Topic Archives: FDA

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices.  Industry should take note, as these developments detail the agency’s current expectations for companies preparing to combat future ...›

Mixed Results on Class Certification for “Cereal” Plaintiff

In Hadley v. Kellogg Sales Company, Plaintiff Stephen Hadley, who has filed at least two additional lawsuits alleging the mislabeling of breakfast foods, sought certification of four California subclasses of purchasers of Kellogg’s cereal and cereal bar products.  On August 17, 2018, Judge Koh issued an order that carefully dissected Plaintiff’s request.  The court concluded ...›

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.  The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices.  Specifically, AM makes objects by sequentially building 2-dimensional layers and joining each to the layer below.  ...›

January 3, 2018Consumer Products, FDA, Retail

Makeup Shake Up: Potential New Federal Cosmetics Regulations

“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible for allegedly confusing customers and complicating regulations.  Lawmakers have tried and ...›

October 24, 2017Drug & Medical Device, FDA

Understanding FDA Guidance On Connected Medical Devices

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 recognizes the growing importance of these connected devices and issued final ...›

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

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.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). ...›

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 juice” (ECJ) instead of “sugar” in the ingredient list of its ...›

Ninth Circuit Revives Gerber Baby Food Class Action

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 case. Background of the Case.  Plaintiff alleged that the labels on ...›