Navigation Links
Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC
Date:12/3/2008

ATLANTA, Dec. 3 /PRNewswire/ -- A patient who was surgically implanted with Medtronic's Infuse(R) Bone Graft product, for an off-label use promoted by Medtronic, suffocated due to severe throat and neck swelling, according to James A. Dunlap Jr. & Associates LLC and Page Perry, LLC who filed the lawsuit in California along with another national law firm.

The Complaint alleges, among other things, that Medtronic improperly promoted its Infuse(R) Bone Graft product for a cervical lumbar surgery procedure, when the product was not approved by the Food and Drug Administration for that use. Infuse(R) Bone Graft product may cause severe swelling in the neck and throat that restricts breathing and can lead to suffocation of the patient if used off-label for unapproved uses, particularly spinal surgery performed from the back.

"The Nisbet family is grieving the loss of Mrs. Nisbet, a beloved wife and mother," said James A. Dunlap, one of the attorneys representing the Nisbet family. "Because of Medtronic's wrongful conduct, many other patients like Shirley Nisbet may have improperly received Medtronic's Infuse(R) Bone Graft product for an off-label use," Mr. Dunlap added.

The FDA has received more than 200 reports of significant side effects resulting from off-label use of the medical device, particularly in the cervical spine, a number of which have led to serious and potentially life- threatening complications. According to the FDA, complications typically occur within two to 14 days after the implant surgery. Some individuals required insertion of feeding tubes, tracheotomies, anti-inflammatory drugs and additional surgery to drain the implant site. Data presented at a recent spine conference reflected a 59 percent complication rate in cervical spinal surgeries using Infuse(R). The study was conducted by a group of North Carolina surgeons between July 2005 and December 2007 and involved 76 patients.

Medtronic's Infuse(R) Bone Graft product has been the subject of a recent whistleblower lawsuit brought by former Medtronic employees who alleged that doctors received over $8 million in 2006 in "sham" consulting fees for using and promoting the Infuse(R) Bone Graft product. Medtronic's marketing and promotion of the device for off-label uses is being investigated by the United States Department of Justice. In addition, the United States Senate is conducting hearings into the matter. Medtronic previously settled for $40 million with the Justice Department on another whistleblower action alleging that, between 1998 and 2003, Medtronic's spinal products division paid kickbacks to doctors in a number of forms, including sham consulting agreements, sham royalty agreements and lavish trips to desirable locations.

The case is "Walter Nisbet et al. v. Medtronic, Inc. and Medtronic Safamor Danek USA, Inc., United States District Court, Central District of California, Case No. SACV08-1361-JVS (RNBx)."

For additional information contact James A. Dunlap Jr. & Associates LLC at 404-354-2363, http://www.jamesdunlaplaw.com, or Page Perry, LLC, at 770-673-0047, http://www.pageperry.com.


'/>"/>
SOURCE James A. Dunlap Jr. & Associates LLC; Page Perry, LLC
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. U.S. District Court in Delaware Reinstates Damage Awards to Cordis Corporation on Patents Infringed by Medtronic, Inc. and Boston Scientific Corporation
2. Shareholder Class Action Filed Against Medtronic, Inc. by The Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
3. Supreme Court Hears Case on Federal Pre-emption of Safety Standards for Medical Technologies (Riegel v. Medtronic, Inc.)
4. Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.
5. Court Rejects Two Medtronic Patents
6. NuVasive Announces Patent Infringement Complaint Brought by Medtronic Sofamor Danek
7. Medtronic Celebration of Courage Set for September 13th
8. Medtronic Spine, Formerly Kyphon Inc., to Pay U.S. $75 Million to Resolve Allegations Of Defrauding Medicare
9. Medtronic Mediterranean Launches Worlds First Arabic-Language Integrated Insulin Therapy for Improved Diabetes Management
10. Wolf Popper Announces Filing of Securities Class Action Lawsuit Against Medtronic Inc. - MDT
11. Another Medtronic Sprint Fidelis Lead Lawsuit is Filed in Federal District Court
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... ... February 13, 2016 , ... With FCPX Overlay Embers from Pixel Film ... Final Cut Pro X. Each user can select from up to 40 effect overlays. ... blur, focus offset, hue, saturation, value, contrast, glow, and more all within a click ...
(Date:2/13/2016)... ... February 13, 2016 , ... Christie Medical Holdings, Inc. presented ... a VeinViewer® Vision vein finder for the nursing school simulation lab. ... and draw blood, combining technology with traditional technique. , “VeinViewer is a wonderful ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi ... Management Solution Providers list for its expertise in eClinical Solutions. DDi has built ... serve the technology needs of global clients. DDi provides smarter technology for Clinical ...
(Date:2/12/2016)... Opelousas, LA (PRWEB) , ... February 12, 2016 , ... ... of St. Landry and Evangeline Parishes. The purpose of these scholarships is to ... to encourage those individuals to seek employment within these two parishes. , “We ...
(Date:2/12/2016)... ... 2016 , ... CDRH Enforcement Trends: , Back to the Future , Feb. 25, 2016 — ... Churchill said, “Those who don’t learn from history are doomed to repeat it.” , An ... knocking this year. But that takes time. , Take a close look at the ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... February 12, 2016 ... auf den ungedeckten medizinischen Bedarf bei Lungen- ... seines klinischen Forschungsprogramms bekannt. Das Programm, das ... Verbesserungen ihrer respiratorischen Funktionen und anderer klinischer ... ein Medizintechnikunternehmen, das sich auf den ungedeckten ...
(Date:2/11/2016)... Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: PDEX) today ... December 31, 2015. The Company also filed its Quarterly Report ... 2016 with the Securities and Exchange Commission today. ... 2015 --> --> Net ... $2.6 million, or 95%, to $5.4 million from $2.8 million ...
(Date:2/11/2016)... 2016   Health 2.0 , the premiere showcase ... announced today " 10 Year Global Retrospective ", a ... the past ten years.   --> ... 2.0 has served as the preeminent thought-leader in the ... of technologies, companies, innovators, and patient-activists through an array ...
Breaking Medicine Technology: