On April 4, 2014, in Messick v. Novartis Pharmaceuticals Corp., the United States Court of Appeals for the Ninth Circuit reversed the district court’s summary judgment in favor of Defendant Pharmaceutical Corporation because the district court improperly excluded expert testimony. The three-judge panel held that the district court erred by excluding causation testimony offered by Plaintiff’s expert it found to be irrelevant and unreliable.
Plaintiff was diagnosed with breast cancer in 2000. In response to her development of osteoporosis after chemotherapy, Plaintiff treated with the drug Zometa for several months in 2002. Zometa is a bisphosphonate, a class of drug commonly used to treat multiple myeloma. Such drugs are generally used to reduce or eliminate the possibility of skeletal-related degeneration and injuries to which cancer patients are particularly susceptible. Novartis Pharmaceuticals Corporation produces Zometa, which was approved by the FDA in 2001 and 2002. In 2005 after encountering issues with her jaw, it was discovered that Plaintiff had osteonecrosis near three of her teeth. The oral specialists treating Plaintiff did so under the assumption that she was suffering from bisphosphonate-related osteonecrosis of the jaw (“BRONJ”), a condition recognized by the American Association of Oral and Maxillofacial Surgeons (“AAOMS”). Plaintiff’s BRONJ healed in 2008 – three years after beginning treatment.
Thereafter, Plaintiff brought suit against Novartis for strict products liability, negligent manufacture, negligent failure to warn, breach of express and implied warranty, and loss of consortium. In support of her claims, Plaintiff offered her expert’s testimony on ONJ and BRONJ, and on the causal link between plaintiff’s bisphosphonate treatment and later development of BRONJ. Novartis filed a Daubert motion to exclude the specific causation testimony of Plaintiff’s experts and a motion seeking summary judgment. The district court granted both motions on the basis that Plaintiff’s expert testimony was irrelevant and unreliable.
On appeal, the Ninth Circuit reversed, finding the district court applied too high of a standard for relevance and reliability. Under Federal Rule of Evidence 702, the relevancy bar is low, demanding only that the evidence “logically advance a material aspect of the proposing party’s case.” Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1315 (9th Cir. 1995) (Daubert II). Relevancy is also dependent on the particular law at issue. In the instant case, California state products liability law requires only that a plaintiff show that the defendant’s conduct was “more likely than not” a substantial factor in causing the injury in order to prove specific causation. Saelzler v. Advanced Grp. 400, 23 P.3d 1142, 1152 (Cal. 2001). The district court found Plaintiff’s expert testimony to be irrelevant because he opined that Plaintiff’s ONJ was related to bisphosphonates, not that the bisphosphonates caused her ONJ. The Court of Appeals ruled that although Plaintiff’s expert never explicitly stated that Plaintiff’s bisphosphonate use caused her BRONJ, he did say it was at least a substantial factor in Plaintiff’s development of BRONJ, and this was enough to satisfy relevancy requirements.
The Court of Appeals also rejected the district court’s finding that the expert’s testimony was unreliable. Specifically, the district court held the expert’s testimony inadmissible based on a lack of scientific basis for his opinions. In evaluating this finding, the Court of Appeals revisited the role of the Court in acting as a ‘gatekeeper’ to exclude methodologies that do not meet Federal Rule of Evidence 702. In Daubert, the Supreme Court suggested a non-exclusive and flexible list of factors that a court may consider when determining the reliability of an expert, including: (1) whether a theory or technique can be tested; (2) whether it has been subjected to peer review and publication; (3) the known or potential error rate of the theory or technique; and (4) whether the theory or technique enjoys general acceptance within the relevant scientific community.
The Court of Appeals noted that it, along with its sister circuits, have held that a reliable differential diagnosis may form the basis of an expert’s causation testimony. Pointing to the expert’s repeated reference to his own clinical experience, his examination of plaintiff’s records, treatments, and history, and his reliance on the AAOMS definition of BRONJ, the Court held that there was an appropriate scientific basis for his opinions. The Court noted its consistent recognition of the challenges faced in establishing certainty in medical sciences, and referenced prior holdings where it found causation can be proved if there is “sufficiently compelling proof that the agent must have caused the damage somehow.” Kennedy v. Collagen Corp., 161 F.3d 1226, 1230 (9th Cir. 1998) (quoting Daubert II). “Because of that inherent uncertainty, [the Court does] not require that an expert be able to identify the sole cause of a medical condition in order for his or her testimony to be reliable. It is enough that a medical condition be a substantial causative factor…” and the district court erred in concluding otherwise.
The district court based summary judgment entirely on the fact that Plaintiff had no expert causation testimony once all of her experts had been excluded. The Court of Appeals found that the admissibility, correctly viewed, of the expert testimony created a genuine issue of material fact and summary judgment was therefore not appropriate. This decision illustrates the Court’s sensitivity to experts in the medical sciences field: with greater inherent uncertainty may come more flexibility in the admissibility of expert testimony on the basis of relevancy and reliability.
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