Warning Labels

News & Analysis as of

Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos

In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners)...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

California Environmental Law & Policy Update - August 2015 #3

Environmental and Policy Focus: Clean Water Act rule faces challenges from both sides - Courthouse News Service - Aug 18: A widely publicized new rule clarifying the definition of ’waters of the United States’ under the...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Blue Bell resumes ice cream production in Alabama. The Alabama Department...more

FDA Regulatory and Compliance Monthly Recap – July 2015

FDA finalizes guidance on analytical procedures and methods validation - The regulator issued recommendations to help applicants submit analytical procedures and methods validation data to “support the documentation of...more

Medical Device Decision Plays PA’s Greatest Hits

When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio...more

International Food Law Gazette - July 2015

King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more

The Alcohol Tobacco Tax and Trade Bureau Frequently Asked Questions: Growlers

What are the concerns for filling a growler? A growler is either a bottle or a large glass. The distinction is solely dependent on the manner in which the brewer fills the container. When is a growler a bottle? A growler is a...more

Little Reprieve for Prisoner Zyprexa Suit

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it...more

California Bill Would Complicate Labeling Requirements for Children’s Products

California state law bill SB 763 has stayed relatively under the radar since its introduction in February 2015. However, with recent traction in the state legislature – including passage in the Senate in June and passage in...more

Liquid Nicotine—New Warnings and Packaging?

FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine. On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more

And That's The Ballgame: Summary Judgment for Forest Labs In Lexapro Suicide Case

Those of us who live in Philadelphia are endlessly fond of rocking on our porches and reminiscing about the halcyon baseball season of 2008, when our beloved Phillies won the World Series. These days, we are resigned to a...more

Food and Beverage News and Trends

California bill to require warning labels on sugary drinks dies in committee. On April 29, a bill that would have required warning labels on sugary soft drinks failed to move forward in the California legislature. The...more

Pharmaceutical Marketing and Unfair-Trade-Practices Claims

Lawsuits against pharmaceutical companies generally center on product-liability claims. A new trend in pharma cases, however, is to include a different kind of claim: a claim for unfair trade practices....more

Impact of California Appellate Decision on Proposition 65 Actions Unclear

On April 28, 2015, the Environmental Law Foundation (“ELF”) filed a petition in the California Supreme Court for review of the Court of Appeal’s recent decision in Environmental Law Foundation v. Beech-Nut Nutrition Corp., et...more

Food and Beverage News and Trends

Judge rejects consumer claim concerning evaporated cane juice - On March 12, a US district judge in the Northern District of Illinois dismissed with prejudice a consumer lawsuit against the manufacturer of Healthy Grains...more

Fraud In The Smoke Will Not Do

This is from the non-Dechert side of the blog. We do not write too often about tobacco decisions. While FDA has added a Center for Tobacco Products and there are still lots of cases against tobacco manufacturers, we...more

New Prop. 65 Regulations Being Considered in California

For nearly three decades, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as “Proposition 65," has, under specified conditions, required businesses that sell or distribute products in...more

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