Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Precedential and Key Federal Circuit Opinions - BETEIRO, LLC v. DRAFTKINGS INC. [OPINION] (2022-2275, 06/21/2024) (Dyk, Prost, Stark) - Stark, J. The Court affirmed the district court’s dismissal of multiple, related...more
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Appeal No. 2023-1169 (Fed. Cir. June 25, 2024) In the Court’s only precedential patent opinion last week, the Federal Circuit reversed the district court’s dismissal of...more
A nationwide class action lawsuit accusing a bottled water company of misleading customers by selling water allegedly containing microplastics has been dismissed on preemption grounds. The court’s decision looms large in...more
Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more
The U.S. Supreme Court will likely decide before the end of its current term whether the failure to make a disclosure pursuant to Item 303 of Regulation S-K can serve as the basis for a securities fraud claim under Section...more
Recent Nuclear Verdicts Highlight Danger of Punitive Damages - In October and November 2023, four separate products liability trials ended with large plaintiff verdicts. Three of these verdicts were against Monsanto in...more
On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. - Elena Nacarino, et al. v. Kashi Company and Molly Brown, et al. v. Kellogg Company, Nos....more
On August 14, 2023, a panel of judges for the United State Court of Appeals for the Ninth Circuit issued a published opinion affirming dismissal of two complaints alleging that food product labels advertising the amount of...more
A potato-chip brand once famously boasted, “No one can eat just one.” And of course, no one can. But according to the Food and Drug Administration (FDA), you aren’t going to eat more than 16 (or 28 grams), because that is the...more
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. - Felix Bermudez et al. v. Colgate-Palmolive Company, No. 1:21-cv-10988-JLR (S.D.N.Y. – March...more
A district court in Utah recently dismissed claims brought against a biotechnology company and its officers under Section 10(b) of the Securities Exchange Act and Rule 10b-5 adopted thereunder. The order in Richfield v....more
Cannabis: In Focus - - DEA Classifies Two Lab-Derived Cannabinoids as Schedule I - Washington Federal Judge Dismisses Suit Challenging Residency Requirements...more
Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved - A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water,...more
FDA Rejects Citizen Petitions, Declines To Regulate CBD as a Dietary Supplement - The U.S. Food and Drug Administration (FDA) announced its conclusion that a new regulatory pathway for cannabidiol (CBD) is needed on...more
In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...more
On June 14, 2022, the U.S. Court of Appeals for the Third Circuit affirmed the dismissal of a securities suit brought by investors in pharmaceutical company, Amarin Corporation, PLC, holding that the investors had failed to...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label”...more
On May 28, 2021, a group of Houston Methodist Hospital employees filed a lawsuit challenging the hospital’s COVID-19 vaccine mandate for employees. The lawsuit, filed by 117 employees, was the first to challenge a health...more
On June 30, 2021, Judge Rosenberg—who presides over the Zantac multidistrict litigation in the Southern District of Florida—dismissed with prejudice a RICO claim against the brand-name manufacturers of Zantac under the...more
The Ninth Circuit last month upheld a trial court’s decision to dismiss a false advertising lawsuit against Trader Joe’s concerning the store’s labeling of its Manuka honey. The case, Moore et al. v. Trader Joe’s Co., Case...more
Last week, a federal district court judge in Texas dismissed a lawsuit filed by a group of Houston hospital workers who object to their employer’s requirement that all employees receive the COVID-19 vaccination. The...more
In April, Houston Methodist Hospital announced its decision to mandate the COVID-19 vaccination for all employees. One hundred seventeen employees sued to block the mandate. But, on June 12th, one day after hearing oral...more