West Virginia’s High Court Rejects Novel Theory of “Innovator Liability”

west vaShould the law recognize a plaintiff’s tort claims against a branded drug manufacturer when the drug that allegedly caused the plaintiff’s injuries was manufactured and sold by the defendant’s generic competitor? State and federal courts have been grappling with this novel question of “innovator liability” ever since the U.S. Supreme Court held, in Pliva and Bartlett, that such tort claims against generic manufacturers are preempted under federal law.

At bottom, innovator liability seeks to hold innovator drug manufacturers liable for injuries resulting from products they neither manufactured nor sold. Such “deep pocket jurisprudence,” as a recent Washington Legal Foundation paper by Shook Hardy & Bacon’s Victor Schwartz explains, marks a radical departure from long-settled principles of product liability premised on a naked policy decision that shifts financial responsibility onto a third party with the deepest pockets. Continue reading “West Virginia’s High Court Rejects Novel Theory of “Innovator Liability””

Second Circuit Shuts Down Duplicative Regulation by Litigation of Organic Products

organicA January 9, 2018 WLF Legal Pulse post applauded a federal district court’s textbook application of implied-preemption analysis in dismissing a consumer-protection suit that alleged mislabeling of an organic infant formula. A recent decision of the U.S. Court of Appeals for the Second Circuit in Marentette, et al. v. Abbott Laboratories, Inc. similarly utilized implied preemption to reject a putative class action presenting nearly identical claims involving another brand of organic infant formula. The decision should put an end to plaintiffs’ use of state consumer-protection suits to regulate products bearing the U.S. Department of Agriculture’s (USDA) “Organic” symbol. Continue reading “Second Circuit Shuts Down Duplicative Regulation by Litigation of Organic Products”

Washington State Officials Usurp Federal Authority with Crusade to Block Export Terminal

Over the past several years, state and local governments have become more aggressive regulators of free-enterprise activity. Some of those states and municipalities have taken action in areas that either federal law or the U.S. Constitution reserve for uniform federal regulation.

For instance, states like Washington and California have either adopted or are pursuing their own “net neutrality” rules after the Federal Communications Commission repealed a 2015 rule. Scores of states, cities, and counties have sued to impose controls on federally approved prescription pain medications that would be different from those required by the Food and Drug Administration. And mayors, county supervisors, and state attorneys general are racing ahead of the federal government with lawsuits aimed at regulating the global concern of climate change.

Another example of what we’ll call extreme federalism has been percolating in the Pacific Northwest for over five years and is now being contested in federal court. Continue reading “Washington State Officials Usurp Federal Authority with Crusade to Block Export Terminal”

Update: Despite Previous Judicial Guidance, Misled-by-Maple Class Action Dismissed Again

maple and brown sugarFood Court Follies—A WLF Legal Pulse Series

Last November, a Food Court Follies series post offered two-cheers for a Central District of California judge’s dismissal of consolidated class actions filed against Quaker Oats (In re Quaker Oats Maple & Brown Sugar Instant Oatmeal Litigation). The two cheers were for properly finding that federal law preempted the suit because it would impose novel (i.e. additional) labeling requirements.

We withheld the third cheer in part because the court not only failed to dismiss the suit with prejudice, but it also counseled the plaintiffs on how they could re-plead around his preemption ruling. The plaintiffs filed an amended complaint on November 10, 2017.

The plaintiffs’ changes apparently amounted to “lipstick on a pig,” because on March 8, the court again dismissed the suit, this time with prejudice. Continue reading “Update: Despite Previous Judicial Guidance, Misled-by-Maple Class Action Dismissed Again”

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.

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”