Consumers, under the law, are able to sue for damages for defective products as a result of negligence or strict liability. Recovery can be based on defects in the manufacturing, inadequate warnings, fraud, defects in the design, and implied warranty (where the product is not fit for the ordinary purpose for which it was sold).
Toxic Tort litigation involving defective drugs is governed by both the FDA under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U.S.C. §§ 301-1012, 42 U.S.C. §§ 262, 264, 266, 282, 284, the Public Health Service Act, as well as State law.
FDA approval of “new drugs” includes virtually all prescription drugs, as well as, some drugs which are sold over the counter. And testing of the new drug may take up to 12 years or longer before FDA approval is obtained.