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
Fair 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
Featured Expert Column – Environmental Law and Policy
by Samuel B. Boxerman, Sidley Austin LLP
with Ben Tannen, Sidley Austin LLP
On January 22, 2016, the U.S. Department of Interior’s (“DOI”) Bureau of Land Management (“BLM”) issued a proposed rule governing oil and natural gas production on onshore Federal and Tribal lands. Bureau of Land Management, Pre-Publication Proposed Rule, Waste Prevention, Production Subject to Royalties, and Resource Conservation (Jan. 22, 2016) (“Proposed Rule”). Coming on the heels of U.S. EPA’s proposed regulation of emissions from certain new and modified oil and gas sources, the BLM proposal represents a further expansion of the federal government’s regulation of the oil and gas business. 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
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
By Jon E. Wright & Pauline M. Pelletier, Sterne, Kessler, Goldstein & Fox*
A hot topic in post-grant proceedings before the Patent Trial and Appeal Board (PTAB) is whether determinations made by the PTAB at the institution stage are reviewable on appeal by the Federal Circuit. In SightSound Techs., LLC v. Apple Inc., 2015 WL 8770164 (Fed. Cir. Dec. 15, 2015), the Federal Circuit held that it lacked jurisdiction to review the PTAB’s decision to consider issues not raised in the petition, but confirmed that it did have jurisdiction to review whether a patent was eligible for covered business method (CBM) review. The difference between these two issues, it noted, is that the petition could be “cured by a proper pleading” whereas CBM review eligibility constitutes a limit “on the Board’s authority to issue a final decision.” Continue reading
Featured Expert Contributor – Intellectual Property (Patents)
Jeffri A. Kaminski, Venable LLP
For years, defendants in patent infringement cases have protested the ease with which patent plaintiffs could file complaints. Since 1938, Form 18—a model form in an appendix of the Federal Rules of Civil Procedure (FRCP)—set the pleading standard that courts in patent cases have applied. Form 18 requires that the complaint merely state that the plaintiff owns the patent(s), that the defendant infringes the patent(s), and that the plaintiff suffered damages. The form is barely over a page long and does not require any information on how the defendant infringes the patent or even what patent claims are allegedly infringed. Continue reading