“Sorrell v. IMS Health” Is Gaining Traction in the Federal Appeals Courts

9thCirSome legal commentators heralded the U.S. Supreme Court’s 2011 decision in Sorrell v. IMS Health, Inc. as a marked expansion of First Amendment protections for commercial speech. Sorrell held that content- or speaker-based restrictions on non-misleading commercial speech regarding lawful goods or services should be subjected to “heightened” judicial scrutiny. But whether Sorrell would have any practical effect on challenges to commercial-speech restrictions was far from clear, particularly because the Court did not explain what it meant by “heightened” scrutiny and because it struck down the speech restrictions at issue under the more relaxed “intermediate scrutiny” standard that it had been applying in commercial-speech cases for more than 30 years. Continue reading

Sixth Circuit Ruling Shows Preemption is Possible in Brand-Name Drug Design-Defect Cases

6th CircuitMost 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

Supreme Court Ought to Re-examine Second-Guessing of FDA-Approved Drug Labeling by State Tort Law

John-Adams-Courthouse-exterior

John-Adams-Courthouse-exterior

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

CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline

cdc_logo(3)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

In the Ninth Circuit, Not All Litigants Are Created Equal

9thCirThe U.S. Court of Appeals for the Ninth Circuit this week denied Uber Technologies’s petition for Rule 23(f) interlocutory review of an order granting class certification in a major challenge to the manner in which Uber operates its ride-sharing business. The four named plaintiffs assert that every Uber driver should be classified as an employee, not (as is currently the case) an independent contractor. The denial of review is not unusual when viewed in isolation. Although Rule 23(f) grants federal appeals courts discretionary authority to hear interlocutory appeals from class-certification orders, appeals courts permit such appeals in only a fraction of all cases, and the default rule continues to be that litigants must await issuance of a final judgment before appealing from pre-judgment rulings to which they object. Continue reading

Court Decision on Berkeley Cell-Phone Warning Undermines Protections Against Compelled Speech

Berkeley once marched for free speech

Berkeley once marched for free speech

No one seriously disputes that the government is entitled to adopt broadly applicable laws that require a product seller to disclose truthful information about its product so that consumers can know what they are buying. But governments with increasing frequency have been requiring sellers to convey information that cannot plausibly be deemed the sort of truthful, noncontroversial information that consumers expect to see on product labeling.

Unfortunately, recent decisions suggest that at least some courts are unwilling to protect the First Amendment right of product sellers not to be forced to communicate controversial government messages that they do not wish to convey. Such rulings undermine constitutional protections against compelled government speech that the Supreme Court has consistently recognized for the past 75 years. Continue reading

Ninth Circuit Panel Eviscerates 2014 ‘En Banc’ Decision That Protects CAFA Removal Rights

9thCirCongress 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