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Government Investigations - How to Respond to a Search Warrant: 10 Practical Steps [Video]

In a highly regulated industry such as health care, it’s not uncommon to be the subject of a government investigation. In-house counsel and leadership must be prepared in advance for the possibility of a search warrant being...more

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Acquittals in Vascular Solutions Case Deal Setback to DOJ

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow...more

Are Compliance Officers the New Enforcement Targets?

For years health care compliance officers have worried about personal liability for the misdeeds of the companies they serve. And why not? Health care is the most heavily regulated of all major industries, and the compliance...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

Who's Going Under the Bus? Federal Policy on Individual Responsibility for Corporate Wrongdoing - Corridors January 2016

In a wake-up call to health care corporate officers and managers, Deputy Attorney General Sally Yates earlier this fall announced a new, tougher U.S. Department of Justice policy regarding individual responsibility for...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

DOJ Clarifies Position on Individual Accountability in Corporate Investigations

Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ). This memorandum, referred to as the “Yates Memo,” reaffirms the Government’s...more

U.S. Department of Justice issues new guidance on individual accountability for corporate wrongdoing

On Sept. 9, 2015, the U.S. Department of Justice issued new guidance (“DOJ Guidance”) instructing DOJ criminal and civil attorneys to place a greater emphasis on accountability of the individuals responsible for corporate...more

Danger Ahead? The Yates Memo and Some Strategic Considerations for Corporations and Individuals

If you are a corporate executive or employee, the U. S. Department of Justice has a message for you: Investigating you for potential misconduct is clearly a top priority. Recently, the DOJ issued a policy memorandum...more

Who’s In Your Wallet? Is Your Company Being Hijacked by Identity Thieves?

The California Secretary of State has detected increased criminal activity aimed at businesses, as identity thieves make phony filings with the Secretary of State’s office that help them gain access to bank accounts and...more

DOJ Hires Compliance Counsel to Assist in Charging Decisions

New Compliance Counsel Will Assess Effectiveness of Corporate Compliance Programs - Last week the U.S. Department of Justice (DOJ) revealed it is hiring a compliance counsel to assist DOJ prosecutors in assessing the...more

White Collar Watch - September 2013

Contents - FDIC filing more suits against officers and directors of failed financial institutions - Third Circuit upholds 12-year prison sentence for former BigLaw associate - Health care executives...more

Medical Device Compliance Solutions - May 2012

In This Issue: - Risky Business? Assessing Risks with A Risk Assessment Checklist - Haunting Prose: Ghostwriting and Transparency in Pharmaceutical and Medical Device Publications - 2012 In The Line Of Fire:...more

Legally Operating a Medical Marijuana Business in California

Pursuant to California law, medical marijuana businesses legally are allowed to operate in the state. However, there are conflicts in the laws and confusion about what is and is not permitted. This article provides some...more

Insurance Industry Developments for Spring 2012

In This Issue: - The Reinsurance Industry Needs to Understand and Comply With the FCPA - Federal Health Care Reform and the Supreme Court...more

"Pharma/Device Enforcement: A Year in Review"

We are pleased to provide "Pharma/Device Enforcement: A Year in Review," Skadden's annual look at trends in the sector. This year's edition includes details on 2011 DOJ settlements, FDA enforcement trends, enforcement...more

November 2011: White Collar Update

In This Update: Excerpt from: Food and Drug Regulators Step up Prosecution of Corporate Officers for Misconduct: U.S. regulatory authorities recently have made increasing use of a long dormant doctrine to prosecute...more

The OIG Backs Off Intended Exclusion of Forest Laboratories’ CEO

On August 5, 2011, the Office of the Inspector General, U.S. Department of Health and Human Services (the “OIG”), notified Howard Solomon, the CEO of Forest Laboratories, that the OIG would take no action against him under...more

Health Headlines - March 21, 2011

In This Issue: - Recent Prosecutions Reflect Heightened Focus by Regulators on Individual Liability of Healthcare Executives - HHS Proposes to Allow State Data Mining for Medicaid Fraud - Eleventh Circuit...more

It’s Not Just the Conviction — It’s Also the Consequences

Attention: top executives in the healthcare industry. Take heed, or you could be forced to seek employment in a different industry, as three former top executives at Purdue Pharma recently found out. In May 2007, Purdue...more

Four Things You Need to Know About the OMIG’s Mandatory Compliance Program

Starting in the New Year, it is anticipated the OMIG will start to vigorously enforce its mandate that certain Medicaid providers adopt and implement an “effective compliance program.” Having a so-called paper compliance plan...more

A Cautionary Note: Obstruction of Justice and the General Counsel

Recent criminal obstruction charges lodged against in-house counsel signal a shifting enforcement climate that focuses specifically on individual responsibility for alleged illegal actions on behalf of a corporation. This...more

Foreign Corrupt Practices Act (FCPA) Alert: The DOJ’s FCPA Crackdown on the Pharmaceutical and Medical Devices Industry

The Foreign Corrupt Practices Act (FCPA), first enacted in 1977, prohibits issuers, domestic concerns, and foreign persons acting within the U.S. from corruptly making payments to foreign government officials in exchange for...more

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