State Attorneys General Support Bill to Restore Legal Rights to Victims of Generic Drug Side Effects

State Attorneys General Support Bill to Restore Legal Rights to Victims of Generic Drug Side EffectsA group representing state Attorneys General across the country has backed a proposed Senate bill that would allow the makers of generic prescription drugs to update safety labels on their products if they become aware of new dangers and side effects from taking them.

According to a statement from the National Association of Attorneys General (NAAG), the bill proposed by Senators Patrick Leahy and Al Franken would give all users of prescription drugs the same legal rights if they suffer a side effect from taking it that’s not expressly noted on safety information included with the drug.

Under current federal law, makers of generic drugs are blocked from updating the safety labels on the copies of name-brand drugs they manufacture and distribute until the company that makes the name-brand drug makes changes. If a patient is prescribed or dispensed a generic drug and suffers a side effect, they are unable to file any legal actions against the makers of the generic drug, which is exempted from facing lawsuits for hiding side effects of that drug.

This law gained attention when the Supreme Court was presented with the case PLIVA Inc. vs. Mensing in which the high court ruled that federal law only granting permission to makers of name-brand drugs to independently update the safety labels on drugs prevented those who’ve been injured by generic prescription drugs from seeking any legal actions against the makers of it.

NAAG states that more than 70 percent of all prescriptions filled in the U.S. are for generic drugs and that’s likely to increase as patents for top-selling drugs expire, as the one for the cholesterol drug Plavix has recently done. In that case, seven companies have been permitted to make copies of Plavix to be sold under its generic name.

If a patient receiving Plavix in the name-brand form were to experience side effects or adverse reactions to taking the drug not mentioned in safety information or expressed by their physician, they could pursue legal action against the makers of it for failing to disclose those dangers. A patient taking the generic form of the drug would not be afforded those same legal rights under current federal laws which the Supreme Court has determined supercede any state consumer protection laws.

“This preemption holding produces arbitrary and unfair results, as both the majority and dissenting opinions in PLIVA recognized. 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 versions are now denied this protection,” the statement reads from NAAG. It was signed by 41 state and U.S. territory Attorneys General and submitted to the Senators co-sponsoring the new bill. “Congress can readily cure this problem by amending federal law.”

A group representing state Attorneys General across the country has backed a proposed Senate bill that would allow the makers of generic prescription drugs to update safety labels on their products if they become aware of new dangers and side effects from taking them.

According to a statement from the National Association of Attorneys General (NAAG), the bill proposed by Senators Patrick Leahy and Al Franken would give all users of prescription drugs the same legal rights if they suffer a side effect from taking it that’s not expressly noted on safety information included with the drug.

Under current federal law, makers of generic drugs are blocked from updating the safety labels on the copies of name-brand drugs they manufacture and distribute until the company that makes the name-brand drug makes changes. If a patient is prescribed or dispensed a generic drug and suffers a side effect, they are unable to file any legal actions against the makers of the generic drug, which is exempted from facing lawsuits for hiding side effects of that drug.

This law gained attention when the Supreme Court was presented with the case PLIVA Inc. vs. Mensing in which the high court ruled that federal law only granting permission to makers of name-brand drugs to independently update the safety labels on drugs prevented those who’ve been injured by generic prescription drugs from seeking any legal actions against the makers of it.

NAAG states that more than 70 percent of all prescriptions filled in the U.S. are for generic drugs and that’s likely to increase as patents for top-selling drugs expire, as the one for the cholesterol drug Plavix has recently done. In that case, seven companies have been permitted to make copies of Plavix to be sold under its generic name.

If a patient receiving Plavix in the name-brand form were to experience side effects or adverse reactions to taking the drug not mentioned in safety information or expressed by their physician, they could pursue legal action against the makers of it for failing to disclose those dangers. A patient taking the generic form of the drug would not be afforded those same legal rights under current federal laws which the Supreme Court has determined supercede any state consumer protection laws.

“This preemption holding produces arbitrary and unfair results, as both the majority and dissenting opinions in PLIVA recognized. 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 versions are now denied this protection,” the statement reads from NAAG. It was signed by 41 state and U.S. territory Attorneys General and submitted to the Senators co-sponsoring the new bill. “Congress can readily cure this problem by amending federal law.”

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