Senate lawmakers are pressuring Medtronic to disclose more about its consulting arrangements with physicians, citing prior allegations the company paid kickbacks to surgeons to boost sales of spinal implants.
In separate letters issued Tuesday, Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., asked the company to provide details about physicians who receive company payments for consulting services.
The two lawmakers have repeatedly criticized the influence pharmaceutical and medical device companies hold over physicians. A bill written by the senators would require companies to disclose all payments to physicians over $500, and last week Eli Lilly became the first drugmaker to volunteer to publish such information.
"I hope that Medtronic will consider making public its payments to physicians in the future and thereby show similar leadership in the device industry," Grassley wrote in a letter to Medtronic Chief Executive Bill Hawkins. Minneapolis-based Medtronic is the world's largest device maker.
The company said it is "very supportive of industrywide transparency" in a statement, and pointed out it has supported Grassley and Kohl's bill.
In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing. As part of the arrangement, the government agreed to seek dismissal of the two cases brought by former employees in U.S. District Court in Memphis, where the company's spinal division has offices.
But recent stories by the Wall Street Journal have attracted new scrutiny to the cases against the company, one of which remains sealed. Citing a copy of the sealed lawsuit, the Journal reported Medtronic allegedly entertained surgeons at a strip club, sent them on fully paid trips to Alaska and awarded some royalties on inventions they had no part in developing.
Medtronic said it would not comment on specifics of the case because it is still sealed.
"The Wall Street Journal rehashed allegations of prior conduct that were part of a case that was settled in federal court in July 2006," the company stated.
In his letter, Grassley also raised questions about more recent allegations. Another lawsuit filed by former employees last year accuses the company of illegally paying doctors exorbitant consulting fees to recommend using its bone graft system for unapproved uses. Doctors are free to use drugs and devices at their discretion, but companies are not allowed to market them for unapproved uses.
Medtronic said it does not pay surgeons to promote Infuse for unapproved uses, but noted "surgeons do have the freedom to practice medicine and use products in an off-label manner."
The company's Infuse graft uses a man-made version of a human protein to encourages bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.
However, serious complications have been reported when the graft is used for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.
In separate letters issued Tuesday, Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., asked the company to provide details about physicians who receive company payments for consulting services.
The two lawmakers have repeatedly criticized the influence pharmaceutical and medical device companies hold over physicians. A bill written by the senators would require companies to disclose all payments to physicians over $500, and last week Eli Lilly became the first drugmaker to volunteer to publish such information.
"I hope that Medtronic will consider making public its payments to physicians in the future and thereby show similar leadership in the device industry," Grassley wrote in a letter to Medtronic Chief Executive Bill Hawkins. Minneapolis-based Medtronic is the world's largest device maker.
The company said it is "very supportive of industrywide transparency" in a statement, and pointed out it has supported Grassley and Kohl's bill.
In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing. As part of the arrangement, the government agreed to seek dismissal of the two cases brought by former employees in U.S. District Court in Memphis, where the company's spinal division has offices.
But recent stories by the Wall Street Journal have attracted new scrutiny to the cases against the company, one of which remains sealed. Citing a copy of the sealed lawsuit, the Journal reported Medtronic allegedly entertained surgeons at a strip club, sent them on fully paid trips to Alaska and awarded some royalties on inventions they had no part in developing.
Medtronic said it would not comment on specifics of the case because it is still sealed.
"The Wall Street Journal rehashed allegations of prior conduct that were part of a case that was settled in federal court in July 2006," the company stated.
In his letter, Grassley also raised questions about more recent allegations. Another lawsuit filed by former employees last year accuses the company of illegally paying doctors exorbitant consulting fees to recommend using its bone graft system for unapproved uses. Doctors are free to use drugs and devices at their discretion, but companies are not allowed to market them for unapproved uses.
Medtronic said it does not pay surgeons to promote Infuse for unapproved uses, but noted "surgeons do have the freedom to practice medicine and use products in an off-label manner."
The company's Infuse graft uses a man-made version of a human protein to encourages bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.
However, serious complications have been reported when the graft is used for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.
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