Each year hundreds of new drugs enter the $60 billion per year prescription-drug industry promising to improve our lives. But every year, 200,000 Americans die and numerous more are injured as a result of false and misleading claims by pharmaceutical companies. Despite the series of clinical trials and tests conducted on prescription drugs to protect the public, many drugs are causing serious injuries. According to the General Accounting Office, 51 percent of FDA-approved drugs have major adverse effects that aren’t detected until after the general public uses them.
Prescription drugs are regulated and approved by the Food and Drug Administration (FDA). Under current FDA regulations, new drugs are approved in half the time they were 15 years ago. This is because under the Food, Drug, and Cosmetic Act, the FDA can approve new drugs for marketing without long-term testing if it will benefit the public interest. 21 C.F.R. 310.303 (1997). Unfortunately, the current incidents of prescription drug injuries suggest that the public’s best interests are not being served. In the last 4 years, the following widely used drugs are among those that have been recalled and banned by the FDA. In many instances, these drugs were recalled within a year due to deaths or serious adverse effects by users.
A significant portion of recalled drugs were aggressively marketed by pharmaceutical companies, even when they knew use of their drugs could result in serious side effects or death. Because side effects for all medications are seriously underreported — some experts estimate that at best one in 10 are actually reported to the FDA — the real danger and number of injuries related to prescription drugs may be significantly higher.
Fortunately, the law provides you with rights. Under 402A of the Restatement (Second) of Torts, prescription drug manufacturers can be held strictly liable for selling products in a defective and unreasonably dangerous condition, even though they may have exercised the utmost care in the preparation and sale of their product. A product may be defective or unreasonably dangerous in several ways. One way is if the manufacturer failed to warn consumers of potential injury risks associated with the product. A product might also be defective or unreasonably dangerous if it was improperly designed (i.e. inappropriate chemical composition or dosage). Lastly, the product may also be defective if an error occurred during the manufacturing process. A prescription drug contains a manufacturing defect when it departs from its intended design even though it was carefully prepared and marketed. Manufacturer liability may also extend to what your physician tells you about the prescription drug.
Congress defined the term “dietary supplement” as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. Whatever their form may be, federal law places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify the FDA if it intends to market a dietary supplement in the U.S. that contains a “new dietary ingredient.” The manufacturer (and distributor) must demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.
FDA regulations require that certain information appear on dietary supplement labels, including: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. By law, the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. The Federal Trade Commission regulates the marketing of dietary supplements. Once the product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace. Manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products.