Depakote Appeal Falls Short of SCOTUS Review

SCOTUS declined to review a ruling on expert witness exclusion in a Depakote birth defect case, leaving questions on Rule 702 and the Daubert standard unresolved.

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 [@portabletext/react] Unknown block type "span", specify a component for it in the `components.types` prop 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 [@portabletext/react] Unknown block type "span", specify a component for it in the `components.types` prop, 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.

About the author

Dani Alexis Ryskamp, J.D.

Dani Alexis Ryskamp, J.D.

Dani Alexis Ryskamp, J.D., is a multifaceted legal professional with extensive experience in insurance defense, personal injury, and medical malpractice law. Her diverse background includes valuable internships in criminal defense, which have enriched her understanding of various legal sectors. She served as the Executive Note Editor of the Michigan Telecommunications and Technology Law Review, demonstrating a strong commitment to legal scholarship. Dani graduated with a J.D. from the University of Michigan Law School in 2007, following a summa cum laude B.A. in English from Ferris State University in 2004. She is an active member of the Michigan State Bar and the American Bar Association, reflecting her dedication to the legal profession.

Currently, Dani has channeled her legal expertise into a successful career as a freelance writer and book critic, primarily focusing on the legal and literary markets. Her writing portfolio encompasses a wide range of topics, including landmark settlements in medical negligence cases, jury awards in personal injury lawsuits, and analyses of legal trial tactics. Her work not only showcases her legal acumen but also her exceptional ability to communicate complex legal issues effectively to a broader audience. Dani's unique blend of legal practice experience and her prowess in legal writing positions her at the intersection of law and literature, allowing her to contribute meaningfully to both fields.

Dani earned her Bachelor of Arts in English from Ferris State University, where she was involved in various activities, including serving as a tutor at the Writing Center, editor in chief of the Muskegon River Review, president of the Dead Poets' Society, secretary of the Public Administration Association, and a member of the varsity synchronized skating team. She obtained her Doctor of Law from the University of Michigan Law School, participating in the Michigan Telecommunications and Technology Law Review, Wolverine Street Law Moot Court, and the Mock Trial Team. Additionally, Dani holds a Master of Arts in English Language and Literature/Letters from Western Michigan University, where she was a graduate assistant for the Hilltop Review.

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