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Depakote Appeal Falls Short of SCOTUS Review

Dani Alexis Ryskamp, J.D.

Written by
— Updated on June 25, 2020

Depakote Appeal Falls Short of SCOTUS Review

Depakote Appeal Falls Short of SCOTUS Review

The U.S. Supreme Court decided not to review a federal appeals court ruling that two expert witnesses were properly excluded from a case against Abbott Laboratories.

The case involved the medication Depakote, which the plaintiff argued was the cause of the severe birth defects her son was born with in 2005. Depakote is manufactured by Abbott Laboratories and is used to treat seizure disorders and acute bipolar mania.

Rule 702: The Line Between Fact Witnesses And Expert Witnesses

At trial, the district court applied Federal Rule of Evidence 702 to the testimony of the child’s doctor, who was submitted as a non-expert fact witness. Pursuant to its analyses, the district court decided that the child’s doctor must be admitted as an expert witness in order to testify about whether or not Depakote caused the child’s birth defects. The court also found that the child’s doctor did not qualify as an expert witness under the Daubert standard.

During trial, the plaintiff chose to submit the child’s doctor as a non-expert fact witness, arguing that the doctor’s opinions were based on her direct treatment of the child. Normally, fact witnesses are not subject to the scrutiny of Rule 702.

However, the district court found, and the Second Circuit affirmed, that because the link between Depakote use and particular birth defects “is presumed not to be within common knowledge and experience,” any witness that testifies as to their opinion about that link would need to be an expert witness, not a fact witness. Therefore, Rule 702’s standard would apply.

The Daubert Standard: Which Witnesses Qualify As Experts

The district court next turned its scrutiny to the question of whether the child’s doctor could qualify as an expert witness under the Daubert standard. It also examined whether a second doctor, a teratologist and toxicologist who was submitted as an expert witness, could qualify under Daubert.

The district court decided that neither of these two witnesses could testify as to causation. The plaintiff appealed this decision, arguing that the district court had abused its discretion.

Once again, however, the Second Circuit Court of Appeals agreed with the district court. The Second Circuit held that the district court had a “gatekeeping role” to play in determining whether a witness was qualified to testify as an expert on particular points relevant to the case.

Here, the district court found that neither of the two doctors could testify as an expert witness because they had failed to lay a foundation for their causation testimony by performing an adequate differential diagnosis. The court noted in particular that neither of the doctors had ruled out the possibility that the child’s birth defects were the result of genetic anomalies rather than exposure to Depakote. It was also noted that while genetic testing had been offered to the plaintiff at least five times, only one of those offers resulted in actual genetic testing.

The Second Circuit wrote in its opinion, “Based in part on the absence of additional genetic testing, the District Court determined that Dr. Lewis could not reliably eliminate the possibility that [the child’s] injuries were caused by genetic defects. We agree with the District Court.” The district court also declined to allow the second expert to testify because that expert “did not conduct an independent differential diagnosis on [the child], but relied upon the same medical records” as the child’s treating physician.

Summary Judgment and SCOTUS Denial

The district court found that, without the two expert witnesses, the plaintiff had failed to prove that Depakote was the cause of her child’s injuries. As a result, the district court entered summary judgment in favor of Abbott Laboratories. The Second Circuit affirmed that decision.

The plaintiff filed a petition for a writ of certiorari with the US Supreme Court on September 7, 2018. In it, the plaintiff argued that the Second Circuit had created “a new rule creating a significant split” in how federal courts interpret and apply Rule 702. Specifically, the petition argued that “the Second Circuit found these experts’ opinions inadmissible in that the defendant pointed to genetics as a cause, and, despite the experts providing an explanation as to why genetics was ruled out, the court required additional genetic testing to eliminate the possibility of a genetic cause.”

This, the petition argued, was not the way in which Rule 702 and Daubert have traditionally been interpreted. Rather, it claimed that experts’ causation opinions have been, and should only be, deemed inadmissible “when the expert does not provide an explanation as to why that alternative cause was ruled out.” Since the plaintiff’s doctor has provided such an explanation, the petition argued, the district court was wrong to exclude the causation testimony and the Second Circuit was wrong to affirm that decision.

A cert petition requires a “yes” vote from four of the nine Justices in order to be granted. On January 7, 2019, however, the Supreme Court denied the petition for certiorari, with Justice Alito not participating in the decision.

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