Imagine having a medical device that is being tested in multiple centers, but one doctor thinks the device has problems. He says so at a national conference despite glowing reviews by others. Should the company sue the doctor for liable and remove him from their investigative panel?
Today, it seems that might not be such a good idea. This is, in fact, what NMT Medical did regarding comments made by Peter Wilmshurst, M.D. regarding NMT’s patent foramen ovale (PFO) closure device called Starflex:
NMT sued Dr. Wilmshurst for libel after he criticized its research at a US cardiology conference in 2007. The doctor vowed to take the case to trial in order to defend scientists’ rights to free academic debate.
The company threatened Dr. Wilmshurst with libel a second time for subsequent comments he made about the case on BBC Radio 4′s Today programme.
“During the last three years, enormous pressure has been placed on my family and me from time wasted dealing with the case, money laid out for legal costs and interference with my ability to work and other activities,” Dr. Wilmshurst said.
“I’m concerned my case will have a chilling effect because other scientists and doctors will realize the enormous financial and time costs of speaking out about products and the risk of being sued by manufacturers.”
For medical device companies that pay doctors as consultants, they have to be willing to have the knife cut both ways during clinical testing of their devices, regardless of the implications to their investors. Releasing an ineffective or defective product would be far more damaging to the company (and patients) in the long run. When concerns arise regarding the performance of a device, companies would be best served by providing additional data or additional independent reviews to support their claims rather than suing their own investigators.
-WesMusings of a cardiologist and cardiac electrophysiologist.
*This blog post was originally published at Dr. Wes*