Products Liability Law

Defective Drug Warning Labels and Off-Label Use

When doctors prescribe drugs they usually take great care to explain the potential side effects you may experience. These warnings are repeated by a pharmacist when you pick up your drugs, and persist on the lengthy warnings labels included with every prescription. These warning labels have been approved by the FDA, often after years of rigorous trials and testing. Drug companies can spend hundreds of millions on drug development which makes the prospect of being denied FDA approval daunting. As a result, drug companies may be inclined to hide or lie about potential side effects of drugs endangering the public.

Drug company duty to consumers

Drug companies are obligated to disclose all known or scientifically knowable risks of a drug for a prescribed use. An adequate warning label for a drug will include information such as dosage, active ingredients, and known harmful side effects. However, it’s often the case a drug is prescribed by a doctor for a use that wasn’t intended, or hasn’t been publically endorsed by the drug developers. This was the case with Fen-Phen.

What about off-label use?

The drugs Phentermine and Fenfluramine were FDA approved to be used separately as appetite suppressants. The two however were not approved to be used together. After it was discovered the two drugs worked better in combination doctors began to write prescriptions for both to be taken together. When a doctor prescribed a drug for a use not intended or advertised by the developer it’s known as “off-label” uses. Although off-label use is popular in the U.S., drug companies are restricted from advertising their drug for off-label use because the use has not been FDA approved. In the case of Fen-Phen, American Home Products knew of the adverse effects of using the drug combination but failed to report this information to the public. The drugs were selling incredibly well and were popular among dieters. It has since been proven that American Home Products allowed the continuous use of Fen-Phen knowing of the harmful side effects.

What if my state requires additional warnings?

In some instances, states pass their own laws which alter drug labeling in the attempt to make prescriptions safer for the public. Although the FDA has approved a nationwide warning label, a state’s law may demand additional language that has not been FDA approved. Drug companies are in a potential bind as to what labeling to use. This issue came to fruition in 2009 in the case Wyeth v. Levine. Here, a woman was injured by a drug whose warning labels were consistent with the FDA but not her own state’s restrictions. The drug manufacturer argued its warnings were consistent with the FDA, and that state law was preempted, thus voided by federal law. The court ultimately sided with the injured plaintiff and found that in certain situations, labeling alterations required by state law were permitted when the changes improved drug safety. The Court was not persuaded by the fact the FDA had approved the warning label.

What to know before taking prescription drugs

Before taking any drug you must be aware of two crucial pieces of information. The first is to find out all the known side effects of the drug. Your doctor is the best resource for this, but doctors can make mistakes. This is why reading the included prescription warnings is an essential check. Secondly, you should ask your doctor whether the prescribed drug is FDA approved, or whether the prescription is for an off-label use. Remember, an off-label use of a drug may not be FDA approved, thus potentially carrying additional unknown risks.

If you have experienced harmful side effects as the result of taking a prescription, the odds are you were warned of the risks. If not, you may have a products liability lawsuit against the drug developer. Contact a personal injury attorney to determine your next course of action.