FDA and Health Care

164 Search Results

The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context

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

Federal Circuit Issues Important Decision Construing the Hatch-Waxman Counterclaim and Section viii Carve-Outs

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

A Summary of the Financial Reporting and Disclosure Implications of the Health Care Reform Legislation

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

The Impact of U.S. Health Care Reform on Employers

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (the "Act").  The Act fundamentally alters the U.S.

Client Alert | April 2, 2010

U.S. Health Care Reform Legislation Significantly Expands the False Claims Act

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act, Pub. L. 111-148, 124 Stat. 119 (PPACA).  Media coverage and public scrutiny of this legislation has been extensive, but falling largely outside the spotlight are several provisions extending the reach of the False Claims Act, 31 U.S.C.

Client Alert | April 2, 2010

Health Care Compliance in 2009 and Going Forward

Los Angeles partner Debra Wong Yang, Orange County partner Nick Hanna and New York Partner Alexander Southwell are the authors of "Health Care Compliance in 2009 and Going Forward: Part 1" [PDF] and "Health Care Compliance in 2009 and Going Forward: Part 2" [PDF] published in the March and April 2010 issues of Westlaw Journal's Health Care Fraud.   Gibson Dunn associates Ladan Stewart, Melissa Epstein Mills, Adam Cohen, Ross Halper, Hane Kim and Kristy Grant also contributed to the articles. 

Client Alert | March 1, 2010

2009 Year-End Health Care Compliance Update

I.  Overview of DevelopmentsEnforcement in the health care compliance arena exploded in 2009, with more enforcement actions, bigger financial penalties, tougher settlement terms, and higher stakes for individuals--including prison sentences.  Many of the top companies in the health care industry found themselves in the government's crosshairs this year, with some entering into record-breaking settlements.  But smaller players were hardly immune from scrutiny, with many similarly targeted in 2009.  This increased regulatory and prosecutorial emphasis on health care compliance was hardly an anomaly; all signs point to a continuation of this upward trend in 2010 and beyond.With the current push for reform, health care's significance in the American dialogue has increased m

Client Alert | January 14, 2010

Health Care Executive Convicted of Wire Fraud in Connection with Misbranding Allegations

On September 29, 2009, a former CEO of a biopharmaceutical company was convicted of a wire fraud felony for his role in the alleged creation and dissemination of false and misleading information about the efficacy of a drug marketed by the company.  The indictment of this executive by the Department of Justice (the "DOJ"), and his eventual conviction, represent important developments in the burgeoning enforcement efforts currently underway in the health care industry.  Given recent trends in health care compliance enforcement, and in particular the government's focus on holding individuals accountable, companies and executives alike should prepare for continued scrutiny.The Proceedings The company, InterMune, Inc., allegedly marketed and sold the drug Actimmune as

Client Alert | October 7, 2009

Physician-Consultants: Five Lessons Learned From the Orthopaedic Monitorships

Orange County partner Nick Hanna and associate Melissa Mills are the authors of "Physician-Consultants: Five Lessons Learned From the Orthopaedic Monitorships" [PDF] published in the August 2009 issue of the Orange County Business Journal.

Client Alert | August 3, 2009

President Obama Signs Legislation Significantly Expanding the Scope of the False Claims Act

On May 20, 2009, President Obama signed into law significant changes to the False Claims Act, 31 U.S.C. § 3729 et seq. ("FCA").  The amendments will increase the liability exposure of every company that does business with the federal government and of every company that supplies goods or services that are reimbursed by federal government dollars.  This update provides an overview of the changes brought about by the new law, which (among other things), legislatively overturns the Supreme Court's 9-0 ruling last term in Allison Engine Co., Inc.

Client Alert | May 26, 2009

Proposed Legislation Amending False Claims Act

In January, we provided you with our 2008 Year-End False Claims Act Update in which we discussed, among other things, legislation proposed in Congress in 2007 that would significantly broaden the scope of the False claims Act (the "FCA").  As we predicted, Senator Grassley (R-IA) recently introduced legislation to amend the FCA that, given the current economic environment, Congress is likely to pass.  Congress may feel more pressure to pass these bills this session to demonstrate a commitment to protect taxpayer's dollars from fraud, waste, and abuse.  First, on February 5, 2009, Senator Grassley introduced the Fraud Enforcement and Recovery Act, S.

Client Alert | February 26, 2009

Deal Note: Gibson Dunn Represents Apria Healthcare in Its Sale to The Blackstone Group

Gibson, Dunn & Crutcher LLP's Health Care and Life Sciences Group is pleased to announce its representation of Apria Healthcare Group Inc. in connection with the company's successful sale to The Blackstone Group, a leading investment and advisory services firm.

Client Alert | October 29, 2008

Deal Note: Gibson Dunn Represents The TriZetto Group in Its Acquisition by Apax Partners

Gibson, Dunn & Crutcher LLP is pleased to announce its representation of The TriZetto Group, Inc. in its agreement to be acquired and taken private by Apax Partners, a private equity firm.

Firm News | April 15, 2008

Deal Note: Gibson Dunn Represents Apria Healthcare in Acquisition of Coram Healthcare

Gibson, Dunn & Crutcher LLP's Health Care and Life Sciences Group is pleased to announce its representation of Apria Healthcare Group Inc. in connection with its acquisition of Coram, Inc., a provider of home infusion and specialty pharmaceutical services.

Client Alert | December 7, 2007