act preempted all of the case’s claims. But the judge determined that federal law did not preempt most of the Plaintiff's claims because Medtronic had advertised the off-label use of Infuse on the Plaintiff, Parker Waichman LLP reports.
New York, New York (PRWEB) August 29, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is reporting that a lawsuit against Medtronic Inc. will proceed, according to court documents filed with the U.S. District Court, Arizona, on Aug. 21, 2013. In the documents, U.S. District Judge G. Murray Snow rejected Medtronic Inc.'s arguments to have the complaint fully dismissed on the grounds that all the Plaintiff’s claims were preempted by medical device amendments to the Food, Drug and Cosmetic Act (Ramirez v. Medtronic Inc. et al., Case No.:2:13-cv-00512). Judge Snow found, according to the documents, that federal law does not preempt most of the Plaintiff's claims because Medtronic advertised the off-label use of its product that was performed on the Plaintiff during her lumbar fusion; off-label uses that are promoted by the device maker are not preempted by federal law as off-label promotion is prohibited.
“As we anticipated, Medtronic will not be able to hide from the many lawsuits expected to follow this decision,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “We are hopeful that this decision will pave a path for compensating those individuals who were injured by Infuse.”
Parker Waichman LLP is reporting that it continues to help Medtronic patients 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.
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
- 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).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636
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