125 Search Results

January 27, 2021 |
2020 Year-End False Claims Act Update

Looking back on the incredible year that was 2020, some observers of the False Claims Act (“FCA”) 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 invest

July 17, 2020 |
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. At the same time, the federal government’s stimulus efforts are sowing seeds f

April 13, 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 da

March 30, 2020 |
COVID-19 And Life Sciences Companies – 10 Actions To Consider

The COVID-19 outbreak has caused major disruptions in global economies, including in particular to life sciences companies that are conducting clinical trials and manufacturing and marketing pharmaceutical products. The following ten actions are among those that life sciences companies may wish to consider in light of current event

March 26, 2020 |
Senate Advances the CARES Act, the Largest Stimulus Package in History, to Stabilize the Economic Sector During the Coronavirus Pandemic

Yesterday, the U.S. Senate passed (96-0) the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), a $2.2 trillion stimulus package designed to mitigate the effects of the novel coronavirus (“COVID-19”). The legislation includes relief for businesses and individuals, assistance to states, and key protections for w

March 19, 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. Notably, the President stated that he

August 15, 2019 |
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.

August 14, 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. The Trump Administration continues to aggressively pursue its high priority initiatives, such as combatting the opioid crisis and reducing health c

August 13, 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.  The list was published on August 4, 2019. Heather Richardson

July 16, 2019 |
2019 Mid-Year False Claims Act Update

As we progress through the Trump Administration’s third year, robust False Claims Act (“FCA”) enforcement continues. At the same time, the Administration has continued to signal a greater openness to tempering overly aggressive FCA theories. In the past six months, the Department of Justice (“DOJ”) issued long-awaited gui

May 20, 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

Decided May 20, 2019 Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290  Today, 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

March 7, 2019 |
2018 Year-End FDA and Health Care Compliance and Enforcement Update – Providers

Two years into the Trump Administration, the regulatory and enforcement landscape impacting health care providers continues to be extraordinarily dynamic and complex.  Recent policy statements and changes indicate that while the government’s health oversight enforcement efforts remain very robust in some areas, particularly in o

March 1, 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. This article is posted with the permission of the Food and Drug Law Institute.

February 12, 2019 |
2018 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Last January, we observed that the new administration had yet to upend pre-existing enforcement and regulatory trends in the pharmaceutical and medical device industries.  But in the past 12 months several Trump administration priorities began to coalesce.  From initiatives to address the opioid epidemic, to efforts to police pat

January 14, 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 ("HHS") personnel and private-sector health care industry leaders published new guidance for health care organizations on cybersecurity best practices.[1]  The guidance—Health Industry Cybersecurity Practices: Managing Threats and Prote

August 29, 2018 |
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. While the U.S. Department of Justice has recently issued statements indicating some new thinking about FCA enforcement, newly filed cases remain at historical peak levels

August 22, 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. While the U.S. Department of Justice has recently issued statements indicating some new thinking about FCA enforcement, newly filed cases remain at historical peak levels

July 31, 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.  Thi

July 30, 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.  This publication covers the waterfront of the opinions most important to this audience issued by the U.S. Court of Appeals for the Federal Circui

July 26, 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

July 11, 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.  Now, with another half-year behind us, the Administration has started to put its stamp on FCA enforcement and to signal openness to less draconian FCA enforcement, at least

June 27, 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. Topics Discussed: Enforcement trends and updates, including: False Claims Act case law update, in

June 20, 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").  The remarks, delivered at the American Bar Association's 12th National Institute on the Civil False Claims Act and Qui Tam Enforcement, included extens

May 30, 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

April 17, 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").[1]  FDA plans to ma

March 29, 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.  This Update also provides a

January 23, 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.  With 2017 behind us, we now have initial indications—and some answers—about what the arrival of this new Administration means for drug and device c

January 5, 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

December 1, 2017 |
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.

November 30, 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.  This Update also provides

September 26, 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

September 4, 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. Department of Just

August 30, 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. The U.S. Department of Justice has made clear that vigorous FCA enforcement is here to stay,  with newly filed cases remaining at historical peak levels and the DOJ 

August 25, 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. Food and Drug Administration ("FDA") Commissioner, was not confirmed until May.  Not surprisingly, t

August 8, 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.  A breach may lead

August 2, 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. The U.S. Department of Justice has made clear that vigorous FCA enforcement is here to stay,  with newly filed cases remaining at historical peak levels and the DOJ 

July 31, 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

June 15, 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. Brands LLC, No. 16-341 (May 22, 2017).[1]  The TC Heartland decision reverses the approach to venue previously adopted by the U.S. Court of Appeals for the Federal

March 28, 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 Feder

February 15, 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. Legislative and executive action

January 26, 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 du

January 12, 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. In the coming year, the 21st Century Cures Act will take effect, ushering in new rules to streamline drug approvals a

January 5, 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.  It is also clear that the U.S. government, state governments, and private whistleblo

January 1, 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.

December 7, 2016 |
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. This term was marked by three en banc decisions concerning: (1) the scope of the patent exhaustion d

November 15, 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, a

October 27, 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.

October 3, 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.

September 29, 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

September 22, 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: Trends in health care fraud and abuse enforcement actions and associated litigation involving health care providers; U.S. regulators' and whistleblowers' a

August 2, 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,

August 1, 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]. ©2016. Published in The Health Lawyer, Vol. 28 No 6

July 27, 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 g

July 7, 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).  And these changes usher in a new and uncertain era of exposure for companies that do business with the government.  As we have reported for years, the FCA routinely r

March 24, 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

February 18, 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. Department of Justice ("DOJ") and the U.S. Department of Health and Human Services ("HHS") continued to develop new a

January 27, 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. Court of Appeals for the Federal Circuit, and a companion to Gibson Dunn's annual Federal Circuit Year In Review.  Each editi

January 19, 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.  The U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA"), in particular, pursued dr

January 6, 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").  An impressive amount, no doubt.  But what is remarkable is t

January 5, 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.  T

December 1, 2015 |
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.

November 20, 2015 |
M&A Report – Depomed Decision Highlights Importance of Careful Monitoring of M&A Non-Disclosure & Use Obligations

On November 19, 2015, in Depomed, Inc. v. Horizon Pharma plc, the Superior Court of California, County of Santa Clara granted Depomed's request for a preliminary injunction to enjoin Horizon's hostile exchange offer to acquire Depomed. The injunction was issued based on Horizon's misuse of Depomed's confidential information under a pre-existing con

August 13, 2015 |
Another Successful Challenge to Restrictions on Off-Label Promotion

​In a pointed and thoughtful repudiation of FDA's longstanding policy, the U.S. District Court for the Southern District of New York held on August 7, 2015, that the First Amendment precludes the prohibition and criminalization of truthful, non-misleading off-label speech under the Federal Food, Drug, and Cosmetic Act ("FDCA").  Am

August 3, 2015 |
RICO Suits Challenge Off-Label Drug Marketing

​Denver associate John D.W. Partridge is the co-author of "RICO Suits Challenge Off-Label Drug Marketing" [PDF] published on August 3, 2015 by Law360.

July 16, 2015 |
2015 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Over the past half year, the U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA") sustained their enforcement efforts against both businesses and individuals, raking in significant civil recoveries while pursuing criminal cases against industry participants. In the meantime, FDA released important

July 8, 2015 |
2015 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

2015 came in like a lion, bringing with it remarkable policy changes regarding corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA").  The Department of Justice's ("DOJ") leadership has articulated new bright-line approaches to post-resolution conduct, including the unprecedented

July 8, 2015 |
2015 Mid-Year False Claims Act Update

I.    INTRODUCTION There is no end in sight to the False Claims Act gold rush. After a record-setting 2014, which saw $5.7 billion in recoveries under the federal False Claims Act (FCA), 31 U.S.C. § 3729 et seq., 2015 looks to be another banner year.  In just the first six months of 2015, the government and qui tam relators have racked up mo

June 12, 2015 |
A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool

Washington, D.C. partner F. Joseph Warin and associates Oleh Vretsona and Lora MacDonald are the authors of "A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool" [PDF] published in the Notre Dame Journal of Law, Ethics & Public Policy, Volume 29, Issue 1.

April 22, 2015 |
U.S. SEC Adopts Final Rules Implementing “Regulation A+” Offering Exemption for Offerings of up to $50 Million

On March 25, 2015, in a unanimous vote, the U.S. Securities and Exchange Commission (the "SEC" or the "Commission") approved final rules to create a new avenue for certain issuers to raise capital in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").

March 25, 2015 |
U.S. Supreme Court Issues Long-Awaited Decision in Omnicare, Resolving Circuit Split Regarding Opinion Statement Liability under Section 11 of Securities Act of 1933

On March 24, 2015, the Supreme Court of the United States issued its long-awaited decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 575 U.S. ___, 2015 WL 1291916 (U.S. Mar. 24, 2015).  In an opinion delivered by Justice Kagan, in which six other justices joined, the Court resolved a circuit split regar

March 2, 2015 |
2014 Year-End FDA Compliance and Enforcement Update – Food and Dietary Supplements

In 2014, food safety spurred significant rulemaking, enforcement activity, and litigation by regulators and lawmakers at both the federal and state levels.  The U.S. Food and Drug Administration ("FDA") and the U.S. Department of Justice ("DOJ") enforced current good manufacturing practice ("cGMP") regulations and

February 17, 2015 |
Cybersecurity and Data Privacy Outlook and Review: 2015

Concerns about cybersecurity and data privacy have exploded into the public consciousness in recent years, accompanied by a host of new and rapidly developing legal issues.  From data breaches potentially affecting millions of consumers, to increasingly active policing of cybersecurity by the FTC and other U.S. regulators, to the protection of "th

January 14, 2015 |
2014 Year-End Health Care Compliance and Enforcement Update – Providers

It is no secret to those in the health care industry that since the U.S. Department of Justice ("DOJ") and Department of Health and Human Services ("HHS") joined forces to create the Health Care Fraud Prevention and Enforcement Action Team ("HEAT") in 2009, government enforcement actions against health care providers h

January 14, 2015 |
2014 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Pharmaceutical and medical device manufacturers are among the most highly regulated enterprises in the United States, and 2014 demonstrated that the regulatory landscape continues to be a minefield for these companies.  This past year, the Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA") susta

January 7, 2015 |
2014 Year-End False Claims Act Update

Just two years ago we noted the staggering level of the federal government's recovery-- approximately $5 billion--under the False Claims Act, 31 U.S.C. §§ 3729-3733 (the "FCA" or the "Act"). Not to be outdone, 2014 saw a new, historical high-water mark of $5.7 billion in recoveries. And this recent history, and forecasts for 2015, suggest the flo

January 6, 2015 |
2014 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

The U.S. Department of Justice ("DOJ") and the U.S. Securities and Exchange Commission ("SEC") continue to deploy DPAs and NPAs aggressively.  This past year left no doubt that such resolutions are a vital part of the federal corporate law enforcement arsenal, affording the U.S. government an avenue both to punish and refor

November 16, 2014 |
Health regulation makes for strange bedfellows

Dallas partner James C. Ho is the author of "Health regulation makes for strange bedfellows" [PDF] published in the November 16, 2014 issue of The Texas Tribune.

July 9, 2014 |
2014 Mid-Year False Claims Act Update

I.          INTRODUCTION It has been an explosive past six months in matters under the federal False Claims Act ("FCA"), 31 U.S.C. § 3729 et seq., which prohibits the knowing submission of false claims for payment to the government or false statements material to false claims.  In that time period alone, the Department of Justice ("

July 8, 2014 |
2014 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

As the debate continues over whether and how to punish companies for unlawful conduct, U.S. federal prosecutors continue to rely significantly on Non-Prosecution Agreements ("NPAs") and Deferred Prosecution Agreements ("DPAs") (collectively, "agreements").[1]  Such agreements have emerged as a flexible alternative

May 5, 2014 |
To Institute or Not to Institute IPR? That Question Is Not Immediately Reviewable by the Federal Circuit

In a series of three opinions issued on April 24, 2014, the Federal Circuit has decided that decisions by the Director of the U.S. Patent & Trademark Office to institute -- or not to institute -- an inter partes review ("IPR") under 35 U.S.C. § 314 are not immediately reviewable by the Federal Circuit, either through an app

May 1, 2014 |
2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 2)

Washington, D.C. partner Joseph Warin and associates Brendan Fleming and J. Matt Williams are the authors of "2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 2)" [PDF] published in the May 2014 issue of Westlaw Journal's White Collar Crime.Part 1 of this article was published in

April 1, 2014 |
2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 1)

Washington, D.C. partner Joseph Warin and associates Brendan Fleming and J. Matt Williams are the authors of "2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 1)" [PDF] published in the April 2014 issue of Westlaw Journal's White Collar Crime.

January 23, 2014 |
U.S. Supreme Court Places the Burden of Proving Infringement on Patent Holders in Declaratory Judgment Actions

On January 22, 2014, the Supreme Court decided Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. ___ (2014), ruling unanimously that a patentee defendant bears the burden of proving infringement in a declaratory judgment action.Medtronic arose out of two patents assigned to Mirowski Family Ventures, which Mirowski licensed to Medtronic in

January 8, 2014 |
2013 Year-End False Claims Act Update

$3.8 Billion—That is the approximate amount recovered by the federal government last year alone in settlements and judgments under the False Claims Act, 31 U.S.C. §§ 3729-33 (the “FCA” or the “Act”).[1]   This amount marks the second largest haul in history and the fourth consecutive fiscal year in which the government recovered more t

January 7, 2014 |
2013 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

Since their emergence in the early 1990s, and especially in the past decade, Non-Prosecution Agreements (“NPAs”) and Deferred Prosecution Agreements (“DPAs”) (collectively, “agreements”)[1] have become embedded in the toolbox of U.S. federal prosecutors to address allegations of corporate misconduct.  Prosecutors and companies alik

October 1, 2013 |
Antitrust Scrutiny of Pharmaceutical Product Hopping

Dallas partner Sean Royall, Of Counsel Ashley Johnson and associate Jason McKenney are the authors of "Antitrust Scrutiny of Pharmaceutical Product Hopping" [PDF] originally published in Antitrust, Vol. 28, No. 1, Fall 2013. © 2013 by the American Bar Association.

July 10, 2013 |
2013 Mid-Year False Claims Act Update

$5 Billion!  That's the approximate amount recovered by the federal government from settlements and judgments in cases filed under the federal False Claims Act, 31 U.S.C. §§ 3729-3733 (the "FCA" or the "Act"), in 2012.[1]  More than 782 new FCA matters were filed in that year, and more than 640 of those were initiated by "whistleblowers" filin

July 9, 2013 |
2013 Mid-Year Update on Corporate Deferred Prosecution Agreements (DPAs) and Non-Prosecution Agreements (NPAs)

Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements ("NPAs") (collectively, "agreements")[1] continue to be a consistent vehicle for prosecutors and companies alike in resolving allegations of corporate wrongdoing.  In the two decades since their emergence as an alternative to the extremes of i

April 23, 2013 |
United States Sentencing Commission Adopts Greater Penalties for Fraud Offenses and Fixes Anomaly in Sentences for Tax Crimes

On April 10, 2013, the United States Sentencing Commission promulgated its annual amendments to the federal sentencing guidelines.  Reacting to congressional directives, the Commission voted to increase penalties for (1) theft and fraud involving pre-retail medical products, (2) trafficking in counterfeit drugs and military equipment

April 1, 2013 |
For Skilled Nursing and Nursing Facilities, Compliance Counts

San Francisco of counsel Winston Chan and associate Vanessa Pastora are the authors of “For Skilled Nursing and Nursing Facilities, Compliance Counts” [PDF] published in the April 2013 issue of Compliance Today.

February 27, 2013 |
The European Commission Launches a Consultation Process in Relation to the Manufacturing Practices for Medicinal Products

On 17 January 2013, the European Commission (the "Commission") initiated a public consultation in relation to the revision of its Good Manufacturing Practice Guidelines (the "GMP Guidelines").[1]  In addition to demonstrating the safety and efficacy of the medicinal product, manufacturing authorisation holders are obliged to guarantee the cons

February 22, 2013 |
2012 Year-End Health Care Enforcement Update

2012 saw a continuation of the trends we have seen in health care enforcement in recent years--wide-ranging enforcement activity, historic settlements, strict settlement terms, and tough penalties for individuals. State and federal governments recovered an astounding $7.2 billion from the health care industry through settlements in calendar year

January 14, 2013 |
Off-Label Promotion: Still a Crime?

San Francisco of counsel Winston Chan and associate Deena Klaber are the authors of “Off-Label Promotion: Still a Crime?” [PDF] published in the January 14, 2013 issue of The Recorder.  

January 8, 2013 |
2012 Year-End False Claims Act Update

For years, the Department of Justice ("DOJ") has sought recoveries under the False Claims Act, 31 U.S.C. §§ 3729-33 (the "FCA" or the "Act"), with a torrid pace.  In 2012, those efforts remained unabated.  The federal government recovered approximately $5 billion in the last fiscal year alone from settlements and judgments in cases filed under

January 3, 2013 |
2012 Year-End Update on Corporate Deferred Prosecution Agreements (DPAs) and Non-Prosecution Agreements (NPAs)

"Over the last decade, DPAs [Deferred Prosecution Agreements] have become a mainstay of white collar criminal law enforcement," Lanny Breuer, the head of the U.S. Department of Justice's Criminal Division, declared on September 13, 2012.[1]  Corporate Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements (

December 4, 2012 |
The End of Off-Label Prosecutions? The Second Circuit Rules That a Pharmaceutical Sales Representative’s Criminal Conviction for Off-Label Promotion Violates the First Amendment

In an opinion with potentially far-reaching ramifications for pharmaceutical and medical device manufacturers, a split panel of the Second Circuit Court of Appeals held on December 3, 2012, that the First Amendment precludes Alfred Caronia's conviction for conspiring to introduce a misbranded drug into interstate commerce in violation of the Feder

November 1, 2012 |
With a Scalpel Not a Sledgehammer: Resolving FDCA Investigations through Deferred Prosecution and Non-Prosecution Agreements

Washington, DC of counsel Steven Tave and associate Jeremy Joseph are the authors of “With a Scalpel, Not a Sledgehammer: Resolving FDCA Investigations through Deferred Prosecution and Non-Prosecution Agreements” [PDF] published in the November/December issue of Update magazine.  Republished with the permission of FDLI.

October 25, 2012 |
U.S. Agencies Release Guidance on Shared Responsibility Employer Penalties and Waiting Period Limitations under the Affordable Care Act

Recently, the Internal Revenue Service released two notices, Notice 2012-58 and Notice 2012-59, regarding the employer shared-responsibility penalties and the 90-day waiting period limitation of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the "Act").  Both of these provisi

July 12, 2012 |
2012 Mid-Year False Claims Act Update

For years, on these pages, we have marveled at the precipitous increase in False Claim Act (FCA) enforcement.  And now, as if waking to the thunderous sound of the Department of Justice's own efforts, the new Acting Assistant Attorney General, "ha[s] been struck by the sheer volume of the cases that are brought -- and the recoveries that are obtai

July 10, 2012 |
2012 Mid-Year Update on Corporate Deferred Prosecution and Non-Prosecution Agreements

Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements ("NPAs") (collectively, "agreements") in recent years have become a primary tool of the U.S. Department of Justice ("DOJ") for resolving allegations of corporate criminal wrongdoing.  Since 2000, DOJ entities have entered into 230 re