Class Dismissed

October 24, 2017 - FDA, Drug & Medical Device
Understanding FDA Guidance On Connected Medical Devices
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also
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July 11, 2017 - Appellate & Supreme Court, FDA, Drug & Medical Device, Product Liability, Consumer Products
FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims
By: Erin M. Bosman and Julie Y. Park
The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.
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July 07, 2017 - False Advertising, FDA, Food Misbranding, Consumer Products
UPDATE: The Revival of ECJ Lawsuits*
*This is an update to a previous post on the Class Dismissed blog, seen here. On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because she failed to provide specifics about her own Sports Beans purchase. The court held that the Complaint
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June 12, 2017 - False Advertising, FDA, Food Misbranding, Consumer Products
The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?
Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”) for allegedly misleading consumers by listing “evaporated cane
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May 08, 2017 - Class Certification, FDA, Food Misbranding, Class Action
Ninth Circuit Revives Gerber Baby Food Class Action
By: Claudia M. Vetesi
Bruton v. Gerber, No. 15-15174. The district court had dismissed Plaintiff’s unjust enrichment claim, denied class certification for lack of an “ascertainable class,” and granted summary judgment to Gerber because Plaintiff lacked evidence of deception. The Ninth Circuit reversed the rulings and remanded the
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April 05, 2017 - FDA, Drug & Medical Device, Product Liability
Another Step Toward Reasonable Preemption Case Law
By: Erin M. Bosman and Julie Y. Park
Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th Cir. Feb. 21, 2017). This defense decision is another
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March 30, 2017 - FDA, Drug & Medical Device, Product Liability
Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of
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October 14, 2016 - False Advertising, FDA, Food Misbranding
To Your Health: FDA Redefining the Term “Healthy” on Food Labels
On September 27, 2016, the U.S. Food and Drug Administration (FDA) announced that it has begun a public process to redefine the term “healthy” on food labels. As part of the public process, the FDA is soliciting input from consumers and businesses on their
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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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