Wyeth at the Supreme Court, Justices Weigh a 100-Year-Old Right Enjoyed by Americans

The Supreme Court will hear the case of Wyeth v. Levine the week of November 3. The case involves Diana Levine, a guitarist and musician, who lost her arm (and her livelihood) due to gangrene from an improperly administered nausea drug made by Wyeth. She was awarded $6.7 million in damages in a Vermont court, who agreed that Wyeth should have put stronger warnings on the drug’s label.

Wyeth appealed the verdict, stating that the FDA approved the drug’s label arguing that the FDA’s judgment should trump state law on issues of product safety. State consumer safety regulations are often stronger than federal standards.

The case has been called the business case of the century. The pharmaceutical industry is hoping that the Supreme Court will sharply curtail the right of Americans to sue drug companies for deaths or injuries caused by medications.
The case also speaks to the FDA’s preeminence in determining safety standards. Wyeth argued it cannot rush to the FDA to change a label every time an issue arises in one of the fifty states, and it cannot change the label on its own.
At present, death is considered an acceptable side effect for prescription medication approved by the FDA. Because the FDA makes mistakes, and companies have admitted they hide information, the patient’s right to sue has been the only deterrent to corporate misbehavior. While money has not been shown to make things better, litigation has been the patient’s tool of choice in cases like the loss of Diana’s arm. Wyeth has suggested that Congress should establish a fund to help victims of drug-related incidents as they have done for vaccine-related injuries. The victims of vaccine-related injury point to the fact that access to this fund does not work very well.
This comes at a time when the number of serious drug reactions and deaths reported to the FDA set a new record in the first three months of 2008. Because the FDA-reporting system captures only a fraction of the adverse events relating to the use of prescription drugs, many agree that the FDA could do a better job of ensuring drug safety.
The case is one more reason it is time to reform the FDA. AAHF has already pointed out that the FDA protects medical monopolies who pay its bills and hires its employees. Now we believe that the FDA is doing Wyeth’s bidding on another crucial issue.