Products Liability
| Punitive Damages Awards in Product Liability Suits |
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| Punitive damages are damages in excess of damages awarded to compensate a tort victim for injuries sustained. Also called exemplary damages, punitive damages are awarded to punish a tortfeasor for wanton or malicious conduct. Punitive damages have often been assessed in product liability actions.
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| Litigation Involving Drug-Related Birth Defects |
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| The Food and Drug Administration (FDA) began monitoring adverse drug reactions in 1961 after it was discovered that thalidomide (a drug used for nausea in pregnancy) caused severe birth defects. An adverse drug event (ADE) is an undesirable side effect experienced by a patient after taking a drug or using a medical device. Serious adverse events must be reported to the FDA, including birth defects, miscarriage, and stillbirths.
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| FDA regulation of dietary supplements |
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| The Dietary Supplement Health and Education Act of 1994 DSHEA gave the FDA authority to establish specific standards for dietary supplements. The law provides that a dietary supplement is adulterated if it or any of its ingredients poses a significant or unreasonable risk of illness or injury when used as directed. More... |
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| Overview of Federal Food, Drug, and Cosmetic Act |
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| Congress passed the Federal Food, Dug, and Cosmetic Act (FDCA) in 1938. The FDCA set up the Food and Drug Administration (FDA) to enforce the Act. The goals of the FDCA were to assure that foods are pure and safe to eat, that drugs and medical devices are safe and effective, and that cosmetics are safe. The FDCA banned adulterated and misbranded food from interstate commerce. The FDCA also regulates the labeling and packaging of foods, drugs, medical devices, and cosmetics. Under the FDCA, the FDA was given authority to adopt regulations dealing with food, drug, medical device, and cosmetic safety. This article discusses important amendments to the FDCA. More... |
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| Manufacturer's Liability for Over-the-Counter Drug-Related Injuries |
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| 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. More... |
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