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
The battle over general jurisdiction in a post-Daimler AG v. Bauman world continued as 2015 drew to a close, with lingering inconsistency. Two recent trial court decisions, Cahen v. Toyota Motor Corp. and Jeffs v. Anco Insulations, demonstrate how judges in different jurisdictions with different interests apply general jurisdiction differently, and in these cases, to the very same defendant. While a federal district court judge held that California could not exercise general jurisdiction over Ford Motor Co.—a company incorporated in Delaware and headquartered in Michigan—Circuit Judge Stephen Stobbs of Madison County, a perennial magnet jurisdiction for plaintiffs, found that his Illinois court could. Continue reading
Officials 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
Featured Expert Column – Environmental Law and Policy
by Samuel B. Boxerman, Sidley Austin LLP, with Joel F. Visser, an associate with the firm.
On September 1, 2015 a federal district court in Texas vacated a United States Fish and Wildlife Service (“FWS”) rule listing the lesser prairie chicken as threatened under the Endangered Species Act (“ESA”). In Permian Basin Petroleum Association v. Department of the Interior, the court found FWS failed to follow its own procedures for evaluating the effects of a voluntary state-lead program designed to protect the species. This decision could serve to limit future ESA listing decisions when state-lead conservation efforts designed to protect species are in place.
The federal government has been considering whether the lesser prairie chicken (a member of the grouse family) should be listed since 1995. The process has drawn substantial attention pitting environmental NGOs asserting the species’ needed ESA protection against landowners concerned with restrictions on their rights to make beneficial use of land across several western states. Oil and gas interests, among others, have been extremely concerned with a potential listing, as the bird’s habitat includes areas with active oil and gas exploration. Continue reading
In a comment critical of his former employer’s proposal to mandate “added sugars” labeling, a former Director of the Food and Drug Administration’s Office of Food Labeling wrote, “‘Added Sugar’ is the ‘bête noir‘ of this decade for many in the nutrition community.” That community’s obsession with added sugars has hit an all-time high (or low) with FDA’s July 27 release of a proposed rule that “supplements” its March 3, 2014 proposed revision of the ubiquitous food Nutrition Facts panel. While U.S. regulators have been busy affirming the righteousness of their irrational approach, health officials in neighboring Canada have taken a far more reasoned stance. The contrast between the latter’s position and FDA’s proposal is quite instructive.
“Added Sugars” Charade. Sound science and the history of government nutrition policy dictate that narrowly focusing on one food, ingredient, or nutrient is exactly the wrong way to reduce obesity. Past government pronouncements on the evils of fat and cholesterol pushed consumers away from items such as lean meat and eggs, and toward products like fat-free cookies packed with sweeteners. Now, government is admitting that we shouldn’t worry so much about fat. It’s also no longer clear that salt deserves its status as a longtime public-health bogeyman. Continue reading
Partially hydrogenated oil
To no one’s surprise, the Food and Drug Administration (FDA) has confirmed its November 8, 2013 initial determination that the agency no longer considers the main source of trans fat in Americans’ diet, partially hydrogenated oils (PHOs), “generally recognized as safe” (GRAS). In its announcement, FDA emphasizes how the three-year window it has granted food companies to comply with the order would “allow for an orderly [transition] process.” Before anyone applauds FDA for being reasonable or magnanimous, however, consider what else the agency says, and doesn’t say, in its Declaratory Order (“Order”). FDA’s statements and omissions essentially set the table for an explosion of private lawsuits that could require PHO-containing products to be reformulated, or removed from the market, far earlier than June 2018.
What the Order Says. Under federal law, an FDA determination that a substance is no longer GRAS is not the equivalent of it being “unsafe.” It means that because some level of uncertainty has arisen from studies of the substance, food producers must seek approval for its use in specific products through a food additive petition. The Order, however, glosses over this inconvenient nuance, and instead consistently and repeatedly states that FDA has concluded PHOs are unsafe. The media has slavishly echoed FDA’s distorted conclusion to an American public that includes prospective judges and jurors for the lawsuits to come. Continue reading
In one of our first WLF Legal Pulse posts five years ago, we wrote about efforts at the Environmental Protection Agency (EPA) to revitalize “environmental justice” (EJ), which had essentially laid dormant since the Clinton Administration. The EJ movement’s influence has gradually spread, with EPA citing “EJ concerns” among its reasons for opposing the Keystone XL pipeline, and activists utilizing EJ to successfully oppose express toll lanes in Arlington, Virginia and agitate for severe development limits in the Los Angeles area.
Several recent developments at EPA aim to inject the environmental justice movement even further into federal regulatory policy-making. Continue reading