Among the bright spots amidst all the bad news lately are the frequent reports of how scientists and engineers have been mobilizing to fight the COVID-19 pandemic with new tests, new treatments and new preventative measures. On March 28, 2020, Abbott Labs announced FDA approval for a new COVID-19 test that can be run in a doctor’s office and return results within 15 minutes.
Dulce co-chairs Fredrikson & Byron’s White Collar & Regulatory Defense Group. With over 18 years of experience representing individuals and business organizations in cases brought by federal and state law enforcement agencies, she understands the unique challenges these cases present. Her practice focuses on criminal and civil regulatory matters involving alleged financial fraud, embezzlement, healthcare fraud, False Claims Act (FCA) violations, Foreign Corrupt Practices Act (FCPA) violations, trade secrets theft, illegal immigration, environmental and other compliance concerns. In the #MeToo era, she has also handled numerous workplace investigations involving allegations of criminal sexual misconduct.
She guides her clients through all stages of their involvement in regulatory and compliance matters: from responding to government subpoenas and search warrants, to conducting internal investigations, reporting crimes to government officials and defending individual and business clients in administrative hearings, criminal and civil trials and appeals.
Dulce investigated reports of major embezzlement at the Town & Country Club in St. Paul by a former employee. She guided club officials and worked with prosecutors to develop criminal claims against the employee, who pleaded guilty in April 2018 to embezzling more than $1 million. Read more here. In 2016, Dulce represented Howard Root, the former CEO of Vascular Solutions, in a landmark federal trial in Texas on felony charges for alleged violations of FDA restrictions against off-label promotion. The month-long trial raised significant questions about the constitutional limits of the FDA’s authority and resulted in a complete acquittal. Read more here.
In addition to investigations and trials, Dulce also works with business clients to help them avoid future problems. She develops compliance plans, leads employee training programs and conducts acquisition due diligence in global transactions with potential corruption risks.
Few situations are as difficult as becoming the target of a criminal investigation. Prosecutors hold most of the cards and the stakes couldn’t be higher. Dulce is a skilled litigator who is not only knowledgeable about the criminal justice system, but an advocate with over 17 years of experience addressing the unique challenges criminal defendants face. She understands that every client is different and listens to each client’s concerns. Dulce has a proven record of success, including:
- Representing Howard Root, a public medical device company CEO, in a federal case in Texas. Following a month-long jury trial for alleged illegal off-label promotion and felony conspiracy, the jury acquitted Mr. Root and the company on all charges. Read more here.
- Representing an insurance agent in a felony prosecution for theft and financial exploitation of a vulnerable adult. After a two-week trial, the jury acquitted her on the felony charges and gave her a gross misdemeanor verdict.
- Representing a medical device company CEO in a felony Medicare fraud trial in federal court. After seven weeks of trial, the prosecution folded and offered a misdemeanor to settle the case.
- Representing a candidate for Minnesota Senate in an election fraud prosecution. The court dismissed the charges without a trial and invalidated the statute on constitutional grounds.
- Representing a caretaker who was accused of abusing a vulnerable adult. The court dismissed the charges without a trial for lack of probable cause.
- Representing a title company executive in a mortgage fraud investigation. Prosecutors dropped the investigation without charges.
Dulce has represented many other individuals, companies, and institutions in federal and state matters across a wide range of industries, from minor misdemeanor infractions to serious, complex felonies.
Dulce has experience handling a wide range of civil matters, from garden variety breach of contract cases to complex civil litigation. Her practice focuses on matters involving fraud, trade secrets theft, embezzlement and other regulatory and compliance violations, including:
- Representing dozens of corporations and non-profit institutions in cases arising under the False Claims Act (FCA). Examples include a Medicare Fraud case against one of the largest healthcare providers in the country. The court dismissed the qui tam claims on a motion to dismiss and the Eighth Circuit affirmed the dismissal on appeal.
- Representing individuals in FCA cases. Examples include an FCA case against over 80 orthopedic and neurosurgeons alleging they had received illegal kickbacks and participated in an off-label marketing scheme with a large medical device company. The district court dismissed the case and the First Circuit affirmed the dismissal on appeal.
- Defending clients against other civil fraud claims. Examples include a case against a group of chiropractors who were accused of violating the Racketeer Influenced and Corrupt Organizations Act (RICO). The claims against our clients settled for a small fraction of the plaintiff’s demand.
- Representing clients who are victims of fraud, theft and other white collar offenses. Examples include the beneficiary of a family trust in a case against the trustee based on misappropriation of trust assets. The trustee was replaced and the case settled on terms satisfactory to our client.
Internal Corporate Investigations
Dulce co-authored the introductory chapter to the Minnesota CLE guidebook on Handling Internal Investigations. She has guided numerous corporations through internal investigations involving high-risk regulatory and compliance concerns. Her practice includes domestic and cross-border investigations and crosses a wide variety of industry sectors: from life sciences to agriculture, construction, industrial manufacturing and academia. She understands the importance of tailoring an investigation to a client’s size, needs and particular business model, and brings the breadth of her experience with law enforcement agencies to bear in developing investigation strategies. Examples include:
- Guided Minnesota’s oldest golf club, the Town & Country Club, through its internal investigation and worked with prosecutors to develop criminal claims against an employee, who pleaded guilty in April 2018 to embezzling more than $1 million. Read more here.
- Working with the Special Risk Committee of a Fortune 500 agriculture company to investigate allegations related to a private foundation.
- Working with an industrial manufacturing company to investigate possible corruption, embezzlement, tax and employment violations reported by a former employee of its subsidiary in China.
- Conducting an investigation for a medical device company into alleged foreign corrupt practices act (FCPA) violations arising from kickbacks paid by a distributor to doctors in China.
- Conducting an internal investigation for a Fortune 500 medical device company into possible FDA violations reported by a group of disgruntled employees.
- Investigating research fraud claims on behalf of a university, and developing reports for its academic review panel on the findings.
- Investigating allegations of criminal sexual misconduct by a patient against a doctor at a healthcare institution.
The Foreign Corrupt Practices Act (FCPA) has become a focus of increased concern among companies with global business operations, as the SEC and federal prosecutors have devoted more and more resources towards FCPA enforcement. Dulce is experienced in leading cross-border investigations into possible corruption and addressing the unique data privacy, linguistic and cultural challenges these investigations present. She also assists corporations that are proactively seeking to strengthen their anti-corruption compliance programs to limit enforcement risk, including:
- Leading anti-corruption acquisition due diligence for companies seeking to acquire businesses with global operations.
- Helping companies develop corruption risk-based strategies for vetting and retaining third party business partners.
- Conducting corruption risk assessments.
- Helping companies develop or improve their anti-corruption compliance programs and policies.
- Developing and leading anti-corruption trainings for officers, employees and third party business associates.
Articles & Presentations
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.
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.
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.
PUBLICATIONS & PRESENTATIONS
Selected Articles & Presentations
- Moderator, “Privacy and Security in Cross-Border Investigations” and “Practical Challenges in Conducting Cross-Border Investigations: A Case Study” Panels, Fredrikson & Byron’s Cross-Border Investigations Seminar, November 12, 2019
- Co-Presenter, “Preserving Privilege in Investigations,” Fredrikson & Byron Health Law Webinar Series, July 11, 2018
- Co-Presenter, “Beyond #MeToo: Conducting Effective and Privileged Workplace Investigations,” Fredrikson & Byron Seminar, June 13, 2018
- Co-Presenter, “Conducting an Effective Internal Investigation,” Lunch & Learn, Association of Corporate Counsel (ACC) Minnesota, April 11, 2018
- Presenter, “Supply Chain Compliance,” Minneapolis Regional Compliance & Ethics Conference, Society of Corporate Compliance and Ethics, March 2, 2018
- Author, MNCLE, Handling Internal Investigations – Best Practices for Investigating Alleged Fraud, Bribery, Regulatory Noncompliance, and Other Types of Corporate Wrongdoing, Ch. 1, “Investigation Planning,” 2017
- Presenter, “Conducting an Effective Internal Investigation – Considerations & Planning,” MNCLE 2017 Health Law Institute, June 15, 2017
- Panelist, “FCPA Updates: The Yates Memo, Pilot Program, and Recent Developments,” MNCLE 41st Annual International Business Law Institute, May 18, 2017
- Presenter, “Collaboration in Embezzlement Investigations,” Fredrikson & Byron Event, May 2, 2017
- Panelist, “Ethical Business Leadership: Setting the Tone for Compliance at the Top,” Fredrikson & Byron/PwC/CEBC Event, September 14, 2016
- Author, “What You Should Know About the New International Bribery Standard,” Law 360, August 11, 2016
- Panelist, “International Investigations,” MNCLE, Conducting Effective Internal Investigations, August 3, 2016
- Panelist, “Best Practices to Prevent, Detect and Investigate Third Party Risk under the FCPA,” Thompson Reuters Seminar, July 26, 2016
- “Recent Off-Label Device Cases Are A Road Map For The Future,”Law360, July 26, 2016
- Presenter, “Bribery, Corruption & the Foreign Corrupt Practices Act,” North Dakota Trade Office, Global Business Connections, March 31, 2016
- Presenter, “Death of an FDA Prosecution: Post-Mortem on the U.S. v. Howard Root Acquittal,” Fredrikson & Byron Event, March 29, 2016
- Author, “Medical device CEO’s acquittal has big implications,”Minnesota Lawyer, March 17, 2016
Sample Media Mentions
- Featured in “Fredrikson & Byron attorneys see workplace misconduct caseload surge in wake of #MeToo movement,” Minneapolis/St. Paul Business Journal, September 26, 2018
Honors & Education
- University of Minnesota Law School, J.D., 1998, magna cum laude
- Macalester College, B.A., Psychology, magna cum laude
- Minnesota, 1998
- U.S. Dist. Court for the Dist. of Minnesota, 2000
- Eighth Circuit Court of Appeals, 2001
- U.S. Dist. Court for the Central Dist. of Illinois, 2002
- U.S. Dist. Court for the Western Dist. of Wisconsin, 2006
- First Circuit Court of Appeals, 2009
- Chambers USA: America’s Leading Lawyers for Business, Minnesota – Litigation: White-Collar Crime & Government Investigations, 2020
- The Best Lawyers in America, Criminal Defense: White-Collar, 2016-present
- Minnesota Super Lawyers, Super Lawyer
- Minnesota Super Lawyers, Top 50 Women, 2013-2014, 2017
- Minnesota State Bar Association, North Star Lawyer, 2013-2014, 2016-2018
- Advocates for Human Rights, Special Recognition Award, 2009
- Minnesota State Bar Association Publications Committee, Elmer H. Wiblishauser Author’s Award, 2008
- Order of the Coif, Member
- Minnesota Law Review
- Phi Beta Kappa, Member
- Federal Bar Association Minnesota Chapter, Diversity Committee Member
- MSBA Member, Criminal Law and Food, Drug & Device Law Sections
- Hennepin County Bar Association
- Eighth Circuit Bar Association
- National Association of Criminal Defense Lawyers, Women in Criminal Defense Committee
- Minnesota Association of Criminal Defense Lawyers
- Fredrikson & Byron, P.A., Foundation Board of Directors, President
- Women’s White Collar Defense Association, Minnesota Chapter Co-Founder and Co-Leader
- Regulatory Affairs Professional Society, Associate Member
- Judicial Clerkship: Honorable John R. Tunheim, U.S. District Court for the District of Minnesota, 1998-2000
- Children of Incarcerated Caregivers, Board Member
- Eighth Circuit History Committee, District of Minnesota, Treasurer