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.
Client Alert | July 16, 2015
2015 came in like a lion, bringing with it remarkable policy changes regarding corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA").
Client Alert | July 8, 2015
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.
Client Alert | July 8, 2015
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.
Article | June 12, 2015
On March 25, 2015, in a unanimous vote, the U.S.
Client Alert | April 22, 2015
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.
Client Alert | March 25, 2015
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.
Article | March 2, 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.
Client Alert | February 17, 2015
It is no secret to those in the health care industry that since the U.S.
Client Alert | January 14, 2015
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.
Client Alert | January 14, 2015
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.
Client Alert | January 7, 2015
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.
Client Alert | January 6, 2015
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.
Client Alert | November 16, 2014
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.
Client Alert | July 9, 2014
As the debate continues over whether and how to punish companies for unlawful conduct, U.S.
Client Alert | July 8, 2014
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.
Client Alert | May 5, 2014
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 2014 (http://www.gibsondunn.com/publications/Pages/2013-Year-End-Update-on-Corporate.aspx).
Client Alert | May 1, 2014
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.
Client Alert | April 1, 2014
On January 22, 2014, the Supreme Court decided Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S.
Client Alert | January 23, 2014
$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.
Client Alert | January 8, 2014
Since their emergence in the early 1990s, and especially in the past decade, Non-Prosecution Agreements (“NPAs”) and Deferred Prosecution Agreements (“DPAs”) (collectively, “agreements”) have become embedded in the toolbox of U.S.
Client Alert | January 7, 2014
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.
Client Alert | October 1, 2013
$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.
Client Alert | July 10, 2013
Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements ("NPAs") (collectively, "agreements") 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 indictment and outright declination, DPAs and NPAs have risen in prominence, frequency, and scope. Such agreements are now a mainstay of the U.S.
Client Alert | July 9, 2013
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, and (3) foreign dissemination of stolen trade secrets. The Commission also made an important change that will reduce sentences for tax offenses. A current rule in several federal circuits frequently causes "tax loss" to be overstated for sentencing purposes because it directs courts to look solely at the amount of undeclared income to determine the tax impact of an offense. The amendment will require courts also
Client Alert | April 23, 2013
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.
Client Alert | April 1, 2013
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").
Client Alert | February 27, 2013
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.
Client Alert | February 22, 2013
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.
Client Alert | January 14, 2013
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.
Client Alert | January 8, 2013
"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.
Client Alert | January 3, 2013
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 Federal Food, Drug, and Cosmetic Act (FDCA) because his off-label promotion was constitutionally protected speech.
Client Alert | December 4, 2012
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.
Client Alert | November 1, 2012
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").
Client Alert | October 25, 2012
For years, on these pages, we have marveled at the precipitous increase in False Claim Act (FCA) enforcement.
Client Alert | July 12, 2012
Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements ("NPAs") (collectively, "agreements") in recent years have become a primary tool of the U.S.
Client Alert | July 10, 2012
On June 28, 2012, the Supreme Court issued its decision on the constitutional challenges to two components of the Patient Protection and Affordable Care Act of 2010 ("ACA"). The plaintiffs in National Federation of Independent Business v. Sebelius sought to invalidate both (1) the individual mandate, which requires most persons to purchase health insurance beginning in 2014 or pay a penalty for failure to do so; and (2) the expansion of the Medicaid program, which, among other things, requires States to expand Medicaid coverage and threatens the loss of all federal Medicaid funding for States that do not comply. In a 5-4 decision written by Chief Justice Roberts, the Supreme Court held that although the individual mandate is not a proper exercise of Congress's power u
Client Alert | June 29, 2012
The United States Supreme Court ruled yesterday that pharmaceutical sales representatives are "outside sales" employees who are exempt from the overtime requirements of the Fair Labor Standards Act ("FLSA").
Client Alert | June 19, 2012
On March 20, 2012, the Supreme Court issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. __ (2012), addressing the scope of the "laws of nature" exception to the definition of patentable subject matter set out in 35 U.S.C.
Client Alert | March 21, 2012
Gibson Dunn provides a detailed review of notable settlements and judgments in the health care area in 2011 as well as significant actions and investigations.
Client Alert | February 6, 2012
San Francisco of counsel Winston Chan and Los Angeles associate Justin Liu are the authors of "The Rising Tide: Recognizing Your Criminal Prosecution Risks Abroad" [PDF] published in the December 2011 issue of Compliance Today.
Client Alert | December 1, 2011
On June 23, 2011, in a case that tested potential conflicts between free speech rights and the power of the state to regulate medical privacy and low-cost healthcare, the Supreme Court struck down a Vermont law that restricted the sale, disclosure, and use of pharmacy records that reveal the prescribing practices of individual doctors. In Sorrell v. IMS Health, No.
Client Alert | June 28, 2011
Printable PDF On March 22, 2011, the United States Supreme Court issued a unanimous opinion affirming the Ninth Circuit's decision in Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167 (9th Cir.
Client Alert | March 25, 2011
Printable PDF 2010 was another blockbuster year in health care compliance enforcement. The trends commenced in 2009--historical settlements, increased enforcement activity, stricter settlement terms, and tougher penalties for individuals--became entrenched in 2010.
Client Alert | January 14, 2011
Denver partner Robert Blume, of counsel Jessica Sanderson and associate Brian Baak are the authors of "Overview of the New Colorado Medicaid False Claims Act," [PDF] published by The Colorado Lawyer on October 1, 2010.
Article | October 1, 2010
In a sign of the Obama administration's continued emphasis on anti-fraud enforcement in the health care field, the joint Department of Justice-Health and Human Services Medicare Fraud Strike Force charged ninety-four people on Friday for their alleged participation in schemes to collectively submit more than $251 million in false claims to the Medicare program. The takedown, which included arrests in Brooklyn, Miami, Baton Rouge, Detroit, and Houston, was the largest operation by the task force since its inception in 2007.The arrests were announced by officials at the highest level of the Department of Justice (DOJ) and the Department of Health and Human Services (HHS), including Attorney General Eric Holder, HHS Secretary Kathleen Sebelius, Assistant Attorney General Lanny A.
Client Alert | July 19, 2010
On June 14, 2010, the United States Supreme Court granted a writ of certiorari to review the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167 (9th Cir.
Client Alert | July 15, 2010
Over the last decade, there has been an explosion in the number of cases challenging alleged exclusion of generic drugs by branded pharmaceutical manufacturers. Often, when a branded pharmaceutical manufacturer is unsuccessful in making patent, scientific, or regulatory arguments in opposition to a prospective generic entrant, the branded manufacturer is faced with high-stakes high-stakes antitrust claims brought on behalf of purported classes of direct and indirect purchasers seeking a significant portion of the branded manufacturer's revenues in compensatory damages.Sean Royall and Joshua Lipton of Gibson Dunn are co-authors of the attached article, "The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context," which addres
Client Alert | April 23, 2010
On April 14, 2010, the U.S. Court of Appeals for the Federal Circuit issued its decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No.
Client Alert | April 16, 2010
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act. Seven days later, the president signed into law a reconciliation measure, the Health Care and Education Reconciliation Act of 2010.
Client Alert | April 9, 2010