News & Analysis as of

Warning Labels Manufacturers

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

California’s New Prop. 65 Warning Regulations Put Primary Burden for Providing Warning on Manufacturers

by Bryan Cave on

Companies that do business in California should be familiar with Proposition 65, which prohibits knowingly and intentionally exposing consumers to a chemical known to the state to cause cancer or reproductive harm without...more

WARNING: Proposition 65 Warning Requirements Have Changed

by K&L Gates LLP on

Thirty years after its enactment, California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly referred to as “Proposition 65”) remains an undiminished irritant to businesses who sell products that are used in...more

Heeding Presumption Only Goes So Far In Post-Sale Warning Case

by Reed Smith on

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the...more

3D Printing of Manufactured Goods: An Updated Analysis

by Reed Smith on

(NEW YORK) December 15, 2016 – Reed Smith LLP today released “3D Printing of Manufactured Goods: An Updated Analysis,” a comprehensive new white paper that provides in-house counsel and industry leaders with an in-depth look...more

New Prop 65 warning rules impose additional burdens on California businesses

by Thompson Coburn LLP on

The California Office of Environmental Health Hazard Assessment (OEHHA), the lead Proposition 65 enforcement agency, recently adopted new Prop 65 regulations. (Title 27, California Code of Federal Regulations, Article 6). The...more

WARNING: Prop 65 Can Expose Product Manufacturers to Increased Litigation in California

by Stinson Leonard Street on

California's Proposition 65 ("Prop 65") requires product manufacturers and sellers to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone in California to a chemical listed by the...more

Proposition 65: New regulations for "clear and reasonable" warnings

by Dentons on

Remember when the warning above was “clear and reasonable” for purposes of Proposition 65? Soon that will no longer be true. Following a two-year rulemaking, the California Office of Environmental Health Hazard Assessment...more

California Prop 65: More Unintended Consequences

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations. Much of the discussions regarding these new regulations have centered on the warning...more

New Modifications to the Proposition 65 Regulations

by Morgan Lewis on

The modifications significantly change both the AG’s Regulations and OEHHA’s Clear and Reasonable Warnings provisions. California’s Office of Administrative Law recently approved important changes to two sets of Proposition...more

California Adopts Amendments to Prop 65 “Safe Harbor” Warning Requirements

In September, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) announced that it had adopted amendments to the regulations governing California’s Proposition 65, which requires that businesses provide a...more

California Adopts New Regulations For Warnings Under Proposition 65: CAVEAT VENDITOR (Sellers Beware)

by Seyfarth Shaw LLP on

Come August 30, 2018, consumer products to be released into the California marketplace must meet new regulations under California’s infamous Proposition 65. On August 30, 2016, the California Office of Administrative Law...more

WARNING: California’s Proposition 65 Warning Requirements are Changing

by Kelley Drye & Warren LLP on

California’s Office of Environmental Health Hazard Assessment (“OEHHA”) recently finalized substantial amendments to the regulations governing the provision of warnings required by “Proposition 65” (a/k/a the “Safe Drinking...more

Prop. 65 Conference Focuses on Compliance With New Warning and Settlement Regulations

by Bryan Cave on

The Prop. 65 Clearinghouse held its annual conference in San Francisco recently, and the speakers and panelists had a number of recommendations for both retailers and manufacturers following the adoption of Proposition 65’s...more

New Proposition 65 Regulation Amendments Modify Clear and Reasonable Warning Requirements and Private Enforcement Settlement...

by Beveridge & Diamond PC on

The California Office of Environmental Health Hazard Assessment (OEHHA) and the California Attorney General each adopted regulatory amendments to the Proposition 65 regulations at the close of August 2016. The OEHHA...more

WARNING: OEHHA amends California Proposition 65 requirements for "clear and reasonable warnings": next steps

by DLA Piper on

The California Office of Environmental Health Hazard Assessment (OEHHA) has introduced the final amendments to the "clear and reasonable warnings" required by Proposition 65. This unique California law, in relevant part,...more

California Adopts New "Clear and Reasonable Warning Requirements" for Proposition 65

If you're modifying packaging or introducing a new product, it may be a good time to update your Proposition 65 warnings. On August 30, 2016, California’s Office of Administrative Law approved the adoption of amendments to...more

California Adopts New Prop. 65 Warning Regulations

by Bryan Cave on

California’s Office of Environmental Health Hazard Assessment (OEHHA) has adopted new Proposition 65 warning regulations. The new regulations will take effect in two years, on August 30, 2018. In the interim, businesses may...more

WARNING: California Adopts New Proposition 65 “How to Warn” Rules

by Morrison & Foerster LLP on

Last Friday, the state published the first major changes to the Proposition 65 regulations in more than a decade. The sweeping changes rewrite the “safe harbor” warning regulations and, in doing so, create a new set of...more

Prop 65 Warning Regulations Adopted

by Alston & Bird on

Today, September 2, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) published its notice of adoption of amendments to Prop 65 – essentially overhauling Title 27 of the California Code of...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

by Reed Smith on

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

EPA Issues Final Rule on Formaldehyde Emission Standards for Composite Wood Products

On Wednesday, July 27, 2016, the Environmental Protection Agency (“EPA”) released a prepublication version of its final rule on Formaldehyde Emission Standards for Composite Wood Products. The authority for the rule comes...more

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other...more

The Toxic Substances Control Act Amendments May Do Little to Relieve California Headaches for Businesses

by Morrison & Foerster LLP on

Business groups largely supported the Toxic Substances Control Act (TSCA) Amendments?recently signed into law by President Obama—in order to address concerns about the emergence of varying state-by-state requirements that...more

California Adds Group of Herbicides to Proposition 65 List

by Bryan Cave on

Following a failed legal challenge by Syngenta Crop Protection, California’s Office of Environmental Health Hazard (OEHHA) has announced that it has added a group of broadleaf herbicides to the list of chemicals under...more

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