AstraZeneca, Bristol-Myers Get Win in Diabetes Drug Litigation

AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. won multidistrict litigation over diabetes drugs, as a federal court in Kentucky said patients’ failure to produce expert evidence linking the medication to heart failure doomed their claims.

The drugs are Onglyza and Kombiglyze, both of which contain saxagliptin as an active ingredient. The plaintiffs allege saxagliptin caused heart failure.

In January, Judge Karen K. Caldwell of the US District Court for the Eastern District of Kentucky excluded the plaintiffs’ sole causation expert, cardiologist Parag Goyal.

His reliance on a single clinical study to show that the drugs could cause heart failure was contrary to reliable scientific methodology, she said. Caldwell also denied the plaintiffs’ motion to bar defense experts who said there was insufficient evidence that saxagliptin causes heart failure.

AstraZeneca and the others are entitled to summary judgment because the plaintiffs have failed to produce admissible expert testimony that saxagliptin is capable of causing heart failure, the court said Tuesday.

Even if expert testimony weren’t required, summary judgment for the companies would still be warranted because the plaintiffs offered no evidence from which a jury could fairly infer that saxagliptin can cause heart failure, the court said.

The study Goyal cited concluded only that saxagliptin treatment was associated with an increased risk of hospitalization for heart failure, not that there was a causal link, the court said. Warnings from the Food and Drug Administration and American Heart Association based on that study also don’t show causation, it said.

The court also denied the plaintiffs’ request for more time to find a new general causation expert.

Moore Law Group PLLC and Tosi Law LLP represented the plaintiffs. Covington & Burling LLP and Stites & Harbison PLLC represented Bristol-Myers Squibb, AstraZeneca, and McKesson.

The case is In re Onglyza (Saxagliptin) and Kombiglyze (Saxagliptin and Metformin) Prod. Liab. Litig., E.D. Ky., No. 5:18-md-02809, 8/2/22.