FDA and Health Care

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Federal Circuit Update (April 2024)

This edition of Gibson Dunn’s Federal Circuit Update for April 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning patent eligibility under 35 U.S.C. § 101, obviousness, and unenforceability due to inequitable conduct and unclean hands.

Client Alert | May 10, 2024

FDA’s Final Rule on Laboratory-Developed Tests: Four Key Takeaways

The U.S. Food and Drug Administration's highly anticipated final rule on laboratory-developed tests was officially published in the Federal Register on Monday, May 6, 2024.

Client Alert | May 8, 2024

Federal Circuit Update (March 2024)

This edition of Gibson Dunn’s Federal Circuit Update for March 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning indefiniteness, obviousness, eligibility under Section 101, and the safe harbor provision under Section 271.

Client Alert | April 5, 2024

Proposed California Legislation AB 3129 Would Require Attorney General Approval for Private Equity and Hedge Fund Acquisitions of Certain Healthcare Entities

Private equity is a growing presence in the healthcare sector, but that trend has drawn a backlash from federal and state regulators. 

Client Alert | March 13, 2024

Federal Circuit Update (February 2024)

Our Federal Circuit Update summarizes the current status of several petitions pending before the U.S. Supreme Court, as well as recent Federal Circuit decisions concerning printed publications, written description, claim construction, and inequitable conduct.

Client Alert | March 5, 2024

False Claims Act 2023 Year-End Update

Our lawyers provide a year-end update on the False Claims Act (FCA), including significant enforcement developments.

Client Alert | March 4, 2024

Cosmetics Regulation – Where Are We Going, Where Have We Been?

This update highlights steps taken by the Food and Drug Administration to implement the Modernization of Cosmetics Regulation Act since its enactment in 2022 as well as actions expected in the cosmetics space this year.

Client Alert | February 27, 2024

Federal Circuit Update (January 2024)

This edition of Gibson Dunn’s Federal Circuit Update for January 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions interpreting a forum selection clause in a settlement agreement, deciding the appropriate scope of an opposition to a motion to amend in an inter partes review proceeding, and reviewing the International Trade Commission’s determination of what satisfies the economic prong of the domestic industry requirement.

Client Alert | February 7, 2024

Gibson Dunn Adds FDA and Health Care Partner Katlin McKelvie to D.C. Office

Gibson, Dunn & Crutcher LLP is pleased to announce that Katlin McKelvie has joined the firm as a partner in the Washington, D.C. office, where she will practice in the firm’s FDA and Health Care Practice Group.

Press Releases | January 29, 2024

Federal Circuit Update (December 2023)

This edition of Gibson Dunn’s Federal Circuit Update for December 2023 summarizes the current status of a couple petitions pending before the Supreme Court, and recent Federal Circuit decisions vacating a $1.5 billion damages award, interpreting infringement of method of use patents under the Hatch-Waxman Act, and reviewing claim constructions in an inter partes review.

| January 10, 2024

Federal Circuit Update (November 2023)

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning attorneys’ fees under 35 U.S.C. § 285, Article III standing, and the Board’s authority to issue a final written decision past the statutory deadline.

Client Alert | December 11, 2023

Federal Circuit Update (October 2023)

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning means-plus-function claims, apportionment, and forfeiting arguments not raised in an inter partes review (“IPR”) petition.

Client Alert | November 6, 2023

False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

Our lawyers discuss recent Federal Food, Drug, and Cosmetic Act amendments requiring cybersecurity information in premarket submissions for cyber devices, as well as the potential implications for False Claims Act liability, and the rise of FCA cases for claims relating to cybersecurity in the healthcare industry more generally.

Client Alert | October 16, 2023

FDA Publishes Proposed Rule Asserting Medical-Device Jurisdiction over Laboratory-Developed Tests

The U.S. Food and Drug Administration announced plans to formally classify laboratory-developed tests as medical devices under its regulations, subjecting these tests to extensive premarket review and postmarket compliance requirements.

Client Alert | October 9, 2023

Federal Circuit Update (September 2023)

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, additional materials released from the ongoing investigation by the Judicial Council of the Federal Circuit, and recent Federal Circuit decisions concerning motions to amend before the Patent Trial and Appeal Board, obviousness, and enablement.

Client Alert | October 3, 2023

FDA Draft Guidance Sheds Light on Agency’s Evaluation of Prescription Drug Use-Related Software

The U.S. Food and Drug Administration recently published a draft guidance document proposing to regulate end-user output of prescription drug use-related software as labeling.

Client Alert | September 29, 2023

Federal Circuit Update (August 2023)

Our Federal Circuit Update summarizes the status of several petitions pending before the U.S. Supreme Court, additional materials released from the ongoing investigation by the Judicial Council of the Federal Circuit, and recent Federal Circuit decisions.

Client Alert | September 6, 2023

Federal Circuit Update (July 2023)

Our Federal Circuit Update summarizes the current status of several petitions pending before the U.S. Supreme Court, the report and recommendation from the ongoing investigation by the Judicial Council of the Federal Circuit, and a number of recent Federal Circuit decisions.

Client Alert | August 7, 2023

Webcast: Stock Buybacks: What You Need to Know (and Disclose) Following Adoption of the SEC’s New Rules

In this briefing, our lawyers cover key SEC rule changes that will significantly impact the timing, manner and nature of the disclosures required for company share repurchases, including nuanced interpretive issues and tax implications.

Webcasts | July 11, 2023

Federal Circuit Update (June 2023)

Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, provides an update on a proceeding by the Judicial Council of the Federal Circuit, and summarizes recent Federal Circuit decisions concerning secondary considerations, inventorship, inherency, and enablement.

Client Alert | July 6, 2023

Supreme Court Upholds The Federal Government’s Broad Authority To Dismiss False Claims Act Lawsuits After It Has Intervened

The U.S. Supreme Court held 8-1 that the federal government may move at any time to dismiss a False Claims Act lawsuit over the objection of a relator, so long as it first intervenes in the action.

Client Alert | June 16, 2023

Federal Circuit Update (May 2023)

Our lawyers summarize news and key cases from the Federal Circuit from May 2023.

Client Alert | June 6, 2023

Supreme Court Holds That False Claims Act Scienter Turns On Defendant’s Knowledge And Subjective Beliefs

The Supreme Court recently held that an objectively reasonable interpretation of an ambiguous statutory or regulatory requirement does not preclude a finding that the defendant acted “knowingly” under the False Claims Act.

Client Alert | June 2, 2023

Supreme Court Rejects Antibody Drug Patent, Clarifies Patent “Enablement” Requirement

Our lawyers review a U.S. Supreme Court ruling rejecting drug patents and clarifying the Patent Act’s enablement requirement.

Client Alert | May 18, 2023

DOJ’s Consumer Protection Branch Releases Second Annual Recent Highlights Report

Gibson Dunn lawyers discuss the second annual Recent Highlights Report recently released by the U.S. Department of Justice’s Consumer Protection Branch, which describes the Branch and its role at DOJ along with reviewing significant litigation and resolutions that occurred in 2022.

Client Alert | May 15, 2023

Federal Circuit Update (April 2023)

Gibson Dunn lawyers summarize the news and key cases from the Federal Circuit in April 2023.

Client Alert | May 1, 2023

Federal Circuit Update (March 2023)

Gibson Dunn lawyers summarize the latest news and key cases from the Federal Circuit.

Client Alert | April 3, 2023

Gas Stoves: Developing Regulatory and Litigation Actions

Thirty-eight percent of American homes use gas stoves, and so stove manufacturers, retailers and the fossil fuel industry could be significantly affected by any regulatory restrictions following Department of Energy proposals and Consumer Product Safety Commission investigations. Here, our partners give an overview of the current regulatory landscape and potential litigation.

Client Alert | March 29, 2023

DOJ’s Consumer Protection Branch Announces New Corporate Enforcement Policies

Companies are facing more compliance and reporting requirements with new policies from the U.S. Department of Justice’s Consumer Protection Branch, for monitoring and disclosing potential criminal conduct. Our White Collar Defense and Investigations groups summarize the changes.

Client Alert | March 28, 2023

2022 Year-End False Claims Act Update

Our lawyers review the past year in False Claims Act activities.

Client Alert | February 8, 2023

Seven Gibson Dunn Attorneys Named Among Washingtonian Magazine’s 2022 Top Lawyers

Washingtonian magazine named seven Washington, D.C. partners to its 2022 Top Lawyers, which features “Washington’s top legal talent,” in their respective practice areas.

Firm News | January 3, 2023

Gustav Eyler, Former Director of DOJ’s Consumer Protection Branch, Joins Gibson Dunn in Washington, D.C.

Gibson, Dunn & Crutcher LLP is pleased to announce that Gustav W. Eyler has rejoined the firm as a partner in the Washington, D.C. office.

Press Releases | November 14, 2022

Law360 Names Eight Gibson Dunn Partners as 2022 MVPs

Law360 named eight Gibson Dunn partners among its 2022 MVPs.

Firm News | September 6, 2022

Anti-Kickback Circuit Split Holds Implications For Defendants

Denver partner John Partridge, Washington, D.C. Jonathan Phillips, and associate Allison Chapin are the authors of "Anti-Kickback Circuit Split Holds Implications For Defendants" published by Law360 on August 11, 2022. 

Article | August 12, 2022

The FTC at Full Strength: What to Expect Next

The addition of Commissioner Alvaro Bedoya establishes the first Democratic majority at the FTC since Commissioner Rohit Chopra left the agency. This alert addresses key issues that may see more activity in light of the new Democratic majority.

Client Alert | May 16, 2022

Recent Settlement Indicates Donations by Healthcare Entities Could Be Subject to Increased DOJ Scrutiny

On February 14, 2022, the Department of Justice and U.S. Attorney’s Office for the Middle District of Florida announced they had reached a $5.5 million settlement with NCH Healthcare System to resolve common law claims arising from NCH’s donations to local government entities—payments that the government alleged were used improperly to fund Florida’s share of Medicaid payments made to NCH.

Client Alert | March 7, 2022

2021 ERISA Litigation Update

This year’s Annual ERISA Litigation Update summarizes key legal opinions and developments to assist plan sponsors and administrators navigating the rapidly changing ERISA litigation landscape.

Client Alert | February 22, 2022

Safe Harbors (and Other Strategies) for Life Sciences and Healthcare Companies in the International Anti-Corruption Storm

Washington, D.C. partners Patrick Stokes and John Partridge and associate Eva Michaels are the authors of "Safe Harbors (and Other Strategies) for Life Sciences and Healthcare Companies in the International Anti-Corruption Storm," published by the American Bar Association in the December 2021 issue of The Health Lawyer.

Article | January 24, 2022

2020 Year-End False Claims Act Update

Looking back on the incredible year that was 2020, some observers of the False Claims Act enforcement space may note that the year’s FCA recoveries were the lowest they have been in twelve years, but the most important takeaway for those who deal in government funds is this: the government opened the most new FCA investigations ever in 2020.

Client Alert | January 27, 2021

2020 Mid-Year False Claims Act Update

As the world reels from the COVID-19 pandemic and certain sectors of the economy struggle, False Claims Act (“FCA”) enforcement and litigation has largely plodded along during the first six months of 2020—and some areas reflect increasing activity.

Client Alert | July 17, 2020

FDA Round-Up: Overview of Emergency Actions to Expedite the Availability of Medical Products to Combat COVID-19

The COVID-19 crisis has prompted a barrage of legislative and regulatory activity affecting drug and device manufacturers. In addition to the CARES Act, one of the most sweeping pieces of legislation in recent memory, the U.S. Food & Drug Administration (FDA) has been releasing new policies and guidance documents on a nearly daily basis.

Client Alert | April 13, 2020

COVID-19 And Life Sciences Companies – 10 Actions To Consider

The COVID-19 outbreak has caused major disruptions in global economies, including to life sciences companies conducting clinical trials and manufacturing and marketing pharmaceutical products. Gibson Dunn lawyers note ten actions that life sciences companies may wish to consider in light of the pandemic.

Client Alert | March 30, 2020

Senate Advances the CARES Act, the Largest Stimulus Package in History, to Stabilize the Economic Sector During the Coronavirus Pandemic

Gibson Dunn provides a comprehensive look at the CARES Act passed by the Senate on March 25, 2020, the largest emergency stimulus package in United States history.

Client Alert | March 26, 2020

The Defense Production Act and COVID-19: What Industry Needs to Know

On March 18, 2020, President Trump announced that he was invoking the Defense Production Act (DPA) in order to allow the administration to marshal American industry to prioritize production of medical supplies and pharmaceuticals that are in short supply to fight the coronavirus pandemic.

Client Alert | March 19, 2020

Gibson Dunn Lawyers Recognized in the Best Lawyers in America® 2020

The Best Lawyers in America® 2020 has recognized 158 Gibson Dunn attorneys in 54 practice areas. Additionally, 48 lawyers were recognized in Best Lawyers International in Belgium, Brazil, France, Germany, Singapore, United Arab Emirates and United Kingdom.

Firm News | August 15, 2019

2019 Mid-Year FDA and Health Care Compliance and Enforcement Update – Providers

Halfway through 2019 and the third year of the Trump Administration, we continue to observe complex trends in the health care regulatory and enforcement environment impacting providers.

Client Alert | August 14, 2019

Benchmark Litigation Names Three Partners to 40 & Under Hotlist

Benchmark Litigation named Los Angeles partner Heather Richardson, New York partner Gabrielle Levin and Orange County partner Blaine Evanson to its annual 40 & Under Hotlist, which recognizes the achievements of the nation’s most accomplished legal partners aged 40 or younger.

Firm News | August 13, 2019

2019 Mid-Year False Claims Act Update

Gibson Dunn lawyers review False Claims Act enforcement activity and litigation during the first half of 2019.

Client Alert | July 16, 2019

Supreme Court Holds That Courts, Not Juries, Must Decide Whether The FDA’s Rejection Of A Proposed Warning Label Provides “Clear Evidence” To Preempt A State-Law Failure-To-Warn Claim

On May 20, 2019, the Supreme Court unanimously held that courts, not juries, must decide as a matter of law whether there is “clear evidence” that the FDA would not have approved a proposed label warning about a risk of a drug, thereby preempting a state-law failure-to-warn claim based on that same risk.

Client Alert | May 20, 2019

2018 Year-End FDA and Health Care Compliance and Enforcement Update – Providers

Gibson Dunn provides an overview of recent DOJ and HHS enforcement efforts affecting health care providers, including a review of notable case law developments in the False Claims Act space, followed by a discussion of recent regulatory and case law developments in the Anti-Kickback Statute and the Stark Law.

Client Alert | March 7, 2019