Add to your list of recent cases applying the recent U.S. Supreme Court decisions that clarified pleading standards, the decision in Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471 (S.D.Ohio).

The federal trial court dismissed a plaintiff’s manufacturing and design defect claims against the maker of an epilepsy drug that allegedly caused her to develop multi-organ sensitivity, citing Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Under Iqbal, a claim is facially plausible when the plaintiff  sufficiently “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”

Plaintiff  used Trileptal for a short time in 2005. A label change was made in Spring, 2005, adding a precaution regarding multi-organ sensitivity. Novartis sent a Dear Doctor letter, advising of the label change, in April.  Plaintiff contended that the drug caused her to develop multi-organ sensitivity and related complications. Plaintiff sued, alleging various claims, including defective design and manufacture. Novartis moved for a partial dismissal under Fed. R. Civ. P. 12(b)(6).

According to the court, plaintiff’s first cause of action for strict liability for defect in the manufacture of Trileptal under Ohio law must be dismissed pursuant to Rule 12(b)(6) for failure to state a plausible claim for relief. Plaintiff did nothing more than provide a formulaic recitation of the elements of a claim under the statute.  She failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Frey’s alleged injuries. Plaintiff’s allegations in this regard fall far short of the sufficiency standard set forth in Twombly.

Similarly, the court said, the design defect claim would be dismissed because plaintiff once again simply provided a formulaic recitation of the elements of a claim under the statute. She did not allege any facts that would permit the court to conclude that there was a defect in the design or formulation of Trileptal and that the defect was the proximate cause of Frey’s alleged injuries. Because plaintiff’s allegations fall far short of the sufficiency standard set forth in Twombly, the claim for design defect must be dismissed.

Importantly, the court rejected plaintiff’s argument that plaintiffs cannot be expected to particularly allege that the scientific makeup of the drug is defective for a specific reason without conducting discovery.

Finally, the court denied the plaintiff’s motion to amend the complaint, saying she had not shown that they were able to allege facts that would state plausible claims for relief to satisfy the pleading standard.