Taylor v. Bristol-Myers Squibb Co. (In Re Onglyza)

Facts

Ds manufacture and sell FDA-approved type 2 diabetes drugs containing saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor. In 2008, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended more clinical studies evaluating the link between diabetes drugs and cardiovascular risk. A randomized-controlled trial (RCT) was initiated called SAVOR. SAVOR examined cardiovascular risk on a primary endpoint as well as a secondary endpoint. SAVOR found no statistically significant difference between the groups for the primary endpoint or for five components of the secondary endpoint. The study did find a statistically significant difference between saxagliptin and a placebo on hospitalizations for heart failure (HHF). The study observed a statistically significant 27% increase in hospitalization for heart failure rates in patients administered saxagliptin compared to patients receiving a placebo (3.5% vs. 2.8%). The study cautioned that the observed association 'was unexpected and should be considered within the context of multiple testing that may have resulted in a false positive.' The study also stated that the HHF 'finding merits further investigation and needs to be confirmed in other ongoing studies, and a class effect should not be presumed.' Saxagliptin's drug label was updated in response. The HHF finding sparked this multi-district litigation. Ps sued Ds in federal courts across the country, asserting claims for strict product liability, negligence, failure to warn, breach of warranty of merchantability, and breach of express and implied warranties, all stemming from heart failure allegedly caused by saxagliptin. The cases were consolidated and the district court ordered phased discovery, with the first phase dedicated to the issue of general causation: whether saxagliptin 'is capable of causing any person to develop heart failure or other conditions alleged by the plaintiffs such as congestive heart failure, myocardial infarction and/or cardiovascular injury.' Ps presented a single general causation expert: Dr. Parag Goyal. Dr. Goyal, a cardiology professor at Weill Cornell Medicine was to testify that 'it is more likely than not that saxagliptin is capable of causing heart failure.' Ds moved to exclude Dr. Goyal, arguing that he: (1) unreliably based his causation finding on SAVOR alone while ignoring all subsequent human data, (2) unreliably used animal data, and (3) unreliably applied the Bradford Hill criteria. The district court conducted a Daubert hearing. It eventually granted Ds’ motion to exclude Dr. Goyal's testimony. Ds moved for summary judgment, arguing that Dr. Goyal's exclusion meant that Ps now lacked admissible evidence raising a triable issue of material fact on general causation. Ps moved to allow them another ninety days to identify a replacement general causation expert for Dr. Goyal. The district court denied Ps' motion for more time to identify a substitute general causation expert, concluding they could not show 'good cause' to modify a scheduling order as required by Federal Rule of Civil Procedure 16(b)(4). It then granted Ds’ motion for summary judgment. Ps appealed. 

Issues

Rule of Law

Holding and Decision

Legal Analysis

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