[I]t's their practical approach that makes them stand out. They are very good at predicting possible outcomes in different situations. - Chambers UK, 2018
Businesses and individuals today confront a challenging enforcement environment. With confidence, they turn to our Government, Regulatory and Internal Investigations Practice Group for sophisticated and effective representation. We are uniquely suited to handle the primary and collateral consequences of government investigations, whether pre-investigation prevention and mitigation, internal investigations, defense of a government investigation, or resolution through settlement or trial.
Day in and day out, in a proactive dialogue with clients, we are in the prevention business — we are well-versed in assessing legal and compliance risk in multiple programmatic areas. We learn our clients’ businesses, and we think about ways to reduce regulatory exposure in light of evolving government enforcement theories and priorities. In that regard, we help clients devise internal compliance and control programs that allocate limited compliance resources in a prudent and cost-effective manner to the organization's highest risks.
If allegations of misconduct are made — whether by the government, a whistleblower, or the media — we have the knowledge and experience to conduct a comprehensive internal investigation and defend the company if a more formal, adversarial government-led investigation is initiated. We are experienced in the many complex investigative issues that can arise, such as confidentiality and privilege, data protection, and parallel civil litigation or Congressional hearings.
Our internationally recognized team includes former senior enforcement professionals from the U.S. Department of Justice (DOJ), the U.S. Securities and Exchange Commission (SEC) and the U.K. Serious Fraud Office (SFO). These individuals have extensive experience in both senior government positions and in leading the defenses of some of the world’s largest multinational corporations. These Kirkland partners also have, while in government service, authored policies and regulations that remain central to the evaluation and disposition of corporate and anti-corruption cases, in both the United States and the United Kingdom.
We offer extensive experience in conducting internal investigations for corporations, their officers and their boards. These investigations deal with complex subject matters, including putative violations of anti-corruption laws like the Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act, the False Claims Act, securities and trading laws, health care marketing statutes, and internal corporate ethics rules, including human resources policies and "#metoo" issues. We address, as appropriate, issues concerning fiduciary duties, corporate governance, shareholder relations and compliance with relevant statutes, such as the Securities Act of 1933, the Securities Exchange Act of 1934, the Sarbanes-Oxley Act, Delaware and other state laws, and NYSE and NASDAQ rules and regulations. We draw upon our partners' deep litigation knowledge for advice about potential litigation issues at the earliest stages of investigations and our performance is greatly enhanced by our corporate and regulatory practices.
We conduct internal investigations of varying size and scope, depending on the needs of the particular client. Smaller investigations typically involve limited documentary and email review, along with some interviews, conducted by a small number of attorneys. Larger investigations can involve extensive documentary and email analyses, including forensic accounting analyses, as well as extensive interviews. In all instances, our senior lawyers can, as appropriate and as needed, present findings to government regulators with credibility.
We have conducted internal investigations for clients across a broad array of industries — including the pharmaceutical, energy, aerospace, telecommunications, manufacturing, technology, consulting, gaming, entertainment, and banking and financial services industries. We have conducted this work in over one hundred countries, on every continent except Antarctica, drawing upon our extensive contacts in all parts of the world to get answers for clients as quickly and cost effectively as possible.
Anti-Corruption / FCPA
The Foreign Corrupt Practices Act (FCPA) imposes a variety of restrictions on U.S. citizens, companies and issuers, including their affiliates and subsidiaries, in connection with their business activities outside the United States. The FCPA also imposes restrictions on foreign companies and persons who transact foreign business through U.S. territory, mail, wires, and/or financial institutions. Among those restrictions, the “anti-bribery” provisions of the FCPA prohibit corruptly promising or providing anything of value to a foreign government official to obtain or retain business or other improper advantage. The FCPA and other international prohibitions, such as the U.K. Bribery Act, affect a company’s government bid process, the ability to engage in transactions with government officials and other individuals in their private capacities, the selection and retention of consultants, agents and other third parties, and the proper manner for selecting and supervising business partners.
We have one of the largest FCPA teams in the world, and it includes the largest Asia-based team of any U.S. law firm. Our practice is highly-decorated, and that ranking has been earned through decades of cutting-edge work.
Teva, the largest generic drug company in the world, in resolving FCPA cases with both the DOJ and SEC.
Baxter, a leading developer and producer of complex medical therapies, in connection with its response to an FCPA investigation brought by the DOJ and SEC. In January 2014, both the DOJ and SEC informed Baxter that they declined to take any enforcement action against the Company.
A leading global extractives company in respect of internal and governmental investigations into alleged bribery and corruption conducted by the SFO, DOJ, SEC, the Australian Securities and Investments Commission and the Australian Federal Police.
United Technologies Corporation, including its Pratt & Whitney and Otis Elevator business, in resolving a FCPA case with the SEC and in the closure of the DOJ’s parallel FCPA investigation.
Global pharmaceutical company, in connection with DOJ and SEC FCPA investigations concerning interactions with health care providers in Eastern Europe.
Leading multinational telecommunications company, in corruption and FCPA investigations involving activities in the United States and Latin America, which resulted in government declinations without settlement or charges.
Leading manufacturing, engineering, and technology company in connection with DOJ and SEC FCPA investigations concerning oil and gas contracts in South America.
Global pharmaceutical manufacturer, for which we handle all FCPA and compliance investigations.
Health Care Fraud
We offer vast experience in the health care arena. Clients include pharmaceutical and device manufacturers, biotechnology and life sciences companies, health care institutions, providers, investors, insurers, and executives.
We have worked with clients on matters involving the full gamut of health care issues, including matters involving allegations of off-label promotion, improper sales and marketing practices, Anti-Kickback Statute violations, FCPA violations, comparative advertising claims, violations of FDA regulations, and of deficient manufacturing practices (cGMP). We also have extensive litigation experience involving allegations of health care fraud, including in the context of the FCA and qui tam (whistleblower) lawsuits and have often handled these matters in both criminal and civil contexts. On many occasions, we have successfully convinced the government not to intervene in a qui tam action and / or have successfully litigated FCA lawsuits, and in many instances, have obtained dismissals of the lawsuits. We have also successfully resolved investigations by achieving a global settlement of all whistleblower, federal and state enforcement agency, and administrative (HHS-OIG) claims.
In addition, we assist health care clients by conducting internal investigations and advising companies regarding Medicare / Medicaid regulations and various options, including disclosure.
Represented numerous pharmaceutical, biotechnology and medical device companies and other health care institutions, providers and executives in health care fraud investigations conducted by federal and state enforcement agencies involving allegations of off-label promotion, improper sales and marketing practices, pricing issues, and alleged violations of the Anti-Kickback Statute and FCA. Virtually all matters resolved confidentially and without incident.
Conducted investigations including multiple cases where the allegations concerned so-called “blockbuster” products with more than a billion dollars per year in sales. These cases have involved the full gamut of health care issues — including off-label marketing, FCPA, Anti-Kickback, FCA and qui tam issues.
Fortune 100 pharmaceutical manufacturer, in a global resolution of federal and state criminal and civil claims, including settlement of FCA whistleblower claims, HHS administrative claims and state consumer protection claims, in a matter involving allegations of off-label promotion and Anti-Kickback Statute violations in connection with a blockbuster product.
Fortune 500 medical device manufacturer, in connection with a civil and criminal investigation in the District of Massachusetts, with potential allegations involving off-label marketing and the Anti-Kickback statute.
Major health care corporation, in connection with a criminal and / or civil litigation in the District of Maryland involving potential off-label marketing and Anti-Kickback Act issues.
FTSE 100 pharmaceutical manufacturer in DOJ and FDA investigation in the Southern District of New York, with potential allegations regarding cGMP practices at European manufacturing facility.
Counseled Fortune 500 health care company, in resolution of a DOJ and FDA investigation concerning alleged cGMP violations at a U.S. manufacturing facility.
False Claims Act & Qui Tam Defense
We have extensive experience in defending qui tam and government-initiated FCA litigation, including a number of complete victories in cases involving alleged damages and penalties exceeding $100 million. Our experience includes matters involving federal health care programs including Medicare, Medicaid, TRICARE, and the Federal Employee and VA health programs, as well as defense against allegations of cost mischarging, “defective pricing,” manipulation of material systems, defective quality, and product substitution.
Large product supplier to the U.S. Department of Defense (DOD), in suspension and debarment proceedings.
Honeywell, in defending an FCA case brought by the DOJ regarding the quality of ballistic-resistant personal body armor fabric.
Major airline, in defending a DOJ civil and criminal FCA investigation.
Leading an internal investigation of a product manufacturing company under review by multiple DOD customers following the submission of information to the Office of the Inspector General (OIG) under the Contractor Disclosure Program.
Fortune 100 pharmaceutical company, in connection with allegations of off-label promotion and alleged violations of the Anti-Kickback statute with respect to a multibillion dollar product.
Fortune 100 health care corporation, in connection with a criminal and civil investigation concerning one of its foundational pharmaceutical products, with potential allegations involving the Anti-Kickback statute, the FCA, and off-label marketing issues.
Major medical device manufacturer, in FCA litigation involving the alleged off-label promotion of medical devices.
Defending criminal and civil DOJ investigations regarding medical devices sold to the federal government under DOD and U.S. Department of Veteran Affairs (VA) contracts requiring “best price” or “most favored customer” pricing and related disclosure duties by the U.S. Attorney’s office for the Eastern District of Pennsylvania.
One of the largest engineering and construction companies in the world, in defending and achieving a favorable settlement in government litigation concerning alleged billing fraud at a multi-billion dollar federal construction project.
Securities & Futures Enforcement
Our experience spans all of the major programmatic areas of financial market regulation and we regularly defend regulatory and enforcement proceedings involving the SEC, DOJ, Financial Industry Regulatory Authority (FINRA), Commodity Futures Trading Commission (CFTC), Public Company Accounting Oversight Board (PCAOB), various State Attorneys General and self-regulatory organizations (SROs).
An investment bank, on its response to the SEC as part of an industry-wide investigation into communications between certain issuers and the research analysts that cover them.
An investment advisory firm, in connection with an examination and subsequent enforcement action by the SEC.
International financial services firm, in SEC, FINRA, CFTC, and exchange investigations into securities, futures, and derivatives trading.
Global financial services firm's broker-dealer arm, in a money-laundering investigation being conducted by the SEC, FINRA, the Financial Crimes Enforcement Network, and the National Futures Association.
Former CEO of a major corporation, in an SEC investigation related to alleged insider trading.
Banking & Financial Institutions
We have extensive experience representing investment banks, private equity firms, and other financial institutions in cross-border and other complex investigations involving a wide array of regulators, including the DOJ, SEC, CFTC, SFO, New York Department of Financial Services, Federal Reserve, and others. Our team has senior experience in relevant SEC and DOJ offices, and deep experience in negotiating favorable resolutions of multi-regulator investigations.
Global financial institution, in a DOJ investigation regarding the financing of billions of dollars of Asian development projects.
Global financial institution, in an internal and cross-border investigation involving inquiries by the DOJ, SEC, New York Department of Financial Services, and Federal Reserve, as well as the Swiss Financial Market Supervisory Authority (FINMA).
Foreign finance ministry of a core U.S. ally in a DOJ matter concerning sale of mortgage backed securities by a nationally-owned foreign bank.
Leading private equity firms, in a variety of enforcement inquiries and compliance matters.
We regularly defend companies in the manufacturing, automotive, and energy sectors in civil and criminal environmental enforcement matters involving the U.S. Environmental Protection Agency (EPA) and DOJ, as well as state regulators. We have succeeded in negotiating declinations or non-prosecution agreements, including in circumstances where we were retained after prosecutors advised companies of their intention to file indictments.
BP, in criminal and civil matters arising out of the Deep Water Horizon incident.
Environmental services company, in obtaining declination in a DOJ criminal investigation involving alleged violations of the Resource Conservation and Recovery Act.
Energy producer, in negotiating a non-prosecution agreement for alleged violations of the Clean Air Act.
Global automaker, in a DOJ and EPA investigation of vehicle emissions-related issues.
Energy company, in an internal investigation regarding emissions monitoring practices.
We have extensive experience defending and advising companies in investigations relating to manufacturing practices, product quality, data integrity, and related issues. Such cases often involve both government enforcement and regulatory investigations, together with civil commercial or class litigation. We work to assure alignment and coordination in protecting all of our clients’ interests.
FTSE 100 pharmaceutical company, in a DOJ and FDA investigation regarding Good Manufacturing Practices (cGMP) compliance at a global production facility.
Global materials manufacturer, in a cross-border DOJ criminal investigation and related civil proceedings relating to alleged data falsification issues.
Global manufacturer, concerning alleged data falsification issues.
Other White Collar Matters
Our experience extends to a diverse array of corporate compliance and regulatory enforcement matters, including advising clients related to risk assessments, compliance reviews, compliance program development, investigations, and civil and criminal enforcement matters.
Numerous individual executives and investors, in confidential inquiries and investigations by the DOJ and other law enforcement authorities.
Numerous clients, in referring criminal conduct to law enforcement in circumstances in which our clients were the victim and wish to pursue prosecution.
Caterpillar, in an investigation related to tax practices, and in related securities litigation.
Tenneco, in an antitrust investigation by the European Commission and DOJ in relation to a larger investigation into cartel agreements among auto parts manufacturers.
Gaming and entertainment company, in compliance-related matters and a DOJ investigation regarding know-your-customer and FINCEN matters.
Multinational medical products and technology company with operations in 100 countries, in building a revamped compliance program, including creation of global policies, trainings, monitoring processes, and third party management tools. Managed multiple in-country anti-corruption risk assessments in Mexico, Colombia, Brazil, Russia, and India.
Consumer products company, in a Federal Aviation Administration investigation regarding alleged improper shipment of various regulated products, resulting in warning letter and no enforcement action.
Technology company, with review and assessment of their compliance program, including developing and implementing whistleblower and anti-retaliation / anti-discrimination compliance programs.