(May 29, 2012) – A group representing state Attorneys General across the country has backed a proposed U.S. Senate bill, allowing 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, or 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 and warnings on the copies of name-brand drugs they manufacture and distribute until the brand-name company 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 suffered injuries caused by generic 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 is likely to increase as patents for top-selling drugs expire, just like the cholesterol drug Lipitor has recently done.
If a patient receiving Lipitor in the name-brand form experienced side effects or adverse reactions to taking the drug not mentioned in the safety label or not explained by their physician, they had the right to take legal action against the makers of it for failing to disclose the dangers and side effects. A patient taking the generic form of the drug would not have the 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 states and U.S. territory Attorneys General, and submitted to the Senators cosponsoring 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 adverse side effects from taking these drugs.
It is about time that victims who used the generic versions of a drug have legal rights. We are no longer in an era where generics are the minority, as an alternative option. As mentioned above, 70% of all prescription drugs are generic. Therefore, these people should have the same rights as those who pay full price for the name-brands.
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