Pfizer filed its brief Friday challenging the appeal of Barbara Gayle and 23 other individuals, who asked the Second Circuit to rehear the case filed an appeal after their 2019 allegations that Pfizer’s Lipitor, a “cholesterol-lowering statin,” caused them to develop type 2 diabetes, were dismissed. Pfizer is challenging the appeal and seeking dismissal of affirmation by the court to dismiss the appeal based on preemption and statute of limitations.
The brief explained that aAfter the FDA ordered a label update for certain statin medications to warn about the risk of glucose increases in 2012, Lipitor, among others, were updated to reflect the order. This resulted in more than 6,000 lawsuits against Pfizer from individuals claiming the drug gave them type 2 diabetes that were eventually granted summary judgment in 2017 based on the lack of causal evidence between Lipitor and type 2 diabetes.
Pfizer initially argued that because Gayle and the 23 others filed their 2019 claims more than seven years after the label update and two years after broader federal litigation was granted summary judgment, the allegations were preempted, as the plaintiffs did not claim Pfizer had any “newly acquired information” that would require another label update. A claim of new information would be the only thing keeping these plaintiffs’ claims from being identical to the litigants’ in 2012, they argued. Additionally, they offered that the statute of limitations in New York means these plaintiffs would have had to claim that they discovered they had diabetes before April 2016; they made no claims about the timelineabout timeline of diagnoses.
Pfizer’s motion to dismiss the 2019 claims on the basis of preemption and statute of limitations was met by the plaintiffs with claims that Pfizer indeed did have “newly acquired information” — that Pfizer “submitted more than 6,000 adverse event reports to the FDA identifying Diabetes as being an unexpected event for Lipitor” in the three years after the label change — and that the motion to dismiss “will need to be revised.”
IThe part of the argument in dispute is whether the plaintiffs’ claims that the 6,000 adverse event reports post-label change equate to “newly acquired information.” If the court finds that the 6,000 reports do not constitute “newly acquired information,” Pfizer maintained that the plaintiffs’ claims would not hold because of preemption and New York’s statute of limitations.
However, Pfizer cited a Second Circuit District Court case from 2019 that “rejected allegations that ‘many reports’ of the injury at issue met the definition of newly acquired information about a known risk previously considered by the FDA,” hoping for the this court to consider its earlier decision.reflect the District Court’s decision.
Pfizer also cited FDA regulations on updating medication label information: Before making a change, one may seek the FDA’s approval, or, unilaterally, the “manufacturer can use the CBE (“Changes Being Effected”) process to ‘add or strengthen a contraindication, warning, precaution or adverse reaction’ where there is ‘reasonable evidence of a causal association.’ ” And, the CBE process only applies when there is “newly acquired information,” which Pfizer maintained is lacking. Thus, Pfizer concluded that the FDA would not have approved another label change based on the 6,000 reports post-the 2012 label change.
Further, the company claimed these adverse event reports are not sufficient to prove any causation because the FDA’s adverse event report databases contain information regarding every “ ‘adverse drug experience received or otherwise obtained that is both serious and unexpected’ ” — which are complaints and experiences of consumers with no controls nor ability to prove causation — and thus “ ‘cannot be used to estimate the incidents of adverse drug reactions, or for comparisons of drug safety.’ ”