Criminal Law, Science, Computers & Technology, Administrative Law

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

Trade Secret Legislation May Increase Infringement Claims and Lead to a Private Right of Action

by Robert Parr, Armand Zottola | Venable LLP on 1/18/2013

Congress recently took new steps to protect trade secrets, which are generally defined as all forms or types of financial, business, scientific, technical, economic, or engineering information that the owner has taken...more

OCC Issues Alert On DDoS Cyber Attacks

by BuckleySandler LLP on 1/8/2013

On December 21, the OCC issued Alert 2012-16, which provides a general description of recent distributed denial of service (DDoS) attacks directed at national banks and federal savings associations, along with risk mitigation...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

by Jeff Ifrah on 1/4/2013

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more

Bill Could Put Reins on Prosecutors’ Efforts to Seize Domain Names

by Jeff Ifrah on 12/28/2012

Rep. Zoe Lofgren (D-Calif), a senior member of the House Judiciary Committee, has indicated that she is drafting legislation that would seek to increase judicial oversight over prosecutors’ efforts to act against Internet...more

Leveson on Data Protection in the UK: What Do Allegations of Phone Hacking Have to Do With Data Protection?

by Maryanne Stanganelli | BakerHostetler on 12/18/2012

The much-anticipated Leveson Inquiry on the Culture, Practices and Ethics of the Press (“Leveson Report” or “Report”) was released on November 29, 2012. The inquiry leading to the Report was initiated as a response to ongoing...more

Second Circuit Rules that Pharma Rep's Promotion of Drug for Off-Label Use is Protected Speech

by S. Jeanine Conley | BakerHostetler on 12/11/2012

The Second Circuit's December 3, 2012 decision in United States v. Caronia, No. 09-5006-CR, could cause a sea change in the growing number of prosecutions brought by the government to prevent the off-label promotion of drugs...more

Does Misdemeanor Misbranding Survive Caronia?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 12/11/2012

The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a...more

Court’s Ruling about Off-Label Drug Promotion Defies Reason

by Patrick Malone & Associates P.C. | DC Injury... on 12/10/2012

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more

Second Circuit Holds that Criminal Penalties for Pharmaceutical Sales Representative’s Off-Label Promotion Violate the First...

by Robin A. Linsenmayer | Orrick, Herrington & Sutcliffe LLP on 12/8/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued an opinion that stands to transform the regulatory landscape in which pharmaceutical and medical device companies operate. In recent...more

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

by Dechert LLP on 12/7/2012

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

Second Circuit Delivers Blow to Off-Label Promotion Prosecutions in U.S. v. Caronia

by Demme Doufekias, Adam S. Hoffinger, Robert A. Salerno | Morrison & Foerster LLP on 12/6/2012

In a much-anticipated decision, a federal court of appeals has ruled that the government cannot criminally prosecute pharmaceutical manufacturers and their representatives under the Food, Drug and Cosmetics Act (“FDCA”) for...more

‘Off-Label’ FDA Cases Can Run Afoul of First Amendment, Appeals Court Holds

by Jeff Ifrah on 12/6/2012

A recent decision by the U.S. Court of Appeals for the Second Circuit may significantly curtail enforcement efforts relating to the so-called “off-label” use of drugs approved by the Food and Drug Administration for specific...more

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

by John T. Bentivoglio, Jennifer L. Bragg, David B. Leland, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2012

In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more

Three Important Lessons from the FCPA Guidance for Pharmaceutical and Medical Device Companies

by Michael Volkov on 12/5/2012

The US Chamber of Commerce “praised” the FCPA Guidance. The Chamber did not get what it wanted but it had to recognize that the FCPA Guidance was helpful for businesses. The FPCA Guidance provides important information for...more

EMRs: The New Health Care Fraud Frontier?

by Robert Radick | Morvillo Abramowitz Grand Iason & Anello P.C.... on 12/5/2012

Whether referred to as electronic medical records, electronic health records, or electronic patient records, there is no doubting the tremendous potential benefits that the digitization of medical data holds for the health...more

Breakdown of FCPA Guidance

by King & Spalding on 12/5/2012

On November 14, 2012, the Criminal Division of the U.S. Department of Justice (DOJ) and the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) released their much-anticipated FCPA guidance, entitled “A...more

Proposed Cloud Computing Act of 2012 Would Aid Employers

by Beth P. Zoller | XpertHR - Partnered with LexisNexis on 11/16/2012

Employers should be aware that the Cloud Computing Act of 2012 was recently introduced in the US Congress as an amendment to the Computer Fraud and Abuse Act (CFAA). +2012 Bill Tracking S. 3569. It would aid employers by...more

State Treasurer and Chairman of the Massachusetts State Lottery Commission Letter to Sen. Reid & Sen Kyl Objecting to Draft...

by Ian Imrich on 10/31/2012

Below is a complete text-version of the attached -- Mass. Treasurer Steven Grossman's Letter to Sen. Reid and Sen. Kyl objecting to the Draft iGaming Prohibition Bill expected to be dropped during the Lame Duck session of...more

Circuit Split: How Does the CFAA Apply to Employment Cases?

by Cullen and Dykman LLP on 10/15/2012

Imagine a disgruntled employee rummaging through your company’s confidential files and covertly stealing trade secrets to use as he builds a competing business. What recourse would you have against the rogue employee?...more

State and Federal Pharmaceutical Enforcement Litigation: What’s Next?

by Mintz Levin - Health Law on 10/8/2012

I recently co-chaired an American Conference Institute (ACI) forum on Pharmaceutical Pricing Litigation, which featured a number of key players who provided their unique perspectives on state and federal litigation involving...more

Time to Check the Entity List: Eleven U.S. and Russian Companies and Individuals Charged in Illegal Export Scheme and 165 Added to...

by Venable LLP on 10/8/2012

On Wednesday, October 3, 2012, a Department of Justice (DOJ) indictment was unsealed charging eleven U.S. and Russian companies and individuals for their alleged involvement in a scheme to illegally export high-tech...more

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

by Jeff Ifrah on 10/8/2012

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100...more

A Widening Circuit Split in the Interpretation of the Computer Fraud and Abuse Act

by White & Case LLP on 10/3/2012

Introduction - The Computer Fraud and Abuse Act (CFAA) criminalizes unauthorized access to a private computer system and allows for individuals suffering harm from such conduct to bring private civil actions for relief....more

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Criminal Law › Science, Computers & Technology › Administrative Law