11th Circuit Affirms Firm Client Novartis’s Summary Judgment Win Based on Daubert Exclusion of Causation Experts’ Testimony in Reclast® Case

04/30/18

11th Cir. -- United States Court of Appeals for the Eleventh Circuit

Complex Litigation

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On April 30, 2018, the U.S. Court of Appeals for the Eleventh Circuit affirmed Novartis’s summary judgment win in Jones v. Novartis Pharmaceuticals Corp., No. 17-1106 (11th Cir. Apr. 30, 2018).  The Court, in a per curiam opinion issued only three weeks after oral argument, affirmed the Northern District of Alabama’s exclusion of the general causation opinions of plaintiff’s expert and agreed with the district court that, without admissible general causation expert testimony, summary judgment for Novartis “was appropriate.”  Id. at 3.

Plaintiff/Appellant Ernesteen Jones alleged that she experienced an atypical femur fracture (“AFF”) as a result of her treatment with Novartis’s prescription osteoporosis medication, Reclast®.  The district court excluded in their entirety the opinions of plaintiff’s bone expert Dr. William Banks Hinshaw, including his opinions regarding both general and specific causation.  The district court excluded Dr. Hinshaw’s general causation opinion because the Bradford Hill methodology that he used required as a first step the existence of an established association between the substance and the disease, but he was unable to establish such an association between Reclast® and AFF.  The court noted Dr. Hinshaw’s admission that he could not point to any Reclast® study finding a statistically significant association, and it rejected Dr. Hinshaw’s attempt to substitute for an established association by extrapolating from an alleged association between AFF and the other medications in the class of bisphosphonates indicated for the treatment and prevention of osteoporosis.  The court found evidence in the record that the different dosing regimens and routes of administration between Reclast®, which is a once-a-year i.v. infusion, and the other class drugs, which are taken orally on a daily, weekly, or monthly basis, could result in materially different impacts on bone, thus making it unreliable to extrapolate from one bisphosphonate to another.  The district court cited to the Eleventh Circuit’s similar ruling in Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002), one of the so-called Parlodel® trilogy cases where the Firm represented the defendant Sandoz, which found a causation expert’s attempt to extrapolate from one class drug to another to be an unreliable methodology.

The district court also excluded the causation opinions of plaintiff’s statistics expert, Wayne Taylor, and two of plaintiff’s treating physicians, finding them unqualified to offer causation opinions and that, in any case, they had not employed a reliable methodology.  The court excluded the differential diagnosis opinion of one of the treaters because he could not reliably rule out other potential causes.  Finally, the court granted in part Novartis’s motion to strike the testimony of plaintiff’s regulatory expert, Dr. Suzanne Parisian, finding both that Dr. Parisian was not qualified to offer a number of her opinions and that her methodology was unreliable.  See Jones v. Novartis Pharmaceuticals Corp., 235 F. Supp. 3d 1244 (N.D. Ala. 2017).

Plaintiff/Appellant appealed the exclusion of the opinions of four of her experts, arguing that the district court abused its discretion by ignoring record evidence and by using incorrect legal standards.  The Court of Appeals disagreed, holding that “[t]he district court determined that Dr. Hinshaw, although qualified, employed unreliable methodologies in reaching [his general causation] conclusion” and that “[n]othing in [the Court’s] review of the record, including Dr. Hinshaw’s deposition testimony, expert reports, and supporting exhibits, leads us to believe that the district court committed a ‘clear error of judgment’ … or that its decision was ‘manifestly erroneous.’”  Op. at 2-3.  Because plaintiff needed the general causation testimony of Dr. Hinshaw to survive summary judgment, the Court looked no further and affirmed judgment for Novartis.  Id. at 3.

Novartis was represented by Firm partners Stephen A. Klein, Robert E. Johnston, and Andrew L. Reissaus, and by Firm associate Tamara Fishman Barago.

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