Newsletters

Food-borne Illness from Fresh Produce

Food-borne illness is caused by pathogens--bacteria (E. coli, Salmonella, Listeria, Shigella), parasites (Giardia, Cyclospora, Cryptosporidium), and certain viruses (hepatitis A). Typical symptoms of foodborne illness include diarrhea, abdominal cramping, fever, headache, vomiting, and exhaustion.

Food and Drug Administration Regulation of Medical Devices

The U.S. Food and Drug Administration (FDA) regulates medical devices. This includes the development, marketing, and monitoring of medical devices. Medical devices are classified into three categories.

Types of Defects in Products

A manufacturer has a duty to make safe products for consumers. It does not, however, have to make products that are completely accident proof or design the safest product possible. In products liability law, a defect does not mean an inferior quality product, instead it refers to the lack of safety in the product--the product has an unexpected defect or danger.

Litigation Involving Drug-Related Birth Defects

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.

Federal Hazardous Substances Act

The Consumer Product Safety Commission (Commission), a federal regulatory agency, enforces the Federal Hazardous Substances Act (Act). The Act regulates hazardous substances. A hazardous substance means a substance that is toxic, corrosive, an irritant, or flammable and which can cause serious personal injury or illness when used. Pesticides and fuels are regulated by other federal agencies and do not fall within the definition of a hazardous substance.