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
Our lawyers review the past year in False Claims Act activities.
Client Alert | February 8, 2023
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
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 named eight Gibson Dunn partners among its 2022 MVPs.
Firm News | September 6, 2022
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 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
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
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
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
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
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
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
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
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
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
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
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 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
Gibson Dunn lawyers review False Claims Act enforcement activity and litigation during the first half of 2019.
Client Alert | July 16, 2019
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
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
Washington, D.C. partner Marian J. Lee is the author of "The Legalization of Hemp" [PDF] published in the February/March 2019 issue of the Food and Drug Law Institute's Update magazine.
Publications | March 1, 2019
Gibson Dunn lawyers discuss enforcement and regulatory developments in the drug and device space during 2018, as well as notable developments in drug pricing and for device manufacturers.
Client Alert | February 12, 2019
On December 28, 2018, a Task Group that includes U.S. Department of Health and Human Services personnel and private-sector health care industry leaders published new guidance for health care organizations on cybersecurity best practices.
Publications | January 14, 2019
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
Webcasts | August 29, 2018
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
Webcasts | August 22, 2018
This July 2018 edition of Gibson Dunn's Federal Circuit Update discusses the recent Federal Circuit Bar Association Bench and Bar Conference, provides a summary of the pending Helsinn Healthcare case before the Supreme Court regarding the on-sale bar, and briefly summarizes the joint appendix procedure at the Federal Circuit.
Client Alert | July 31, 2018
In this mid-year analysis of government contracts litigation, Gibson Dunn examines trends and summarizes key decisions of interest to government contractors from the first half of 2018.
Client Alert | July 30, 2018
A year and a half into the new Administration, we are seeing new and shifting enforcement and regulatory trends in the health care provider space. While the staying power of these trends remains uncertain, it is increasingly clear that the Administration is implementing changes—including potentially significant ones—at each of the principal health care enforcement agencies.
Client Alert | July 26, 2018
Six months ago, we remarked in these pages on the largely unchanged and unrelenting pace of False Claims Act ("FCA") enforcement under the Trump Administration.
Client Alert | July 11, 2018
Gibson Dunn and BDO provides an overview of significant trends and key issues in government enforcement actions and litigation involving allegations that services or items billed to government health programs were not medically necessary.
Webcasts | June 27, 2018
On June 14, 2018, Acting Associate Attorney General Jesse Panuccio gave remarks highlighting recent enforcement activity and policy initiatives by the Department of Justice ("DOJ").
Client Alert | June 20, 2018
This May 2018 edition of Gibson Dunn's Federal Circuit Update discusses the proposed elimination of the broadest reasonable interpretation standard during post-issuance proceedings before the PTAB, provides a summary of the pending WesternGeco case before the Supreme Court regarding extraterritorial damages, and briefly summarizes the differences between precedential and non-precedential opinions.
Client Alert | May 30, 2018
On April 12th, 2018, the Food and Drug Administration ("FDA") released draft guidance proposing a significant expansion of the abbreviated 510(k) pathway for medical devices that would allow applicants to rely on performance characteristics rather than direct comparisons to predicate devices ("Draft Guidance").
Client Alert | April 17, 2018
This March 2018 edition of Gibson Dunn's Federal Circuit Update discusses the three pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings and extraterritorial damages, and a brief summary of the process for seeking an interlocutory appeal.
Client Alert | March 29, 2018
As 2016 came to a close, pharmaceutical and medical device companies waited expectantly and wondered aloud about what 2017 and the arrival of the Trump Administration would bring.
Client Alert | January 23, 2018
How will the Trump Administration alter enforcement of the False Claims Act ("FCA")? This is a question we fielded frequently at the end of 2016. Our answer at the time: We do not expect there to be significant changes in FCA enforcement, and we expect that the Department of Justice ("DOJ") and private qui tam plaintiffs will continue to brandish the FCA as a powerful weapon.
Client Alert | January 5, 2018
San Francisco partner Winston Chan and associate Ian Long are the authors of "Elder Abuse Reporting Under Scrutiny," [PDF] published in Provider Magazine in December 2017.
Article | December 1, 2017
This November 2017 edition of Gibson Dunn's Federal Circuit Update discusses the recent Friedman Lecture on Appellate Advocacy by Judge Alan Lourie, the two pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings, and the Federal Circuit's en banc procedures.
Client Alert | November 30, 2017
This September 2017 edition of Gibson Dunn's Federal Circuit Update discusses the court's upcoming sitting in New York, the two pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings, and the Federal Circuit's changes to two local rules involving certificates of interest and statements of related cases. This update also provides summaries of the three pending en banc cases involving motions to amend claims during inter partes review proceedings, judicial review of timeliness determinations in inter partes review proceedings, and attorneys' fees for litigation involving the PTO. Also included are summaries of three recent decisions relating to the applicability of the Seventh Amendment to requests for attorneys' fees
Client Alert | September 26, 2017
There is no doubt that with the new year in 2017 came a great deal of uncertainty for health care providers. But even with the change in administration, new leadership in the key health care oversight positions at the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and U.S.
Client Alert | September 4, 2017
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
Webcasts | August 30, 2017
At the midpoint of 2017, much has changed, and yet much has stayed the same for U.S. manufacturers of pharmaceuticals and medical devices. Although the new administration arrived in January, Dr. Scott Gottlieb, the new U.S.
Client Alert | August 25, 2017
Cyberthreats are ubiquitous, and significant cyberattacks on private and publicly traded companies occur on a near-daily basis. As a result of the ongoing barrage of increasingly advanced and evolving cyberattacks, even companies with sophisticated security systems are potentially susceptible to a cybersecurity breach.
Client Alert | August 8, 2017
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
Webcasts | August 2, 2017
This July 2017 edition of Gibson Dunn's Federal Circuit Update discusses four recent Supreme Court decisions covering venue, exhaustion, biosimilars, and offensive trademarks, and two Federal Circuit cases regarding inter parties review now pending before the Supreme Court. This update also includes summaries of the two appeals pending before the en banc court, also regarding inter partes review procedures. Also included is an overview of the process for cross-appealing before the Federal Circuit, as well as summaries of a pair of key recent decisions relating to fee awards that reach opposite results.Federal Circuit NewsThe Supreme Court continues to be very active in its review of Federal Circuit decisions, issuing four opinions in the last two months.
Client Alert | July 31, 2017
On May 22, 2017, the U.S. Supreme Court narrowed the scope of proper venue for patent infringement actions for domestic corporations. See TC Heartland LLC v. Kraft Foods Grp.
Client Alert | June 15, 2017
This March 2017 edition of Gibson Dunn's Federal Circuit Update discusses summary affirmance at the Federal Circuit, two recent Supreme Court decisions on laches and exhaustion, and the Federal Circuit cases now pending before the Supreme Court. This update also provides an overview of the process for petitioning for mandamus before the Federal Circuit. Also included are summaries of the two pending en banc cases involving motions to amend claims during inter partes review and judicial review of timeliness determinations in inter partes review, as well as a two key recent decisions relating to admissibility of settlement agreements in support of a reasonable royalty and eligibility of a patent for covered business method review.Federal Circuit NewsSummary Affirmance Before the
Client Alert | March 28, 2017
Just days into the new administration's regime, the U.S. health care sector is at the forefront of the President's and Congress's attention. Repeal and, perhaps, replacement of the Affordable Care Act ("ACA"), a much-debated Republican stalking horse for more than half a decade, could now be near at hand.
Client Alert | February 15, 2017