Generic Drug Labeling in Georgia

In Georgia, Brand Name Drug Manufacturers are Not Responsible for the Labeling of Generic Drugs

In Pliva, Inc. v. Dement, Case No. A15A1157 (decided November 20, 2015), the Georgia Court of Appeals joined the majority of jurisdictions that have held that a party who claims to have been injured by allegedly incorrect or inadequate warnings on a drug produced by a generic manufacturer cannot attempt to blame the manufacturer of the identical brand name drug.

Under federal law, a generic drug manufacturer is obligated to use the same labeling that the FDA has approved for the identical brand name drug. When sued, generic drug manufacturers contend that they cannot be blamed for the content of the warnings because they are required to use the labeling used by the brand name manufacturer. In response to that, plaintiffs claiming to have been injured by inadequate warnings on a generic drug have sued the manufacturer of the identical brand name drug. Even though they did not use the brand name drug, those plaintiffs contend that the manufacturer of the brand name drug is ultimately responsible for the content of the warnings provided with the generic drug. The majority of courts across the country have rejected that liability theory. Georgia has now joined that majority.

The opinion of the Georgia Court of Appeals is available at https://efast.gaappeals.us/download?filingId=d7b15e8a-281f-4750-b3e1-0d1e049bd643

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