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Whistleblowers › FDA Approval

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

Morgan Lewis - As Prescribed on

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

The Volkov Law Group

St. Jude Agrees to Pay $27 Million to Settle False Claims Act Charges for Selling Defective Heart Devices (Part III of V)

The Volkov Law Group on

St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities.  St. Jude was acquired by Abbott Laboratories in early 2017....more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Robinson+Cole Health Law Diagnosis

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

Robinson+Cole Health Law Diagnosis on

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

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