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 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
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
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
by Sara Thornton, a 2015 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.
What do copyright law, a WWE professional wrestler, and ESPN have in common? They were all involved in an appeal before the U.S. Court of Appeals for the Eighth Circuit in Ray v. ESPN, Inc., decided on April 22, 2015. Steve “Wild Thing” Ray sued ESPN under Missouri law for broadcasting WWE rerun matches featuring Ray in the early 1990s.
The specific claims were for (1) invasion of privacy, (2) misappropriation of name, (3) infringement of the right of publicity, and (4) interference with prospective economic advantage. ESPN moved to dismiss the suit, asserting that federal copyright law preempted the state-law claims. The district court construed Ray’s first two claims as being identical under Missouri law, so analyzed them as one. It also assumed that since Ray did not challenge ESPN’s argument that copyright law preempted his first and fourth claims, Ray had waived those claims. The court concluded that the Copyright Act preempted Ray’s remaining misappropriation and right of publicity claims. Continue reading
Partially hydrogenated oil
To no one’s surprise, the Food and Drug Administration (FDA) has confirmed its November 8, 2013 initial determination that the agency no longer considers the main source of trans fat in Americans’ diet, partially hydrogenated oils (PHOs), “generally recognized as safe” (GRAS). In its announcement, FDA emphasizes how the three-year window it has granted food companies to comply with the order would “allow for an orderly [transition] process.” Before anyone applauds FDA for being reasonable or magnanimous, however, consider what else the agency says, and doesn’t say, in its Declaratory Order (“Order”). FDA’s statements and omissions essentially set the table for an explosion of private lawsuits that could require PHO-containing products to be reformulated, or removed from the market, far earlier than June 2018.
What the Order Says. Under federal law, an FDA determination that a substance is no longer GRAS is not the equivalent of it being “unsafe.” It means that because some level of uncertainty has arisen from studies of the substance, food producers must seek approval for its use in specific products through a food additive petition. The Order, however, glosses over this inconvenient nuance, and instead consistently and repeatedly states that FDA has concluded PHOs are unsafe. The media has slavishly echoed FDA’s distorted conclusion to an American public that includes prospective judges and jurors for the lawsuits to come. Continue reading