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Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
New Suit Claims "Scientifically False" Pheromone Ads Are "Pure" False Advertising - "It's not myth. It's science." So claims Pure Instinct in its ads for pheromone perfumes. But a new class action lawsuit claims it's not...more
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
Connecticut AG William Tong announced that his office has settled with four over-the-counter hearing aid companies: Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., and Wonder Ear, Inc. (collectively, “OTC...more
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
Delaware Court of Chancery Finds that Director’s Email on Outside Email System Remains Confidential; Delaware Supreme Court Overrules Longstanding Precedent Regarding Derivative Versus Direct Standing; SEC Files Crowdfunding...more
On June 10, 2020, the US Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative securities fraud class action against Endologix, Inc., a medical device company, on the grounds that the shareholder’s core...more
The United States District Courts for the District of New Jersey and the Southern District of New York recently dismissed putative securities class action complaints filed against life science companies in Smith v. Antares...more
The Private Securities Litigation Reform Act of 1995 protects “forward-looking statements”—that is, predictions about the future, at least when they are accompanied by “meaningful cautionary statements” that could cause the...more