No Shield In Drug Labeling, Justices Rule

A major consumer victory was ruled upon by the United States Supreme Court on Wednesday. It was perhaps the most important consumer protection decision in the last few years. I applaud the court and think this is a good thing for protecting the consumers in our country. The case was Wyeth v. Levine and there is plenty of talk on and offline about the decision.

The case began in 2000, when Diana Levine, suffering from migraine headaches, visited a clinic. She was given injections of Demerol for the pain and Wyeth's drug Phenergan for nausea. If Phenergan is exposed to arterial blood, it can cause swift and irreversible gangrene. For that reason, it is usually administered by intramuscular injection or intravenous drip. This time, a physician's assistant used a third method, injecting the drug into what she thought was a vein,  a method known as "IV push."

In the weeks that followed, Ms. Levine's hand and forearm turned black, and they were amputated in two stages. Although a huge loss for anyone, it created further financial problems for Ms. Levine who was a bass player and author of children's music in Vermont. She settled a lawsuit against the clinic and went to trial against Wyeth, claiming its warnings against IV-push administration were not strong enough. After an extensive trial in which both sides were allowed to state their case, the jury found in Ms. Levine's favor and awarded damages in excess of 6 million dollars.

The issue presented to the Supreme Court was whether federal approval of labels giving warnings about effects of drugs would bar an individual from bringing a state action if it claimed the warning was inadequate or that the company had additional information that was not available to the federal government. The court ruled in a 6-3 decision that the federal approval was not a bar and that Congress did not intend to bar failure to warn lawsuits that are based on state law.

Justice John Paul Stevens' opinion provided a reinforcement for the idea that drug companies are primarily responsible for keeping their warning labels up to date and complete and that the FDA not only needs to police the industry more closely - even if it lacks resources - but that it also had better have a clear mandate from Congress before it tries to destroy a patients right to bring a lawsuit in state court.

Justice Stevens, conceding that "the FDA has limited resources to monitor the 11,000 drugs on the market," wrote a lengthy footnote recounting a whole series of studies acknowledging the agency's inability to use its drug approval authority to ensure that the pharmaceutical companies are doing all that they can to warn doctors and patients about the risks of new drugs, and of the methods of administering them to patients.

He also had praise for the function that patients' lawsuits may serve. "State tort suits," he wrote, "uncover unknown drug hazards and provide incentives for drug manufactures to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information."  When those lawsuits are based on claims of manufacturers' failure to warn about risks, Stevens added, they "lend force to the promise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times." He further recognized that "state law offers an additional, and important, layer of consumer protection that complements FDA regulation."

Let's not also forget that once a drug is marketed to thousands of people, the company learns of things that we never knew in the clinical trials for that drug. It sometimes takes years before the information is discovered. It is really the responsibility of the drug manufacturer to bring this to the consuming publics attention. If they don't people can die or suffer serious injury. The state tort system provides an important check and balance to assure that you and I can feel safe taking these drugs. It helps make sure we don't have to say good-bye to a loved one or watch our child suffer for the rest of their life. That in my mind is a good thing.

Think about all the issues and decide for yourself how important they are to you. For me and my family they are extremely important. The following link is the position of Brian Wolfman, Director at Public Citizen. I agree with Brian. http://www.citizen.org/pressroom/release.cfm?ID=2833.

Art Kosieradzki