Warning Labels

News & Analysis as of

Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption

With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options. After all, as we’ve discussed before, if state common law can’t require changing a...more

Where’s the Beef? Are Stricter Warning Label Requirements on the Horizon for the Meat Industry?

The World Health Organization (WHO), the United Nations’ public health arm, issued a report on October 26, 2015, based on research performed by the International Agency for Research on Cancer (IARC), linking cancer to...more

EPA Safer Choice Partner And Stakeholder Summit Announced

On October 7, 2015, the U.S. Environmental Protection Agency (EPA) announced the first ever Safer Choice Partner and Stakeholder Summit. The summit will be the first of several meetings intended to explore topics of...more

CPSC Recall Snapshot

Earlier this month, the CPSC’s Office of the General Counsel sent the CPSC a proposal for a safety standard for highchairs under the Danny Keysar Child Product Safety Notification Act, Section 104 of the Consumer Product...more

Lack of Warning Causation Dooms Aredia-Zometa Case

Warning: You have heard all this before. Still reading? Okay. But please don't tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more...more

Heedless Heeding Presumptions – How New York Law Became a Morass

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.” This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning...more

M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

Today’s case gives us a lesson and a laugh. The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes. The...more

SDNY Sacks Treanda Failure to Warn Claim

Failure to warn cases remind us of sports talk radio and paleontology. Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination. The Iggles are terrible, their deficiencies...more

Another Major Earthquake: California Creates Big Fissures in Proposition 65 Regulations – Proposals Could Shatter Defenses

In the midst of making Proposition 65’s longstanding warning regulations far more onerous, and vexatious litigation far more likely, California’s Office of Environmental Health Hazard Assessment (OEHHA) has unveiled still...more

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

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