Criminal Law, Health Law, Science, Computers & Technology

HIPAA Enforcement: Unleashing The Dogs

by Michael Volkov on 5/21/2013

Prosecutors are a fun bunch and they love their jobs and their mission – to prosecute law-breakers for violating the law. ...more

"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

Law Enforcement In The Health Care Industry: What Do New Cases Against Novartis Tell Us?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 5/9/2013

In recent years, pharmaceutical companies have faced criminal investigations and charges in regard to alleged off-label marketing of prescription drugs and kickbacks to doctors. For this reason, the filing last month of two...more

HHS Considers Amending HIPAA Privacy Rule to Permit Disclosure of Mental Health Information for Firearm Background Checks

by Cory Fox, Lynn Sessions | BakerHostetler on 5/8/2013

Adding yet another wrinkle to the nation’s contentious gun control debate, the U.S. Department of Health and Human Services (HHS) has released an Advance Notice of Proposed Rulemaking (ANPRM) soliciting information and public...more

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 4/30/2013

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

White Collar Watch - April 2013

by Bruce D. Armon, Andrea P. Brockway, Michael Finio, Christopher R. Hall, Keith Lorenze, Nicholas J. Nastasi, Courtney L. Schultz, Brian Simons | Saul Ewing LLP on 4/23/2013

In This Issue: - Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status - Doing Time: A Requirement for White Collar Crime? - Casting a Smaller Net:...more

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

by King & Spalding on 3/14/2013

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

by King & Spalding on 3/14/2013

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

Health Care Enforcement in 2012: A Year in Review

by Hope Foster, Samantha Kingsbury, Tracy Miner, Jessica Sergi, Stephanie Willis | Mintz Levin - Health Law on 2/26/2013

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

DEA’s Proposed New Regulations Regarding the Disposal of Controlled Substances

by King & Spalding on 2/20/2013

The Drug Enforcement Administration (DEA) recently issued a notice of proposed rulemaking with regard to the disposal of controlled substances. These regulations seek to implement the Secure and Responsible Drug Disposal Act...more

False Press Release Leads To Exclusion From Federal Programs

by Robert Rose | Sheppard Mullin Richter & Hampton LLP on 2/20/2013

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

10 Fraud and Abuse Enforcement Trends You Can't Afford to Ignore in 2013

by Cory Fox, Gregory Saikin | BakerHostetler on 2/15/2013

To paraphrase a famous quote, "Those who do not learn from history are doomed to repeat it," and providers who ignore the significance of the federal government's healthcare fraud enforcements efforts in 2012 do so at their...more

Disposing Of Pharmaceutical Waste: Some Progress

by William J. Walsh | Pepper Hamilton LLP on 1/22/2013

In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...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

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

by Jiayan Chen, James S. Cohen, Glenn Engelmann | McDermott Will & Emery on 12/11/2012

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...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

Physicians and Pharmacies Must Be Aware of the Dangers and Potential Penalties Associated with Importing Prescription Drugs

by Fuerst Ittleman David & Joseph, PL on 10/11/2012

Introduction - As the price of healthcare continues to increase, healthcare practitioners have become more innovative and creative in their attempts to keep costs affordable for their patients. One technique which has...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

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

Joint CMS, DOJ Letter on EHR’s Potential for Billing Fraud; AHA, AAHC Respond

by Mintz Levin - Health Law on 9/26/2012

Secretary Sebelius and Attorney General Holder issued a joint letter to the American Hospital Association and four other associations representing hospitals and medical centers, warning of indications that some providers are...more

The Top 5 Corruption Risks for Pharmaceutical and Medical Device Companies

by Michael Volkov on 9/20/2012

Pharmaceutical and medical device companies are fast becoming the enforcement punching bag, eclipsing the long-suffering status of the oil and gas energy. If you ignore the political and public relations challenges facing...more

D.C. Circuit Holds That Former Purdue Pharma Executives Who Pleaded Guilty to Misdemeanor Misbranding May Be Excluded From...

by Ropes & Gray LLP on 8/2/2012

On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs...more

Medical Device Manufacturer Resolves FCPA Violations Related to Conduct in Mexico

by BuckleySandler LLP on 7/17/2012

On July 10, medical device manufacture Orthofix International N.V. became the latest in a string of companies in the medical device sector to resolve an FCPA matter with the U.S. government....more

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