News & Analysis as of

Warning Labels

When Plaintiff Conduct Matters

by Reed Smith on

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries. We specifically examined this doctrine’s most common...more

Food & Beverage Litigation Update | September 2017 #2

FDA Seeks Comment on Regulation Changes for "Meaningful Burden Reduction" - Implementing an executive order titled "Reducing Regulation and Controlling Regulatory Costs," the U.S. Food and Drug Administration (FDA) has...more

WARNING! Prop 65 regulations are a year away in California. Is Your Product’s Warning Label Compliant?

by Wilson Elser on

After many years of debate, consideration and public input, California’s new regulations go into effect on August 30, 2018, under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 - commonly known as Prop 65....more

OEHHA Attempts to Clarify New Proposition 65 Clear and Reasonable Warning Regulations by Issuing Guidance and Proposed Amendments

by Beveridge & Diamond PC on

On August 30, 2016, the California Office of Environmental Health Hazard Assessment (“OEHHA”) repealed and readopted Article 6 of Title 27 of the California Code of Regulations, which sets forth the method and content deemed...more

Is Your Company Ready for the New Prop 65?

by Polsinelli on

One year from now, companies that do business in California will have to comply with new warning regulations under the state’s Safe Drinking Water and Toxic Enforcement Act (“Proposition 65”)....more

Good Risperdal Times, Part Three: Summary Judgment for Janssen in Philadelphia

by Reed Smith on

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday...more

A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug

by Arnall Golden Gregory LLP on

Last month, FDA district offices issued Warning Letters to two cosmetic companies for making claims that established their products as drugs. In finding that the products were new drugs requiring premarket approval, FDA...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Proposition 65: New “Naturally Occurring” Level Proposed for Rice

by Morrison & Foerster LLP on

The California Office of Environmental Health Hazard Assessment (OEHHA) recently proposed levels of inorganic arsenic in rice that would be deemed “naturally occurring” and thus exempt from the Proposition 65 warning...more

Compensatory Damages Allowed to Stand in Depakote Trial, Despite Adequate Warnings and Lack of Warnings Causation

by Reed Smith on

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts). Last week, we saw the...more

The Luck of The Draw: A Strong Preemption Ruling from an Anticoagulant MDL

by Reed Smith on

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak. We think design defect claims usually are clearly preempted in...more

Six things to know about glyphosate

by DLA Piper on

Glyphosate, one of the most widely used herbicides in the world, is under scrutiny by media and plaintiff groups amid recent reports that it is potentially carcinogenic. A key ingredient in consumer and industrial...more

Warning: New Proposition 65 Warning Regulations Taking Effect

by Morrison & Foerster LLP on

A year from now, dramatic changes to California’s Proposition 65 warning regulations take full effect. The new regulations (formally published by the State in August 2016) significantly alter the “safe harbor” rules for...more

California’s Prop 65: More Form Over Substance

California’s Safe Drinking Water & Toxic Enforcement Act of 1986 (affectionately known as “Proposition 65”) has long been the subject of discussion, both pro and con. Much of the conversation is on various issues surrounding...more

Food and Beverage News and Trends - July 2017 #2

by DLA Piper on

What impact will the listing of glyphosate under Prop 65 have on food companies? On July 7, glyphosate, the active ingredient in common herbicides, was added to California's Prop 65 list. This means that starting in July...more

insights Newsletter - Summer 2017

Shumaker is pleased to present the Summer 2017 issue of insights. In it we discuss: - Proposition 65 Amendments Require Re-evaluation of Products and Warnings - Privacy Compliance Driven by the European...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

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

Boxed Warnings and Adequacy as a Matter of Law

by Reed Smith on

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FRANCHISOR 101: Donut Franchise Relationship Dissected by Court

by Lewitt Hackman on

The parent of Dunkin' Donuts was named along with Starbucks and about 80 other coffee sellers, distributors and retailers in a 2010 lawsuit alleging violations of California's Proposition 65 and Safe Drinking Water and Toxic...more

Failure To Contraindicate Claims and Preemption

by Reed Smith on

We were recently asked the question, “are failure to contraindicate claims preempted?” Our immediate response was, “How could they not be”? However, it’s not helpful to answer a question with a question, and as with all...more

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Old Grounds: A Lack of Prop 65 Warnings Brew Trouble for Coffee Franchisors

by Lewitt Hackman on

California Prop 65 warnings – many residents barely notice these anymore, as we’ve lived with Safe Drinking Water and Toxic Enforcement Act notices for over 30 years now. They appear at gas pumps; in apartment and office...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

229 Results
|
View per page
Page: of 10
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.