Morrison Mahoney Partners Arthur Liederman and Nicole Battisti obtained a favorable decision from the U.S. District Court for the Southern District of New York in a pharmaceutical liability action. The lawsuit, involving 67 patients across 21 states, alleged that the client, a national generic pharmaceutical company participated in, or failed to prevent, off-label use of the generic product amiodarone and alleged that they had failed to receive medication guides constituting a failure to warn. The court dismissed all of the counts in an 18 page decision primarily finding that the causes of action were preempted by federal law.
The court ruled that the company could not have made changes to the labeling without violating the Food, Drug and Cosmetic Act. Additionally, while the patients alleged that the company had failed to provide medication guides, the court found that federal law only required that the company make the guides available to distributors, not directly to patients.
The case was reported in both HarrisMartin Publishing and Law360. To view the respective articles, please click here [subscription only] and here.