Navigation Links
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
Date:7/25/2013

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.

(*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 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 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_lawsuit/07/prweb10966387.htm.


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

Related medicine news :

1. Anorexics Cant Judge Own Body Size: Study
2. New study suggests that same-sex parents are judged more harshly than heterosexual parents
3. DrugRisk Update: Mirena Maker Asks to Keep Lawsuits With Local Court, Judge
4. Johnson & Johnson Ethicon Transvaginal Mesh Lawsuits Update: Resource4thePeople Reports Judge Schedules More Trials for This Summer
5. Judge: Make Morning-After Pill Available to All Females
6. Work By Female Scientists Gets Judged More Harshly: Study
7. Presence Technology Chosen to Judge Startup World’s First Visit to Spain
8. Obama Administration to Challenge Judges Ruling on Morning-After Pill
9. NuvaRing Lawsuits Move Forward, as Federal Judge Rules that Plaintiffs’ Experts May Testify on “Bursts” of Estrogen Allegedly Delivered by NuvaRing, Wright & Schulte LLC
10. Actos Lawyers at Bernstein Liebhard LLP Comment on California Judge’s Decision to Set Aside Verdict in Nation’s First Actos Bladder Cancer Trial
11. NuvaRing Lawsuit News: Rottenstein Law Group Responds to Judge’s Refusal to Dismiss Punitive Damages Claims
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 2016 , ... Stephanie Hebert Insurance Agency, serving families of ... charity campaign. As part of their ongoing community involvement program, funds are now ... children deserve a voice, and in the spirit of neighbors helping neighbors in ...
(Date:2/8/2016)... , ... February 08, 2016 , ... A man who has struggled to quit smoking, ... Laser Therapy , was determined to find solutions to his problems – and he did. ... Digest is ready to introduce his breakthrough inventions to the world and better people's ...
(Date:2/8/2016)... York, NY (PRWEB) , ... February 08, 2016 , ... ... are too much to handle, you are not alone. According to the Center for ... include heart disease, stroke, type 2 diabetes and certain types of cancer, some of ...
(Date:2/8/2016)... Hilton Head Island, SC (PRWEB) , ... February 08, 2016 , ... ... Head and surrounding areas with a vital new community enrichment program, has teamed up ... to local women and children suffering from intimate abuse. To support all those victimized ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local ... the greater Venice, FL area, has initiated a fundraiser for a two year ... just four days after Christmas. To support this beautiful child who is facing ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Cardiovascular Surgery Devices - Medical Devices Pipeline Assessment, ... report, "Cardiovascular Surgery Devices - Medical Devices Pipeline ... Devices currently in pipeline stage. ... comprehensive information on the pipeline products with comparative ... development. The report reviews major players involved in ...
(Date:2/8/2016)... 2016  Labvantage Lx, a newcomer to the ... sexual enhancement product, EnduramenT. Setting a new standard ... a patented biomedical breakthrough molecule that promotes the ... responsible for many biological functions including erectile function. ... Forgoing the use of prescription medications, scientists working ...
(Date:2/8/2016)... TOKYO and FAIRFIELD, N.J. ... (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that ... exclusive development and commercialization rights for OPA-15406 in the ... agreement also provides manufacturing rights.  OPA-15406 is a topical, ... for atopic dermatitis. --> ...
Breaking Medicine Technology: