Navigation Links
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
Date:8/26/2013

(PRWEB) August 26, 2013

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
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

Read the full story at http://www.prweb.com/releases/medtronic_infuse_arizona/08/prweb11062998.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Snoring Isn't Sexy Member Dr. Mark Levy attends Academy of Clinical Sleep Disorders Disciplines Conference in Phoenix, Arizona
2. Arizona State University secures defense contract
3. 40,000 Arizona student athletes receive concussion tests from Mayo Clinic
4. Arizona Dental Heights Moves to Using the New Nomad Pro Hand Held X-Ray System
5. The Goodie Boxes - Providing Affordable Meals for Families begins Operations in the Phoenix, Scottsdale, Arizona Area
6. Copper Vista Dental Care LLC in Arizona Announces the Opening of its Globe Dental Office
7. Fitness 4 Home Superstore, Inc. Announces Nation’s Largest Online Retailer to Charge Arizona Residents Full Sales Tax Beginning February 1, 2013
8. Top Elliptical Machines in Arizona named by TopConsumerReviews.com
9. Dr. Lattie Coor to Discuss "The Arizona We Want" Initiative March 27 at Scottsdale Community College
10. Maricopa Community Colleges Provost Dr. Maria Harper-Marinick Named Among Arizona's Most Influential Executives
11. Arizona Assisted Living Placement Service Above and Beyond Is Offering New Promotion for Clients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... ... , ... PKF O’Connor Davies , LLP, the nation’s 26th largest accounting ... Firm, will participate in the 40th Annual "Empire State Building Run Up" on Feb. ... steps, a vertical distance equal to about a fifth of a mile, to reach ...
(Date:1/23/2017)... ... ... plastic balance boards have been around since at least the 1950s and are a great ... and only balance board to use a patent-pending design featuring high-pressure inflation technology and drop-stitch ... well as skill-level adjustable for all ages and abilities. The board can be rolled ...
(Date:1/23/2017)... , ... January 23, 2017 , ... ... on Crystallization in Process Chemistry by Applying Simple PAT Tools . , ... compounds to isolate and purify the desired product. Chemists now spend more ...
(Date:1/23/2017)... ... January 23, 2017 , ... The ... of Anesthesiologists® (ASA®), the Foundation for Anesthesia Education and Research (FAER), the ... and the Cigna Foundation, encourages proposals supporting high quality research using perioperative ...
(Date:1/23/2017)... ... , ... “Life Under Blankets”: an entrancing story about one woman's travels ... is the creation of published author, Kimberly Mitchell, who earned her bachelor’s degree in ... to pursue a master’s degree in education in the field of curriculum and instruction. ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... 2017 Endo International plc (NASDAQ / TSX: ... filed a joint motion in the U.S. District Court ... seeking the entry of a ten-year Stipulated Order ... between the FTC and Endo relating to the patent ... Opana® ER and Lidoderm® products.  It also resolves the ...
(Date:1/23/2017)... , Jan. 23, 2017 MouthWatch LLC announced today ... was ranked as the best intraoral camera on DentalCompare,s list ... #2 spot overall. The #1 product was the CollaPlug ... MouthWatch intraoral camera was "…incredibly popular because it is by ... has a small sticker price, it doesn,t sacrifice quality imaging." ...
(Date:1/23/2017)...  Allergan plc, (NYSE: AGN ), a leading ... International Headache Academy (IHA). Designed to inspire a long-term commitment ... offers a three-day, intensive overview on research and treatment options. ... sole sponsor since the inception of IHA in ... Europe in 2014. "Allergan ...
Breaking Medicine Technology: