Manufacturer's Liability for Over-the-Counter Drug-Related Injuries Today many drugs begin as prescription medications but are later sold as over-the counter (OTC) drugs. Prescription drugs are drugs that are considered unsafe (due to their toxicity or potential for harmful effects) for use except under a physician's supervision. OTC drugs must be safer than drugs that are dispensed by prescription because they are taken by a consumer without any medical supervision. Manufacturers of OTC drugs can decrease the harmful potential of the drugs by adequately labeling the products. The label must include the appropriate dosage, instructions on the use of the product, any potential side effects, and symptoms or conditions that contraindicate use of the OTC drug. The U.S. Food and Drug Administration (FDA) regulates the labeling and advertising of OTC drugs. Manufacturer's Duty to Warn The manufacturer has a duty to provide adequate warning labels on OTC drugs. The manufacturer must warn the consumer of any inherent dangers in the use of the product, which are known by the manufacturer. The warning has to be prominent enough to call the consumer's attention to it. A manufacturer might be held liable for failing to adequately warn the consumer of the risks of using an OTC drug product. Strict Liability Strict liability means liability without any fault. A manufacturer can be held strictly liable for any injuries resulting from the use of an OTC drug if the manufacturer fails to warn of the drug's known dangers. The failure to provide an adequate warning is considered a product defect. Negligence As noted above, a manufacturer has a duty to warn consumers of any dangers inherent in the use of the OTC drug. A manufacturer who fails to provide adequate warning labels on OTC can be held liable for negligence or lack of due care. Copyright 2007 LexisNexis, a division of Reed Elsevier Inc. |