Last month, the Arizona Supreme Court became the most recent state high court to recognize the “learned intermediary doctrine” (LID). The LID provides a defense to drug companies in failure-to-warn products-liability cases so long as the manufacturers provided the prescribing doctor with all required safety information. In so doing, the court joined the 36 other state high courts that have expressly adopted the LID.
The case, Watts v. Medicis Pharmaceutical Corp., arose from the plaintiff’s use of the defendant’s acne medication. The plaintiff alleged that she was not properly warned about the possible side effects of taking the medication and developed lupus, she claimed, as a result of her usage of the drug. Importantly, the plaintiff did not allege that the defendant drug company failed to provide her prescribing doctor adequate warnings, just that the company did not warn her personally. The Arizona court of appeals reversed a dismissal of the claim, holding that the LID was no longer a viable legal theory and was abrogated by statute. Continue reading
by Matthew A. Reed, Sedgwick LLP
When plaintiffs bring state tort causes of action against the manufacturers of medical devices that have passed the Food and Drug Administration’s (“FDA”) rigorous pre-market approval (“PMA”) process, they enter a realm highly regulated by the federal government, and thus face a daunting task to avoid dismissal of their claims. They must demonstrate that their state-law claims require nothing more or different of the manufacturer than what the federal Food, Drug, and Cosmetic Act (“FDCA”) already requires, or else their claims are not “parallel” and thus expressly preempted by § 360k of the Medical Device Amendments (“MDA”) to the FDCA. But they also must show that their claims are based on state law distinct from the FDCA, because claims predicated on the FDCA are impliedly preempted as private attempts to enforce federal law. Continue reading
Featured Expert Contributor – Intellectual Property (Patents)
Jeffri A. Kaminski, Venable LLP
For years, defendants in patent infringement cases have protested the ease with which patent plaintiffs could file complaints. Since 1938, Form 18—a model form in an appendix of the Federal Rules of Civil Procedure (FRCP)—set the pleading standard that courts in patent cases have applied. Form 18 requires that the complaint merely state that the plaintiff owns the patent(s), that the defendant infringes the patent(s), and that the plaintiff suffered damages. The form is barely over a page long and does not require any information on how the defendant infringes the patent or even what patent claims are allegedly infringed. Continue reading
The U.S. Supreme Court held its first Conference of 2016 on Friday, January 8, where it considered cert petitions in several high-profile cases impacting free enterprise. The Court issued an orders list on January 11 from that Conference, which, while it did not include any cert grants in these cases, potentially offers positive results for free-market enthusiasts.
First, the Court issued a CVSG in State Farm v. U.S. ex. rel. Rigsby. For those not versed in Supreme Court-speak, CVSG=Calling for the Views of the Solicitor General. The U.S. government is not a party in Rigsby, but because the case involves a key federal law, the False Claims Act (FCA), the justices want to give the government a chance to weigh in with a yay or nay on cert before deciding. It takes the vote of four justices—the same number it takes to grant cert—for the Court to seek the Solicitor General’s views. A CVSG is thus a very good sign that the Court has an elevated interest in a case. Continue reading
The battle over general jurisdiction in a post-Daimler AG v. Bauman world continued as 2015 drew to a close, with lingering inconsistency. Two recent trial court decisions, Cahen v. Toyota Motor Corp. and Jeffs v. Anco Insulations, demonstrate how judges in different jurisdictions with different interests apply general jurisdiction differently, and in these cases, to the very same defendant. While a federal district court judge held that California could not exercise general jurisdiction over Ford Motor Co.—a company incorporated in Delaware and headquartered in Michigan—Circuit Judge Stephen Stobbs of Madison County, a perennial magnet jurisdiction for plaintiffs, found that his Illinois court could. Continue reading
Most product-liability claims against drug manufacturers fall into one of two categories—the plaintiff alleges that his/her injury was caused by: (1) the manufacturer’s failure to include adequate safety warnings on its label; or (2) a defect in the drug’s design. In a major defeat for drug-company defendants, the U.S. Supreme Court ruled in 2009’s Wyeth v. Levine that state-law failure-to-warn claims against brand-name drug companies are not preempted by federal law in most instances, even though (as is virtually always the case) the product bears labels approved and mandated by the federal Food and Drug Administration (FDA). Some commentators concluded that Wyeth foreshadowed a similar rejection of preemption defenses in design-defect cases. However, a December 11, 2015 decision from the U.S. Court of Appeals for the Sixth Circuit suggests that those commentators likely erred; the appeals court concluded in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that design-defect claims are preempted in most instances. Continue reading
Featured Expert Contributor – Civil Justice/Class Actions
By Frank Cruz-Alvarez, Shook, Hardy & Bacon L.L.P. (co-authored with Rachel A. Canfield, an associate with the firm)
Last week, in a 6-3 decision, the U.S. Supreme Court reversed and remanded a California Court of Appeal’s interpretation of and refusal to enforce an arbitration agreement. Justice Breyer delivered the Court’s well-reasoned opinion, which concluded that the California court’s arbitration-specific interpretation of contractual language was preempted by the Federal Arbitration Act (“FAA”). DirecTV Inc. v. Imburgia, et al.
Petitioner DirecTV entered into service agreements with certain customers. Although governed by the FAA, the agreement’s arbitration provision contained a class-action waiver which rendered the entire provision unenforceable if the waiver clause was deemed unenforceable under the law of the customer’s state. Seeking damages for early termination fees that allegedly violated California law, respondents Amy Imburgia and Kathy Greiner filed suit against DirecTV in California state court. Continue reading