By Karin Hicks, J.D.
Federal preemption and statute of limitations issues barred consumers’ suit based on state-law failure-to-warn claims.
A federal court in New York has granted Pfizer Inc.’s motion for judgment on the pleadings in a lawsuit involving its Food and Drug Administration (FDA)-approved cholesterol-lowering medication, Lipitor®. The court found that patients’ state-law claims were preempted by federal law. The court also found that the claims were time-barred by New York’s three-year statute of limitations on personal injury claims, declined to allow the patients leave to amend their complaint, and refused to convert Pfizer’s motion for judgment on the pleadings to one for summary judgment (Gayle v. Pfizer Inc., April 7, 2020, Pauley, W.).
Background. Pfizer manufactures the FDA-approved statin, Lipitor, which is prescribed for the prevention of cardiovascular disease and the treatment of high cholesterol. The FDA first approved Lipitor for marketing and sale in 1996, although updated labeling for the drug was approved in 2009 based on the results of the clinical trial, "Stroke Prevention by Aggressive Reduction in Cholesterol Levels" (SPARCL). Lipitor’s updated label described the clinical trial and stated that diabetes was reported as an adverse reaction in 6.1 percent of the group assigned the atorvastatin drugs and 3.8 percent of the placebo group.
The FDA issued a drug safety announcement, directed at doctors and patients, indicating that statins may have an effect on incident diabetes and increases in HbA1C and/or fasting plasma glucose. However, the February 2012 announcement also stated that the agency had concluded that the benefit of statins outweighs the increased risk. At the same time, the FDA approved an updated Lipitor label that included the following language: "Increases in HbAlc and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR."
On April 15, 2019, 24 patients filed suit against Pfizer alleging that Lipitor caused their type 2 diabetes. The patients claimed that had the drug label warned their doctors of the risks of type 2 diabetes, their doctors would not have prescribed it for them. Pfizer moved for judgment on the pleadings on September 16, 2019, arguing that the patients’ claims were preempted if they arose after 2012 and that the claims were untimely if they arose before April 2016.
Preemption. Pfizer asserted that to the extent the patients’ failure-to-warn claims arose after February 2012, they were preempted by federal law. Specifically, Pfizer claimed there was an issue of conflict preemption.
The court reviewed the two avenues that exist for manufacturers to update their drug labels. The first avenue is FDA approval, and the second is label updating, not requiring FDA approval, through" changes being effected" (CBE) regulation. The CBE regulation allows a manufacturer to change its label on the basis of "newly-acquired information." The possible changes include adding or strengthening a contraindication, warning, precaution, or adverse reaction as soon as there is reasonable evidence of a causal association. A causal relationship need not have been definitely established to warrant a change in a drug label.
The court utilized the test established by the U.S. Court of Appeals for the Second Circuit to determine when a failure-to-warn claim is preempted. In order to state a claim for failure to warn that is not preempted by the Food, Drug, and Cosmetic (FDC) Act, a plaintiff must plead a labeling deficiency that could have been corrected using CBE regulation. If the plaintiff meets that standard, the party asserting preemption must demonstrate that clear evidence exists that the FDA would not have approved a change to the label. Using this analysis, the court determined that the patients’ claims in the instant case failed because they were vague and did not allege the existence of newly acquired information that would have required Pfizer to revise the Lipitor label through CBE regulation. The court dismissed the patients’ theory that 6,000 adverse event reports sent from Pfizer to the FDA relating to Lipitor constituted newly acquired information. These reports did not indicate causality between the drug and type 2 diabetes and could not constitute newly acquired information, the court held.
Timeliness. Pfizer asserted that to the extent the patients’ claims accrued before April 2016, they were untimely. There is a three-year statute of limitations for New York personal injury claims. Further, the New York borrowing statute uses the shorter of New York’s limitations period or the period of state where the claims accrue. Because the patients had brought their action in April 2019, using the maximum statute of limitations of three years, the judge stated that any claims that accrued before April 2016 would be untimely.
Ruling. With preemption barring claims accruing after February 2012, and the statute of limitations barring claims before April 2016, the judge ruled that there were no surviving claims in the patients’ suit. The court declined to allow the patients leave to amend their complaint or additional time to respond to Pfizer’s motion. Additionally, the court declined to convert Pfizer’s motion for judgment on the pleadings to one for summary judgment. The court asserted that the patients’ claims were futile and did not warrant relief. Therefore, Pfizer’s motion for judgment on the pleadings was granted.
The case is No. 1:19-cv-03451-WHP.
Attorneys: Keith L. Altman (Excolo Law) for Barbara Gayle and Norma Clark. Mara Caitlin Cusker Gonzalez (Skadden, Arps, Slate, Meagher &Flom LLP) for Pfizer Inc.
Companies: Pfizer Inc.
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