The Basics of Pharmaceutical Liability Law

Pharmaceutical liability refers to legal theories and ways to demonstrate that the manufacturer of a dietary supplement, an herbal remedy, a prescription drug, or an over-the-counter medication may be responsible when the drug causes death or injury. The Food and Drug Administration (FDA) is the government agency that is responsible for making sure that our drug supply is safe and effective. Approval of prescription drugs is the job of the FDA Center for Drug Evaluation and Research (CDER).

Since 1938, every new drug has to have gone through an approved New Drug Application (NDA) process before it can be commercialized in the United States. The NDA is the mechanism by which drug sponsors formally request that the FDA approve a new pharmaceutical for marketing and sale in the U.S. The data gathered during the animal studies and human clinical trials period of an Investigational New Drug become part of the NDA. The FDA reviews the medication and may approve it for sale, but the FDA does not guarantee that a drug or other pharmaceutical is in fact safe for human use.

The NDA documents a given pharmaceutical’s history including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies are, how the drug behaves in the body, and how it is manufactured, processed and packaged. After the FDA approves a drug for a certain use, patients who are injured by the drug must look to the manufacturer for redress, whether the drug is used for its approved purpose or for some other reason (known as “off-label” use).

Mueller Hillin specializes in Pharmaceutical Liability in Philadelphia, Atlanta, Houston and Austin.