November 8, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. Supreme Court recently decided a case involving the issue of federal preemption of state law warning claims against manufacturers of the generic drug metoclopramide.  See Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  The plaintiffs were users of the drug who filed state court actions alleging that their long-term use of metoclopramide had caused them to suffer tardive dyskinesia.  In the first case, the U.S. District Court for the Eastern District of Louisiana granted in part and denied in part the manufacturer's motion to dismiss, and the manufacturer appealed.  The U.S. Court of Appeals for the Fifth Circuit affirmed.  In the second case, the U.S. District Court for the District of Minnesota granted the manufacturers' motions for summary judgment, and the consumer appealed.  The U.S. Court of Appeals for the Eighth Circuit reversed in part.  The Supreme Court granted certiorari, and the cases were consolidated.  The Court ruled that federal law preempts state laws imposing a duty on generic drug manufacturers to change a drug's label.

Following approval by the Food and Drug Administration ("FDA") of the sale of metoclopramide under a brand name, generic manufacturers began producing the drug, which is used to treat digestive disorders.  The plaintiffs had been prescribed the brand-name drug but had received generic metoclopramide from their pharmacists.  After having used the drug for several years, both plaintiffs developed tardive dyskinesia, a severe neurological disorder.  They sued the manufacturers in state court for failing to provide adequate warnings of the dangers of the drug.  The manufacturers argued that federal statutes and the FDA regulations preempted the state products liability causes of action, and they asserted that because federal law required them to use the same safety and efficacy labeling as was used in their brand-name equivalents while state law required the use of a different label, it was therefore impossible for them simultaneously to comply with both federal law and state law.  The Court noted that evidence has mounted that metoclopramide can cause tardive dyskinesia.  As a result, warning labels for the drug have been strengthened and amended several times.  In 2004, the brand-name manufacturer requested, and the FDA approved, a label change to provide that therapy with the drug should not exceed 12 weeks.  In 2009, the warning was intensified to caution that treatment with the drug can cause tardive dyskinesia, an often irreversible movement disorder.

August 4, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

A recent decision by the West Virginia Supreme Court of Appeals addressed the doctrine of forum non conveniens in the context of the availability of an action in another state whose law was significantly less favorable to the plaintiff than that of the chosen forum.  See Mace v. Mylan Pharm., Inc., No. 35710, 2011 WL 2446644 (W. Va. June 16, 2011).  The plaintiff in Mace was the estate of a patient who allegedly had died from an overdose of the defendants' drug delivery apparatus, called the "Mylan Fentanyl Transdermal System."  The purpose of the device was to introduce narcotic pain medication into the user's body.  The patient was a resident of North Carolina at the time of her death.  Her husband, as personal representative of the estate, filed suit in West Virginia against the manufacturer of the drug and related entities.  The defendants were variously incorporated in West Virginia and Pennsylvania and had their headquarters in West Virginia, Vermont, and Pennsylvania.

The plaintiff alleged that the patient had been prescribed "the patch" on October 21, 2005 and had died from an overdose a mere four days later while wearing the device.  The personal representative filed his action on July 1, 2008.  The plaintiff set forth claims for strict products liability, negligence, breach of express warranty, and breach of implied warranty.  The estate sought punitive damages based upon the defendants' "deliberate, intentional reckless and/or malicious behavior."  Id. at *3.  The complaint further alleged that the plaintiff had not known, and that a reasonable person under the circumstances would not have had reason to know, that "the patches" prescribed for the decedent were manufactured by Mylan until less than two years before filing the complaint.  The court noted that both West Virginia and North Carolina have two-year statutes of limitations for wrongful death claims.

The defendants filed a motion to dismiss based on the doctrine of forum non conveniens.  In support of their motion, the defendants argued that North Carolina was the appropriate forum because the decedent had been a resident of that state at the time of her death, she had been prescribed and had used the drug apparatus in North Carolina, and she had died there.  The defendants also asserted that the cause of action arose in North Carolina and that the lawsuit's only connection with West Virginia was that two of the defendants were incorporated under West Virginia law and one defendant had its headquarters there.

In resolving the defendants' motion, the court had occasion to apply West Virginia's forum non conveniens statute.  This statute provides that a West Virginia court may decline to exercise jurisdiction over a matter if it finds that in the interest of justice and for the convenience of the parties, a claim or action would be more properly heard in a forum outside the state.  In making this determination, the court may consider, among other things, whether an alternate forum exists in which the claim or action might be tried.

April 26, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

A recent decision by a U.S. District Court in Pennsylvania combined, in an interesting way, the issues of removal of a case to federal court and of the potential responsibility under a products liability theory of the publisher of an "education monograph" containing warnings about a prescription drug.  See Slater v. Hoffman-La Roche, Inc., Civ. Action No. 10-6956, 2011 WL 1087240, at *1 (E.D. Pa. Mar. 24, 2011).  The plaintiff sued the manufacturer of the acne drug Accutane, alleging that the drug had caused him to develop colitis and ulcerative colitis.  The plaintiff also sued the publisher of a monograph explaining the dangers of Accutane.  The plaintiff was a resident of Wisconsin, the drug manufacturer was a resident of New Jersey, and the publisher of the educational monograph was a Delaware corporation with its principal place of business in Pennsylvania.  Following the plaintiff's filing in Pennsylvania state court, the defendants removed the action to the federal district court.  The plaintiff moved to remand the case to the state court.  The court noted that unless the publisher had been fraudulently joined, the claims against it had to be remanded, in light of the rule that removal to federal court is permissible only if none of the parties in interest properly joined and served as defendants is a citizen of the state in which the action has been brought.  See 28 U.S.C. § 1441(b).