Generic Drug Warning Updates Would Be Permitted by Proposed Legislation, Restoring Patient Rights

By Austin Kirk
Posted May 23, 2012

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New legislation has been introduced by Senator Patrick Leahy, which aims to restore the rights of citizens to hold generic drug makers accountable for failing to adequately warn about side effects associated with medications they manufacturer and sell.

To protect yourself, your family and other consumers, the lawyers at Saiontz & Kirk, P.A. urge all readers of this blog to contact their representatives in the U.S. House of Representatives and U.S. Senate, demanding that they support this legislation.

If passed, this would reverse a 2011 Supreme Court decision, known as the “Mensing” decision, which allows generic drug makers to continue profiting from dangerous medications while failing to provide information for consumers and the medical community about the risk of serious and potentially life-threatening side effects.

In March, I wrote about the injustice created by the Supreme Court opinion in Pilva v. Mensing, which has resulted in the dismissal of cases throughout the United States, including those involving generic Accutane, Reglan and Darvocet.

Most consumers are not even aware that they are giving up all legal recourse by taking a generic version of a medication, and in many cases patients are not even given a choice about whether to receive a generic or brand-name medication.

The new legislation, which was introduced on April 18, is known as the “Patient Safety and Generic Labeling Improvement Act of 2012.” If enacted, the bill would alter FDA regulations so that generic drug makers would be allowed to update the labels to add new drug warnings that were not on the brand name drug. A companion bill has been introduced in the house.

In a press release announcing the legislation, Senator Leahy stated:

The Mensing decision creates a troubling inconsistency in the law governing prescription drugs. If a consumer takes the brand-name version of the 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.