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.