On May 22, 2019, Fredrikson hosted a seminar that featured a panel discussion on state and federal enforcement priorities with regard to opioids, practical on-the-ground issues cropping up for providers, and the future of opioid prescription and regulation.
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.
Recent Off-Label Device Cases Are A Road Map For The Future, published by Law360
Watch the videos from Fredrikson’s Cross-Border Investigation Seminar held on November 12, 2019.
What We Do
No business or executive ever expects to become the target or subject of a white-collar criminal investigation by a federal or state agency. In today’s regulatory environment, however, ethical businesses of all sizes and in all industries may find themselves under scrutiny by law enforcement or regulatory agencies investigating allegations of fraud, false reporting, or other acts of white-collar wrongdoing. These investigations invariably carry not only potential criminal penalties, but possible civil exposure as well as significant collateral consequences such as debarment from government programs. We guide and advocate for our clients in the most difficult legal challenges they will ever face, from sensitive investigations to high-stakes trials and complex appeals.
Our team includes a former Chief of the Fraud and Public Corruption Section for the U.S. Attorney’s Office for the District of Minnesota, who has also served as Deputy General Counsel for a leading national healthcare organization; a former member of the Office of IRS District Counsel, and two full-time criminal defense lawyers with more than ten years’ experience defending white collar cases. The core group is supported by a dedicated team of younger partners and associates and the broad array of cross-disciplinary experience within our firm.
When a case moves into the White Collar arena, our attorneys provide strong, confident defense in a wide variety of areas. We represent corporations and executives in criminal investigations and prosecutions, regulatory compliance investigations, and enforcement actions, as well as civil fraud claims, RICO cases, qui tam lawsuits, and “whistleblower” litigation. We also spearhead internal investigations within corporations, non-profits, and government agencies. In each case, we strive to provide the best possible outcome for our clients through aggressive and experienced representation.
Our White Collar & Regulatory Defense practice group offers a comprehensive range of services, including:
- Anti-Bribery and Foreign Corrupt Practices Act
- Anti-Kickback Laws
- Anti-Trust and Price-Fixing
- Bank Fraud
- Bankruptcy Fraud
- Currency and Money Laundering
- Customs Fraud and Import/Export Laws
- Debarment and Exclusion
- Elections and Campaign Finance
- Environmental Crimes
- False Claims Act & Qui Tam Defense
- Food and Drug Administration
- Government Contracts, Procurement and Grants
- Health Care Fraud
- Internal Investigations
- Mail & Wire Fraud
- Real Estate and Mortgage Fraud
- Research Fraud
- Securities Fraud
- Sex Crimes
- Tax Evasion and Reporting
The following is a representative list of our clients:
- The CEO of a medical device company in a criminal FDA prosecution.
- A major medical device company in a DOJ investigation under the Trade Agreements Act.
- An agriculture business in a criminal Department of Homeland Security investigation.
- A major medical center in a Medicare billing investigation.
- Construction companies in federal DOT investigations under the Disadvantaged Business Enterprise regulations.
- Over 80 orthopedic and neurosurgeons in anti-kickback litigation against the government.
- A financial advisory firm in a criminal anti-trust investigation and parallel class action litigation involving the municipal derivatives industry.
- Two oil and gas companies charged with violating the Migratory Bird Treaty Act.
- A Mexico-based business subject to civil forfeiture of hundreds of thousands of dollars in assets.
- The CEO of a medical device firm charged in a health care fraud prosecution involving a 7-week trial.
- The CEO of a non-profit foundation charged in a multi-million dollar mail fraud prosecution involving a 6-week trial.
- A food manufacturer in a criminal FDA contaminated food investigation.
- An ethanol plant in a federal prosecution under the Clean Water Act.
- A medical device company in a Foreign Corrupt Practices investigation involving transactions in China.
- Businesses and executives in criminal tax investigations.
- Public companies in parallel DOJ and SEC financial fraud investigations.
- Political party candidates in campaign and election investigations and prosecutions.
- Individuals prosecuted for fraud, embezzlement, theft, sex crimes, immigration violations, violent crimes, and narcotics and firearms violations in state or federal court.
- Medical device manufacturers, health care providers, academic institutions, an Indian tribe, and a variety of public and non-public companies that retained us to conduct internal investigations covering numerous criminal and regulatory issues.
News & Articles
January 14, 2019
Four women attorneys join forces to create local chapter of the Women’s White Collar Defense Association.
December 10, 2018
The arrest of Meng Wanzhou, one of China’s leading tech executives, highlights the broad reach of U.S. sanctions and the increasing boldness with which the U.S. government is acting to control the conduct of foreign actors. But U.S. companies engaged in global trade should also remain vigilant and take precautions to avoid tripping over the lines.
May 2, 2018
On June 13, Fredrikson & Byron’s Employment & Labor and White Collar & Regulatory Defense Groups hosted a seminar on how to conduct effective internal investigations and how to preserve privilege while you do so.
December 1, 2017
The DOJ has announced a potentially dramatic shift in its enforcement policy with regard to the Foreign Corrupt Practices Act (FCPA), the federal statute that prohibits bribery of foreign officials.
April 4, 2017
On May 3, 2017, Fredrikson & Byron’s White Collar & Regulatory Defense group hosted a panel presentation on the real issue of employee malfeasance in large and small organizations.
March 22, 2017
Fredrikson & Byron co-sponsored a program with Federal Bar Association, Minnesota Chapter on May 2, 2017. The program focused on how prosecutors, defense attorneys and forensic accountants work together to uncover employee theft and bring embezzlers to justice.
August 10, 2016
On September 14, 2016, speakers from Center for Ethical Business Cultures, Fredrikson & Byron and PwC addressed the ethical, legal and organizational issues in play as companies attempt to foster a compliant culture.
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.
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.
March 8, 2016
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.
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.
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.