Navigation Links
Medtronic's InFuse Under Intense Scrutiny and Class Action Lawsuit
Date:6/11/2013

Miami, FL (PRWEB) June 11, 2013

Miami attorney Spencer Aronfeld believes that InFuse (a man made version of human protein to stimulate bone growth) which was originally approved by the FDA to treat degenerative disc disease in the lower spine as well as for oral and dental procedures should be recalled in light of the results from a U.S. Justice Department formal investigation against Medtronic for illegally recommending that physicians use InFuse for "off-label" surgeries.

The Justice Department's investigation led to a 16 month inquiry by the Senate Finance Committee led by Max Baucus (D-Mont) and Chuck Grassely (R-Iowa) (read a complete article on Bloomberg published October 25, 2012 http://www.bloomberg.com/news/2012-10-25/medtronic-manipulated-bone-product-data-senators-say.html). As a result of the Senate’s investigation, the committee found Medtronic had improperly collaborated with the physician consultations that performed InFuse procedures by rewriting the results of the testing in such a manner that inaccurately reflected the risks of InFuse.

A full June 21, 2011 Senate report can be found here: http://www.finance.senate.gov/imo/media/doc/Medtronic_Report1.pdf

The Senate inquiry revealed that Medtronic paid over $200 million in consulting fees, royalties and other payments directly to the doctors that were involved in the research. The Senate relied in large part on a recent issue of The Spine Journal (the preeminent medical peer reviewed publication in the field of orthopedic spine surgery) and evidence in spinal care articles regarding treatment related to the spine which was performed by doctors funded by Medtronic. These doctors failed to accurately report the findings of the research and failed to reveal that one of the primary risks of InFuse was male sterility particularly when the product is used “off-label.” A New York Times article published May 25, 2011 outlines the male sterility issues found with InFuse: nytimes.com/2011/05/25/business/25spine.html?_r=0.

During its inquiry, the Senate reviewed Medtronic’s internal documentation and found Medtronic had claimed that InFuse was a superior alternative to traditional bone grafting surgeries because it was less painful and eliminated the need for a second surgical site. These findings are outlined in the June 21, 2011 Senate report linked above.

Medtronic responded October 24, 2012 to the Senate’s financing committee and sent $2.5 million to Yale Medical School’s Open Data Access Project (YODA) to conduct an “independent” study on the efficacy of InFuse and to fact check research led by Dr. Harlan Krumholtz who is a cardiologist (and professor of investigative health and public health), but not an orthopedic surgeon. An August 3, 2011 article on Spine.org discusses the Medtronic/Yale research project in detail. Details on the YODA project found here.

The results of the investigation were promised to be released in February 2013. Now, according to a recent update of YODA’s website, the results of Dr. Krumholtz’s long awaited investigation is due sometime this month.

Details from Yale's website: medicine.yale.edu/core/projects/yodap/medtronic_data/medtronic_data.aspx

Details on a previous legal settlement in 2012 with Medtronic shareholders can be found here: reuters.com/article/2012/03/30/us-medtronic-settlement-idUSBRE82T1A920120330.

Aronfeld Trial Lawyers is currently investigating claims on behalf of people who have been injured after receiving InFuse in off-label surgeries.

Read the full story at http://www.prweb.com/releases/2013/6/prweb10815773.htm.


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

Related medicine news :

1. Medtronic Infuse Bone Graft Questioned As Allegations Unfold – Bisnar
2. Chase Attorneys Offer Free Consultations
3. Medtronic Infuse bone-graft lawsuit consultation referrals offered by Resource4thePeople
4. 2013 Cases Involving Medtronic Infuse Bone Graft Failure Allegations Now Being Investigated by Resource4thePeople Lawyers
5. Medtronic Infuse Bone Graft Lawsuits: Bernstein Liebhard LLP Notes New Report Predicting Hundreds of Medtronic Infuse Lawsuits
6. Ready for debut: Fruit-juice-infused chocolate with 50 percent less fat
7. Medtronic Infuse Bone Graft Failure Allegation Lawsuits Information Bank for Consumers Now Available through Resource4thePeople
8. Medtronic Infuse Lawsuit News: Bernstein Liebhard LLP Awaits Expected Release of Medtronic-Commissioned Analysis of Infuse Bone Graft Trials
9. Moringa Source Launches Natura Veda™, an Age-Defying, All-Natural Skin Care System Infused with Moringa
10. Medtronic Infuse Lawsuit News: Parker Waichman LLP Alerts the Public to the June Release of Yale’s Infuse Bone Graft Study
11. Medtronic Infuse Bone Graft Failure Allegation Lawsuits Update: New Legal Consultations Available Over Alleged Medical Malpractice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... 20, 2017 (PRWEB) , ... ... ... a global provider of enterprise-grade IT operations analytics and application performance monitoring ... one of world’s largest healthcare services providers. , According to Peter Ohrenberger, ...
(Date:7/20/2017)... ... ... Doctors on Liens, the leading network of medical providers working on a ... Russell Horine, DC to their exclusive list of medical professionals. Horine Chiropractic is a ... the clinic director and his son Dr. Lee Horine and daughter-in-law Dr. Natalie Horine ...
(Date:7/20/2017)... ... July 20, 2017 , ... TCGRx announced today ... existing adherence automation lines. The ATP® Mini and InspectRx® Mini are ... standard products, but at a size and price point that can help pharmacies ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... LINET, an ... latest innovation to their product line: the AVE 2 birthing bed. , Perfectly suitable ... bring a new level of comfort and efficiency to every phase of childbirth. The ...
(Date:7/20/2017)... ... July 19, 2017 , ... ... million Health Resources and Services Administration (HRSA) grant to train predoctoral dental students ... care needs in rural and underserved areas. , The Predoctoral Pediatric Training Project ...
Breaking Medicine News(10 mins):
(Date:7/11/2017)... , July 11, 2017  The global market for ... of approximately $394.1 million in 2016.  Although in early ... solid growth, in particular as a result of the ... and the recent introduction of a significant number of ... less-invasive testing of tumor biomarkers to guide treatment decisions. ...
(Date:7/11/2017)... , July 11, 2017 Oramed Pharmaceuticals ... a clinical-stage pharmaceutical company focused on the development of ... Food and Drug Administration (FDA) has agreed to schedule ... completed Phase IIb trial of its oral insulin capsule ... Phase IIb trial met primary and secondary endpoints by ...
(Date:7/10/2017)... S.C. , July 10, 2017  BDI ... purchasing and patient support services organization serving specialty ... today the launch of four significant, value-added member ... market insights, better manage reimbursement and improve access ... and factor therapies. ...
Breaking Medicine Technology: