Supreme Court Ruling Called "Major Win" for Patients

Wednesday March 4, 2009

NEWSBRIEF: The U.S. Supreme Court has ruled that pharmaceutical companies can be help liable if a patient is harmed by one of their drugs, even when the drugs carry FDA-approved warning labels.

The case involved a former professional guitarist who was improperly injected with the anti-nausea medication Phenergan (promethazine), from Wyeth Pharmaceuticals. A Vermont jury awarded Diana Levine $7 million in damages and the case eventually was appealed to the high court.

In a decision consumer groups are calling this a "major win" for patients, the court ruled 6-3 that FDA labeling approvals do not protect companies from damages as part of liability claims.

This ruling could be especially important to people with fibromyalgia and chronic fatigue syndrome, because these conditions can make you especially prone to side effects. Also, some of the drugs frequently prescribed for them come with a relatively high risk of serious side effects, including an increased risk of suicidal thoughts and behaviors.

According to a Consumer Reports poll, 1 in 6 Americans who's taken a prescription drug has had a serious side effect - bad enough to go to the doctor or hospital, or to cause a disability or incapacity. Still, most people don't know they can report side effects to the FDA. Patient reporting is an important part of developing a drug's safety profile. If you experience a negative side effect of medication, you can report it to the FDA's MedWatch program or call 1-800-332-1088.