Class Dismissed

July 21, 2016 - FDA, Drug & Medical Device, Product Liability
FDA Releases Draft Guidance For Updating Generic Drug Labels
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD)
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June 15, 2016 - FDA, Drug & Medical Device
Still Waiting—FDA Delays Rulemaking
By: Erin M. Bosman and Julie Y. Park
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form. The rule, originally proposed
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May 13, 2016 - FDA, Food Misbranding, FTC
FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products
By: Claudia M. Vetesi
As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling (see our previous post here ). The announcement came as a surprise since FDA had previously declined requests from consumers, the food industry,
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April 26, 2016 - FDA, Food Misbranding, Consumer Products, Class Action
Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals
We’ve recently reported on numerous district court—and even Ninth Circuit—stays in false advertising actions. Many of these stays have been based on FDA’s consideration of food labeling issues, such as those involving evaporated cane juice (ECJ), the term “natural” or the presence of partially
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March 30, 2016 - FDA
Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted
Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate ® coffee-creamer products, finding plaintiff’s claims were preempted by federal regulations set to be implemented three years from enactment. Backus v.
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March 30, 2016 - False Advertising, FDA, Food Misbranding
Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered
By: Claudia M. Vetesi
There has been much recent discussion of the primary jurisdiction doctrine, as well as stay motions based on the doctrine, related to FDA’s review of its evaporated cane juice (ECJ) draft guidance. Now, in its recent memorandum disposition in Kane v. Chobani , LLC
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March 30, 2016 - FDA, Drug & Medical Device, Product Liability
Federal Preemption Claims: Clear Evidence and an Unclear Standard
By: Erin M. Bosman and Julie Y. Park
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc. , 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of
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March 29, 2016 - FDA
The (Not So) Sweet Sound of FDA’s Silence: Judge Seeks Answers from FDA on ECJ Draft Guidance
We recently reported on developments in evaporated cane juice (ECJ) stays pending the FDA’s finalized guidance on the ingredient. ( See Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims .) In March 2014, FDA announced that it would revise its
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March 18, 2016 - FDA, Food Misbranding, MDL, Retail
Testing 101: Court Dismisses Whole Foods’ Yogurt MDL over Failure to Comply With FDA Testing Requirements
By: Claudia M. Vetesi
On February 16, 2016, U.S. District Judge Sam Sparks of the Western District of Texas dismissed a multidistrict litigation involving 11 putative class action lawsuits against various Whole Foods corporate entities and Skotidakis, Inc. , a third-party manufacturer, based on an alleged misrepresentation regarding
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March 16, 2016 - Privacy, Internet of Things, FDA
HIPAA and Health Care Apps: Is Your App Covered?
By: Erin M. Bosman and Julie Y. Park
Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that, among other things, broadened the definition of a
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Topic Archives: FDA

FDA Releases Draft Guidance For Updating Generic Drug Labels

By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok

Still Waiting—FDA Delays Rulemaking

By: Erin M. Bosman and Julie Y. Park

FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products

By: Claudia M. Vetesi

Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals

Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted

Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered

By: Claudia M. Vetesi

Federal Preemption Claims: Clear Evidence and an Unclear Standard

By: Erin M. Bosman and Julie Y. Park

The (Not So) Sweet Sound of FDA’s Silence: Judge Seeks Answers from FDA on ECJ Draft Guidance

Testing 101: Court Dismisses Whole Foods’ Yogurt MDL over Failure to Comply With FDA Testing Requirements

By: Claudia M. Vetesi

HIPAA and Health Care Apps: Is Your App Covered?

By: Erin M. Bosman and Julie Y. Park