News & Analysis as of

Court Issues Sweet Ruling for Plaintiffs in Mislabeling Action – Ignorance That “Evaporated Cane Juice” Is An Added Sugar Not...

In Morgan v. Wallaby Yogurt Co., Inc., the U.S. District Court for the Northern District of California denied defendant’s motion to dismiss a class action complaint alleging violations of the UCL, FAL, and CLRA for...more

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

Proposed FDA Labeling Revisions Would Impact Wines Below 7 Percent ABV and Certain Non-Malt Beers

On March 3, 2014, the Food & Drug Administration (FDA) published a Notice of Proposed Rulemaking (NPRM) that, if and when finalized, would make important changes to the labeling of all foods subject to FDA’s primary labeling...more

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R....more

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer,...more

FDA Makes A Federal Case Out Of Local Food Product Mislabeling In New Jersey

Any product manufacturer has a strict responsibility to create products that are safe for consumer use. Even inherently-dangerous products, such as chainsaws and other power tools, must carry clear instructions and warnings...more

Medical Device Postmarket Compliance in the United States

Introduction - Once the U.S. Food and Drug Administration (FDA or “the agency”) has cleared or approved a medical device for marketing in the United States, there are still significant postmarketing requirements with...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Court May Ask FDA to Weigh In on “All Natural” Debate

California federal courts, particularly those in the Northern District, have become a magnet for food labeling litigation—in particular, cases challenging “All Natural” labels on products containing genetically modified...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Advertising Law -- May 09, 2013

Harsh Criticism for Ad Industry Over DNT - The advertising industry faced harsh criticism at a hearing held by Sen. Jay Rockefeller (D-W.V.). He addressed the implementation of a federal Do Not Track program and...more

FDA Shines a Light on Tanning Bed Safety, Proposes Device Reclassification and Warnings to Users Under 18

After issuing a public warning regarding the dangers of tanning nearly three years ago, this week the U.S. Food and Drug Administration (“FDA”) issued a proposed order to reclassify sunlamp devices and require labeling...more

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (2nd Edition)

In October 2009, we published the first edition of this White Paper, focusing primarily on social media issues in the United States. The response was overwhelming and far beyond our expectation — clients, friends, press and...more

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more

Stefanie Fogel On What’s Next For Food Labeling Issues In 2013

After a year that saw labeling issues come to the forefront of the food safety conversation, I sat down with DLA Piper trial lawyer Stefanie Fogel to get her take on how manufacturers, producers, and retailers can expect the...more

FDA Releases CPG for Labeling and Marketing of Therapeutic Animal Foods

On September 10, 2012, the U.S. Food and Drug Administration (FDA) released a draft compliance policy guide (“CPG”) entitled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat...more

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