Friday, September 26, 2008

Ex-Medtronic Lawyer: Company took Docs to Strip Club

From the Minneapolis paper:

'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million.'

The suit, filed by former senior legal counsel Ami P. Kelley, claimed that the company lavished spine surgeons with a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.


OK, so why does this matter? Senator Grassley has been investigating such activities to determine if the perks offered by Medtronic to doctors induce them to use the company's spine products in "off-label" ways not approved by the Food and Drug Administration (FDA). The FDA has warned that surgeons' off-label use of a Medtronic bone graft called Infuse has led to potentially life-threatening side effects in dozens of patients.

The Infuse Bone Graft has been claimed to cause complications when used in surgeries on the cervical spine, or the area around the neck. The bone protein is approved for use in a variety of spinal, oral and dental graft procedures, but the paper reported that Infuse has been linked to complications when used in "off-label" procedures, or operations for which is has not specifically been approved.

Earlier this summer, the FDA warned doctors that it could cause dangerous complications when used in neck surgeries. The complications included swelling that caused difficulty in swallowing, breathing and speaking, which in some cases lead to tracheotomies and further surgeries. Source here.