Dangerous Pharmaceutical Side Effects in Georgia: Drug Injury Lawsuits

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A patient harmed by a prescription drug’s side effect, who believes the label failed to warn of that risk, meets federal law before Georgia law: whether the manufacturer could have changed the warning at all depends on whether the drug was brand-name or generic. Georgia law decides whom the warning had to reach, who can be sued, and how long a claim against the manufacturer remains possible.

Brand-Name Drugs: The Manufacturer Controls the Label

A brand-name manufacturer is responsible for its label and can strengthen a warning before the FDA approves the change, so a state failure-to-warn claim against it is not preempted without clear evidence that the FDA would have rejected the stronger warning. In Wyeth v. Levine, No. 06-1249 (U.S. Mar. 4, 2009), a jury found that the maker of the brand-name drug Phenergan failed to warn adequately of the risk of injecting it directly into a vein, and awarded damages for the amputation of the patient’s arm. The Supreme Court of the United States explained that “it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times,” and that an FDA regulation, the “changes being effected” (CBE) regulation, lets a manufacturer strengthen a warning before receiving the agency’s approval. It held: “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements,” and it affirmed the judgment of the Vermont Supreme Court upholding the verdict.

Generic Drugs: The Label Must Match

A generic manufacturer must keep its label the same as the brand-name label, so a state claim that it should have changed the warning on its own is preempted. In PLIVA, Inc. v. Mensing, No. 09-993 (U.S. June 23, 2011), patients sued generic manufacturers of metoclopramide for failing to warn. The Court explained that a generic drug application must show that its labeling “is the same as the labeling approved for the [brand-name] drug,” and that the FDA reads its regulations to impose on generic manufacturers “an ongoing federal duty of ‘sameness.'” Because “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,” the state-law failure-to-warn claims were pre-empted.

Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S. June 24, 2013), involved a patient who developed toxic epidermal necrolysis after taking generic sulindac and recovered on a design-defect theory. The Court held “that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA,” and it rejected the idea that the manufacturer could avoid the conflict by pulling the drug from the market.

The Warning Goes to the Prescribing Doctor

In McCombs v. Synthes (U.S.A.), 277 Ga. 252 (2003), a case about a spinal plate, the Supreme Court of Georgia described the learned intermediary doctrine as reaching prescription drugs as well as medical devices: the manufacturer’s duty to warn runs not to the patient but to the patient’s doctor, who stands between the two as the learned intermediary.

Georgia’s Product Statute and Its Time Limits

Under OCGA 51-1-11(b)(1), the maker of a product sold as new answers in tort for an injury proximately caused by the product’s condition at the time of sale, if in that condition it was not merchantable and reasonably suited to its intended use. The Supreme Court of Georgia has divided product defects into three general categories, namely manufacturing, design, and marketing or packaging defects (Banks v. ICI Americas, Inc., 264 Ga. 732 (1994)).

The subsection allows no action more than ten years after the product that caused the injury was first sold for use or consumption (OCGA 51-1-11(b)(2)). The same limit reaches negligence claims against a manufacturer, with two exceptions: negligence in making products that cause a disease or birth defect, and conduct showing a willful, reckless, or wanton disregard for life or property (OCGA 51-1-11(c)). Industry-wide theories, such as market share or enterprise liability, are not available against a manufacturer (OCGA 51-1-11(d)).

Frequently Asked Questions

Does it matter whether the pharmacy filled the prescription with a brand-name or a generic drug?
It can. In PLIVA, the Court acknowledged that had the patients “taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted,” but because pharmacists substituted the generic, “federal law pre-empts these lawsuits.”

Is a pharmacy liable as a manufacturer?
Not in a strict liability action. The definition of “product seller” reaches a business that sells a product or otherwise takes part in putting it into commerce, and in a strict liability action such a seller is neither treated nor held liable as a manufacturer under OCGA 51-1-11 (OCGA 51-1-11.1(a), (b)).

Does the ten-year limit end a manufacturer’s duty to warn?
No. The repose provision does not relieve a manufacturer of the duty to warn of a danger arising from use of a product once the manufacturer learns of it (OCGA 51-1-11(c)).

  • Wyeth v. Levine, No. 06-1249 (U.S. Mar. 4, 2009)
  • PLIVA, Inc. v. Mensing, No. 09-993 (U.S. June 23, 2011)
  • Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S. June 24, 2013)
  • McCombs v. Synthes (U.S.A.), 277 Ga. 252 (2003)
  • OCGA 51-1-11(b)(1), (b)(2), (c), (d); Banks v. ICI Americas, Inc., 264 Ga. 732 (1994)
  • OCGA 51-1-11.1(a), (b)

Disclaimer

This article provides general information about drug injury claims under federal and Georgia law. It is not legal or medical advice and does not create an attorney-client relationship. Whether a claim exists depends on the drug, whether it was brand-name or generic, the labeling, the dates of sale and injury, and the specific facts. A person injured by a medication should consult a licensed Georgia attorney promptly about the particular situation.

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