The case

The case involves a 54-year husband and father of two who started experiencing depression related to stress. His doctor prescribed the popular anti-depressant, Paxil, to combat his depression. After a few weeks on the drug, his doctor increased his dosage. Although the patient had no previous suicide attempts, he committed suicide after taking Paxil for only four weeks in total.

His family sued GSK, but the pharmaceutical giant claimed that the family was preempted from bringing a lawsuit because the U.S. Food and Drug Administration (FDA), a federal agency, was ultimately responsible for allowing the drug to be placed into the marketplace. The Pennsylvania judge disagreed and the case will be allowed to move forward.

Preemption: A hot topic

Preemption of drugs and medical devices is a hot topic. The U.S. Supreme Court, the highest court in the nation, recently ruled that lawsuits against medical device manufacturers are limited due to preemption in the Medtronic case. Another case involving pharmaceutical companies is currently in front of the same court. However, industry analysts think that the court's anti-consumer ruling in the medical device cases may not be extended to drug manufacturers – especially after the FDA has been accused of being too tight with many of the largest pharmaceutical manufacturers.

Accusations against the FDA

Two congressmen, Maurice Hinchey (D-NY) and Bart Stupak (D-MI), have accused the FDA of maintaining inappropriate relationships with some of the nation's largest pharmaceutical companies. According to a press release from the House of Representatives, Hinchey and Stupak claim that, "The FDA has essentially become the government affairs office of the pharmaceutical industry" and that, "[T]he agency and drug industry continue to have a relationship that is far too cozy and inappropriate. By treating the drug industry like a privileged client that deserves preferential treatment rather than a regulated industry, the FDA is jeopardizing the health and safety of the American public."