OB/GYN Experts May Discuss FDA Warning Labels for IUDs

    Court: United States District Court for the Western District of Missouri, Western Division
    Jurisdiction: Federal
    Case Name: Sellers v. Bayer Healthcare Pharms. Inc.
    Citation: 2016 U.S. Dist. LEXIS 188476


    The plaintiff filed a suit against the defendant, a pharmaceutical company, alleging she developed idiopathic intracranial hypertension/pseudotumor cerebri (IIH/PTC) after using the defendant’s intrauterine contraceptive. IIH/PTC is an increased pressure around the brain that causes vision problems and headaches. The plaintiff claimed the label for the contraceptive did not contain an IIH/PTC warning as a possible side effect. The defendant retained two obstetrics/gynecology (OB/GYN) expert witnesses to support their case.

    The OB/GYN Expert Witnesses

    The defendant’s OB/GYN experts testified to give the jury an understanding of the technical aspects of contraceptive options. The experts also explained how physicians consider those choices when advising patients and whether the plaintiff’s proposed IIH/PTC warning would affect the assessment and representation of those options.

    The plaintiff sought to exclude the defendant’s experts from testifying about drug labeling, IIH/PTC, endometrial, and epidemiological studies under Federal Rules of Evidence 403 and 702. The plaintiff argued that the OB/GYN experts provided reports that each contained almost verbatim opinions about the aforementioned topics. The plaintiff contended that the opinions were cumulative, irrelevant, unhelpful, unreliable, unfairly prejudicial, and misleading. The plaintiff further asserted that the defendant’s OB/GYN experts developed their opinions based on sources provided by the defendant, despite medical and scientific literature available in support of the plaintiff’s allegations.

    The defendants argued their OB/GYN experts relied on their knowledge, training, and experience to form their testimony. The defendant further argued that the experts’ reports were bolstered by their review of the related practice guidelines and peer-reviewed literature. The defendant asserted their OB/GYN experts were qualified to assess a patient’s individual needs and to contemplate the benefits and risks of the various contraceptive options when prescribing.


    The court noted that one of the defendant’s experts had cited 121 references in support of her opinion and presented a meticulous analysis pointing to her conclusions. Similarly, the second expert report cited 68 publications. The court concluded that even though their opinions were opposed to that of the plaintiff’s experts, that did not make them inadmissible under Daubert. The court further explained that the presentation of contrary evidence, careful instruction on the burden of proof, and vigorous cross-examination were the proper means of challenging the methodology and opinions of the OB/GYN experts.

    The court also noted that according to Rule 403, the experts’ testimony would only be excluded if its probative value was substantially outweighed by needlessly presented cumulative evidence, wasted time, or risk of undue delay. The court did not find that the risk outweighed the probative value and the testimony was, therefore, admissible.


    The motion to exclude the defendant’s OB/GYN expert witnesses was denied.