Court Affirms Defense Win In Pelvic Mesh Case: The United States Court of Appeals for the Fourth Circuit (“Federal Appellate Court”), in its unpublished opinion dated March 10, 2023, upheld the district court’s exclusion of the plaintiff’s causation expert’s testimony in a pelvic mesh lawsuit, stating: “We hold that the district court did not abuse its discretion in excluding Dr. Luciani’s proffered testimony on causation. Dr. Luciani’s disclosed report was comprised of a summary review of his qualifications and Donalds’ treatment records, followed by an ipse dixit conclusion that Donalds’ symptoms “were proximately caused by the erosion of the mesh product.” J.A. 909. He did not identify a specific defect that could have caused erosion of the mesh, nor did he address the other possible causes of Donalds’ symptoms, even though Donalds had been alerted to the presence of these alleged deficiencies in Dr. Luciani’s report well prior to the expiration of her time to file a rebuttal disclosure in the MDL proceedings. Because Dr. Luciani’s opinion failed to supply the basis and reasons for his opinion and he offered no explanation of his methods or how he reached his conclusion, the district court held, “his opinion does not rise above the level of ‘belief or speculation’ and is ipse dixit.””
Underlying Facts
On July 17, 2014, Paula Donalds’ treating physician, Dr. Christine O’Connor, implanted a TVT Abbrevo device to treat Donalds’ urinary incontinence. In 2016, Donalds began experiencing bladder spasms, pain, burning sensations, and a recurrence of her urinary incontinence. On July 25, 2016, Dr. Richard Ellerkmann removed portions of the TVT Abbrevo device, and, on October 3, 2016, he implanted Donalds with the TVT Exact device, another mesh device produced by Ethicon.
Donalds alleged that the TVT Abbrevo device was defectively designed. Ethicon argued that Donalds could not establish her design defect claim because Dr. Luciani had not performed a proper differential diagnosis on causation but instead ipse dixit concluded that the TVT Abbrevo was the cause of Donalds’ injuries. Ethicon also pointed out that Dr. Luciani had failed to specify any defect in the design of the TVT Abbrevo, and had offered no opinion that Donalds’ injuries were caused by a design defect.
The Federal Appellate Court stated that under her products-liability theory of recovery, Donalds was required to “show
three product litigation basics—defect, attribution of defect to the seller, and a causal relationship between the defect and the injury” … “If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.” Fed. R. Civ. P. 37(c)(1).
Source Donalds v. Ethicon, Inc.; Johnson & Johnson, No. 22-1737.
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