News & Analysis as of

Food, Drug and Cosmetic Act

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set... more +
The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections.  The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices. less -

In the First Case of its Kind, Court Rules Federal Law Does Not Trump Employee Protections under State Medical Marijuana Law

by Littler on

Employers nationwide take note: if your workplace drug and alcohol-testing policies take a zero tolerance approach to medical marijuana because the use, distribution, or possession of marijuana is unlawful under federal law,...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

by Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

U.S. Supreme Court’s Decision Not to Take Certiorari in United States v. DeCoster is a Reminder to the Food and Drug Industries to...

by Liskow & Lewis on

Earlier this year there was hope in the food and drug industries that the Supreme Court would revisit and possibly revise the Responsible Corporate Officer Doctrine, also known as the Park Doctrine, by granting certiorari to...more

FDA Announces New Digital Health Innovation Programs

by Ropes & Gray LLP on

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has announced new plans to streamline the development and availability of high...more

SDNY Brushes Away Presumption Against Preemption and Stays Class Action Via Primary Jurisdiction

by Reed Smith on

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients. By and large, those associates do an excellent job. On those rare occasions when we find...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Boxed Warnings and Adequacy as a Matter of Law

by Reed Smith on

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FSMA: What Every Food Industry Executive Should Do & Why

by Strasburger & Price, LLP on

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more

Food & Beverage Litigation Update | June 2017 #2

Seattle Approves Tax on SSB Distributors - The Seattle City Council has approved a tax on distributors of sugarsweetened beverages (SSBs) proposed by the city’s mayor. SSBs covered by the tax include sports, fruit, energy...more

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts

by Reed Smith on

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

The Cheese Runneth Over...Into Illinois

by Reed Smith on

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district...more

The New England Compounding Center: The CEO of a Massachusetts Drug Company on Trial for Murder

by DLA Piper on

This was really a public health tragedy . . . I re- member feeling very scared.’’ This is how Dr. Benjamin Park, a division chief at the U.S. Center for Disease Control and Prevention (‘‘CDC’’), described the deadly...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more

Parallel Claims in PMA Medical Device Complaint Warrant Federal Question Removal

by Reed Smith on

We were wondering when the courts would catch on to this Catch 22. In order to survive preemption, plaintiffs suing the manufacturers of pre-market approved (“PMA”) medical devices have to allege “parallel claims” in which...more

Beware the Empty Space - Defending Food Packaging Design Against Slack Fill Claims

by Bryan Cave on

There is a recent proliferation of slack fill litigation involving food products – both class and non-class suits. If you are a food manufacturer, distributor or seller, you need to be prepared to deal with these claims....more

DELAYED: The FDA’s Intended Use Rule

by Strasburger & Price, LLP on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Blog: FDA Delays “Intended Use” Final Rule until March 2018

by Cooley LLP on

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use...more

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