Criminal Law, Commercial Law & Contracts, Health Law

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

Intermountain Healthcare Settlement – Dangers Of Hospital Agreements With Physicians

by Michael Volkov on 4/30/2013

Hospitals continue to be under the Department of Justice-HHS/Office of Inspector General microscope. DOJ-OIG is a potent combination and carry with them the threat of criminal prosecution, civil false claims enforcement and...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

California Court of Appeal Upholds Dental Board's Revocation of License Based on No Contest Plea to Medi-Cal Fraud

by Timothy Aspinwall | Nossaman LLP on 3/11/2013

On first impression, it is no surprise that a health care professional would lose his or her license to practice based upon a criminal conviction for Medi-Cal fraud. In the case of Hanna v. Dental Board of California, Cal....more

Pfizer FCPA Settlement Emphasizes the Importance of Robust Compliance Programs for the Healthcare Industry

by Bora Rawcliffe | Sheppard Mullin Richter & Hampton LLP on 1/23/2013

The healthcare industry has been under increased SEC and DOJ scrutiny lately for potential FCPA violations. What has been described as an “industry sweep,” has focused primarily on medical device and pharmaceutical companies....more

DOJ and SEC Issue Highly Anticipated FCPA Guidance

by Mintz Levin - Health Law on 11/16/2012

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated...more

Criminal Antitrust Update - October 2012

by Patton Boggs LLP on 10/12/2012

In this issue: - INDUSTRY SCORECARD - E-books: Following its settlement with the U.S. Justice Department’s Antitrust Division (the “Division”) regarding price-fixing allegations related to electronic book sales,...more

Corporate Integrity Agreements and Anti-Corruption Compliance Schedules

by Michael Volkov on 10/10/2012

It is interesting to compare how the Justice Department handles compliance issues in different contexts. The Justice Department, with the Office of Inspector General/Health and Human Services, enters into Corporate...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

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

The Six Most Significant Recent Amendments to the False Claims Act

by Michael Volkov on 7/23/2012

If you do business with the government (e.g. defense industry or health care), your greatest risk is the False Claims Act. The United States government is the world’s largest purchaser of goods and services. The...more

Challenges in Ensuring Anti-Corruption Compliance by Distributors

by Michael Volkov on 7/5/2012

The Justice Department’s recent enforcement action against Smith & Nephew underscored an important point – companies can be responsible for FCPA violations committed by distributors of the company’s products. FCPA compliance...more

Health Care Enforcement: 2012 Trends Quarterly Review — Part IV in a Continuing Series on Health Care Enforcement

by Mintz Levin - Health Law on 5/9/2012

Introduction Mintz Levin’s Health Care Fraud Enforcement Defense group has published a series of “Year in Review” articles discussing its observations about health care fraud enforcement trends in 2011 and its opinions...more

DOJ Reaches FCPA Settlement With Medical Device Company

by BuckleySandler LLP on 4/2/2012

On March 26, the U.S. Department of Justice (DOJ) announced it had reached a settlement with a medical device company to resolve allegations that the company and its subsidiaries made improper payments in violation of the...more

Government Health Care Enforcement: How 2011 Actions Are Impacting 2012 Priorities

by Mintz Levin - Health Law on 3/1/2012

Health care providers and pharmaceutical and medical device manufacturers are operating in an environment of intense scrutiny. As discussed in a Mintz Levin client advisory, in 2011, the federal government directed...more

Fighting Off-Label Qui Tam Suits: Have Federal Courts Encouraged Filing Of Speculative FCA Claims?

by Morrison & Foerster LLP on 4/27/2010

Pharmaceutical and medical device companies that would like to discuss off-label uses of their FDA approved products with health care professionals face a treacherous path paved with substantial uncertainty, including the...more

Amgen Accused of Kickback Scheme to Boost Aranesp Sales

by Robert Kraft on 11/2/2009

The New York Times reported, “The biotechnology giant Amgen has been accused by New York and some other states of engaging in illegal kickbacks to promote sales of its anemia drug Aranesp [darbepoetin alfa].” The states filed...more

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