Serious injuries can occur through the use of limited or improper medical testing, improperly labeled medications, false drug advertising, and improperly filled medications. Under the legal doctrine of products liability, the manufacturer of a prescription drug, over-the-counter medication, herbal or dietary supplement may be held liable for injuries caused by its use.

Theories of Liability

If a manufacturer makes a defective product, then the manufacturer is strictly liable for the injuries sustained by the user of the product. Under a strict liability theory, a manufacturer will be held liable for damages even where no intent to harm is proven and the manufacturer has exhibited care in the design, manufacture, or testing of the product. Under a theory of negligence, a manufacturer of a drug can also be held liable for injuries caused when a person uses its drug if the manufacturer fails to take reasonable care to keep its products safe. Courts treat these two types of liability theories as separate theories of recovery. While a plaintiff might prevail under a negligence theory against a drug manufacturer, he may be unable to do so under a strict liability theory. However, the two theories are not mutually exclusive.

The law varies from state to state with some statutes combining the two theories. If an injured party proceeds on a theory of strict liability, the drug, over-the-counter medication, herbal or dietary supplement itself is at issue and the injured party must prove that the product or its manufacturing process was defective. The injured party must also prove that the defect made the product unsafe, that the defect injured him, and that he suffered monetary damages as a result.

If an injured party proceeds under a negligence theory, they must prove that the manufacturer owed him a duty to protect him from harm, the manufacturer breached this duty, causing injuries and monetary loss.

Effect of Meeting FDA Standards

The U.S. Food and Drug Administration (“FDA”) is charged with creating standards by which drug manufacturers test and label their products. The FDA reviews a medication and its safety before a manufacturer is allowed to market the drug. However, a manufacturer’s compliance with FDA standards and regulations does not preclude it from being held liable for its pharmaceutical products.

Duty to Warn

A drug manufacturer has a duty to warn of known side effects. If a manufacturer provides the necessary information to a prescribing doctor or pharmacist, the manufacturer’s duty to warn may be deemed satisfied. The duty to warn a patient then lies with the prescribing doctor or the pharmacist filling the prescription. Alternatively, the failure of the prescribing doctor or pharmacist to warn the may constitute professional malpractice and form the basis for an additional claim.

A drug that is unavoidably unsafe and cannot be made safe through the manufacturing process is a special case. A manufacturer may be free from liability if the unavoidably unsafe drug is helpful to the patient, despite potentially harmful side effects. An example is the use of chemotherapy drugs that can be unsafe, yet helpful. In an instance such as this, the manufacturer must give adequate warnings of any known or possible side effects or dangers.

Another aspect of defective drug litigation is the use of class action suits. Class action suits are undertaken when a drug harms a large number of people and individual litigation would cause great expense. Through the use of a class action suit, one trial is held for all the plaintiffs, known as “members of the class.” Thus, each plaintiff’s litigation costs are greatly minimized.