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:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Finally, a ... after venous procedures, dermaka cream can be incorporated into the post-surgical treatment plans of ... surgical procedures. , dermaka cream is very effective for bruising and causes a ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Dr. Seema Daulat, ... Evans Dermatology in the South Lamar location as of July 13, 2016. , Dr. ... School. As a medical student, she regularly volunteered at the Agape Clinic serving Dallas’ ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
(Date:6/23/2016)... Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment ... Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... General Manager of Astellas Farma Colombia ... ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Surgical Procedure Volumes: Global Analysis (United States, China, Japan, ... report to their offering. ... tool for healthcare business planners, provides surgical procedure volume ... surgery trends with an in-depth analysis of growth drivers ...
Breaking Medicine Technology: