The Supreme Court recently ruled 8-1 that if a medical device maker received pre market approval from the FDA it over rides most claims under state law. Justice Scalia writing for the majority basically said that the FDA is responsible for evaluating risks and the safety of the devices. For more information on the decisions check out http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf. Justice Scalia, found a key aspect lacking in lawsuits by juries was their focus only on the dangers. He pointed out a jury “ is not concerned with its benefits. The patients who reaped those benefits are not represented in court.”

On several occasions I have written about risks and the responsibility of the organizations to weigh risks and have a risk plan. Every action brings risks. A risk plan that staff is trained on and which is utilized by the whole organization will reduce the likelihood of lawsuits due to negligence by the organization. The more staff/volunteers an organization has; the more customers that the organization serves; the more likely something will happen. The risk plan should be useful enough to have prepared employees, volunteers and management for the protocol to utilize for the circumstances.

This entry was posted on Tuesday, February 26th, 2008 at 12:01 am and is filed under Business Plan, Strategic Planning, Consulting, Public Policy. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.