Navigation Links
Lawsuit Against Medtronic Inc. Will Proceed, as Judge Rejects Device Maker's Preemption Arguments to Have Medtronic Infuse Case Dismissed, Parker Waichman LLP Reports
Date:8/29/2013

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.
(*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

Read the full story at http://www.prweb.com/releases/medtronic_preemption/08/prweb11076900.htm.


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

Related medicine news :

1. Transvaginal Mesh Lawsuit News: New Orders Issued in Vaginal Mesh Litigations Underway in West Virginia Federal Court, Bernstein Liebhard LLP Reports.
2. Massachusetts Woman Seriously Injured by Ethicon Transvaginal Mesh Device, Alleges Parker Waichman LLP in Lawsuit
3. Pradaxa Lawsuit News: Bernstein Liebhard LLP Comments on Boehringer Ingelheim’s Application to Expand Approved Uses for Pradaxa
4. Skechers Lawsuit Filed by Wright & Schulte Alleges that a Virginia Woman Sustained a Serious, Painful Knee Injury Due to the Dangerous Design of Shape-Ups
5. Transvaginal Mesh Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Release of New Order in Federal Ethicon Vaginal Mesh Litigation
6. Oregon Man Developed Bladder Cancer Brought on by Years of Ingesting Diabetes Drug Actos, Alleges Lawsuit Filed by Parker Waichman LLP
7. Baron and Budd Has Begun Investigating Claims for Transvaginal Mesh Lawsuits
8. Januvia Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Order Transferring Federal Claims Over Januvia and Pancreatic Cancer to California Federal Court
9. Byetta Lawsuit News: Bernstein Liebhard LLP Notes Establishment of Multidistrict Litigation For Federal Lawsuits Involving Byetta, Similar Diabetes Drugs
10. DePuy ASR Lawsuit News: Bernstein Liebhard LLP Notes Release of Latest Case Management Order in New Jersey DePuy ASR Recall Litigation
11. 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
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... ... is launching a new client service center in La Vergne, Tennessee, near Nashville. ... provide the full range of Empyrean client services. , “Our Nashville-area center allows ...
(Date:5/3/2016)... ... May 03, 2016 , ... Each year, about 800,000 people suffer from ... the United States and account for one death every four minutes. Many people ... disabled. HCR ManorCare is launching a video series called “Your Brain,” in conjunction with ...
(Date:5/3/2016)... Indianapolis, IN (PRWEB) , ... May 03, 2016 ... ... employee benefits advisory organization, announces Benefits Alliance Insurance Services as the latest addition ... powerhouse Southern California-based Firm comprised of Partners Wayne Blasman, David Styles, and Paul ...
(Date:5/3/2016)... ... May 03, 2016 , ... Octo ... solutions and digital consulting services to the federal government, has been awarded a ... / Indefinite Quantity (ID/IQ) contract in support of the U.S. Army Program Executive ...
(Date:5/3/2016)... ... May 03, 2016 , ... AvePoint, ... release of DocAve 6 Service Pack (SP) 7, the enterprise-class infrastructure ... 2016 and take advantage of the platform’s latest features – whether in an ...
Breaking Medicine News(10 mins):
(Date:5/2/2016)... May 2, 2016 Kalorama Information noted the ... Records) market in a recent white paper.  The healthcare ... physician usage, a growing market are among the top ... Kalorama,s report EMR 2016: The Market for ... seventh complete study of the EMR industry, and the ...
(Date:5/2/2016)... , May 2, 2016  Deerfield announced ... financing of Graybug Vision, Inc. Graybug Vision is ... therapies that may transform care for ocular diseases ... Graybug Vision,s technology was first developed at Johns ... a startup venture. Graybug Vision ...
(Date:5/2/2016)... , May 2, 2016  Celsion Corporation (NASDAQ: ... today announced data from the first cohort of ... trial (the OVATION Study) combining GEN-1, the Company,s ... the treatment of newly-diagnosed patients with advanced ovarian ... interval debulking surgery.  In the first three patients ...
Breaking Medicine Technology: