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White Collar Posts

Third Circuit Rejects FCA Claims of Medicare Part D Fraud Applying Post-Escobar Materiality Bar; Acknowledges Validity of Government Knowledge Inference Defense >
November 29, 2017
By: Barbara Rowland and Carolyn H. Kendall
Earlier this month the United States Court of Appeals for the Third Circuit ended a long-fought False Claims Act case of alleged Medicare Part D fraud, holding that a pharmacy benefit manager's limited non-compliance with pharmacy claims processing requirements was not material to Medicare's payment decisions within the meaning of the Supreme Court's Escobar decision. On November 16, 2017, in United States ex rel. Spay v. CVS Caremark Corporation, the Third Circuit affirmed the district court's summary judgment dismissal in its second significant post-Escobar materiality decision. Interestingly, the appellate court veered away from the district court's holding that the "government knowledge inference" defense precluded liability for the PBM and instead found that the Relator failed to demonstrate that the alleged non-compliance met the Escobar materiality threshold.
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Off Label-Marketing and Free Speech: Report from APhA 2017 Annual Meeting >
April 5, 2017
By: Matthew T. Newcomer
On March 26th, I presented to pharmacy professionals, clinicians, researchers, and educators in San Francisco for the American Pharmacists Association's (APhA) 2017 Annual Meeting & Exposition. There was a lot of buzz about the growing opioid epidemic, the proliferation of illegal online pharmacies, and off-label marketing.
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Government Contests Assertion of Attorney-Client Privilege in Assessing Cooperation >
January 5, 2017
By: Ronald H. Levine
However else one characterizes 2016, it was a very good year for the government's Foreign Corrupt Practices Act (FCPA) profit center. Twenty-seven companies paid about $2.48 billion to resolve FCPA cases, a record. Although the incoming Administration may shift priorities, there exists considerable institutional momentum behind continued FCPA enforcement. In that light, it's worth taking a look back at one of the last FCPA cases of 2016.
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Pennsylvania's Medical Marijuana Law, Health Care Providers, and Enforcement >
October 13, 2016
By: Barbara Rowland
With other members of our Firm's Regulated Cannabis Group, I recently co-authored an article for the Life Sciences, Pharmaceuticals, and Health Care Supplement of The Legal Intelligencer. We examined Pennsylvania's April 2016 medical marijuana law from four essential legal standpoints - professional liability, health care law, employment law, and enforcement - and the related implications for health care providers in the state.
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The Enforceability of FDA's Off-Label Marketing Restrictions Following the Amarin Decision >
February 17, 2016
By: Matthew T. Newcomer and Yune D. Emeritz
Today, February 17, 2016, AHLA's Journal of Health & Life Sciences published as its “Featured Article” our analysis of the enforceability of FDA's off-label marketing restrictions in the aftermath of the August 2015 Amarin Pharma, Inc. v. United States FDA decision. The article, entitled, “To Promote or Not to Promote? The Enforceability of FDA's Off-Label Marketing Restrictions Following Amarin,” traces the recent string of judicial decisions challenging the government's restrictions on drug companies, truthful and non-misleading off-label speech as violating the First Amendment's free speech protections.
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DOJ's New Appetite for Prosecuting Food Companies and Their Executives >
January 13, 2016
By: Barbara Rowland and Yune D. Emeritz
The DOJ, together with the FDA, is increasingly investigating and prosecuting food companies for the sale of adulterated food products. Coupled with the Yates Memo, the September 2015 memorandum by DOJ Deputy Attorney General Sally Yates announcing DOJ's emphasis on holding individual employees accountable for corporate misconduct, this puts food company executives, as well as food companies, at increased risk of being charged criminally for adulterated products.
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HHS-OIG Senior Counsel Riordan Focuses on Kickbacks, Accountability, and the Role of Compliance in Pharma Compliance Congress Keynote >
October 27, 2015
By: Barbara Rowland
On Wednesday, October 22, 2015, the 16th Annual Pharma Compliance Congress in Washington, D.C., was kicked off by keynote speaker Mary Riordan, HHS-OIG Senior Counsel and perhaps OIG's most well-known face to the pharmaceutical industry. In her talk, Ms. Riordan laid out three hot button areas for company compliance professionals: kickbacks, individual accountability, and the role of compliance in business operations. We thought these were worth sharing, particularly because two of the areas -- a jump in kickback cases and individual accountability in the investigation and resolution of corporate investigations -- were themes also emphasized by the government speakers at the AUSA Roundtable panel.
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Takeaways for the Hospitality Industry from FDA's Draft Food Labeling Guidance >
September 16, 2015
By: Barbara Rowland, Charles W. Spitz, and Abraham J. Rein
The FDA has issued draft guidance regarding previously announced menu-labeling rules set to take effect on December 1, 2015. The scope of those rules, which require certain businesses to post nutrition information about food offered for sale, has raised questions for the hospitality industry.
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PharMerica Settlements Highlight Potential for Dual False Claims Act and Controlled Substances Act Liability for Invalid Prescriptions >
August 29, 2015
The American Society for Pharmacy Law's (ASPL) Rx Ipsa Loquitur
By: Barbara Rowland and Matthew T. Newcomer
In the July/August 2015 issue of Rx Ipsa Loquitur, the newsletter publication of the American Society for Pharmacy Law (ASPL), Internal Investigations & White Collar Defense Principal Barbara Rowland, and Principal Matthew T. Newcomer, examine potential dual False Claims Act and Controlled Substances Act liability for Medicare Part D and Medicaid providers.
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Recent Developments in FTC vs. Wyndham Underscore Importance of Cybersecurity Vigilance in the Hospitality Industry >
March 30, 2015
By: Abraham J. Rein and Marc H. Perry
On Friday, March 27, the parties in FTC vs. Wyndham, a key data security case with the potential to deeply impact the hospitality industry's cybersecurity practices" filed special supplemental briefs that the Third Circuit Court of Appeals requested during oral arguments earlier in the month.
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Decriminalized Marijuana and the Promise of Legal Profits >
April 2, 2014
Business Crimes Bulletin
By: Barbara Rowland
In an April 2014 article for American Lawyer Media's Business Crimes Bulletin, Principal Barbara Rowland explores recent changes in the law surrounding use and distribution of marijuana. In particular, Ms. Rowland analyzes how models and standards from other highly regulated industries may help enterprises considering entry into the legal marijuana industry, including entrepreneurs and financial institutions.
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Article: "The Federal Prosecutor As Regulator: Good Manufacturing Practices and The False Claims Act" >
May 29, 2013
By: Ronald H. Levine
In the May 2013 issue of the Law Journal Newsletter's Business Crimes Bulletin, Post & Schell Principal Ron H. Levine explores the potential expansion of False Claims Act actions against medical device and pharmaceutical manufacturers for alleged violations of the FDA's current good manufacturing practices (cGMP) regulations.
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Sleepless Nights: Compliance Challenges Facing Today's Medical Device Executives >
May 3, 2013
By: Ronald H. Levine
In an article in the May 3, 2013 issue of Pharmaceutical Compliance Monitor, Ron Levine examines the list of compliance challenges that medical device executives need to consider as they risk analyze to allocate compliance resources.
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