NLRB Authority in Jeopardy, Pregnant Worker Protections, Non-Compete Order Rescinded, EEOC Right-to-Sue Rule - #WorkforceWednesday® - Employment Law This Week®
The Presumption of Innocence Podcast: Episode 68 - The Legacy and Lessons of Guantanamo Bay: A Defense Attorney’s Perspective
Meeting the Moment: How Lawyers Can Unite to Protect Democracy and the Rule of Law - On Record PR
False Claims Act Insights - The Mathematics of Nuclear FCA Verdicts
Podcast - Diamond Alternative Energy, LLC v. EPA: The Intersection of Constitutional and Environmental Law
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Presumption of Innocence Podcast: Episode 65 -The Power of Interpretation: Constitutional Meaning in the Modern World
The Presumption of Innocence Podcast: Episode 64 - Cages We Built: The Making of Mass Incarceration in America
Solicitors General Insights: The Legal Frontlines in Iowa and Indiana — Regulatory Oversight Podcast
Ampliación del fuero de paternidad
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
Consumer Finance Monitor Podcast Episode: Everything You Want to Know About the CFPB as Things Stand Today, and Lots More - Part 2
Podcast - FTC Commissioner Dismissals: Background and Implications
FCPA Compliance Report: Death of CTA
Consumer Finance Monitor Podcast Episode: Prominent Journalist, David Dayen, Describes his Reporting on the Efforts of Trump 2.0 to Curb CFPB
Consumer Finance Monitor Podcast Episode: Prof. Hal Scott Doubles Down on His Argument That CFPB is Unlawfully Funded Because of Combined Losses at Federal Reserve Banks
The Presumption of Innocence Podcast: Episode 55 - The Power of the Presidential Pardon: Traditions and Turning Points
False Claims Act Insights - Are the FCA’s Qui Tam Provisions Unconstitutional? One Federal Judge Says “Yes"
In That Case: Alexander v. South Carolina State Conference of the NAACP
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more
On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more
Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more
On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...more
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more
The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....more
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more
Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more
On Aug. 29, the Centers for Medicare & Medicaid Services (“CMS”) issued the inaugural list of drugs selected for price setting under the Inflation Reduction Act of 2022 (IRA). Those selected drugs are Eliquis, Jardiance,...more
On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
When members of the U.S. House of Representatives and Senate were sworn into office in January 2019, Democrats took control of the House and its oversight agenda for the first time in eight years, 235-200 seats, and...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
The long-awaiting safe harbor proposed rule was published last week as the Administration looks to get out in front of the drug pricing debate that is sure to shape the 116th Congress. Under the proposed rule,rebates offered...more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...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 THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more