News & Analysis as of

Prescription Drugs Dept. of Justice

Teva FCPA Enforcement Action – Part II

by Thomas Fox on

Yesterday, I began an exploration of the Foreign Corrupt Practices Act (FCPA) enforcement action involving Teva Pharmaceuticals Industries Ltd. (Teva). It was brought jointly by the Department of Justice (DOJ) and Securities...more

Teva FCPA Enforcement Action-Part I

by Thomas Fox on

Just when you were thinking things could not get any bigger after the Odebrecht/Braskem Foreign Corrupt Practices Act (FCPA) enforcement action, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC)...more

A Cautionary Tale: DOJ Intervenes in Another Web Accessibility Lawsuit

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Fighting a web accessibility lawsuit could invite DOJ’s intervention, as did a Florida retailer’s recent Motion for Judgment on the Pleadings. Fighting a website accessibility lawsuit is very tempting...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Some good news for the UK after a brutal few days for the pound? It appears that the pound’s precipitous fall has acted as a sort of “giant shock absorber” against Brexit—a release valve of sorts that has meant decreased...more

When It Absolutely, Positively Has to Be Indicted Overnight: How to Prevent Future Debacles Like the FedEx Prosecution

by Pepper Hamilton LLP on

Against the backdrop of years of unprecedented monetary penalties imposed through DOJ civil settlements and deferred prosecution agreements with financial institutions embroiled in the 2008 financial meltdown, the DOJ came...more

Drug Companies and Charitable Patient Foundations

by Michael Volkov on

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

by Michael Volkov on

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

by Arnall Golden Gregory LLP on

So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

by Dorsey & Whitney LLP on

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

President Obama Signs Zika Priority Review, Controlled Substances Laws

by Reed Smith on

President Obama has signed into law S. 2512, which adds Zika virus to the Food and Drug Administration priority review voucher program to encourage the development of treatments for neglected tropical diseases. In addition,...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

by K&L Gates LLP on

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

Drug and Medical Device Corruption Risks in China

by Michael Volkov on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Health Care Physicians in the Crosshairs: Criminal Prosecution

by Pullman & Comley, LLC on

Recent changes to our health care system have been at the forefront of the American news cycle for several years. But certain aspects have not received adequate attention. One example is the scrutiny federal and state...more

Health Law Pulse - October 2015

by Robinson & Cole LLP on

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

by Saul Ewing LLP on

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

by Saul Ewing LLP on

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

KMART Settles False Claims Act Allegations for $1.4 Million

by Robinson & Cole LLP on

The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

Medical Marijuana and Commercial Real Estate in California and Beyond

by Best Best & Krieger LLP on

BB&K attorney Seena Samimi discussed in a Lawline presentation how conflicting medical marijuana laws impact commercial real estate owners, and what they should know in leasing to dispensaries. Real estate impacts...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

by K&L Gates LLP on

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

by BakerHostetler on

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

Health Update - July 2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

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