The Food and Drug Administration (FDA) faces a difficult balancing act in its role as the federal regulator of drug and medical-device manufacturers. On the one hand, it is charged with ensuring that medical products are both safe and effective for their intended uses. On the other hand, it must avoid imposing overly stringent regulations, lest it harm public health by blocking or delaying access to life-saving products, or to truthful information about those products.
Through its public-interest litigating, publishing, and communications capabilities, Washington Legal Foundation has long been at the forefront of efforts to ensure that FDA maintains the proper balance. Those activities have generated an impressive body of material that would be instructive for new FDA leadership to review. We provide a summary of and links to those documents below (limited to WLF’s FDA-related work product in the past several years) to simplify access to that work product. Continue reading
In its seminal 2014 decision, Daimler AG v. Bauman, the U.S. Supreme Court imposed strict limits on the authority of courts to exercise personal jurisdiction over out-of-state corporate defendants. It condemned as “grasping” and “exorbitant” a California court’s efforts to exercise jurisdiction over claims lacking any connection with the State based solely on a corporate defendant’s regular conduct of business there. But apparently the California Supreme Court did not get the message. This week it ruled 4-3 that out-of-state plaintiffs whose tort claims arose outside the State could sue an out-of-state corporation in California courts simply because other plaintiffs who live in California have filed similar claims against the corporation. Bristol-Myers Squibb Co. v. Superior Court (BMS). That decision conflicts both with Daimler and basic notions of due process. The U.S. Supreme Court ought to reverse it in short order. Continue reading
No one any longer contests that President Obama acted in excess of his constitutional powers when, on January 4, 2012—a day on which the Senate was not in recess—he purported to grant a recess appointment to Richard Cordray to head the Consumer Financial Protection Bureau (CFPB). Yet, in a troubling decision issued last week, the U.S. District Court for the District of Columbia indicated that it was of no moment that for a period of 18 months Cordray, although no more than a private citizen, issued dozens of significant decisions in the name of CFPB. Judge Ellen Huvelle ruled in State National Bank of Big Springs v. Lew that Cordray, after finally receiving Senate confirmation, could simply wave a magic wand and retroactively approve all of his unauthorized acts. That decision eviscerates the Constitution’s explicit limitations on the President’s appointment powers and encourages future Presidents to disregard those limitations. Continue reading
The U.S. Supreme Court’s June 16, 2016 decision in a closely watched False Claims Act (FCA) case, Universal Health Services, Inc. v. United States ex rel. Escobar, had a little bit in it for everyone. It held (as had most of the federal appeals courts) that a contractor can be held liable under the FCA for making a fraudulent claim for payment from the federal government, even if the claim was never expressly made but was merely implied. On the other hand, Universal Health unanimously vacated a First Circuit ruling that had reinstated the plaintiffs’ claims, concluding that the First Circuit applied an insufficiently rigorous test for determining whether the defendant’s allegedly false claims were “material.”
So which side really “won” the case? If the correct answer to that question turns on whether the Court’s decision will make it more difficult for private relators to prevail in future FCA cases, then the decision was a win for FCA defendants. For example, the Court unequivocally rejected assertions—frequently raised by FCA plaintiffs—that an FCA claim is proven any time a contractor submits a claim for payment of a contractual claim despite awareness that it has breached a significant provision of its contract. Continue reading
*Editor’s Note: This is the Spanish-language version of a WLF Legal Pulse post, It Would Be Premature for Federal Court to Lift the Argentina Bond Injunction, published earlier today.
El gobierno argentino afirma haber dado vuelta la página y que son serios acerca de tomar las medidas necesarias para recuperar el visto bueno de la comunidad financiera internacional. El gobierno del nuevo presidente, Mauricio Macri, ha entrado en negociaciones extendidas con los tenedores de bonos en default, algunos de los cuales no han recibido ningún pago hace más de 15 años. Esa aparente predisposición a un compromiso merece un aplauso. Pero las acciones hablan más fuerte que las palabras. El pedido argentino de levantar la orden judicial vigente (realizado en los escritos presentados el jueves pasado en el juzgado y para ser presentado hoy por vía oral ante del juez) no se justifica hasta que la Nación lleve a cabo sus negociaciones en la buena fe prometida. Continue reading
The Argentinian government claims to have turned over a new leaf and become serious about taking the steps necessary to get back into the good graces of the international financial community. The regime of new President Mauricio Macri has entered into extended negotiations with holders of defaulted government bonds, some of whom have received no payments in over 15 years. That apparent willingness to compromise is to be applauded. But actions speak louder than words. Argentina’s request to lift the existing court injunction (made in court papers filed last Thursday and to be orally argued before the court today) is unwarranted until the nation carries through fully with its promised good-faith negotiations. Continue reading
Some 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