Two Senate committees wrote the device maker seeking info about consulting contracts given doctors over its Infuse Bone Graft, which is approved for use in the lower spine, but has been linked to life-threatening complications. There are also questions about complications suffered by patients who underwent off-label procedures involving use in other parts of the spine.
Both the Senate Special Committee on Aging (see letter) and the Senate Finance Committee also want to know why Medtronic has refused to disclose the names of docs who received payments and how much they were paid. For instance, one committee wants Medtronic to provide info about a trip to Europe made by UCLA spine surgeon Jeffrey Wang and his family, which was allegedly paid for by the device maker. We have left a message for Wang.
The move comes shortly news broke of a lawsuit brought by a former Medtronic lawyer, who alleged the device maker gave surgeons all sorts of interesting goodies to use its spinal implants, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in devising (back story). The relationships with docs generated another lawsuit brought by two other former Medtronic employees, who filed complaints against doctors, specifically.
The Senate letters were reported today by The Wall Street Journal, which was told by Medtronic that the device maker will respond to the senators, but has been "very supportive of industry-wide transparency" and backs federal legislation requiring all device makers to disclose payments to physicians. Medtronic calls the issues raised by former employees in lawsuits are "mere allegations of inappropriate business practices" and that they were "said to have occurred years ago."
More recently, Medtronic tells the paper that it has "put more rigorous systems and processes into place to assure alignment with our standards, identify any break from standards and address behavior that is in violation."
The senators also asked for more info about a 2002 lawsuit filed by former Medtronic legal counsel Ami Kelley that has been largely sealed by a federal judge. The lawsuit and one other led to a $40 million settlement agreement between Medtronic and the government covering federal health insurance. The deal, however, is being challenged in court by former Medtronic travel manager Jacqueline Kay Poteet, who is also one of two former employees suing dozens of doctors (see above).
In her appeal, Poteet says the $40 million settlement is too low. In a letter Wednesday to US Attorney General Michael Mukasey, her lawyer charges the government investigation of alleged wrongdoing at Medtronic has been marked by "irregular and questionable conduct" by Justice Department lawyers, according to the Journal.
Poteet's attorney, Andrew Carr Jr., alleges that a lead government lawyer in the investigation, assistant US attorney Robert McAuliffe, was taken off the case because the Justice Department learned he was married to Susan McAuliffe, a lawyer at the law firm hired by Medtronic to represent it in the federal probe, the paper writes, adding that Carr maintains McAuliffe was removed from the matter after the $40 million settlement had been negotiated.
"Contrary to the implication in Mr. Carr's letter the settlement was reviewed and approved by the department and entered into with Medtronic after a new attorney had been assigned," Charles Miller, a Justice Department spokesman, tells the paper. "Moreover, Mr. Carr was aware that Mr. McAuliffe had stopped working on the case. The department is confident that the settlement was appropriate and in the best interests of the public."
Susan McAuliffe declined to comment, and Robert McAuliffe couldn't immediately be reached for comment. Carr also tells the Journal that other government investigators told him they "were not permitted to conduct a standard and thorough investigation" of the case.