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Supreme Court Ruling Limits Lawsuits against Generic Drug Makers

December 19, 2011

A U.S. Supreme Court decision this past summer regarding the obligations of the manufacturers of generic drugs regarding labeling and warning the public of adverse side effects may leave many injured by defective drugs without a legal remedy.

Pharmaceutical manufacturers of brand name drugs must provide FDA mandated warning labels regarding adverse effects and update those warning when new adverse events are reported. This FDA label warning system is an important check on drug companies that protects consumers by permitting victims of defective drugs to bring a lawsuit against drug companies that fail to disclose and warn of reported adverse events.

This new U.S. Supreme Court decision in the case of Pilva Inc. vs. Mensing has now made this protection illusionary for the vast majority of those injured by dangerous drugs. The U.S. Supreme Court ruled in a 5-4 decision that the duty to warn consumers of new adverse effects did not extend to generic drugs. The potential impact of this decision can hardly be overstated as 75 percent of all prescriptions in the U.S. are for generic drugs rather than more costly brand name drugs.

The decision was along ideological lines with conservative justices siding with the pharmaceutical companies and the liberal minority siding with the patients who developed tardive dyskinesia. The condition is a debilitating neurological disease that developed in the patients after taking a generic version of Reglan, an acid reflux drug. The patients brought their defective pharmaceutical lawsuit because the manufacturer of the generic drug did not provide a warning regarding the risk of developing the condition in users who take the drug longer than 12 weeks. Multiple studies have indicated a potentially increased risk of developing tardive dyskinesia for those who use Reglan for more than 12 weeks.

The Supreme Court, in ruling that generic drug makers were not bound by the same rules as brand name manufacturers, relied on the notion that generic drugs were merely copycat drugs so there was no reason to impose the obligation to update the labeling if the original brand name drug did not carry such a warning. Justice Clarence Thomas who wrote the majority opinion indicated that the obligation to provide warnings on drug labeling was the responsibility of the brand name drug company and the FDA.

Given that two-thirds of patients in the U.S. take generic rather than brand name drugs, this ruling poses the dual risk of both leaving patients uninformed of potential dangerous effects of certain generic drugs and barring lawsuits against generic drug makers who fail to update such labels upon receiving reports of adverse events. The decision was based on a finding that federal regulation of generic drugs pre-empts state tort claims alleging inadequate labeling. This decision could leave many injured by the generic version of Reglan with no legal remedy for serious medical conditions resulting from a lack of warning from the drug manufacturer.

The Georgia defective pharmaceutical attorneys at Montlick and Associates are committed to representing those injured by defective drugs. Our Georgia dangerous drug attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located we are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.