Class Dismissed

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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February 29, 2016 - Privacy, Internet of Things, FDA, Drug & Medical Device, Product Liability
FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices
By: Erin M. Bosman and Julie Y. Park
The FDA’s recently issued draft guidance on “ Postmarket Management of Cybersecurity in Medical Devices ” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of
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February 24, 2016 - FDA, Drug & Medical Device, Product Liability
Liability for Brand Drug Manufacturers All But Clear
By: Erin M. Bosman and Julie Y. Park
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand drug manufacturers. Judge Zagel found that GSK had not shown “clear evidence” that
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February 22, 2016 - FDA
Court Stays Away from Trans Fat in General Mills Case
A recent decision from the Central District of California demonstrates the challenges serial plaintiffs may have with pursuing similar class actions and showcases the primary jurisdiction doctrine. On December 29, 2015, in Red v. General Mills, Inc., et al., Case No. 2:15-cv-02232-ODW(JPR), U.S. District
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February 15, 2016 - FDA, Food Misbranding, Retail
Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims
We’ve all heard about food fads: Paleo, artisanal, farm-to-table. But what about food litigation fads? Plaintiffs’ lawyers must scour the same grocery aisles, judging from their past “sweet tooth” obsession with “evaporated cane juice” (ECJ). But—with most courts in this District staying ECJ cases
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February 12, 2016 - False Advertising, FDA, Consumer Products
Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action
The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On January 26, 2015, the Ninth Circuit granted General Mills’ motion to dismiss plaintiff Troy Backus’ appeal of a district
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February 08, 2016 - FDA, Drug & Medical Device, Product Liability, MDL
Defendants Find Relief from Burdensome Discovery Requests
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving end of unreasonable discovery requests in an attempt to overwhelm the party and stall litigation. A recent district court decision in In re
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December 17, 2015 - FDA, Drug & Medical Device, Product Liability, Government Actions
New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing
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November 12, 2015 - False Advertising, FDA, Food Misbranding
FDA Requests Public Comments on “Natural” Food Labeling
By: Claudia M. Vetesi and William F. Tarantino
On November 10, the federal Food and Drug Administration (FDA) announced that it is seeking public comments on use of the term “natural” on food labeling. FDA, “Natural” on Food Labeling (Nov. 10, 2015). The agency explained that its actions were prompted by the
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February 18, 2015 - FDA, Drug & Medical Device, Product Liability
FDA Proposed Rule in Flux?
By: Erin M. Bosman and Julie Y. Park
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and discuss alternatives to the much-criticized rule, which
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Topic Archives: FDA

HIPAA and Health Care Apps: Is Your App Covered?

By: Erin M. Bosman and Julie Y. Park

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

By: Erin M. Bosman and Julie Y. Park

Liability for Brand Drug Manufacturers All But Clear

By: Erin M. Bosman and Julie Y. Park

Court Stays Away from Trans Fat in General Mills Case

Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims

Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action

Defendants Find Relief from Burdensome Discovery Requests

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

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

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

FDA Requests Public Comments on “Natural” Food Labeling

By: Claudia M. Vetesi and William F. Tarantino

FDA Proposed Rule in Flux?

By: Erin M. Bosman and Julie Y. Park