Morrison Mahoney Partner Arthur Liederman and Associate Nicole Battisti obtained a dismissal of causes of action against an insured generic pharmaceutical manufacturer in the United States District Court for the Eastern District of Kentucky.
In a 26-page decision, the court dismissed all but one cause of action out of seven involving alleged failure to warn, strict liability, and negligence in connection with serious personal injuries from the use of the drug amiodarone. The drug has been prescribed for use in the treatment of atrial fibrillation. Allegations of injury include death and blindness.
This action is one of a multitude of lawsuits filed throughout the United States against the insured, including over 100 plaintiffs in California. The court dismissed the causes of action focusing on failure to warn and the alleged failure to provide a medication guide (as required by federal regulations). The determined that these causes of action were barred by federal preemption. With respect to the failure to provide the guide, the court found, as we argued, that Kentucky law would not recognize a cause of action for negligence per se based on the alleged failure to comply with the statute. The sole cause of action that remains is for fraudulent off label promotion. The court permitted the plaintiff the right to amend to provide the required specificity to avoid dismissal, though it is unlikely that any evidence exists of off label promotion, the likely reason that such specificity had been omitted.