News & Analysis as of

Food and Drug Administration (FDA) Life Sciences Product Defects

Harris Beach Murtha PLLC

Medical and Life Sciences: New York 2024 Year in Review

From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

DLA Piper

Life Sciences Year in Review and What's Ahead

DLA Piper on

2024 was eventful in the life sciences space – and key trends are expected to continue in the new year. ...more

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

Jones Day on

The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

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Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Console and Associates, P.C.

Federal Investigation of Anterior Growth Guidance Appliance (AGGA) Dental Device Prompts Wave of Lawsuits

When a doctor suggests that a medical device may help you, they’ll explain a little bit about how the device works; however, truly understanding how any given device works often requires either a medical or scientific...more

Nelson Mullins Riley & Scarborough LLP

Heartburn for Valisure: Controversial Testing Lab Under Fire

In early December, a federal judge tossed plaintiffs’ expert evidence and dismissed some 2,450 lawsuits in the sprawling litigation involving the heartburn medication Zantac. U.S. District Judge Robin L. Rosenberg’s December...more

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

The Volkov Law Group on

Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

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Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

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