Epidemiology Expert Witness Testimony in Birth Defect Case Denied in Part and Granted in Part

Plaintiff filed suit against defendant pharmaceutical company for breach of duty and breach of warranties. The plaintiffs hired an epidemiology expert witness to assist in their case.  A motion to exclude this expert witness was granted in part and denied in part.

Facts:  This case (Hutchens et al v. Abbott Laboratories Inc. – United States District Court – Northern District of Ohio – January 13th, 2017) is a products liability action involving the drug Depakote, an anti-seizure medication.  The plaintiffs (Hutchens) claim that Christin’s use of Depakote during her pregnancy caused severe birth defects in their child, Z.H. and they sued the defendant (Abbott) for breach of duty of reasonable care, breach of express and implied warranties, and misrepresentation and omissions about the known risks of Depakote.  The plaintiffs hired Godfrey Oakley, Jr. M.D. (Epidemiology Expert Witness) to provide expert witness testimony.  Abbott has filed a motion to exclude Dr. Oakley’s opinions on 1) a registry that he claims Abbot should have set up in the 1980’s; 2) testimony comparing Depakote to Accutane and Thalidomide; and 3) Any testimony on Dr. Oakley’s statement that Depakote is the most dangerous anticonvulsant drug.

Discussion:  Dr. Oakley opined that Abbott should have established a registry of pregnant women in the 1980s.  This registry of women exposed to valproic acid would have helped Abbott on seeing the incidence and types of birth defects resulting from exposure.  Abbott then would have known about the effect of Depakote on cognitive development much earlier.  Abbott counters that a pregnancy registry in the 1980s is not relevant to the issues in the case.  The court agreed with Abbott, in part, stating that Dr. Oakley’s opinions on creating a registry is relevant to what Abbott knew about the birth defects at the time Christin was prescribed Depakote.  Dr. Oakley, however, will not be allowed to opine that a registry created in the 1980s would have resulted in the same knowledge as a registry created in the 1996.

Abbott also argues that Dr. Oakley’s opinion about what teratogenic risk information should have been included on the 2002 Depakote label should be excluded because Dr. Oakley is not an expert on labeling, does not possess a degree in neurology, and has never prescribed AEDs.  The court agreed with Abbott, stating that Dr. Oakley will not be able to opine on the labeling claims.

Abbott also seeks to exclude Dr. Oakley’s opinion that Depakote is the most dangerous drug of anticonvulsants and is part of the top three drugs for for causing serious birth defects.  They claim that this testimony is current and postdates the time when Christin starting taking Depakote as well Z.H.’s birth.  They argue that Dr. Oakley does not have a scientific basis for forming such an opinion and its prejudicial value outweighs its probative value.

The court agreed with Abbott, stating that Dr. Oakley’s opinions are present sense  and does not reflect that Depakote was the most dangerous drug of its kind in 2002.  Thus, this part of his opinion will be excluded.

Conclusion:  The motion to dismiss the expert witness testimony of Godfrey Oakley, Jr. M.D. is granted in part and denied in part.