News & Analysis as of

Pharmaceutical Industry Misleading Statements

A&O Shearman

Ninth Circuit Affirms Dismissal of Putative Class Action Against Pharmaceutical Company for Failure to Adequately Allege Falsity...

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On August 20, 2025, the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative class action asserting claims under the Securities Exchange Act of 1934 against a pharmaceutical company and...more

Venable LLP

Policymaking Priorities to Address Animal Vaccine Hesitancy

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U.S.-licensed vaccines currently exist for hundreds of animal diseases. Among these are vaccines for diseases that affect both animals and humans, including rabies, West Nile virus, brucellosis, leptospirosis, and Lyme...more

A&O Shearman

Western District Of Pennsylvania Denies Motion For Judgment On The Pleadings In Securities Class Action Against Pharmaceutical...

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On July 8, 2025, Judge Nicholas Ranjan of the United States District Court for the Western District of Pennsylvania denied a motion for judgment on the pleadings, allowing a putative securities class action to proceed against...more

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

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FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

A&O Shearman

Northern District Of California Dismisses Securities Class Action Against Biopharmaceutical Company For Failure To Adequately...

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On May 5, 2025, Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California granted a motion to dismiss a proposed class action asserting claims against a biopharmaceutical company...more

A&O Shearman

Central District Of California Dismisses Putative Securities Class Action Against Healthcare Technology Company For Failure To...

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On April 18, 2025, Judge André Birotte Jr. of the Central District of California granted a motion to dismiss a putative class action asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the...more

Arnall Golden Gregory LLP

It Cuts You Up: OPDP Issues an NOV to a Dermatologic Drug Company

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more

Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

Alston & Bird

Class Action & MDL Roundup 2023 Q4 - Not All Cases Survive and Advance

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Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more

Troutman Pepper Locke

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

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Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

Gardner Law

OPDP is Back Sending Untitled Letters after a Yearlong Hiatus

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For a little over a year, the Office of Prescription Drug Promotion (OPDP) sent no untitled letters. OPDP ended this untitled letter hiatus this summer when it sent two untitled letters—one in June and another in August—and a...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Office of Prescription Drug Promotion Issues Second Untitled Letter of the Year to Exeltis for Misleading Statements...

On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post...more

A&O Shearman

District Of New Jersey Allows Securities Fraud Claim To Proceed Against Outside Accounting Firm, Finding Plaintiff Sufficiently...

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On June 15, 2023, Judge Michael A. Shipp of the United States District Court for the District of New Jersey, in an unpublished opinion, adopted a Special Master’s Report and Recommendation denying a motion to dismiss claims...more

Arnall Golden Gregory LLP

FDA’s Not Dead Yet: The Agency’s OPDP Issues First Untitled Letter for 2023

Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail,...more

A&O Shearman

Second Circuit Affirms Dismissal Of Putative Class Action Against Pharmaceutical Company For Failure To Allege Misstatements and...

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On May 16, 2023, the United States Court of Appeals for the Second Circuit affirmed a district court’s dismissal of a putative class action asserting claims against a pharmaceutical company (the “Company”) under Sections...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

BCLP

Paris Litigation Gazette Issue 2 - March 2023

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Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....more

A&O Shearman

Southern District Of New York Grants Pharmaceutical Company’s Motion To Dismiss Putative Class Action Alleging Misrepresentations...

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On March 1, 2023, Judge Jesse Furman of the United States District Court for the Southern District of New York granted a motion to dismiss a putative class action against a pharmaceutical company (the “Company”) and its...more

Harris Beach Murtha PLLC

Medical and Life Sciences: Year in Review 2022

From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

BakerHostetler

AD-ttorneys@law - May 2022

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NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more

Goodwin

Northern District of Illinois Grants Motion for Partial Reconsideration of Summary Judgment Decision Regarding Whether Former...

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Northern District of Illinois Grants Motion for Partial Reconsideration of Summary Judgment Decision Regarding Whether Former Walgreens CFO’s Statements Were Actionable; Securities Fraud Claims Against Chicken Producer for...more

A&O Shearman

Second Circuit Affirms Dismissal Of Suit Against Pharmaceutical Company After Failed Clinical Trial

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On March 11, 2022, the United States Court of Appeals for the Second Circuit affirmed the dismissal of claims under Sections 10(b), 20(a), and 20A of the Securities Exchange Act of 1934 (“Exchange Act”) against a...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Arnall Golden Gregory LLP

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post

Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more

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