Products Liability
| 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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| Types of Defects in Products |
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| 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. More... |
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| The Role of the Food and Drug Administration in Product Safety |
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| The Role of the Food and Drug Administration in Product Safety More... |
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| Breast Implant Law |
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| Over one million women in America have had breast implants. Approximately 80 percent of breast implant surgeries are for cosmetic purposes. For years, many physicians, scientists, and researchers have believed that silicone breast implants cause autoimmune diseases in women who have them. While there has been no conclusive proof connecting breast implants with autoimmune disease, a U.S. Food and Drug Administration (FDA) study suggests an association between silicone gel and fibromyalgia when women's breast implants rupture and silicone gel escapes into tissue. More... |
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| Cellular Phone Radiation |
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| Cellular phones are hand-held wireless telephones that have a built-in antenna. Cellular phones are regulated by the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA). The FCC sets safety guidelines that limit radiofrequency energy on wireless phones sold in the U.S. The FDA monitors the health effects of cellular phone use. Cellular phone use has skyrocketed. There were 16 million cellular phone users in the United States in 1994. By 2001, there were more than 118 million cellular phone users. This article focuses on the FDA's regulation of cellular phones. More... |
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