News & Analysis as of

Warning Labels

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

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...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: Lawyers May Be Hazardous To Your Health

by Reed Smith on

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

by Reed Smith on

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

by Bass, Berry & Sims PLC on

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

by Roetzel & Andress on

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

by Reed Smith on

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...

by King & Spalding on

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

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