New York, New York (PRWEB) July 17, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, comments on the expected Aug. 1 debut of the Physician Payment Sunshine Act provision of the Affordable Care Act, which is designed to highlight cases of allegedly fraudulent relationships between doctors and pharmaceutical companies and medical device manufacturers, as detailed in the Feb. 8, 2013, Federal Register.
Under the Sunshine Act, all manufacturers of pharmaceuticals, medical devices, and biologicals must report to the National Physician Payment Transparency Program at the Centers for Medicare & Medicaid Services (CMS). These outfits are compelled to report how much money they pay doctors and hospitals, as well as certain information regarding the ownership or investment interests held by physicians or their immediate family members in these companies.
Senate Finance Committee Chairman Max Baucus (D-Mont.) prominently linked the Sunshine Act with a 16-month U.S. Senate investigation that had revealed previously undisclosed ties between Medtronic and some doctors to whom it had paid $210 million to help promote and launch its Infuse bone graft product. The investigation also disclosed that Medtronic employees had collaborated with physician authors to edit, and sometimes write, clinical studies promoting Infuse for publication in medical journals. “These findings emphasize the value of the… Physician Payments Sunshine Act, which will result in public disclosure of industry payments to physicians starting next year,” said Senator Baucus, according to an Oct. 25, 2012, U.S. Senate Finance Committee release.
The Finance Committee had also found problems with most of the initial Medtronic-supported Infuse research, as noted in an Oct. 25, 2012, Bloomberg Businessweek report. The article noted that doctors and researchers had authored at least 11 medical journal reports about Infuse for their multimillion-dollar payment, which was in the form of royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to Infuse side effects, as well as to promote off-label use.
“Ultimately, the public deserves accurate information regarding the benefits and risks associated with any medication or medical device they are considering putting inside their bodies,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “Examples like the Senate’s investigation into the Infuse product show the potential value of the Sunshine Act.”
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).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
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