Textbook Application of “Obstacle” Preemption Negates Activists’ Organic Food-Labeling Suit

formulaFood Court Follies—A WLF Legal Pulse Feature

Several of our recent commentaries (here and here) have extolled the virtues of national uniformity for the regulation of interstate commerce. Those posts focused on litigation involving federally regulated prescription drugs and devices. But state consumer-protection litigation poses an even greater threat to regulatory uniformity.

Federal preemption—the constitutional doctrine that state-law litigation targets regularly cite as a defense—has generally been an ineffective argument against consumer-protection suits, especially those alleging misleading or false labeling of food and other packaged goods. A January 3, 2018 federal trial court ruling, Organic Consumers Association v. Hain Celestial Group, Inc., is a welcome exception to that trend. It’s also notable for how clearly the court explained implied preemption and the broader principle of uniformity underlying the defense. Continue reading “Textbook Application of “Obstacle” Preemption Negates Activists’ Organic Food-Labeling Suit”

Same-Old Drug Advertising Ban Proposal Would Fail for the Same-Old Reasons

first-amendmentAs the country debates the best path forward for the nation’s healthcare system, interest groups continue to advance different ideas to address their pet causes.  One popular cause is the reduction of drug prices.  Though that debate often occurs based on narrow perceptions of the dollar figures at issue, ideas for price reduction are worthy of consideration, especially given the increasing budgetary percentage that government and personal spending healthcare now occupies.  One drug-price-reduction idea advanced toward the end of last year, however, should be vigorously opposed. Continue reading “Same-Old Drug Advertising Ban Proposal Would Fail for the Same-Old Reasons”

FDA Cannot Remain MIA as States’, Cities’ Drug-Litigation Crusade Threatens Regulatory Uniformity

FDAA November 30, 2017 post discussed the Food and Drug Administration’s (FDA) return to third-party courtroom advocacy for national, uniform regulation of products under its authority. In separate amicus briefs, the agency argued that federal law preempted both New York City’s enforcement of an expanded menu-labeling ordinance and certain claims in a products-liability suit against a medical-device maker. FDA also urged the International Trade Commission (ITC) to terminate an investigation into the drug-or-dietary-supplement status of an imported omega-3 substance because the inquiry would directly conflict with the agency’s authority in that area.

As a long-time proponent of regulatory uniformity, Washington Legal Foundation is encouraged by these developments, and we trust that FDA’s courtroom advocacy is a work in progress. The agency can make an even bigger difference in 2018 by weighing into litigation involving one of FDA’s most highly regulated class of prescription drugs: opioid-based pain medications. Continue reading “FDA Cannot Remain MIA as States’, Cities’ Drug-Litigation Crusade Threatens Regulatory Uniformity”

FTC Pharma Workshop Focuses on Supply Chain Issues and “Gamesmanship” of FDA Regulation

Featured Expert Column: Antitrust & Competition Policy — Federal Trade Commission

06633 - Royall, M. Sean ( Dallas )By M. Sean Royall, a Partner with Gibson, Dunn & Crutcher LLP, with Richard H. Cunningham, Of Counsel in the firm’s Denver, CO office, and Abiel Garcia, an Associate Attorney in the firm’s Los Angeles, CA office.

On November 8, 2017, the Federal Trade Commission hosted a workshop examining competitive dynamics in the pharmaceutical sector.  Participants in the workshop included professors Michael A. Carrier, Aaron Kesselheim, Stephen Schondelmeyer, Neeraj Sood, Erin Fox, and Rena Conti; representatives from industry interest groups Mark Merritt and Todd Ebert; consumer advocate David Mitchell; economists Adam Fein and Hal Singer; FDA Commissioner Dr. Scott Gottlieb; and FTC Acting Chairman Maureen Ohlhausen.

While FTC workshops are informal and have no binding effect on the policies of the agency, they frequently foreshadow areas of future investigative or enforcement focus.  Participants’ comments generally affirmed that areas of long-standing FTC activity in the pharmaceutical sector, including reverse payments and merger enforcement, are likely to remain areas of ongoing focus.  Two notable new issues also emerged:  scrutiny of the industry’s distribution system and potential abuse of FDA regulatory processes to inhibit generic entry.  In addition, Dr. Gottlieb announced three new FDA initiatives to facilitate generic entry into pharmaceutical markets. Continue reading “FTC Pharma Workshop Focuses on Supply Chain Issues and “Gamesmanship” of FDA Regulation”

Food Court Follies: Yogurt Buyers’ Attempt to Milk “All Natural” Litigation Trend Rejected

yogurtAmong the hundreds of food-labeling class actions filed this decade, claims challenging a product’s “natural” or “all natural” declaration have stood out in number and notoriety. The latter characteristic is especially true about suits where a product is purportedly unnatural because an ingredient was “genetically modified.” A recent federal court decision reminds us that no matter how notable GMO-related claims are, or how convinced some are that their food contains GMOs and is thus not natural, a plaintiff still must plausibly allege such facts in her suit. Continue reading “Food Court Follies: Yogurt Buyers’ Attempt to Milk “All Natural” Litigation Trend Rejected”

FDA Makes a Welcome Return to Courtroom Advocacy for Uniform, National Regulation

FDAThrough the Food, Drug & Cosmetic Act (FDCA) and its amendments, Congress put the Food and Drug Administration (FDA) in charge of establishing uniform, national regulation of consumer products. In the past decade, private litigants and state officials have increasingly undercut regulatory uniformity through state tort and consumer-protection lawsuits. Rather than defend its congressional mandate through amicus briefs or other courtroom advocacy, FDA remained mostly silent during that period.

This year, under the leadership of Commissioner Scott Gottlieb and Chief Counsel Rebecca Wood, FDA has stepped off the sidelines and is once again promoting uniformity by defending its regulatory role in several third-party legal action. That is a positive development for the producers and purchasers of FDA-regulated goods, which comprise nearly 25% of U.S. consumer spending. Continue reading “FDA Makes a Welcome Return to Courtroom Advocacy for Uniform, National Regulation”

Federal Preemption Ruling Flushes Another Eye-Drop Class Action

eyedropAnyone who’s ever used eye drops has experienced solution overflow. You tilt your head back, pry your eye open, hold the dispenser close to your eyeball, and even though you squeeze very gently, some of the liquid flows onto your cheek. What is your logical next move? Is it to grab a tissue and dab up the excess, or reach for the phone and call your lawyer? As readers of the WLF Legal Pulse learned from a March 31, 2017 post, some overflow sufferers have actually done the latter.

That March 31 commentary recounted the U.S. Court of Appeals for the Seventh Circuit’s dismissal of a class action against nine eye-drop makers alleging that consumers suffered economic harm from a needlessly oversized drop of medicine. A decision in another eye-drop-overflow suit filed in Massachusetts, Gustavesen v. Alcon Laboratories, et. al, recently came to our attention (HT to our friends at the indispensable FDA Law Blog).

The outcome of this suit was the same as the Eike v. Allergan, Inc. in the Seventh Circuit—class dismissed. Unlike Judge Posner’s typically curt, fanciful opinion in Eike, which tossed out the claims for lack of constitutional standing, District of Massachusetts Judge Mark Wolf found that federal regulation of the prescription eye drops preempted the state-law fraud claims. Judge Wolf’s thorough analysis is worth a careful read. Continue reading “Federal Preemption Ruling Flushes Another Eye-Drop Class Action”