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Result-Driven Affirmance of Birth Defect Verdict

We have said it before – birth defect cases are hard. Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter. We have also said that we do not like it when judges frame the...more

Calif. Appellate Court Endorses Averaging Lead Exposure in Food and Beverage Prop. 65 Disputes

In a rare published decision concerning California’s expansive Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as “Prop 65,” the California Court of Appeal on March 17, 2015, dealt companies a victory in...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

Court Finds that Class Action Plaintiffs’ False Advertising Claims are Stripped Bayer Based on Federal Preemption

In the recent case of Gallagher v. Bayer AG, Case No. 14-cv-04601-WHO (N.D. Cal. March 10, 2015), the plaintiffs asserted that the defendants Bayer AG and related entities (collectively, “Bayer”) engaged in false advertising...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

California: Service of Suit Endorsement Trumps Forum Selection Clause in Case Involving Product Recall Due to Contamination.

On February 5th in a case involving the recall of over $500,000 worth of oyster products made from Korean shellfish, the Southern District of California held: (1) that the policy’s service of suit clause, which gave the...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

Albany County, NY Enacts Stringent Children’s Product Safety Law

Do local governments, such as town councils and county legislatures, have a role in regulating consumer products that is typically reserved for the federal and state governments? Apparently, the legislature and executive of...more

Q&A Series: Class Action Litigation Has Focused On Claims By Spirits Producers on Labels, Websites, and In Marketing Campaigns

In some cases class action plaintiffs are making claims based on an allegedly incorrect statement on a label. Does TTB approval of a label protect a producer against claims based on the content of the label? TJC: There...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

Pom Wonderful Drops Ninth Circuit Appeal of State Claims Filed Against Coca-Cola

On September 19, 2014, Pom Wonderful, LLC dropped its Ninth Circuit appeal of a ruling that dismissed its state deceptive advertising and unfair competition claims against Coca-Cola, a sibling case to a recent Supreme Court...more

Ongoing Reglan Litigation — New Appellate Ruling

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

Lanham Act Claims Are Not Precluded by Compliance with the FDCA

In POM Wonderful LLC v. Coca-Cola Co., decided last month, the U.S. Supreme Court confirmed that companies can bring unfair competition actions under the Lanham Act even when their competitors have complied with the Federal...more

Food Litigation Newsletter - August 2014

In This Issue: - Recent Significant Rulings ..Court Dismisses Most of plaintiff’s Claims Based on Regulatory Violations ..Court Dismisses MSG Claims in Part on Preemption Grounds ..Court Partially...more

Huskey V. Ethicon: Case Survives Federal Preemption Argument by Ethicon

Johnson & Johnson’s Ethicon division tried, as it had before, to have its upcoming federal transvaginal mesh case thrown out of court. The healthcare giant was unsuccessful. On July 8, Judge Joseph Goodwin, who is...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

Supreme Court Decision May Lead to More False Advertising Claims in Food and Beverage Industry

The Supreme Court's ruling in Pom Wonderful LLC v. Coca-Cola Co. may open the door to more false advertising claims regarding food and beverage labeling....more

The Supreme Court Gives Juice To Lanham Act Claims

The Supreme Court’s unanimous opinion in POM Wonderful LLC v. Coca-Cola Co. (Dkt. No. 12-761) (June 12, 2014) highlights the key role of Lanham Act false advertising claims in protecting consumers from misleading advertising...more

POM v. Coke Does Not Alter The Landscape for Food False Advertising Class Actions

After the oral argument in POM Wonderful LLC v. Coca-Cola Co., No. 12-761, the Supreme Court appeared all but certain to allow competitors to sue for false advertising under the Lanham Act over labels of FDA-regulated food...more

Recent Supreme Court Decision on “Truth-in-Labeling” Has Far-Reaching Implications

On April 28, 2014, we reported on the United States Supreme Court’s involvement in the juice-labeling lawsuit between POM Wonderful LLC (“POM”) and Coca-Cola (“Coke”). In POM Wonderful LLC v. Coca-Cola Co. (“POM”), POM sued...more

U.S. Supreme Court: Pom’s Mislabeling Suit Against Coke Not Precluded by FDA Regulations

Recently, the Supreme Court ruled, 8-0, that Pom Wonderful LLC could pursue mislabeling claims under the federal Lanham Act against the Coca-Cola Company, even though the label at issue complied with FDA labeling regulations....more

Supreme Court Holds That Lanham Act False Advertising Claims Are Not Preempted by FDCA

Earlier today, the U.S. Supreme Court unanimously held that a Lanham Act false advertising case may be brought even if Food and Drug Administration (FDA) beverage labeling regulations permit use of the challenged claim....more

Supreme Court Decides POM Wonderful LLC v. Coca-Cola Co.

Petitioner POM Wonderful LLC makes and sells juice products, including a pomegranate-blueberry juice blend. Coca-Cola Company makes a juice blend with a label that prominently displays the words "pomegranate" and "blueberry"...more

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