Gayle v. Pfizer Inc.

Background

Barbara Gayile and 23 additional individual plaintiffs alleged that Lipitor, a cholesterol-management drug manufactured by Pfizer, caused their type 2 diabetes. They claimed that if Lipitor’s label had warned doctors about the risk of type 2 diabetes, their doctors would not have prescribed the drug.

The FDA approved Lipitor in 1996. A 2009 label described diabetes results from a clinical trial. In February 2012, the FDA announced label changes for statin drugs concerning diabetes, increases in hemoglobin A1c, and fasting blood glucose. The updated Lipitor label warned that increases in hemoglobin A1c and fasting serum glucose had been reported with statins, but it did not add a separate warning about type 2 diabetes and did not change the earlier trial description.

The plaintiffs filed the action in New York state court on April 15, 2019. Pfizer removed it to federal court and later moved for judgment on the pleadings under Federal Rule of Civil Procedure 12(c), which allows judgment based on the pleadings when the moving party is entitled to judgment as a matter of law.

Preemption

The court applied the same standards used for a motion to dismiss. It explained that federal drug-labeling law allows a manufacturer to change a label without prior FDA approval through the “changes being effected” regulation only when there is newly acquired information showing reasonable evidence of a causal association with the drug.

The court held that the plaintiffs’ post-February 2012 claims were preempted by federal law. Their complaint did not identify newly acquired information that Pfizer could have used to change Lipitor’s label through the changes-being-effected process. The plaintiffs later argued that about 6,000 adverse-event reports sent by Pfizer to the FDA between July 2012 and June 2015 qualified as newly acquired information. The court rejected that argument because the reports showed only that people taking Lipitor were diagnosed with type 2 diabetes; standing alone, they did not analyze or establish a causal connection between Lipitor and diabetes.

The court also rejected the plaintiffs’ argument that Pfizer should have analyzed the reports and that this alleged failure itself created newly acquired information. The court said the plaintiffs had to identify existing newly acquired information before the burden could shift to Pfizer to show that the FDA would not have approved a label change.

The plaintiffs further argued that a warning about increases in hemoglobin A1c did not adequately warn about type 2 diabetes. The court concluded that the FDA’s 2012 label decision undermined that argument because the FDA added the hemoglobin A1c warning but did not add a separate type 2 diabetes warning or change the earlier description of diabetes risk.

Timeliness

The court held that claims accruing before April 2016 were untimely. It applied New York’s three-year limitations period for personal-injury claims and explained that New York’s borrowing statute applies the shorter limitations period between New York and the state where a claim accrued. Because the action was filed in April 2019, claims accruing before April 2016 were too late under the New York period.

The court considered a New York rule that can extend the filing period when the cause of an injury was discovered later, but concluded that the plaintiffs had not alleged facts supporting that exception. It also rejected equitable tolling based on alleged fraudulent concealment because the plaintiffs did not plead the alleged concealment, its effect on discovery, and their diligence with sufficient detail.

The court concluded that there was no possible overlap in which a claim would be timely but not preempted: claims arising after February 2012 were preempted, while surviving earlier claims were time-barred.

Other Requests and Disposition

The plaintiffs sought leave to amend, conversion of Pfizer’s motion into a summary-judgment motion, discovery, and additional time to respond. The court found amendment futile because the proposed amended complaint still did not state when the claims accrued, did not identify qualifying newly acquired information, and did not show how the claims could be timely. The court declined to convert the motion because the label changes were publicly available and integral to the complaint. It also found that discovery and additional response time would not cure the pleading deficiencies.

Judge William H. Pauley III granted Pfizer’s motion for judgment on the pleadings dismissing the action and dismissed the case with prejudice. The Clerk was directed to terminate the motion at ECF No. 21 and mark the case closed.