U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical …
Read the full story »
The Milwaukee-Wisconsin Journal Sentinel reports that Dr. Thomas Zdeblick, a spinal surgeon and chair of the University of Wisconsin’s orthopedic department, has received over $25 million in royalty payments from Medtronic since 2003.
Dr. Zdeblick has maintained strong financial ties to Medtronic since 2003, receiving royalty payments ranging from $1.7 million to $4.6 million per year. During this time period, Dr. Zdeblick published several positive research papers on Medtronic spine products, including a 2003 study on a new Medtronic spinal product that wrote in “unusually glowing language” that the product could “become ‘the new gold standard’ in spine surgery.” Read the full story »
U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical …
Mercury News reports that Medtronic, Inc. has agreed to pay $23.5 million to the U.S. Justice Department to settle claims that the company paid kickbacks to doctors to implant its pacemakers and defibrillators.
Medtronic, Inc. disclosed last week that California Attorney General Kamala Harris issued a subpoena on October 14, 2011, for documents related to its Infuse bone graft product.
Medical device manufacturer Medtronic is under scrutiny for its financial ties to surgeons who researched and promoted its Infuse bone graft device. Recently a full issue of The Spine Journal was devoted to voicing the concerns of spine specialists who in an unprecedented action repudiated what they considered to be misleading and biased research on the Infuse bone graft, published by colleagues with financial ties to Medtronic. Conflict of interest created when a surgeon is financed by a medical device maker is not limited to complications from the off-label use of Medtronic’s Infuse bone graft.
In September 2011, the Milwaukee Journal Sentinel profiled Tom Engel of Milwaukee and his experience with failed back surgery syndrome. Engel has undergone two spinal surgeries, one in 2002 and another in 2004, in an effort to manage his excruciating back pain.
Dr. Charles D. Rosen, founder of the Association for Medical Ethics (AME), sharply criticizes certain physicians and medical industry practices in an opinion editorial published in the latest issue of The Spine Journal. Dr. Rosen examines …
Jennifer English of Lake Worth, Florida, has filed a complaint against against Medtronic for allegedly misrepresenting the risks and benefits of its Infuse bone graft device and improperly marketing Infuse for non-FDA approved uses.
Patients have been implanted with the Medtronic Infuse bone graft device without knowing the limited scope of the device’s FDA approval or its history of complications, according to a report in the Milwaukee Journal Sentinel.
The Milwaukee Journal Sentinel reports that Medtronic, currently under a U.S. Senate investigation into alleged financial ties to doctors who authored positive papers on its Infuse bone graft product, will spend $2.5 million to hire Yale University researchers to study the safety and effectiveness of Infuse.
The government’s system for regulating many medical devices should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to one of the nation’s top scientific groups. More…
Lieff Cabraser attorney Kent Klaudt discusses Infuse bone graft side effects and related lawsuits
