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.

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”

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”