Warning Labels

News & Analysis as of

Prop 65 Amendment Would Limit Frivolous Claims and “Overwarning”

Legislation was introduced in the California Assembly last week to provide much-needed relief from frivolous Proposition 65 claims and avoid “over-warning” the public where scientific evidence shows that products or premises...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Federal judge declines to dismiss olive oil consumer class actions. A US...more

Proposed Prop 65 Rules Won't Please Calif. Businesses

California’s Proposition 65 warning requirements (Health & Safety Code Sections 25249.6 et seq.) have long been a major concern for businesses that want their products offered for sale in the state’s large marketplace....more

Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations

On January 12, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) proposed important new regulations that would repeal and replace the existing Article 6 regulations regarding the all-important "clear and...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

California Earthquake: “Proposition 65” About to be Rocked?

California’s “Proposition 65” warning requirements (Health & Safety Code Sections 25249.6 et seq.) have long been a major concern for businesses that want their products offered for sale in the State’s large marketplace....more

Proposition 65 May Mean More Than Warning Signs and Lawsuits

As this space has discussed, Proposition 65 has been the subject of attempts by the California Legislature to reform the enforcement of the law. Recently, the California Office of Environmental Health Hazard Assessment...more

Proposition 65 Plaintiff Group Seeks to Rescind “Safe Harbor” Standard for Lead

Mateel Environmental Justice Foundation, which has a long history as a Proposition 65 plaintiff, filed a writ petition earlier this week seeking to challenge and rescind the “safe harbor” level for lead under Proposition 65. ...more

New Requirements for Proposition 65 Warnings Proposed

On January 12, 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed the first significant revisions to Proposition 65’s warning requirements since the 1980s. The updated regulations seek to...more

New Proposed Proposition 65 Warning Requirements: What You Need To Know

On January 12, 2015, California’s Office of Environmental Health and Hazard Assessment (“OEHHA”) released the long anticipated Notice of Proposed Rulemaking that proposes changes to the warning requirements under Proposition...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Warning! If You Assume Your Case Will Survive Because You Have a “Creative” Warnings Expert, You Do So At Your Own Risk

Those of us in the business of defending products look at the world in a slightly different way. When I come across a warning label, I actually study it because in a failure to warn case, the language of the warning, the...more

OSHA To Provide Enforcement Discretion On June 2015, Deadline For SDS

On October 31, 2014, the Occupational Safety and Health Administration (OSHA) responded to an August 2014 petition from the American Coatings Association (ACA) and other trade associations to extend the June 1, 2015,...more

Product Liability Update - October 2014

In this Issue: - Massachusetts Appeals Court Holds Trial Court Properly Instructed Jury on Absolute “Unreasonable Use” Warranty Defense Where Plaintiff Ignored Warning Label and Safety Manual and Had Been Drinking, and...more

Get Ready Now for the Upcoming Proposition 65 Warning Requirements for DINP and Other Chemicals

With the 2014 holiday season fast approaching, businesses should not lose sight of what the Proposition 65 “bounty hunter” plaintiffs’ lawyers are eagerly awaiting. And that’s the opportunity to send out 60-Day Notice letters...more

E-Cigarette Companies Choosing to Use Warning Labels

Several large e-cigarette companies are beginning to brand their e-cigarette vaporizer products with detailed warning labels, without there being a legal mandate for them to do so. It is becoming increasingly frequent for...more

Ongoing Reglan Litigation — New Appellate Ruling

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

Proposition 65 "Reform": Consumer Protection or Litigation Stimulation?

Proposed new regulations may have unintended consequences. Despite the California governor’s call for meaningful Proposition 65 reform and a reduction in frivolous enforcement lawsuits, the California Office of...more

Regulation Creep In The Nanny State:The Proposed Not-So-Safe-Harbor Enactment In Proposition 65 Advertising Regulations

Thomas Jefferson once famously warned that, “The natural progress of things is for liberty to yield and government to gain ground.” In the current political climate, this certainly seems to be the case. Businesses are being...more

Closing the Loop-Holes in Generic Drug Warnings

The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs. Under current law, only the brand name...more

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...more

The Ninth Circuit Affirms Dismissal of Lazy Cakes Suit Where Product Packaging Belies Misrepresentation and Omissions Claims

On November 18, 2013, the Ninth Circuit affirmed a district court’s dismissal of a putative class action suit against HBB, LLC. Cheramie v. HBB, LLC, Case No. 12-55148 (9th Cir. Nov. 18, 2013). HBB produces Lazy Cakes, a...more

Amendment to Prop 65 Provides Businesses a Grace Period: AB 227 Aims to Reduce Frivolous Lawsuits and Excessive Penalties

Gov. Brown recently signed Assembly Bill 227 into law, which amends California's Safe Drinking Water and Toxic Enforcement Act of 1986, otherwise known as Proposition 65. Prop 65 provides that businesses may not expose...more

Cocamide-DEA Causing Prop. 65 Headaches for Personal Care Products Companies

When Proposition 65 (Prop. 65) warning requirements took effect for a common ingredient in shampoo and skincare products this past June, the plaintiffs’ bar took notice. To date, 29 notices of violation have issued to dozens...more

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