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”

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”

Food Court Follies: Misled-By-Maple Class Action Against Quaker Oats Preempted

maple and brown sugarIn all the blogging we’ve done on food-related consumer-protection litigation over the past five years, we’ve said very little about one of our favorite federal constitutional doctrines, federal preemption. That’s because the Food Court Bar has filed the vast majority of its claims in California, which has a statute, the Sherman Food, Drug, and Cosmetic Law, that explicitly incorporates all federal food laws and regulations. Plaintiffs’ lawyers have been able to defeat most preemption arguments by asserting Sherman Act violations, remedies for which would impose the same requirements as would federal law. Preemption defenses can prevail only when state law (or a state court decision) imposes obligations in conflict with federal law.

But in a series of recent suits against Quaker Oats Company, plaintiffs’ lawyers took a shot at imposing controls on oatmeal-product labeling that went beyond what federal rules required. Perhaps they thought the Central District of California would give them a pass, or that they could convince the court through some legal slight-of-hand. Judge Philip S. Gutierrez, who is presiding over the consolidated class actions, wasn’t buying it, however. On October 10, 2017, he dismissed the plaintiffs’ claims as preempted by federal law. In re Quaker Oats Maple & Brown Sugar Instant Oatmeal Litigation. Continue reading “Food Court Follies: Misled-By-Maple Class Action Against Quaker Oats Preempted”

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”

News Flash! Jelly Beans Contain Sugar—The Continuing Saga of Evaporated Cane Juice Litigation

mckenziy_printGuest Commentary

By Yvonne M. McKenzie, a Partner with Pepper Hamilton LLP in the firm’s Philadelphia, PA office, and Colleen Kelly, an Associate with the firm.

In February, plaintiffs filed a class-action lawsuit in California against candy maker Jelly Belly on behalf of consumers who purchased jelly beans marketed as “Sport Beans.” They claimed that Jelly Belly used the phrase “evaporated cane juice” (ECJ) in its ingredient labeling to mislead consumers about the amount of sugar in Sport Beans.

Jelly Belly markets the product to athletes seeking a jolt of “quick energy,” which is usually accomplished through ingesting sugar and carbohydrates. Far from masking its ingredients, the product labeling clearly states that Sport Beans contain 19 grams of sugar per serving. Despite this, the plaintiffs claimed that the term ECJ misled them into thinking that the product contained juice, not sugar. Never mind that juice itself typically contains sugar. Continue reading “News Flash! Jelly Beans Contain Sugar—The Continuing Saga of Evaporated Cane Juice Litigation”

FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators

FDAThe 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 “FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators”

Update: Colorado Sues Boulder County Over Divergent Oil and Gas Regulation

coloradoagA February 8 post, Kudos to Colorado AG for Rebuking Boulder County on Its Fracking Moratorium, discussed a letter Colorado Attorney General Cynthia H. Coffman sent to the Boulder County Board of County Commissioners warning that the state would file suit if the county did not end its moratorium on new oil and gas development permits by February 10.

After giving the Board four extra days to comply, Attorney General Coffman filed suit against Boulder on February 14. The suit alleges that the moratorium conflicts with the Colorado Oil and Gas Conservation Act. The state supreme court held in a 2016 decision that the Act preempted anti-fracking rules adopted by two other Colorado localities.

The complaint can be viewed here. Upon filing suit, Attorney General Coffman stated:

The Boulder County Commissioners responded [to the Attorney General’s letter] that they needed yet more time to draft regulations and prepare to accept new applications for oil or gas development.  Because five years is more than reasonable time to complete such a project, and because Boulder County continues to operate in clear violation of Colorado law, the Attorney General today is filing suit in Boulder County District Court to compel compliance.  It is not the job of industry to enforce Colorado law; that is the role of the Attorney General on behalf of the People of Colorado.  Regrettably, Boulder County’s open defiance of State law has made legal action the final recourse available to the State.