Products Liability Newsletters
It seemed like a miracle cure to many Americans battling obesity. “Fen-phen” — a combination of the two diet drugs fenfluramine and phentermine — was achieving great success in treating obesity. Both fenfluramine and phentermine had been approved by the U.S. Food and Drug Administration (FDA). However, the use of the drugs in combination had not been FDA-approved and was being used “off-label.” When it was determined that fenfluramine was linked to heart-valve damage, manufacturers voluntarily removed the drug fenfluramine from the market upon recommendation to do so by the FDA. Phentermine is still on the market as there have been no studies linking that drug to heart valve damage. The FDA recommended that patients who took the combination phen-fen consult their physicians about having an echocardiogram to determine whether heart valve damages occurred.
In the mid-1980s, a few cases in Massachusetts and Michigan recognized an exception to the learned intermediary doctrine for oral contraceptives. The courts concluded that birth control pills were significantly different from other prescription drugs in several ways.
Natural rubber latex is used to make surgical and examination gloves, adhesive bandages, intravenous catheters, and anesthesia equipment. Some users of latex products have developed sensitivities or allergies to latex. The problem is significant. U.S. government officials estimate that almost one million health care workers have developed an allergic reaction to latex. In 1997, the U.S. Food and Drug Administration (FDA) adopted a rule requiring manufacturers to place cautionary statements on products that come in contact with human skin and contain rubber latex.
Product liability laws protect consumers from unsafe products. What happens if a consumer doesn’t know who manufactures the product? Can anyone else be held liable? What about sellers, resellers, assemblers, and manufacturers of component parts? Can anyone in the product chain from conception to purchase be held liable for a product’s defects? Can anyone in the product chain be held liable for all of the damages of an injured consumer?
The Cigarette Labeling and Advertising Act (CLAA) was passed by Congress in 1965 to make Americans more aware of the adverse health effects of smoking. The CLAA requires health warnings on cigarette packages. As amended by the Comprehensive Smoking Education Act, the CLAA requires cigarette packaging to contain one of four specific labels warning of the adverse health effects of cigarette smoking. Warning statements must also be included in newspaper, magazine, transit and outdoor advertising. Cigarette advertising is banned from radio and television.