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| Childers, Schlueter & Smith

Senator Patrick Leahy has recently introduced new legislation in hopes to restore the rights of citizens and hold drug manufacturers of generic brand drugs accountable for failing to warn adequately regarding the side effects which can be associated with the generic medication.

This legislation will help restore and protect citizen rights. We strongly encourage you and your family to contact your representatives in the U.S. Senate and House of Representatives to ask for them to support this new legislation.

According to a recent Press Release, Senators Richard Blumenthal, Jeff Bingaman, Sheldon Whitehouse, Christopher Coons, Sherrod Brown, and Al Franken have cosponsored the legislation. The new legislation is titled the Patient Safety and Generic Labeling Improvement Act.

The reason for the introduction of this legislation comes after a 2011 Supreme Court case, Pilva v. Mensing, where the Court found in a 5-4 majority opinion that generic drug manufacturers cannot be held liable under state tort law for failing to warn consumers even when the companies know the label on the drug is inadequate. This decision does not make sense when compared to a 2008 case where the Supreme Court held that manufacturers of brand name drugs can be held liable under state tort law for failing to warn consumers of the possible side effects associated with that specific drug. In Mensing, the Court reasoned that federal law requires generic manufacturers to use the same label as their brand name counterparts.

If the Patient Safety and Generic Labeling Improvement Act of 2012 is passed, it will change FDA regulations allowing generic drug manufacturers to update the labels and add new drug warnings that were not present on the brand name drug.

Consumers may not know that they are giving up legal recourse if they choose to take the generic version of the drug. In many cases, patients do not have the choice about receiving a generic or brand name medication. Furthermore, the generic drug is usually more reasonably priced than the brand name drug.

Senator Leahy said, “The Mensing decision creates a troubling inconsistency in the law governing prescription drugs. If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries. The Patient Safety and Generic Labeling Improvement Act will promote consumer safety by ensuring that generic drug companies can improve the warning information for their products in the same way that brand manufacturers can under existing law.”

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