Wyeth Pharmaceutical's sedative drug, Phenergan, now contains a black box warning from the U.S. Food & Drug Administration (FDA). Also known as promethazine, the drug was at the center of the U.S. Supreme Court's decision that those injured by dangerous drugs are not preempted from suing drug companies in state court.

What is Promethazine?

Promethazine is generally used as a sedative which the FDA says should be injected deep into muscle, never into an artery or under the skin and, when given intravenously, it should be done slowly and at a low concentration to avoid leaching and damaging the surrounding tissue – which could lead to gangrene and possible amputation. It is sold in the United States and other countries under the brand names Atosil, Avomine, Fargan, Farganesse, Lergigan, Phenergan, Promethegan, Prothiazine, Receptozine and Romergan.

The FDA is now requiring promethazine to carry a black box warning, the strongest warning available to the Administration, that incorrect usage of the drugs could lead to amputation. Unfortunately, that warning came too late for Diane Levine.

What the U.S. Supreme Court decided

For years, U.S. courts have struggled with whether those injured by dangerous drugs could sue manufacturers and pharmaceutical companies. Some courts ruled that they could; others ruled that they were preempted – or prohibited – from doing so because the FDA, a federal agency, was primarily responsible for approving the drug and allowing it to be sold in the marketplace.

Along came Diane Levine, a professional piano player who took Wyeth's drug Phenergan to relieve migraine headaches. After the drug was incorrectly injected into her, right arm, she suffered tissue damage in that arm and it had to be amputated. Having never been warned about the side effects of the drug, she sued Wyeth and was awarded $6.7 million in damages by a lower court. Wyeth took the matter to the U.S. Supreme Court which, in March 2009, ruled that injured parties are not preempted from suing drug manufacturers for their injuries in state court. Click here to read more about the ruling.

Damages available after the Court's ruling

The damages available to injured victims after the Supreme Court's ruling may consist of both economic (lost wages, medical bills, etc.) and non-economic damages (pain and suffering, emotional distress, etc.). State laws may vary on the specific damages which may be available to you, so make sure to consult with an experienced product liability attorney from your state.