FDA-Mandated Listing of Drug Prices in Ads Would Flunk Legal and Constitutional Tests

first-amendmentWe’ve read with amusement the recent, overblown claims of some constitutional-law commentators and even U.S. Supreme Court justices that the First Amendment has been “weaponized” as a tool of deregulation. Of course, First Amendment challenges increasingly have become indispensable as politicians and regulators target more and more speech rather than regulate conduct directly.

Consider, for instance, the advertising-disclosure requirement floated last May as a part of the Department of Health and Human Services’ (HHS) blueprint to lower prescription drug prices. HHS asked the Food and Drug Administration (FDA) “to evaluate the inclusion of list prices in direct-to-consumer advertising.” The proposal appears to be under serious consideration. HHS Secretary Alex Azar has specifically invoked it when briefing the press and testifying before two Senate committees (here and here). And FDA Commissioner Scott Gottlieb indicated (in a May interview) that an agency working group will soon study the idea.

If that study includes a dispassionate legal and constitutional analysis, the working group should recommend that HHS scrub the list-price mandate from its policy blueprint. Not only does FDA lack the statutory authority to impose the mandate, but even if it could legally do so, the regulation cannot survive a First Amendment challenge. Continue reading “FDA-Mandated Listing of Drug Prices in Ads Would Flunk Legal and Constitutional Tests”

‘Merck, Sharpe & Dohme v. Albrecht’: The Supreme Court’s Chance to Re-Open a Preemption Door the Third Circuit Tried to Close Forever

Joe_Hollingsworth_thumbnail 1Featured Expert Contributor, Litigation Strategies

By Joe G. Hollingsworth, Partner, Hollingsworth LLP, with Stephen A. Klein, Partner, Hollingsworth LLP

*Ed. Note: This is Mr. Hollingsworth’s inaugural post as the WLF Legal Pulse’s newest Featured Expert Contributor. He is a nationally renowned courtroom advocate who specializes in trials and appeals and leads a practice group of seventy-five attorneys. 

No one ever said preemption should be easy.  But then there’s the U.S. Court of Appeals for the Third Circuit’s preemption decision last year in Merck, Sharpe & Dohme v. Albrecht, 852 F.3d 268 (3d Cir. 2017).  Continue reading “‘Merck, Sharpe & Dohme v. Albrecht’: The Supreme Court’s Chance to Re-Open a Preemption Door the Third Circuit Tried to Close Forever”

Update: Federal District Court Rejects Minority View on Pharma “Innovator Liability”

pillsIn a recent post, West Virginia’s High Court Rejects Novel Theory of “Innovator Liability”, WLF Senior Litigation Counsel Cory Andrews discussed a state court decision that declined liability on a pharmaceutical manufacturer for alleged harms caused by a drug it did not produce. In doing so, the West Virginia Supreme Court of Appeals parted company with the highest courts of two other states, California and Massachusetts, which earlier this year embraced the minority view that plaintiffs can recover damages from so-called branded pharmaceutical companies for harms allegedly caused by the generic copy of the the brand-name drug.

On May 21, a U.S. District Court for the District of Massachusetts judge overseeing a multidistrict litigation, In re: Zofran (Ondansetron) Products Liability Litigation, followed the majority view of innovator liability and dismissed three claims filed by plaintiffs who had only ingested the generic version of Zofran. Continue reading “Update: Federal District Court Rejects Minority View on Pharma “Innovator Liability””

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””

FTC Enforcement Powers Face Serious Challenge

FTC_Man_Controlling_TradeThe Federal Trade Commission (FTC) has long asserted broad authority to sue businesses for engaging in unfair or deceptive acts or practices.  But a recent federal court decision (Federal Trade Commission v. Shrire Viropharma Inc.) calls that authority into serious question.  If upheld on appeal, the decision could lead to major changes in the way FTC carries out its enforcement responsibilities.

The decision focused on § 13(b) of the Federal Trade Commission Act (FTCA).  That statute authorizes FTC to seek injunctive relief in federal court against anyone who “is violating, or is about to violate” a law enforced by FTC.  FTC has long contended that § 13(b) also authorizes actions against entities based on past violations, even in the absence of evidence that the entity “is about to” commit new violations.  A Delaware federal district judge’s rejection of that contention has thrown a monkey wrench into FTC’s enforcement apparatus. Continue reading “FTC Enforcement Powers Face Serious Challenge”

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”