Legislative Overseers Continue to Criticize FDA for its Regulation by Guidance

FDA

Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. Members of the committee had previously written the FDA Commissioner about the agency’s use of guidance in May 2014, to which FDA responded nearly a year later in March 2015. During his confirmation hearing before the HELP Committee last November, Commissioner Califf addressed several questions about the use of guidance and pledged to investigate the Senators’ questions. Continue reading

Utah Federal District Court Lights Alternative Paths to Impossibility Preemption

ReedGuest Commentary

By Matthew A. Reed, Sedgwick LLP

“Impossibility preemption,” the US Supreme Court has warned, “is a demanding defense” to a state tort claim for failure to warn about the risks of a prescription drug.  Wyeth v. Levine, 555 U.S. 555, 573 (2009).  It is not, however, impossible to prove.  Indeed, the Utah federal district court on March 16, 2016 acknowledged in Cerveny v. Aventis, Inc. two ways by which a prescription drug manufacturer may prove the impossibility of complying with conflicting state law and federal regulations.  Continue reading

WLF Media Briefing, New Paper Address the Freeing of Off-Label Medical-Product-Use Information

On Monday, May 2, 2016, Washington Legal Foundation hosted a program in its Media Briefing series entitled Freeing Off-Label Use Information: Three Lingering Questions for Medical-Product Innovators and Regulators. The recording of that program is available below. Also below are links to related materials, including an April 29, 2016 WLF Legal Backgrounder that draws lessons from a medical-device company’s successful defense of a criminal prosecution for alleged off-label promotion.

Participants:

  • Edward Berg, Sanofi US
  • John Osborn, Hogan Lovells LLP
  • Coleen Klasmeier, Sidley Austin LLP
  • Eric Grannon, White & Case LLP (moderator)

The program can also be viewed through WLF’s website—with a higher-quality video and integrated slides—by clicking here.

John Osborn’s Yale Journal article, “Can I Tell You the Truth?”, cited by the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, is available here.

WLF’s Legal Backgrounder, “The US v. Vascular Solutions Acquittal: Three Lessons for Targets of ‘Off-Label Promotion’ Enforcement,” is available here.

If Companies Cave on GMO Labeling, Supply-Chain Concerns Could Be the Next Mandatory Labeling Gambit

Ivory CoastCalifornia’s federal district courts, which are already overstocked with food-labeling class-action suits, are now being asked to impose new food-product disclosure mandates. Courts have thus far dismissed lawsuits seeking on-package statements regarding alleged concerns in companies’ overseas supply chains, such as forced labor. But don’t expect those losses to dampen corporate-disclosure activists’ resolve. Such suits are just one part in a larger campaign, following in the footsteps of the mandatory “GMO labeling” crusade, to require supply-chain information on product packaging.

Manufacturers of chocolate, pet food, and seafood have been targeted for their failure to disclose on their packaging the existence of forced labor and other possible human-rights violations in foreign countries from which they source their products or product ingredients. Such an omission, the class actions claim, violates California consumer-protection laws. One remedy the plaintiffs seek is disclosure of this supply-chain data on product labels and point-of-sale advertising. Continue reading

Yes, Shampoo Grows on Trees: The Ninth Circuit, “Natural,” and the Need for FDA Clarification

davidwallacehsfcomLGSmichaelkellyhsfcomLGSGuest Commentary

by David L. Wallace and Michael R. Kelly, Herbert Smith Freehills LLP*

It is often said in food-labeling class actions that the term “natural” is vague and undefined. Until recently, there was little reason to believe that the Food and Drug Administration would take action to define “natural,” and there still is no legal definition or common consumer understanding of what the term means. That uncertainty puts sellers at risk because the term can carry different meanings for different consumers. But what about situations in which context plainly limits the term’s meaning, or in which the consumer doesn’t bother alleging a particular understanding of the term “natural,” or asserts a belief that strains credulity? Continue reading

Arizona Supreme Court Joins Overwhelming Majority in Recognizing the Learned Intermediary Doctrine

az s. ct.Last month, the Arizona Supreme Court became the most recent state high court to recognize the “learned intermediary doctrine” (LID). The LID provides a defense to drug companies in failure-to-warn products-liability cases so long as the manufacturers provided the prescribing doctor with all required safety information. In so doing, the court joined the 36 other state high courts that have expressly adopted the LID.

The case, Watts v. Medicis Pharmaceutical Corp., arose from the plaintiff’s use of the defendant’s acne medication. The plaintiff alleged that she was not properly warned about the possible side effects of taking the medication and developed lupus, she claimed, as a result of her usage of the drug. Importantly, the plaintiff did not allege that the defendant drug company failed to provide her prescribing doctor adequate warnings, just that the company did not warn her personally. The Arizona court of appeals reversed a dismissal of the claim, holding that the LID was no longer a viable legal theory and was abrogated by statute. Continue reading

Federal Officials Display Disregard for Due Process in Opposing “Mens Rea” Reform

barsFair notice of the law is a basic principle that separates liberal democracies like the United States from more authoritarian governments. Fair notice is an especially critical due-process check against government’s power to criminally prosecute. Government must not only prove that a person did the unlawful act, but also that he intentionally engaged in wrongful conduct or knew the conduct was illegal—that it, that he had a guilty mind. So why, then, is the Obama Administration and other elected representatives opposing reforms to ensure that federal criminal laws include a clear criminal-intent standard?

The idea being advanced seems far from revolutionary or controversial, which may explain why politicians and interest groups of every ideological stripe support it: Federal laws with criminal provisions must require prosecutors to prove that the accused possessed the mens rea, or culpable mental state, to commit a crime. If a law lacks such language, then a default intent provision will apply, such as showing that the defendant acted “willfully” or “recklessly.” Continue reading