Wednesday, December 01, 2010

The Need for Doctors' Right To Investigative Free Speech

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, MD 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 Four'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.



Anonymous said...

UK libel laws are very restrictive. Seems like it causes lots of problems.

Keith said...

Kudos to Dr Wilmhurst! It is always much easier to to keep your mouth shut and go with the flow, but it is this unwilingness of many to take a stand for what they know is right that is eroding our moral fiber.

Too many docs and business people who are willing to put profits over patients. If companies and their products cannot be criticized openly without fear of legal retribution, how will these potential problems ever come to light? Hope he countersues for all his legal costs and loss of time.

Dennis said...

Seems like it was pretty dangerous to speak out against the church during the Inquisition...