The Supreme Court decision, made last year, that generic drug companies cannot be sued for failing to warn patients about the risks associated with the drug, has caused dozens of lawsuits to be thrown out of court. While nearly 80 percent of all prescriptions filled in the United States are generic, the ruling places the risk of taking cost effective generics over more expansive brand named drugs directly on the shoulders of the consumers.
Based on the 1984 Hatch-Waxman Act, generic pharmaceutical companies do not have to put their drugs through the lengthy approval process if they prove the generic drug is equivalent to the brand name drug. Generic drug makers are required to use the same drug labels as its brand name counterpart. Brand name drug makers are responsible for label changes; therefore, the law contends that generic drug makers cannot be held responsible for failure to alert patients and their physicians regarding issues with the drug.
Rep. Henry A. Waxman, D-Calif, co-writer of the Hatch-Waxman Act, said that “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug,” the Star Advertiser reported.