Warning Labels

News & Analysis as of

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

Statins Litigation Summary

Lawsuits gainst Pfizer were recently certified into MDL 2502 before U.S. District Judge Richard M. Gergel in South Carolina. Plaintiffs allege that the LIPITOR® (atorvastatin calcium) warning label used medical jargon that...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

Incremental Reform Bill Passes, But Governor’s Broader Changes Stall

California Gov. Jerry Brown promised earlier this year to get serious about reforming some of what the business community calls the worst abuses of Proposition 65 (Prop. 65) – changes in the definition of what constitutes a...more

New Football Helmet Warning Labels Beg the Question – Do you really want to get your head in the game?

Football helmet companies make attempts to avoid future athletes’ injuries and lawsuits: The topic of traumatic brain injuries (TBI) in sports has recently become a very pressing issue. Most notably, the occurrence of...more

California Appellate Court Emphasizes Significance of Warnings for Manufacturers Seeking to Avoid Liability in Product Misuse...

On July 9, 2013, the Second Appellate District of California handed down an opinion curtailing the pursuits of plaintiffs attempting to inflate their claims by dragging in manufacturers of products used in conjunction with,...more

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

Generic Drug Preemption Expanded by Supreme Court's Bartlett Decision

Not surprisingly, the Supreme Court reaffirmed the broad preemptive scope of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and further extended the reach of impossibility preemption to design defect claims, in issuing its...more

Proposition 65 Reform Efforts Drawing Strong Support From Legislature and Governor

There may be reforms coming to Proposition 65 (Prop. 65) after several previous failed attempts and a growing chorus of complaints from business large and small over the years concerning the unfairness of the law, which was...more

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

Mutual v. Bartlett Further Shields Generic Drug Manufacturers from Liability

Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

Out of the Box - Volume 1, Issue 1, June 2013: Proceed With Caution When Warning Product Users

For most consumer product companies, in-house counsel and risk managers can never be too careful when it comes to providing warnings or other disclosures that describe (and qualify) the potential risks and benefits associated...more

What the Product Label Doesn’t Tell You

California is unique in that its residents have been protected against cancer-causing chemicals in many household products since1986 by Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act. Under this...more

California Environmental Law and Policy Update - May 9, 2013

Environmental and Policy Focus - Gov. Brown joins move to rewrite California's Prop. 65 - The Sacramento Bee - May 7: Gov. Jerry Brown is throwing his weight behind a push to update Proposition 65, California's defense...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Product warning labels - How well-written product warning labels can lessen a company’s liability

When screwdrivers were created, they had an obvious use — to turn screws. But over time people started using them as chisels and pry bars, which led to injuries and the addition of warning labels that laid out the proper use...more

Quitting Smoking? How Chantix May or May Not Be Able to Help

Individuals looking to quit smoking may turn to popular smoking-cessation drugs like Chantix (varenicline). Almost everyone has seen the commercials for Chantix, where a handful of people indicate that the drug has helped...more

FDA Energy Drink Regulation in the News: Health Experts Push for Regulatory Changes and Monster Moves to Market as a Beverage...

On March 19, 2013, a group of doctors, researchers, and public health experts sent a joint letter to the Commissioner of the U.S. Food and Drug Administration (“FDA”) urging the FDA to make changes to the regulation of energy...more

Breaking Down The Bartlett Oral Argument

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

Under the Dome: Inside The Maine State House Special Edition 1-24-13

With a population of roughly 1.3 million people, Maine is a small player in national markets. At the same time, Maine legislators have attempted to have an out-sized voice in the national marketplace of legislative policy by...more

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