Warning Labels

News & Analysis as of

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine (“LID”), which has been adopted in almost every state, was...more

The New One-Two Is Back

A couple of years ago the one-two punch was all the rage in prescription drug cases. “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

Product Liability Alert: Changes to California Prop. 65 Warning Requirements May Create New Pitfalls for Consumer Businesses – Key...

California’s Proposition 65 requires businesses to provide “clear and reasonable” warnings when they “expose” Californians to listed chemicals identified by the state to cause of cancer or reproductive harm (currently, over...more

Alabama No Longer An Outlier State: Legislature Says “No” To Innovator Liability

I. Introduction - Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more

Proposition 65: OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing...more

California Changes Course in Amendments to Proposition 65 Warning Label Requirements

Businesses in California have been thrown another curveball in following developments related to the state’s Proposition 65, the much-criticized statute requiring prolific warnings of exposure to toxic substances and fueling...more

California Issues New Draft of Proposition 65 Warnings Overhaul - Significant Changes Respond to Public Comment

In January 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed the most significant revisions to the Proposition 65 warning regulations since the 1980s. Not surprisingly, OEHHA received...more

New Draft Prop. 65 Warning Regulations: What Manufacturers and Suppliers Need to Know

On November 24, 2015, the Office of Environmental Health Hazard Assessment (“OEHHA”) issued proposed revisions to its January 15, 2015 draft Prop. 65 warning regulations. 27 CCR §§25600 et seq. The full text of the new draft...more

After Years of Starts and Stops, OEHHA Commences New Rulemaking to Change the Prop 65 Product Label Requirements

After nearly a year of heavy industry opposition and objections to the proposed draft regulations requiring all manufacturers selling goods in California to change their Prop 65 product label warnings, the California Office...more

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

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