Navigating Civil Standing Requirements for Defense Success — RICO Report Podcast
Consumer Finance Monitor Podcast Episode: Universal Injunctions, Associational Standing, and Forum Shopping - Their Effects on Legal Challenges to Regulations
Recent Trends in Article III Standing - The Consumer Finance Podcast
Eleventh Circuit Grants en banc Review to Resolve Controversial TCPA Standing Ruling
AGG Talks: Background Screening - A Refresher on Responding to Consumer File Requests under Section 609 of the FCRA
Law School Toolbox Podcast Episode 313: Listen and Learn -- The Basics of Justiciability (Con Law)
#WorkforceWednesday: SCOTUS in Review, Biden Acts to Limit Non-Competes, NY HERO Act Model Safety Plans - Employment Law This Week®
SCOTUS Watch: The ACA and Key Health Law Areas Justice Barrett Could Impact - Diagnosing Health Care Podcast
Bar Exam Toolbox Podcast Episode 110: Listen and Learn -- The Basics of Justiciability (Con Law)
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Podcast: Texas v. United States of America
Supreme Court’s Rulings On Same-Sex Marriage Spark Many Questions On Employee Benefits
DynCorp's 'Strategic' Defense In Drug Crop Spraying Suit
Bill on Bankruptcy: MF Global Creditors Undeterred by Low Value
Same-Sex Marriage Cases in 90 Seconds
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more
On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more
On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more
On June 13, 2024, the U.S. Supreme Court decided Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23-235, together with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, No. 23-236,...more
The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma GmbH (“UCB”) and is directed to chemical derivatives of a drug for treating...more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more
In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more
In his October 17th post, Josh Dunlap describes in detail the First Circuit’s landmark ruling in In re Asacol Antitrust Litigation concerning classes that include uninjured members. ...more
The recent releases of highly effective, and highly priced, drugs to treat chronic diseases has bred a spate of efforts by activists to disenfranchise drug developers of their patent rights. One recent chapter is instructive,...more
In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with the support of the Laura and John Arnold foundation, has...more
Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more
The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis...more
Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more
It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more
One of the “hot” issues in class actions today is whether, or to what extent, a class can be defined to include members who were not injured, and do not have standing to sue. ...more