DISCLOSURE ON YOUR MIND: The Pedicle Screw Case Aftermath "The pedicle screw litigation [marks] the end of innocence for CME."
With that cautionary note, Shawn M. Collins, chief counsel, pedicle screw litigation, North American Spine Society (NASS), began his address during the Hot Topics in CME session at the recent Alliance for CME conference.
While the four medical societies named as defendants in the first mass tort case to hit CME were, finally, exonerated, there are still negative repercussions for the CME community. (See Pedicle Screw Cases Thrown Out--at a Price, MM December, page 14.)
Fearing similar lawsuits, some organizations are reacting by offering "sanitized CME," Collins said, avoiding programs that deal with off-label drugs or devices. "If you trim your sails in reaction, the bad guys have won, and patients have lost," Collins said. "Be aware, but not afraid."
Take steps to make your organization less vulnerable, he suggested. In other words, follow the Standards for Commercial Support and insist thatdisclose financial relationships with drug manufacturers, and the FDA status of drugs/devices.
Here's Collins' advice:
* Create an environment of disclosure throughout your organization. That means, for instance, insisting that board members disclose to each other. "Disclosure must be on your mind, in your blood and bones," Collins said.
* Remember your mission. "Some organizations think their job is to do what manufacturers tell them to," Collins said. While providers need positive relationships with commercial supporters, "Be cautious. Guard jealously your independence."
* Walk your talk. "If you say you abide by[guidelines], you better follow through," Collins stressed. "The easiest way to be vulnerable is to set up rules you don't follow."
* Prove it: Keep all documentation of disclosure.
* Wear a life jacket: Get insurance that covers you for similar litigation. "I'm very proud of the [NASS] for authorizing me to say, 'We will die before we will settle,'" Collins said. The NASS was able to take that stance because it had insurance.