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 “Sixth Circuit Ruling Shows Preemption is Possible in Brand-Name Drug Design-Defect Cases”
Featured Expert Contributor – Civil Justice/Class Actions
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 “DirecTV Inc. v. Imburgia: The Supreme Court’s Latest Word on Arbitration and Federal Preemption”
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 “Supreme Court Ought to Re-examine Second-Guessing of FDA-Approved Drug Labeling by State Tort Law”
Matthew G. Kaiser, Partner, Kaiser, LeGrand & Dillon PLLC
A court case that should be on the radar screen of all business executives and white-collar criminal-defense attorneys in 2016 is United States v. Clay, in which the U.S. Court of Appeals for the Eleventh Circuit heard oral argument on October 2.
The case, about which I authored a Washington Legal Foundation Legal Backgrounder last March, implicates the fundamental question of who decides the meaning of a law—a judge or a jury? The Eleventh Circuit will also implicitly decide whether the government can cast aside more appropriate civil or administrative remedies and prosecute corporate officers operating a business in a complex regulatory environment when their interpretation of a law is objectively reasonable. Continue reading “U.S. v. Clay: A Federal White Collar Criminal Case to Keep an Eye On”
Over the past year, the Centers for Disease Control and Prevention (CDC) has been drafting a Guideline for Prescribing Opioids for Chronic Pain in relative secrecy, relying upon the input of a hand-picked group of advisers and a limited number of stakeholders. Such a stealth approach drew criticism from numerous interested parties, including Washington Legal Foundation, which explained in a November 17, 2015 letter to CDC that the agency’s drafting process ran afoul of the Federal Advisory Committee Act (FACA).
This week, CDC took several unexpected steps towards greater transparency for its prescribing guideline project, implicitly conceding its prior FACA violations. The director of CDC’s National Center for Injury Prevention and Control informed WLF on December 14 of its about-face in a letter responding to our November 17 missive. That same day, CDC published a notice in the Federal Register that seeks comments on the draft guideline and also directs the public to numerous previously-unreleased documents. In addition, CDC announced that it will ask a federal advisory committee, its Board of Scientific Counselors, to review the draft guideline and public comments and make recommendations to the agency. Continue reading “CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline”
After successive defeats at the hands of the U.S. Court of Appeals for the Fifth Circuit, the National Labor Relations Board (NLRB) has taken its crusade against class-action arbitration agreements to California. In a recent decision, Bristol Farms, the NLRB once again held that an arbitration agreement that would require individual arbitration violated the National Labor Relations Act (NLRA).
Over a strong dissent, the NLRB reasoned that an agreement requiring individual arbitration—even if the agreement was optional—prevents employees from engaging in protected activities (collective action) and thus is an unfair labor practice in violation of NLRA § 8(a)(1): “[A]n arbitration agreement that precludes collective action in all forums is unlawful even if entered into voluntarily, because it requires employees to prospectively waive their Section 7 right to engage in concerted activity.” Continue reading “Rebuffed Twice in Texas, the NLRB Takes its Crusade Against Arbitration to California”
Featured Expert Column – Antitrust/Federal Trade Commission
Andrea Agathoklis Murino, Goodwin Proctor LLP
On December 7, 2015, the Federal Trade Commission voted 4-0 to file suit against Staples Inc.’s acquisition of Office Depot, Inc. (“OD”), finding that it would combine the number one and number two market participants and therefore lead to an anticompetitive reduction in nationwide competition in the market for consumable office supplies sold to large business customers. This vote surprised many observers as it came just two years after the FTC cleared Office Depot’s acquisition of Office Max (“OM”), which combined the then number two and number three participants.
To this observer, the decision to block was, however, not a surprise. In looking at recent FTC enforcement actions, especially the Sysco/US Foods challenge, and in closely examining the bases on which the OD/OM transaction was cleared, several key differences emerged that are almost certainly what led to such wildly divergent enforcement outcomes. Continue reading “FTC Takes Scissors to Staples/Office Depot Merger”