Conn. Federal Inhaler Action Dismissed on Preemption Grounds
October 5, 2020
HARTFORD, Conn. — A Connecticut federal judge has dismissed an action alleging that a COPD inhaler delivered only half of the doses than what the labeling represented, ruling that the manufacturing defect claims are preempted because the plaintiffs failed to present “newly acquired evidence” allowing a label change without FDA approval.
On Sept. 25, Judge Stefan R. Underhill of the U.S. District Court for the District of Connecticut explained that newly acquired information must provide evidence of a causal association of a clinically significant adverse reaction linked to a drug.” plaintiffs’ self-reporting and collection of online reviews are not “reports …
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