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Appeals Court Holds Drug Manufacturers Not Liable for Patient’s Skin Cancer

Prescription drugs often produce significant negative side effects in patients. But under Georgia law, the burden is generally on the prescribing physician, not the drug’s manufacturer, to warn patients of any risks. The Georgia courts refer to this as the “learned intermediary” rule. The manufacturer still has a duty to warn physicians of risks, but it is then up to the physician to serve as the “learned intermediary” between the drug company and the patient.

While a typical manufacturer has a duty not to market defective products, the learned intermediary rule often shields drug companies from the injuries its products may cause. A recent example comes from a federal appeals court which, applying Georgia’s learned intermediary rule, upheld a trial court’s dismissal of a woman’s lawsuit against the manufacturers of an antibiotic that produced a severe allergic reaction.

Brown v. Roche Laboratories, Inc.

The patient in this case saw her primary care physician to treat a sinus infection. The doctor prescribed an antibiotic. Two weeks later, the patient returned to the doctor with additional symptoms. The physician diagnosed the patient with bacterial meningitis and proceeded to administer a second antibiotic. Half an hour later, the patient developed a severe rash. A dermatologist diagnosed the patient with two forms of skin cancer known to occur as the result of adverse reactions to antibiotics.

The patient sued the manufacturers of the two antibiotics. She argued the drugs were defectively labeled as they failed to contain proper warnings about their potential side effects. The patient produced an expert witness who said the manufacturers should have expressly warned physicians to perform “precautionary skin testing” before administering the antibiotics to patients with a sensitivity to penicillin, as the plaintiff here was.

A federal judge excluded the expert’s testimony, however, and dismissed the plaintiff’s complaint for lack of any other evidence. Even if there was proof that the drugs in question caused the plaintiff’s cancer, the judge said Georgia’s learned intermediary rule would still bar her lawsuit. The 11th U.S. Circuit Court of Appeals in Atlanta, which has jurisdiction over federal courts in Georgia, affirmed the trial judge’s decision. The three-judge appeals panel reiterated that under Georgia law, “[I]f a manufacturer of a prescription drug warns a patient’s physician of any risks or hazards of the drug and, despite the known risk of harm, the physician administers the drug, the manufacturer is insulated from liability for injuries suffered by the patient.”

The 11th Circuit also found no error in the trial judge’s decision to exclude the testimony of the plaintiff’s expert. The appeals court noted that the expert lacked expertise in either the drugs at issue or the Food and Drug Administration’s labeling requirements. A trial court is required to assess the “reliability” of offered expert testimony, and here, the judge lacked that confidence. But, again, even if the plaintiff presented a more credible expert, her lawsuit would still fail because of the learned intermediary rule.