Update: FDA’s Amicus Views Prevail in Third Circuit Medical-Device Preemption Case

FDALate last year we highlighted steps the Food and Drug Administration (FDA) made in 2017 to reestablish its authority as uniform regulator of drugs and medical devices.  That role, we explained, was in danger due to the ever-increasing list of state tort and consumer-protection lawsuits brought by plaintiffs’ attorneys on behalf of private litigants.  In the post, we examined three instances where FDA independently stepped in to ongoing litigation to advance arguments supportive of regulatory uniformity.

In one instance, FDA submitted an amicus brief to the Third Circuit in a case where the plaintiff alleged that the manufacturer of his artificial hip promoted the device illegally.  In its brief, FDA emphasized that the Food, Drug & Cosmetic Act (FDCA) expressly preempted state-law claims that would impose “different or additional requirements on approved devices.”  Because each of the plaintiffs’ claims challenged the safety and effectiveness of an approved device, FDA argued that any state-law claim would “impose additional requirements” and was thus preempted by the FDCA.

In its March 1, 2018 opinion in Shuker v. Smith & Nephew, PLC, the Third Circuit agreed with FDA.  Holding that the plaintiffs’ claims “would impose non-parallel state law requirements,” the appellate court found the state-law claims preempted.

The Third Circuit’s decision is just another example of the importance of FDA’s role as uniform regulator.  Hopefully FDA’s current leadership will continue to lead the way in ensuring the consistency that all consumers expect when making choices about their medical products.

DOJ Memo and Court Opinion Show Trend in Damming Flood of False Claims Act Suits

11th CircuitBusinesses that routinely contract with the government know that while the relationship comes with high financial rewards, it also can expose those companies to massive civil liability.  Under the False Claims Act (FCA), government contractors can find themselves sued for hundreds of millions of dollars based on mere technical violations of complex regulatory schemes.

Luckily, as highlighted in several of our previous posts, the U.S. Supreme Court has recently reinforced the high evidentiary threshold FCA plaintiffs need to meet to bring a successful claim under the most common theory of FCA liability.  A recently disclosed U.S. Department of Justice (DOJ) memo and a recent opinion from the U.S. Court of Appeals for the Eleventh Circuit might similarly lead to fewer baseless claims against government contractors. Continue reading “DOJ Memo and Court Opinion Show Trend in Damming Flood of False Claims Act Suits”

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

formulaFood Court Follies—A WLF Legal Pulse Series

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”