Generic Drug Bill Endorsed By Attorneys General From 41 States

States attorneys general are lining up behind proposed legislation that is designed to restore the right to sue generic drug makers for failing to warn about dangerous and potentially life-threatening side effects associated with their products. 

In April, Senator Patrick Leahy of Vermont introduced legislation that would make generic drug makers responsible for warning consumers if their products contain dangerous risks that are not adequately outlined on the label of the brand-name version of the drug, effectively reversing a Supreme Court ruling last year, which found that such claims were pre-empted by federal regulations that require generic medications to carry the same warnings as the brand name version.

To date, attorneys general from 41 states and American territories have signed onto the legislation, known as the “Patient Safety and Generic Labeling Improvement Act” (S.2295). The National Association of Attorneys Genera (NAAG) sent a letter of support (pdf) to Senator Leahy and Senator Al Franken, a co-sponsor, on May 11.

Last year, in Pliva v. Mensing, the Supreme Court ruled 5-4 down ideological lines that generic drug makers can not be held liable for failing to warn about risks associated with their medications, even if they knew or should have known that the warning label is inadequate. The majority of the Court determined that FDA regulations that require generic drug labels to match their brand-name equivalents made it impossible for generic drug makers to comply with both federal and state law.

As a result of the Supreme Court decision, thousands of product liability lawsuits pending against the manufacturers of generic medications have been dismissed or at risk of being thrown out, including lawsuits over generic Reglan, Accutane, Darvocet, Zocor and others.

In supporting the proposed legislation, the Attorneys General indicate that the Supreme Court has denied consumers of generic drugs the same protections that are afforded to those who use brand-name drugs.

In many cases consumers are not able to control whether they receive a generic version of a medication, and certainly are not being told that they may be left without a remedy if they use a generic equivalent.

“Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic version are now denied this protection,” the letter states. “The adverse consequences are magnified by the fact that over 70% of prescriptions in the United States are filled with generic drugs.”

The new legislation would give generic drugmakers the ability and responsibility of updating their drug labels to adequately warn users about the risks that are discovered in connection with the use of their products.