Whether we are helping a global MedTech company navigate a multi-jurisdictional investigation by the U.S. DOJ, SEC, or the UK SFO – or convincing DOJ not to intervene in a False Claims Act case against a U.S. company – our clients benefit from a team that marries investigations experience with a deep industry regulatory background and integrated technology.
We are well-positioned to advise you on:
False Claims Act investigations and litigation
In the United States, we have a particularly strong reputation for supporting life sciences and health care clients in both federal and state False Claims Act (FCA) investigations and litigation against the government and whistleblowers. We also defend clients against whistleblower claims under the California Insurance Frauds Prevention Act and the Illinois Claims Fraud Prevention Act.
We leverage our mastery of the nuances of the federal Anti-Kickback Statute, the Physician Self-Referral (Stark) Law, and their safe harbors and exceptions – as well as related state fraud and abuse authorities – to defend our clients in a range of inquiries, audits, and investigations alleging fraudulent activity in everything from the structuring of physician-owned hospital ventures to billing for allegedly medically unnecessary services, as well as with respect to speaker programs, vouchers, discounts, rebates, loyalty programs, discount cards, and more.
Where FCA investigations proceed to litigation, our team’s combined litigation and regulatory experience enables us to provide substantive, effective advocacy. We have won a number of FCA cases at the dismissal stage, including motions resulting in reported opinions. Working together, our litigators have identified the legal deficiencies in pleadings and allegations, while our regulatory attorneys have spotted the flaws in proffered legal theories. We have also successfully won at the summary judgment and trial stages of litigation. In numerous jurisdictions, we were able to flush out factual and regulatory issues that did not reveal themselves in the pleading stage, leading to favorable findings by judges and juries.
Importantly, our lawyers are innovative in their use of technology within the legal profession. They are regularly called upon for their skills in forensic data analysis, with their efforts leading to the defeat of a number of major FCA claims. In recent years, the Department of Justice and FCA plaintiffs have increasingly relied on data analytics to support their fraud allegations. Data mining also opens the door for industry outsiders to formulate and pursue FCA liability theories as plaintiffs in FCA suits against defendants with whom they have no personal dealings. Our team has significant experience in defeating plaintiff Big Data analyses, designing compelling defensive Big Data models, and marshalling extraordinarily complex Medicare and Managed Medicare regulations.
Internal investigations
We conduct highly sensitive and confidential internal investigations for corporations, audit committees, special board committees, and senior management. Our team conducts internal investigations all over the world, often in the local language. We also have a robust practice in the United States, conducting internal investigations for clients stemming from allegations of violations of key health care and FDA laws and regulations, such as the Anti-Kickback Statute, the Stark Law, the Food, Drug, and Cosmetic Act, and the False Claims Act. Based on our findings in such investigations, and as called for, we assist clients in developing and implementing suitable remedial actions and initiating claim repayments, as necessary, and self-disclosures, as appropriate.
Foreign Corrupt Practices Act
While clients benefit from our coordinated international approach to any cross-border investigation, we have particular strength in advising on the U.S. Foreign Corrupt Practices Act (FCPA). Given the high stakes, we routinely help our clients develop robust compliance systems and controls that enable them to quickly locate and manage potential breaches of the FCPA. Our team also draws on its long-standing interaction with government regulators to successfully resolve investigations and litigation dealing with foreign corrupt practices.
FDA and related EU regulatory inspections and investigations
Additionally, when FDA- and EU regulatory-related matters are the subject of internal compliance concerns or government inquiries, audits, or investigations, our team brings a breadth and depth of experience based on years of advising companies ranging from start-ups to large multinational manufacturers. For more information, please visit our FDA & EU Regulatory, Compliance, and Enforcement page.
Privacy and cybersecurity-related investigations
Our health privacy and security team regularly and successfully represents clients that are subject to investigations by U.S. federal and state regulators regarding alleged failures to comply with applicable privacy, security, and data breach notification obligations. These government investigations typically follow cybersecurity breaches or complaints from individuals regarding alleged violations of their privacy rights (such as not adequately responding to access rights or unauthorized sharing of personal health data). Our team’s advocacy commonly results in the closure of investigations with no monetary penalties or corrective action plans.
State attorneys general
We have experience counseling clients through government investigations and litigation, as well as private litigation that may have a U.S. state policy component. We regularly represent clients on high-stakes legal matters involving AGs and work with clients to anticipate and, where possible, avoid litigation altogether. Our attorneys have deep experience in litigating and resolving AG investigations and lawsuits, and maintain strong relationships with AGs to mitigate issues proactively before they arise.
Beyond this, we regularly represent clients before AGs and monitor policy and legal trends that may impact clients at the National Association of Attorneys General (NAAG), the Attorney General Alliance (AGA), and the Democratic and Republican Attorneys General Associations (DAGA and RAGA).
