White Collar & Regulatory Defense
Our White Collar Group has broad experience in successfully guiding clients through everything from internal reviews of regulatory and ethical compliance to criminal prosecutions.
MAIN CONTACTS
Email: dfoster@fredlaw.com
Office: 612.492.7110
Email: jdixon@fredlaw.com
Office: 612.492.7258
News & Articles
What Companies Should Know About the New ISO Anti-Bribery Standard
August 9, 2016
Global companies in the United States have an uneasy relationship with the Foreign Corrupt Practices Act. Most recognize that corruption can be damaging to business, but decry the statute as unfair: Because the United States is more aggressive about enforcing its anti-corruption laws than other countries, U.S. companies are more likely to be prosecuted for bribing foreign officials. The FCPA effectively tilts the playing field against us in foreign business transactions. But the global landscape gradually may be changing. Corruption prosecutions outside the U.S. are becoming more common, and many foreign governments have signaled a change in perspective by enacting new and stricter anti-corruption laws.
Read MoreA Map to the Road Ahead: The Significance of Recent Verdicts in Off-Label Cases
July 28, 2016
On July 20, a jury in Massachusetts convicted former Acclarent executives William Facteau and Patrick Fabian of 10 misdemeanor counts of misbranding and adulteration based on alleged off-label promotion of the Stratus sinus spacing device. They were acquitted of 14 related felony charges, but they have vowed to fight the misdemeanor convictions in future motions and appeals. The Facteau verdict contrasts with the clean sweep obtained by Vascular Solutions and its CEO, Howard Root, last February, when a Texas jury acquitted them of all counts of misbranding and conspiracy for allegedly promoting the Vari-Lase varicose vein device off-label. The two cases are different in significant respects, which may account for the disparate results. But they also bear many similarities, which provide a road map for medical device and pharma manufacturers to future off-label prosecutions in the wake of recent First Amendment precedents.
Read MoreJury Acquits Medical Device CEO Charged With FDA Crimes
March 7, 2016
On February 26, 2016, a jury in West Texas acquitted Minnesota-based medical device company Vascular Solutions, Inc., and its CEO, Howard Root, in a federal criminal case involving FDA alleged crimes. The indictment in the case charged Vascular Solutions and Mr. Root with misbranding and conspiracy based on allegations that Vascular Solutions marketed its Vari-Lase® device for off-label use and sought to conceal that activity from the FDA. The jury wholly rejected the government’s case and delivered a stunning defeat to the FDA and the Department of Justice (DOJ) by acquitting Vascular Solutions and Mr. Root on all counts.
Read MoreFredrikson & Byron White Collar Team Wins Not Guilty Verdict in Landmark Criminal FDA Case
March 1, 2016
On February 26, 2016, Fredrikson & Byron attorneys John Lundquist, Dulce Foster and Kevin Riach won a hard-fought victory for Vascular Solutions’ CEO Howard Root in a federal criminal prosecution with far-reaching implications for medical device companies and FDA practitioners.
Facing an indictment on four counts of misbranding under the Federal Food, Drug and Cosmetic Act and one count of conspiracy, Mr. Root made the exceedingly rare decision for a public company CEO to fight the charges instead of settling or stepping down.
Read MoreFormer United States Attorney Joins Fredrikson & Byron’s White Collar & Regulatory Defense Group
May 11, 2015
Prominent trial attorney Joseph T. Dixon, III has joined Fredrikson & Byron as a shareholder and co-chair of the White Collar & Regulatory Defense Group. Dixon offers clients a unique blend of trial, government and strategic business experience.
Read More
