In a nation like the U.S. with both state and federal laws, the issue of pre-emption often arises. It is the issue of whether federal laws or regulations take precedence over – pre-empt — a state’s law on the same question.
The issue at stake in this case was whether a drug company that has complied with the FDA’s testing and requirements in the process of bringing a new drug to the market is thereby protected from lawsuits over that drug. Many believe the drug companies should be protected, having done all that is asked of them in the way of safety studies and labeling, not to mention the years of expensive drug development to begin with.
Musician Loses Her Arm
The drug company Wyeth developed Phenergan, an antihistamine used to treat allergy symptoms and nausea, and also used as a sedative.
In 2001, one Diana Levine was admitted to hospital for migraine treatment. It was just the latest of many times she had done this and her treatment was the same as previously, Demerol for the pain and Phenergan for nausea. The Phenergan was given quickly as a “drug push” through an intravenous line to her right arm. This method had been FDA-approved.
During the following few weeks her lower arm turned purple and then black. The tissue was dying because of gangrene. Gangrene is a complication of cell death (necrosis) and is caused by an infection or inadequate blood flow. Her lower arm had to be amputated and she now has a prosthetic.
Levine plays guitar, piano and electric bass, sings, writes songs, and runs a children’s record label. Loss of her lower arm has made it hard for her to play any instruments.
Levine v Wyeth
Gangrene is a risk on the Phenergan label. When Levine’s IV line had administered the Phenergan into a vein, it had struck an artery accidentally and somehow caused gangrene. Levine sued Wyeth for not having a strong enough warning about gangrene on its label and won in a Vermont court. Wyeth appealed, stating that after the FDA has approved a warning label it can only be changed with further FDA approval, and until that happens, consumers cannot use state laws to override the (federal) FDA.
The case went to the Supreme Court and its decision has given strength to the idea that state laws can after all pre-empt federal laws or regulations.
All drugs have side effects, some far more severe than others. Typically they are not a problem as long as the drug is properly prescribed and administered, and as long as both physicians and patients are aware of their possibility. The patient will then know to avoid alcohol, for instance, and the doctor will know which patients will probably do well with a given drug.
When a drug turns out to be defective, one must look into the labeling, the FDA approval for how it is to be used, and whether the drug company has made known to the public all that it knows about this drug. At the Law Offices of Michael Barszcz, we have extensive experience in representing clients in dangerous drug cases.
If you have been hurt by a drug and wonder if you might have a valid legal claim, please contact our personal injury law firm today for a free case evaluation.