Raymond J Collette v. Wyeth Pharmaceuticals, Inc.

Background

The defendants moved to dismiss Raymond J Collette’s third amended complaint. The court described it as Collette’s fourth attempt to state a plausible complaint and said that the amendments violated the court’s prior dismissal order. The opinion also states that Collette was deceased and that a motion to substitute Jeanne Collette as the personal representative and executrix of his estate was expected, but no substitution motion had been filed as of the order’s date.

Off-Label-Marketing Claims

The second, third, and fourth causes of action concerned alleged off-label marketing of Amiodarone/Cordarone. They asserted negligence based on failure to warn, negligence based on off-label marketing and sale, and fraud and deceit based on off-label marketing and sale.

The court had previously directed Collette to provide specific facts about what each defendant said or did, how those actions related to Collette and his physician, Dr. James Yhip, and how they caused a specific injury. The court found that the third amended complaint still did not identify which promotional activities or sales efforts Dr. Yhip encountered, when they occurred, or who was responsible. It therefore found the allegations too general and conclusory to satisfy the pleading standards under Rules 8 and 9(b) of the Federal Rules of Civil Procedure. The court dismissed the second, third, and fourth causes of action under Rule 12(b)(6), which permits dismissal when a complaint does not adequately state a legal claim.

Strict-Liability Claims

The first cause of action alleged strict products liability based on failure to warn, asserting that the defendants failed to disclose adverse drug events to the Food and Drug Administration. The fifth cause of action alleged strict liability based on a manufacturing defect and asserted that the manufacturer defendants failed to comply with federal good-manufacturing regulations concerning packaging and labeling.

The court found that these claims exceeded the earlier order’s permission to amend, which was limited to claims based only on off-label marketing. Because Collette added the claims without obtaining permission, the court dismissed the first and fifth causes of action under Rule 41(b). The court also discussed additional problems with the claims, including that the manufacturing-defect claim appeared to rest solely on duties created by federal regulations and that the adverse-event allegations lacked facts about what events were not reported, when they occurred, or how timely reporting would have reached Collette’s doctors and prevented his injuries. The court declined to allow another amendment.

Disposition

Judge James Donato granted the defendants’ motions to dismiss and dismissed Collette’s third amended complaint with prejudice. The order did not decide whether the alleged marketing, reporting, or manufacturing conduct actually caused Collette’s injuries; it ruled that the complaint’s allegations were inadequate and that some claims were added contrary to the court’s prior order.