FTC’s Action against “Repetitive” Filing of Citizen Petitions Reflects Expanding Pharma-Sector Enforcement Program

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 Andrew B. Blumberg, an Associate Attorney in the firm’s Dallas, TX office.

On February 7th, 2017, the Federal Trade Commission (FTC) filed a complaint alleging that Shire ViroPharma Inc. (Shire) violated the antitrust laws by filing sham citizen petitions in an effort to forestall generic competition for its branded prescription drug, Vancocin.  The case is another stepping stone in the agency’s steadily expanding efforts to police what it views as potential antitrust abuses in the pharmaceutical sector. Continue reading “FTC’s Action against “Repetitive” Filing of Citizen Petitions Reflects Expanding Pharma-Sector Enforcement Program”

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”

Eye Drops, Water Fountains for Cats, and the Demise of a No-Injury Class Action

cat fountain

In creating the federal judicial branch, the Framers of the US Constitution did not intend that courts would right every possible wrong. Article III authorizes federal courts to resolve “Cases” and “Controversies.” The US Supreme Court has interpreted that power to mean that civil-litigation plaintiffs must prove they suffered an “injury in fact,” which is concrete and particularized, and not speculative. We’ve discussed Article III standing jurisprudence here in numerous contexts, most frequently in consumer class actions targeting food labels or data-security breaches, areas where the ever-amorphous concept of “economic harm” is often alleged. A March 6, 2017 Seventh Circuit decision, Eike v. Allergan, Inc. et al., shot down an especially outlandish attempt to expand standing based on an alleged economic injury. Continue reading “Eye Drops, Water Fountains for Cats, and the Demise of a No-Injury Class Action”

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”

A Q&A with Federal Regulation Scholar Susan Dudley on Reconsidering Regulations

dudleysusan-2015_crop_webSusan E. Dudley is Director of the George Washington University Regulatory Studies Center, which she founded in 2009, and a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. From 2007 to 2009, she served as the Administrator of the Office of Information and Regulatory Affairs (OIRA) in the U.S. Office of Management and Budget.

WLF Legal Pulse: As promised, Congress and the Administration have quickly gotten to work reconsidering and removing a host of federal regulations while also setting the stage for a much different approach to regulation.  Let’s first talk about what Congress is doing.

Professor Dudley: Under the Congressional Review Act of 1996 (CRA), Congress has 60 legislative days after a regulation is published to vote to disapprove it.  The procedures for disapproval are streamlined (including requiring a simple majority in the Senate) and if a rule is disapproved, the agency cannot issue something substantially similar. Continue reading “A Q&A with Federal Regulation Scholar Susan Dudley on Reconsidering Regulations”

A 2017 Food-Court Resolution: End Regulation-through-Litigation Crusade Against Trans Fat

Partially hydrogenated oil chemical structure
Partially hydrogenated oil
chemical structure

In 2016, class-action lawsuits alleging that a processed food product or its labeling violated state consumer-protection laws continued to clog the federal courts, especially in California. The number of new food-related consumer class actions filed last year nearly equaled the number filed in 2015, according to a report in Food Navigator USA. It’s unclear whether these trends will hold in 2017, but there is one set of blatantly frivolous claims that should disappear this year: those that seek judicial regulation of products that contain partially hydrogenated oil (PHO), the main source of trans fat. A December 13, 2016 Southern District of California decision should frustrate such claims in the short term, and a forthcoming US Court of Appeals for the Ninth Circuit decision in a pending case may (and should) end them permanently. Continue reading “A 2017 Food-Court Resolution: End Regulation-through-Litigation Crusade Against Trans Fat”