Arizona Supreme Court Joins Overwhelming Majority in Recognizing the Learned Intermediary Doctrine

az s. ct.Last month, the Arizona Supreme Court became the most recent state high court to recognize the “learned intermediary doctrine” (LID). The LID provides a defense to drug companies in failure-to-warn products-liability cases so long as the manufacturers provided the prescribing doctor with all required safety information. In so doing, the court joined the 36 other state high courts that have expressly adopted the LID.

The case, Watts v. Medicis Pharmaceutical Corp., arose from the plaintiff’s use of the defendant’s acne medication. The plaintiff alleged that she was not properly warned about the possible side effects of taking the medication and developed lupus, she claimed, as a result of her usage of the drug. Importantly, the plaintiff did not allege that the defendant drug company failed to provide her prescribing doctor adequate warnings, just that the company did not warn her personally. The Arizona court of appeals reversed a dismissal of the claim, holding that the LID was no longer a viable legal theory and was abrogated by statute. Continue reading

Federal Officials Display Disregard for Due Process in Opposing “Mens Rea” Reform

barsFair notice of the law is a basic principle that separates liberal democracies like the United States from more authoritarian governments. Fair notice is an especially critical due-process check against government’s power to criminally prosecute. Government must not only prove that a person did the unlawful act, but also that he intentionally engaged in wrongful conduct or knew the conduct was illegal—that it, that he had a guilty mind. So why, then, is the Obama Administration and other elected representatives opposing reforms to ensure that federal criminal laws include a clear criminal-intent standard?

The idea being advanced seems far from revolutionary or controversial, which may explain why politicians and interest groups of every ideological stripe support it: Federal laws with criminal provisions must require prosecutors to prove that the accused possessed the mens rea, or culpable mental state, to commit a crime. If a law lacks such language, then a default intent provision will apply, such as showing that the defendant acted “willfully” or “recklessly.” 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

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

Advisory Committee’s Violations of Federal Law Threaten Credibility of 2015 Dietary Guidelines

MyPlateIn introducing an October 7, 2015 oversight hearing on the forthcoming 2015 Dietary Guidelines for Americans (DGA), House Agriculture Committee Chairman Michael Conaway stated, “It is essential that the guidance that comes out of this process can be trusted by the American people.” Chairman Conaway framed that remark in the context of the scientific evidence the 2015 Dietary Guidelines Advisory Committee (DGAC) relied upon in its Scientific Report. Lawmakers should question the quality of the report’s science, but their probe of the DGAC and its work shouldn’t stop there. Another, perhaps greater, threat to the Dietary Guidelines’ credibility is the significant breaches of federal law that occurred in the creation of the DGAC. Violations of the Federal Advisory Committee Act (FACA) infect the entire Scientific Report and call into question its recommendations and any federal regulatory proposals that rely on the report or the resulting DGA. Continue reading

WLF Overcriminalization Timeline: Mens Rea, Public Welfare Offenses, and Responsible Corporate Officer Doctrine

matt_kaiser300Guest Commentary

Matthew G. Kaiser, Partner, Kaiser, LeGrand & Dillon PLLC

Editor’s Note: This is the second in a series of six guest commentary posts that will address the six distinct topic areas covered in Washington Legal Foundation’s recently released Timeline: Federal Erosion of Business Civil Liberties. To read the other posts in this series, click here.

To commit a crime, normally you have to have met two requirements. First, you have to have done something bad. Second, you have to have done the bad thing with a bad intent.

Take mortgage fraud. If you write on your mortgage application that you earn $1,000,000 a year, but you only earn $100,000, you’ve committed mortgage fraud if that’s what you intended to submit and you knew it was false. If, though, you’re using an online application and the “0” key on your keyboard was stuck so an extra zero appeared, you haven’t committed mortgage fraud, you’ve just made a mistake; you have no bad intent. Continue reading

Will 2015 Dietary Guidelines for Americans Further the Demonization of Caffeine?

cup of coffeeOfficials at the U.S. Department of Agriculture and the U.S. Department of Health and Human Services are currently finalizing the 2015 Dietary Guidelines for Americans (DGA). Those agencies will rely quite heavily on the Scientific Report of a USDA/HHS advisory panel—the Dietary Guidelines Advisory Committee (DGAC)—that Washington Legal Foundation and many other interested parties have criticized as driven more by ideology than sound science. The USDA and HHS Secretaries recently assured the public that the DGA will provide “nutritional and dietary information … based on a preponderance of the evidence.” One test of the Secretaries’ fidelity to that statutorily-mandated criterion will be whether the Dietary Guidelines embrace the Scientific Report’s thoroughly unscientific conclusions on caffeine. Continue reading