Critics blast feds' legal shields for manufacturers

On June 29, 2008, the Chicago Tribune published an article recapping Bridget Robb's horrific tale of being shocked 31 times in 13 minutes due to a faulty, Medtronic Sprint Fidelis Lead. The article is one of many discussing how injured people, like Ms. Robb, are many times are precluded from recovering for their injuries due to a legal doctrine called "preemption." In effect, injured individuals are precluded from recovering against a company for defects in a product's design and labeling.

Proponents of preemption argue that manufacturers are not insurers and the FDA always has the option of holding a product from the market. During the June 11, 2008 Senate Judiciary Committee hearing at which Ms. Robb testified, Senator Specter called the FDA a joke and said that it is ludicrous to have preemption by an agency that is dysfunctional.

Before the hearing abruptly came to a halt because of a 2-hour rule invoked by a certain Republican Senator, Senator Whitehouse discussed "Regulatory Capture" -- which is when an agency that purports to be a public agency is taken over by the groups it was meant to regulate. Senator Whitehouse believes that the FDA falls within this definition.