Pharmacology Expert Drug LableA child, Z.H., was born in 2003 in Ohio with several severe birth defects allegedly caused by his mother’s use of Anti-epileptic drugs (“AEDs”). The anti-epileptic drug in question was formulated, tested, manufactured, and marketed by Defendant drug company during her pregnancy.

As part of that case, the U.S. District Court for the Northern District of Ohio recently heard Defendant’s Motion to Exclude Testimony from the plaintiffs’ pharmacology and toxicology expert witness, who was the president of a pharmaceutical consulting firm that specialized in development and registration activities related to products regulated by the FDA.

Plaintiffs listed the exec as a pharmacologist as the expert witness on drug labels, and the defendants sought to exclude the expert’s opinions concerning the warnings to consumers on drug labels.

United States District Judge Christopher A. Boyko wrote in his opinion that under Federal Rules of Evidence, a trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable, and that courts aren’t required to hold a formal hearing on Daubert challenges.

Among its arguments for excluding the expert’s testimony, Defendants sought to exclude her from testifying that the drug label contained an “anti-warning” when it noted that children exposed to other AEDs also experienced birth defects. Defendants argued that because the expert wasn’t a medical doctor and never prescribed medication, only the treating physician could discuss how she interpreted the warning. Defendants further contended that it was absurd to say that a drug with a Black Box warning about birth defects was an anti-warning.

The expert opined that the medical evidence at the time indicated that the specific drug manufactured by Defendant was significantly more teratogenic (an agent that can disturb the development of the embryo or fetus) than other AEDs. As such, its label was wrong and the drug maker knew or should have known that it conveyed false information.

The Court found the expert to be qualified to opine on whether the information provided on the drug warning label was inaccurate or falsely portrayed the drug as similarly teratogenic to other AEDs. The expert was a pharmacologist and toxicologist and directed interactions with the FDA on new drug applications. She had experience in collecting data on adverse drug events, updating labeling of drugs and in providing information on drugs to healthcare providers and patients. Based on her training and experience, Judge Boyko found that she was qualified to opine on the adequacy of the drug warning label. Defendants’ challenges, he said, went to the weight accorded the expert’s testimony, not its relevance.

Judge Boyko agreed with Plaintiffs that the expert provided sufficient detail on what the failings of the drug label were and what risks it should have warned against based on the medical literature available at the time.

The judge held that the pharmacologist expert witness outlined the basis for her opinions that the defendant’s drug label failed to adequately warn of the risks associated with its use by women of child-bearing age—and she specifically outlined what risks it should have warned against.

Therefore, Defendants’ Motion to exclude the expert’s testimony was denied.


Z.H. v. Abbott Laboratories, Inc., 2017 U.S. Dist. LEXIS 1466 (N.D. Ohio January 5, 2017)