Warning Labels

News & Analysis as of

Warning: Lawyers May Be Hazardous To Your Health

Most of the cases we defend involve claims of inadequate warnings. What makes a warning inadequate? Falsehood is the first thing that comes to mind. But the Pontius Pilate question of “What is truth?” continues to vex. We...more

What If We Win? Off-Label Promotion & Product Liability

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

Reminder: Cigar Warning Statements and Warning Plans

The Deeming Regulations enacted by the Food and Drug Administration (FDA) on May 10, 2016, expanded the agency’s tobacco regulatory authority to cigars and certain other tobacco products. Among the regulatory provisions made...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

Plain Packaging and Warning Labels—While the WTO is Examining the Legality of Packaging and Labeling Requirements that Prohibit...

There have been several pieces of research recently calling for the use of plain packaging and graphic health warnings, similar to those used on tobacco products, on soft drinks and alcoholic beverages as a means of...more

New CPSC Safety Standard on Baby Slings

In early January, the U.S. Consumer Product Safety Commission (CPSC) adopted a new federal safety standard for infant sling carriers. 82 Fed. Reg. 2326-1 (Jan. 9, 2017). CPSC’s new rule follows its 2010 warning that baby...more

“Regulatory Causation” Roundup

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called...more

Latin American Environmental Regulatory Tracker

This month’s tracker reflects key initiatives from November 16-December 15, 2016. Happy New Year! As 2016 ended, Latin America continued its focus on sustainability issues and renewable energy policies, spurred in large...more

WARNING: Proposition 65 Warning Requirements Have Changed

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

Prop 65 Update: The Rules They Are a Changin'

Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, among other things requires businesses employing ten or more people to warn consumers if the business’ products contain a chemical...more

OEHHA Adopts Revised Temporary Regulations for BPA Warnings in Food & Beverage Packaging

The Office of Environmental Health Hazard Assessment (OEHHA) recently adopted revised regulations providing safe harbor warnings for food and beverage product packaging containing BPA. These new regulations, which take effect...more

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

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

(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

Latin American Environmental Regulatory Tracker

This month’s tracker reflects key initiatives from October 16 - November 15, 2016. During this last reporting period, key developments include: - Argentina’s congress proposes a spate of new initiatives to govern wastes...more

Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!

Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach. For several years after...more

Regulatory Burdens On Retailers Continue to Evolve

In the run up to the Presidential Election, you may have missed some of the following regulatory developments that might impact your business....more

Smoking Out the Scope of Preemption

Last month, while grappling with an aphrodisiac false-advertising case, we joked that we felt like having a cigarette after reading the court’s opinion. Today we get our cigarette. Or, rather, our e-cigarette. Today’s post...more

New Prop 65 warning rules impose additional burdens on California businesses

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

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

Bootstrapped Claim Against the FDA Gets the Boot

We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a...more

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

Emerging Trends Newsletter - Q3

We are thrilled to bring you the third installment of Stinson Leonard Street's Emerging Trends newsletter. We are proud of the depth and breadth of experience and knowledge across our firm's 13 offices nationwide and are...more

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

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

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