Reference no: EM133034175

Patient Sues over Drug-Labeling Issue

In 2000, Diana Levine, a Vermont woman in her fifties, sought medical help for migraine headaches. As part of the treatment, the antinausea drug Phenergan, made by Wyeth, was injected in her arm. An artery was accidentally damaged during the injection, gangrene set in, and Levine's right arm was amputated. The amputation was devastating for Levine, a professional musician who had released 16 albums, and she filed a personal injury action against Wyeth in Vermont state court.

Levine asserted that Wyeth should have included a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because the warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The Superior Court of Vermont found in favor of Levine and denied Wyeth's motion for a new trial. Levine was awarded $7 million in damages for the amputation of her arm. The Supreme Court of Vermont affirmed this ruling on appeal, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. Therefore, states are free to create more stringent labeling requirements than federal law provides.

The U.S. Supreme Court eventually heard the case and issued a decision in March 2009. Wyeth had argued that because the warning label had been accepted by the FDA, any Vermont state regulations making the label insufficient were preempted by the federal approval. The U.S. Supreme Court affirmed the Vermont Supreme Court, holding that federal law did not preempt Levine's state law claim that Wyeth's labeling of Phenergan failed to warn of the dangers of intravenous administration.

As you read the case study, consider both parties in this case and the issues that were addressed by the court.

Once you have read and analyzed the case study, consider the concepts and topics discussed within this chapter and how they play into this situation. Next, answer the following questions/prompts regarding the liability of pharmaceutical companies:

1. Explain the ethical issues presented in the case.

2. How do you feel about the warning labels that we find on nearly all medical containers or attached to every prescription?

3. Do you think that these labels are exhaustive enough? Discuss if enough information is presented on labels.

4. Do you feel that these warnings absolve the pharmaceutical company from liability for any of the listed conditions?

5. Do you think that even with the list of possible side effects that is provided, the pharmaceutical company would still be liable?

6. Do you think that people actually read through this information?