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Earlier this week, the Canadian government introduced Bill C-13, Protecting Canadians from Online Crime Act. The proposed legislation covers a lot of ground, including the introduction of a suite of new investigation powers...more
The Office for Civil Rights (OCR) of the Department of Health and Human Services recently announced the release of its guidance, “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: A Guide for Law...more
Full text copy of the federal indictment filed September 27, 2013 against Silk Road founder Ross Ulbricht – aka Dread Pirate Roberts, DPR, and Silk Road – for narcotics trafficking, computer hacking, and money laundering (the...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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