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
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
The U.S. Supreme Court’s 2009 decision in Wyeth v. Levine placed significant limits on the ability of brand-name drug manufacturers to defend against failure-to-warn state tort-law claims. Even though manufacturers invariably label their products precisely as the Food and Drug Administration (FDA) has mandated, Wyeth held that state courts could penalize manufacturers for failing to include additional health warnings on their labels. The Court explained that it was possible for manufacturers to simultaneously comply with both FDA and state-court-determined labeling requirements because FDA’s “Changes Being Effected” (CBE) regulation permits brand-name companies to unilaterally change the FDA-mandated label and then seek FDA’s after-the-fact approval of the changes. But as the Court recognized, the CBE regulation limits the circumstances under which unilateral label changes are permissible—and when a unilateral change is not permitted, any tort claim premised on a state-law duty to make such a change is still preempted.
Unfortunately, many lower courts have failed to recognize this important limitation imposed by Wyeth on tort liability. At its January 8, 2016 conference, the U.S. Supreme Court will consider a certiorari petition that provides it with an opportunity to clear up the confusion among the lower courts regarding when federal law preempts failure-to-warn claims against the manufacturers of drugs bearing FDA-mandated labels. The Court should seize that opportunity by granting review in Johnson & Johnson v. Reckis, a case in which the Massachusetts Supreme Judicial Court upheld a $140 million judgment against a manufacturer of ibuprofen—a generic over-the-counter pain-relief medication sold under such brand names as Advil and Motrin. Continue reading
The Schindler Elevator Corporation recently petitioned the Supreme Court of New Jersey to rebuke the plaintiffs’ bar’s most recent attempt to circumvent the longstanding prohibition on “Golden Rule” arguments. During closing arguments in Tufaro v. Headquarters Plaza, et al., a personal-injury trial, plaintiff’s counsel asked the jurors to think of awarding compensation “in terms of putting a want ad in the paper.” The hypothetical want ad would describe a job offer, one in which the applicant’s only duty is to suffer the plaintiff’s specific injuries. The insinuation is simple: How much payment would the jurors require to voluntarily endure the plaintiff’s injury? In other words, plaintiff’s counsel asks the jury to award damages based on how much compensation they would negotiate ex ante before agreeing to suffer the plaintiff’s injuries. This is exactly the type of Golden Rule argument that courts have long forbidden. Continue reading
Featured Expert Column − Complex Serial and Mass Tort Litigation
By Richard O. Faulk, Hollingsworth LLP
Can a public-nuisance lawsuit be based solely on property owners’ fear that their property values will be diminished by proximity to an adjacent contaminated tract? The U.S. Court of Appeals for the Eighth Circuit recently—and correctly—rejected a creative, but flawed, attempt by landowners to recover damages for such claims in Smith v. ConocoPhillips Pipeline Co.
The use of public nuisance litigation to redress environmental claims has proven extraordinarily controversial—and generally unsuccessful. Perhaps the most famous failure occurred when plaintiffs employed nuisance theories to redress environmental contamination at Love Canal, in which case over a decade of litigation failed to produce a solution.1 Thereafter, appellate courts generally rejected the tort’s use for a wide variety of claims ranging from lead paint contamination to climate change.2 Continue reading
by David L. Wallace and Michael R. Kelly, Herbert Smith Freehills LLP*
Since the 1950s, partially hydrogenated vegetable oils (PHOs) have been used to produce all sorts of packaged foods. These ingredients increase food shelf life and flavor stability. They also contain artificial trans fats, which have been linked to various health risks, including cardiovascular disease. Despite these risks, PHOs were until recently “generally recognized as safe” (GRAS) for use as a food ingredient. The tide began to swing two years ago, though, when the Food and Drug Administration (FDA) tentatively proposed to withdraw GRAS status for PHOs “based on current scientific information” about the health risks of trans-fat consumption. It finalized this determination in a June 2015 order, declaring “that there is no longer a consensus among qualified experts that partially hydrogenated oils … are generally recognized as safe for any use in human food.”
Lawyers Running With Regulations
This regulatory action makes PHOs a “food additive” subject to pre-market approval by the FDA. Without FDA approval, foods containing PHOs would be deemed “adulterated” under both federal and state laws. The agency left industry breathing room, however, giving it until June 2018 either to comply or to obtain approval for certain uses of PHOs. But, like time, regulation-chasing plaintiffs’ lawyers wait for no one, and pounced on the agency’s new stance in the name of “consumer protection.” Before the FDA had even finalized its decision on PHOs, they had already installed trans fats as the latest bogeyman on supermarket shelves and the food-litigation landscape—alongside such hated fighting words as “natural,” “healthy,” “freshly baked,” and “handcrafted.” Continue reading
Congress adopted the Class Action Fairness Act (CAFA) in 2005 in response to concerns that plaintiffs’ lawyers were gaming the system to prevent removal of class actions and “mass actions” (lawsuits with more than 100 named plaintiffs) from state court to federal court. CAFA provided state-court defendants the option of removing a case to federal court when the suit is both substantial and involves numerous plaintiffs, even when complete diversity of citizenship is lacking.
Immediately thereafter, the plaintiffs’ bar began to undermine CAFA by coming up with new ways to keep their mass lawsuits in state courts. Among other schemes, plaintiffs’ lawyers divided their clients (often numbering in the thousands) among multiple lawsuits in the same state court, thereby ensuring that CAFA’s 100-plaintiff threshold would not be surpassed in any one lawsuit. An excellent 2014 en banc decision from the U.S. Court of Appeals for the Ninth Circuit imposed strict limits on use of this removal-defeating tactic. The court held in Corber v. Xanodyne Pharmaceuticals, Inc. that if, after filing their separate lawsuits, the plaintiffs ask the state court to coordinate the cases for all purposes, the cases should be deemed unified and thus removable under CAFA’s mass-action provision. But a Ninth Circuit panel decision this month, Briggs v. Merck Sharp & Dohme, creates a roadmap that allows plaintiffs to coordinate their lawsuits yet avoid removal—thereby eviscerating Corber. The decision suggests that the panel (Judges Fletcher, Berzon, and Paez) feels free to thumb their collective nose at Ninth Circuit en banc decisions; it ought to be reversed. Continue reading