FDA and Health Care

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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

The Legalization of Hemp

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

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

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

U.S. Department of Health and Human Services Issues New Guidance on Voluntary Cybersecurity Practices for Health Care Industry

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

Webcast: The False Claims Act – 2018 Mid-Year Update: Three Industry-Specific Programs

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

Webcast: The False Claims Act – 2018 Mid-Year Update: Drug and Device Industries

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

Federal Circuit Update (July 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

2018 Mid-Year Government Contracts Litigation Update

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

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

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

2018 Mid-Year False Claims Act Update

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

Webcast: Defending Medical Necessity Enforcement Actions

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

Acting Associate AG Panuccio Highlights DOJ’s False Claims Act Enforcement Reform Efforts

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

Federal Circuit Update (May 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

FDA Releases Draft Guidance Proposing a Significant Expansion of the Abbreviated 510(k) Pathway for Medical Devices

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

Federal Circuit Update (March 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

2017 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

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

2017 Year-End False Claims Act Update

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

Elder Abuse Reporting Under Scrutiny

​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

Federal Circuit Update (November 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

Federal Circuit Update (September 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

2017 Mid-Year FDA and Health Care Compliance and Enforcement Update – Providers

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

Webcast: 2017 Mid-Year Update: The False Claims Act and Health Care Providers

​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

2017 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

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

Cybersecurity & Data Privacy: An Overview for Health Care, Pharmaceutical, and Biotech Companies

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

Webcast: 2017 Mid-Year Update: The False Claims Act and Drug and Device Manufacturers

​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

Federal Circuit Update (July 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

TC Heartland—A Renewed Opportunity to Challenge Venue in Patent Infringement Cases

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

Federal Circuit Update (March 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

2016 Year-End Health Care Compliance and Enforcement Update – Providers

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

Federal Circuit Update (January 2017)

This January 2017 edition of Gibson Dunn's Federal Circuit Update discusses current news and pending Federal Circuit cases before the Supreme Court and provides an overview of the oral argument process and panel assignment at 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 series of key recent decisions relating to the requirements for standing when appealing a decision of the Patent Trial & Appeal Board ("PTAB"), divided infringement, and indefiniteness of claims using terms of degree.  Federal Circuit NewsFormer Chief Judge Rader is reportedly in consideration for leadership of the U.S.

Client Alert | January 26, 2017

2016 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

This January more than most, it is tempting to focus on questions regarding what is to come. Aside from the uncertainties associated with a new administration, two key pieces of legislation seem to be heading in opposite directions.

Client Alert | January 12, 2017

2016 Year-End False Claims Act Update

I. INTRODUCTION What a year. With two Supreme Court decisions and nearly $5 billion in recoveries (among other interesting entries) in 2016's now-closed books, we can say with certainty that 2016 delivered plenty of False Claims Act ("FCA") headlines.

Client Alert | January 5, 2017

Using and Defending Against Statistical Sampling in False Claims Act Cases

​Washington, D.C. associate Jonathan Phillips is the co-author of "Using and Defending Against Statistical Sampling in False Claims Act Cases," [PDF] published in AHLA Connections in January 2017.

Article | January 1, 2017

2015/2016 Federal Circuit Year in Review

We are pleased to present Gibson Dunn's fourth "Federal Circuit Year in Review," providing a statistical overview and substantive summaries of the 134 precedential patent opinions issued by the Federal Circuit over the 2015-2016 year.

Client Alert | December 7, 2016

The Trump Presidency: Selected Initial Observations and Considerations

There is widespread speculation regarding what President-elect Donald Trump and a Republican-controlled Congress will choose to prioritize and pursue in 2017 and beyond.  With the majority of pollsters and media observers incorrectly forecasting a victory for Hillary Clinton, many are just now beginning to assess how they will operate under, and the potential opportunities presented by, the policies of the Trump administration and the Republican-led Congress.  We would like to share with you some of our initial observations about the potential effects that may be forthcoming in the near term.  With Republicans claiming the White House and maintaining control of both the House of Representatives and the Senate, we expect a flurry of legislative and administrative activity con

Client Alert | November 15, 2016

FCA Liability after Escobar: Challenges and Opportunities for Device Companies

​Denver partner John D.W. Partridge, associate Reid Rector and Washington, D.C. associate  Jonathan Phillips are the authors of "FCA Liability after Escobar: Challenges and Opportunities for Device Companies" [PDF] published in the October 2016 issue of Medtech Insight.

Article | October 27, 2016

Compliance Perspectives on the Developing Contours of the PSQIA

​Washington, D.C. associates Jonathan Phillips and Julie Rapoport Schenker are the authors of "Compliance Perspectives on the Developing Contours of the PSQIA" [PDF] published in the October 2016 issue of Compliance Today.

Article | October 3, 2016

Federal Circuit Update (September 2016)

This September 2016 edition of Gibson Dunn's Federal Circuit Update discusses the steep rise in appeals from the Patent Trial & Appeal Board due to the America Invents Act.  The Update also includes a practice tip regarding the procedure for seeking rehearing of an adverse panel decision.  Also included are summaries of the pending en banc case involving motions to amend claims during inter partes review as well as a trio of key recent decisions including two recent developments in Federal Circuit jurisprudence on patent eligibility under Section 101 and one recent decision on the application of common sense in an obviousness inquiry.Federal Circuit NewsOn September 16, 2012, the Leahy-Smith America Invents Act ("AIA") became effective and established the Patent Tri

Client Alert | September 29, 2016

Webcast: Hot Topics in Fraud and Abuse Enforcement Involving Health Care Providers

​Join Gibson Dunn for a ninety-minute discussion of hot topics—and key jurisprudential developments—in fraud and abuse enforcement actions against health care providers, including:

Webcasts | September 22, 2016

2016 Mid-Year Health Care Compliance and Enforcement Update – Providers

As reported in our 2015 Year-End Update, in recent years, both the Department of Justice ("DOJ") and the Department of Health and Human Services ("HHS") have demonstrated an increased commitment to holding providers accountable for fraud and abuse of the health care system; 2016 is no different.  So far this year, the DOJ and HHS have continued to find more ways to ensure compliance with the relevant health care laws and regulations, setting 2016 up to be another blockbuster year for enforcement.  In this latest installment in our series of semiannual updates, we discuss regulatory and enforcement developments impacting health care providers.

Client Alert | August 2, 2016

Evaluating U.S. Fraud and Abuse Compliance Controls, Including Corporate Integrity Agreement Provisions, for a Global Anti-Corruption Compliance Program

​Denver partner John D.W. Partridge, Washington, D.C. partner Daniel Chung and Denver associate Micah Sucherman are the authors of "Evaluating U.S. Fraud and Abuse Compliance Controls, Including Corporate Integrity Agreement Provisions, for a Global Anti-Corruption Compliance Program" [PDF].

Article | August 1, 2016

2016 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

From the Supreme Court to the Congress and from the federal agencies to the state legislatures, 2016 has produced noteworthy legal and regulatory developments for companies in the pharmaceutical and medical device industries.  Like our 2015 Year-End FDA and Health Care Compliance and Enforcement Update, this update begins with an overview of government enforcement efforts against drug and device companies under the False Claims Act ("FCA"), the Federal Food, Drug, and Cosmetic Act ("FDCA"), and other laws.

Client Alert | July 27, 2016

2016 Mid-Year False Claims Act Update

Major changes -- that is how we would describe the developments in the first half of 2016 as related to the scope of liability and damages under the federal False Claims Act (FCA).

Client Alert | July 7, 2016

Federal Circuit Update (March 2016)

Included in this March 2016 edition of Gibson Dunn's Federal Circuit Update is a brief overview of the upcoming Federal Circuit Judicial Conference, a summary of the pending en banc case (Medicines Co.), and a practice update regarding a proposed change to one of the Federal Circuit's internal operating procedures.  Also included are summaries of a number of key recent decisions related to patent exhaustion, the patent-agent evidentiary privilege, due process issues related to election of asserted claims, and the overlap between antitrust and inequitable conduct.  Gibson Dunn prevailed in two cases since our last update:  In Rembrandt Social Media, LP v. Facebook, Inc., No.

Client Alert | March 24, 2016

2015 Year-End Health Care Compliance and Enforcement Update – Providers

This past year marked 50 years since the establishment of the federal Medicare and Medicaid programs, but U.S. enforcement agencies did more than commemorate the programs' anniversary in 2015.  Both the U.S.

Client Alert | February 18, 2016

Federal Circuit Update (January 2016)

Gibson Dunn is pleased to announce its inaugural edition of the Federal Circuit Update, a bimonthly electronic newsletter designed to provide our clients and friends with a concise summary of recent activity at the U.S.

Client Alert | January 27, 2016

2015 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

While massive mergers and pharmaceutical pricing dominated industry headlines in 2015, the U.S. Government continued to shape the drug and device industries through enforcement actions and other regulatory activities this past year.

Client Alert | January 19, 2016

2015 Year-End False Claims Act Update

A bit less, but no less impressive--that is how we would characterize False Claims Act enforcement in 2015. This past year, the federal government recovered approximately $3.6 billion in either settlements or judgments in cases brought under the False Claims Act ("FCA" or the "Act").

Client Alert | January 6, 2016

2015 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

2015 was a blockbuster year in corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA"), by sheer numbers alone. Skyrocketing to 100, in 2015 the number of agreements more than doubled the numbers in every prior year since 2000, when Gibson Dunn first began tracking NPA and DPA data.

Client Alert | January 5, 2016

Compliance Implications of the Rise of False Claims Act Cases Based on the 60-Day Rule

​Washington D.C. associate Jonathan M. Phillips is the author of "Compliance Implications of the Rise of False Claims Act Cases Based on the 60-Day Rule" [PDF] published in the December 2015 issue of Health Care Fraud Westlaw Journal.

Article | December 1, 2015