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Warning Labels

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

"Toxic" Tort Food Litigation: The Truth Behind the Headline

by Bryan Cave on

Chicago Partners Susan Brice and Thor Ketzback, along with San Francisco Associates Merrit Jones and Thomas Lee, presented on "Toxic" Tort Food Litigation: The Truth Behind the Headline, May 4, via a live presentation in our...more

Practitioner Insights: California Crowdsources Chemical Rules: What Could Go Wrong?

by Alston & Bird on

Environmental and product regulations, traditionally a science-obsessed and labyrinthine area of the law dominated by experts in administrative agencies, will receive an internet-age overhaul to make them more accessible to...more

Summary Judgment for Concentric Medical on Design Defect and Warnings Claims Related to Fracture of Merci Retriever Device

by Reed Smith on

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the...more

N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings

by Reed Smith on

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable,...more

Another Accutane Verdict Vacated in New Jersey

by Reed Smith on

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious....more

Food and Beverage News and Trends - April 2017

by DLA Piper on

Six consumer groups ask major food companies to oppose regulatory reform bill. On April 11, a coalition of six consumer organizations sent a letter to 11 major food manufacturers, retailers and restaurant chains, calling upon...more

Smoke Screens & Side Shows

by Reed Smith on

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time. It’s...more

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