On June 15, 2016, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in three related bids to invalidate separate Hawaiian county ordinances. The counties of Maui and Hawaii ban the cultivation of genetically engineered crops or plants, while Kauai County requires that cultivation of genetically modified organisms (GMOs) be annually disclosed to the county. Opponents allege that the ordinances are preempted by state and federal statutes and regulations governing agriculture and “plant pests.” Three separate federal district courts found that the ordinances were preempted, causing the counties, or their interested intervenors, to appeal to the Ninth Circuit. Continue reading
The U.S. Supreme Court: October 2015 Term Review
Speakers: The Honorable Jay Stephens, Kirkland & Ellis LLP; Andrew J. Pincus, Mayer Brown LLP; Elizabeth P. Papez, Winston & Strawn LLP; Jeffrey B. Wall, Sullivan & Cromwell LLP
Our speakers discussed Court rulings in the areas of class actions, arbitration, the federal False Claims Act, intellectual property, federal regulation, and property rights.
By Matthew A. Reed, Sedgwick LLP
“Impossibility preemption,” the US Supreme Court has warned, “is a demanding defense” to a state tort claim for failure to warn about the risks of a prescription drug. Wyeth v. Levine, 555 U.S. 555, 573 (2009). It is not, however, impossible to prove. Indeed, the Utah federal district court on March 16, 2016 acknowledged in Cerveny v. Aventis, Inc. two ways by which a prescription drug manufacturer may prove the impossibility of complying with conflicting state law and federal regulations. Continue reading
Fracking is alive and well in Colorado. This past Monday, the Colorado Supreme Court delivered a unanimous and resounding victory to property-rights owners in two important hydrofracking cases. Joining states like Texas, Oklahoma, and Ohio, the Centennial State determined that local activism must give way to state law when it comes to permitting the fracking of oil and gas wells.
A 2012 vote in Longmont (pop. 90,000+) had banned fracking there by adding Article XVI to the municipality’s home-rule charter, and a 2013 vote in Fort Collins (pop. 156,000+) adopted a city ordinance that imposed a five-year moratorium on fracking or storing fracking waste in city limits. The state’s oil and gas association took both cities to court, prevailing against each in 2014. Longmont and Fort Collins appealed to the Colorado Court of Appeals, which transferred the cases to the state supreme court. Although this maneuver sped the cases to final resolution, the local laws remained in place during the pendency of the appeal, so half of the Fort Collins moratorium already elapsed before the supreme court could overturn it for good. 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
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