Plaintiff sued defendant for failing to warn of possible effects from taking the drug Depakote. The plaintiff hired two expert witnesses to prove their case. These experts were excluded from testifying after a Daubert motion was filed by the defendant
Facts: This case (N.K. AN INFANT BY HIS MOTHER AND NATURAL GUARDIAN, TANJA BRUESTLE-KUMRA v. ABBOTT LABORATORIES – United States District Court – Eastern District of new York – May 22nd, 2017) involves the drug Depakote. The plaintiffs sued the defendant for failing to warn of the teratogenic effects of the drug. The active ingredient in Depakote, valproic acid, has been linked to an increase of birth defects if the drug is taken during pregnancy. To help prove their case, the plaintiff hired Dr. Rachel Lewis, M.D. (Pediatrics Expert Witness) and Christopher Stodgell, Ph.D. (Pharmacology Expert Witness) to provide causation expert witness testimony. The defendant has filed a motion to exclude this expert witness testimony.
Discussion: Dr. Lewis is a pediatrician who has been treating the defendant infant since he was very young. She has never conducted research on the drug Depakote or valproic acid and she has never performed any research on the effects of valproic acid on in utero exposure. Dr. Lewis has opined that the infant’s condition is a result of her mother’s taking of the drug Depakote.
Dr. Stodgell is a pharmacologist whose research focuses on teratology and autism and has conducted testing on the effect of valproic acid of babies in utero. In addition, he has not conducted this type of testing on humans and has not diagnosed a human patient with valproate exposure. His expert report opines that the infant’s injuries were caused by the in utero exposure to valproic acid.
The defendant has challenged the qualifications of these experts and the methodology used to form their opinions. First, the court looked at the qualifications and opined that neither expert is qualified to offer an expert opinion in this case. Dr. Lewis, while qualified in pediatric medicine, does not have the experience to testify on the issue of specific causation. The court went on to state that she has no training in teratology, has never prescribed Depakote, and does not have any training, expertise, or experience that would qualify her in this particular case. Dr. Stodgell does have a substantial background in valproate exposure and is qualified as to general causation, but, the court ordered, he is not qualified to testify in this particular case. Dr. Stodgell has never evaluated children, and is not a clinician, and has only studied the effect of valproic acid in animals. Thus, the court opined, Dr. Stodgell is not qualified to off an opinion on specific causation in this case.
The court also ruled that Drs. Lewis and Stodgell’s opinions are not based on reliable data and methodology. While Dr. Lewis arrived at her conclusion using a differential diagnosis, the court opined that she failed to eliminate alternative causes before she reached her final conclusion. In addition, she lacked the knowledge to rule out genetic causes. As to Dr. Stodgell, the court opined that he did not conduct his own independent investigation, basing his report on reviewing existing reports and clearly did not review all of the reports needed to form an opinion.
Conclusion: The motion to exclude the expert witness testimony of Drs. Lewis and Stodgell was granted.