Plaintiff Marlyn Riley had a Cordis Corp. stent implanted in a coronary artery and, apparently, suffered a heart attack two years later when a blood clot formed at the site of the stent. The way the stent functions, it prevents build-up of new tissue on implantation by a slow release of medicine but, in doing so, the normal healing process is slowed and there is an increase of risk of blood clot formation.
In a 33-page Memorandum & Order, District Court Judge Patrick Schiltz granted defendants’ motion for judgment on the pleadings but gave plaintiffs 30 days to file an amended complaint consistent with the Court’s legal requirements set out in the order. The gist of the Court’s ruling was the reconciliation of the federal Food, Drug, and Cosmetic Act (“FDCA”) with plaintiff’s claims under state law (that is, the legal doctrine of preemption).
“[T]he conduct that is alleged to give the plaintiff a right to recover under state law must be conduct that is forbidden by the FDCA.”
It is not enough, however, for plaintiffs to show that a defendant violated the FDCA, the Court continued. That, by itself, would not give plaintiff a cause of action. In addition, plaintiff must allege and prove that defendant’s acts or omissions not only violated the FDCA but also constituted a violation of some state law or standard.
The Court went through all of plaintiff’s state law claims — failure to warn, fraudulent and negligent misrepresentation, breach of express warranty, analyzing them all, finding them all to fall short of the Court’s articulated standard for viable claims, giving plaintiff the opportunity to replead but setting the bar quite high and warning plaintiffs that any amended pleading would be subject to court rules for completeness and accuracy, rules enforceable through sanctions if not adhered to.