False Claims Act enforcement poses a significant and growing threat to corporations and institutions, with billions of dollars at stake. Whistleblowers and the U.S. Department of Justice (DOJ) use the Act aggressively, seeking to extract multiple damages and civil penalties. State Attorneys General (AGs) increasingly conduct investigations and assert claims under state laws modeled on the federal False Claims Act. The opportunity for significant whistleblower monetary awards are resulting in more qui tam actions being filed every year. In addition, recent statutory changes and circuit court decisions are making these claims more difficult to dismiss.
Ropes & Gray attorneys have long been at the forefront of False Claims Act defense. Deploying resources across practices, we effectively respond to investigations and successfully litigate actions pursued by whistleblowers or the government. We have achieved favorable resolutions of False Claims Act cases for numerous Fortune 500 companies by effectively responding to government investigations, challenging whether government intervention is warranted at all and defending companies when the government intervenes.
Our team, which spans our government enforcement, securities & shareholder litigation, health care, and labor & employment practices, includes former federal prosecutors from the U.S Department of Justice and leading United States Attorney’s Offices that aggressively pursue False Claims Act cases, and a former Assistant to the U.S. Solicitor General with extensive Supreme Court False Claims Act experience. We understand the complexities of the government’s approach to False Claims Act matters and offer our clients creative and practical approaches to managing the challenges presented in threatened and intervened qui tam actions.
Our attorneys are skilled at addressing the added challenges posed when an active False Claims Act case runs in parallel to criminal investigations, agency investigations, congressional inquiries, state AG matters or other civil actions. We also strategically prepare our clients for the numerous legal challenges that often follow False Claims Act matters, including consumer and third-party class actions, securities litigation, product liability claims, state AG consumer protection investigations and litigation, and employment disputes.
Ropes & Gray has successfully handled False Claims Act cases on behalf of some of the world’s leading pharmaceutical companies, medical device manufacturers, biotechnology firms, hospital systems, academic medical centers, health care providers, financial institutions, defense contractors and construction companies.
Our False Claims Act experience in the life sciences and health care arenas, in particular, is difficult to match. We have been involved in many of the most significant investigations and litigations in these industries in recent years, and have successfully resolved several high-profile and business-critical matters for our clients.
We have represented clients in investigations conducted by more than 25 different U.S. Attorney's Offices, the U.S. Department of Justice and the state Attorney Generals' offices, including those most active in enforcing the FCA. We have experience litigating FCA cases in more than 20 different state and federal district courts around the country.
False Claims Act matters inevitably begin with a DOJ investigation into a whistleblower’s allegations and can unfold in multiple directions. As demonstrated below, we have vast experience in both challenging government investigations and successfully litigating qui tam cases against the government or whistleblower when the government decides not to intervene. Some recent matters include:
- Government Investigations
- Civil Qui Tam Litigation
- Compliance & Risk Management
- Avoiding & Resolving Whistleblower Employment Claims
Our long history of successfully resolving all types of False Claims Act matters has established Ropes & Gray as a “go-to” firm when it comes to navigating the False Claims Act landscape.
- Represented a medical device manufacturer in connection with an investigation in the District of Massachusetts and two related qui tam actions focusing on promotional and billing practices. Obtained dismissal of one qui tam, and achieved a favorable resolution of the second qui tam as a part of a global resolution with the USAO in Boston and the DOJ.
- Represent a medical device manufacturer in the Western District of New York in connection with False Claims Act allegations arising out of its provision of Medicare reimbursement advice to physicians and hospitals for surgeries utilizing the manufacturer’s device.
- Represented a leading defense contractor in connection with a False Claims Act investigation conducted by the U.S. Attorney for the Northern District of Alabama. The matter, which involved allegations that the contractor had not performed proper testing of various missile parts, resulted in a favorable disposition without any admission of liability by the company.
- Represent a major medical device company in connection with an investigation in the Northern District of California and related qui tam actions in federal and state court. The qui tams allege that the company engaged in off-label promotion and improper payments of consulting fees to physicians.
- Defended an international pharmaceutical company in resolving parallel criminal and civil False Claims Act investigations in the District of Massachusetts into off-label promotion and kickback allegations.
Civil Qui Tam Litigation
- Secured dismissal in the Eastern District of Pennsylvania of a False Claims Act complaint alleging that our client, a leading pharmacy benefit manager, engaged in improper distribution of controlled substances. Affirmed on appeal by the Third Circuit.
- Represent a large provider of pharmacy and related services in False Claims Act litigation pending in the District of Massachusetts. The whistleblowers in this action allege receipt of kickbacks from a pharmaceutical manufacturer for increasing sales through therapeutic interchange programs.
- Secured dismissal of all 24 False Claims Act counts in a qui tam suit filed against a leading medical device maker by two former employees who alleged the company engaged in off-label promotion.
- Secured dismissal of a qui tam action brought against a major medical device manufacturer in the U.S. District Court for the Southern District of Texas alleging violations of the False Claims Act by alleged off-label promotion of a cardiac device.
- Represented the only defendant to take on the United States and prevail in court in a nationwide False Claims Act case brought by the United States and initiated by a professional whistleblower that alleged hospitals around the country were routinely up-coding inpatient claims for certain types of pneumonia, convincing a federal court that the United States had failed to intervene in time to comply with the False Claims Act’s limitations period.
- Achieved dismissal of a qui tam action brought in the District of Arizona against a leading hospital group in which the whistleblower alleged that the hospitals violated federal restrictions under the Stark and Medicare Anti-Kickback laws. Defended the dismissal successfully before the Ninth Circuit Court of Appeals and, after the whistleblower was provided with the opportunity to amend his complaint, achieved a dismissal with prejudice, as well as a finding of ethical misconduct against the whistleblower and sanctions against opposing counsel.
- Served as nationwide counsel to a major pharmaceutical company in multi-jurisdictional federal and state consumer protection and False Claims Act claims arising out of allegedly inflated drug pricing in more than 29 proceedings brought by insurers, state AGs, and individuals across the country. Won dismissal of a False Claims Act count carrying with it the possibility of billions of dollars in penalties in one of these lawsuits, leading to numerous subsequent favorable settlements.
Compliance & Risk Management
- Developed, organized and directed independent audits of a global biotechnology company’s compliance program, including development of activity-specific scope documents and document requests for each area under review, conducting interviews with employees, engaging an external consulting firm to test the audit documents, and communicating audit results to internal legal counsel and senior management.
- Assisted a global biotechnology company in preparing for implementation of a CIA. We have supported the client in initial interactions with the government related to the CIA, including preparing white papers and presentations to the OIG and other authorities. We are also assisting the client’s Chief Compliance Officer and other Compliance personnel to prepare for the receipt of a draft CIA, to understand and prepare for expected CIA requirements, and to develop communications about the CIA to staff, officers and directors.
- Assisted a significant medical device maker in conducting a regulatory assessment across various aspects of its business, helping the company draft internal policies and guidance, and working with the company to enhance certain regulatory controls.
- Counseling a global pharmaceutical company on compliance assessment of a major product in the face of a government investigation, addressing practical issues such as field force incentive compensation, e-mail review, promotion compliance and field force training.
- Created a compliance monitoring program for the U.S. health care operations of a major biotechnology company, identifying controls for each activity with health care compliance risk, developing monitoring activities to determine the ongoing effectiveness of the controls, and providing ongoing counsel to the company as it implements the monitoring program.
- Counseled a device manufacturer in establishing a comprehensive compliance program covering FDA regulations as well as the federal Anti-Kickback statute, and training the company’s sales force on compliance with those policies.
- Presented legal educational programs to in-house counsel of various pharmaceutical manufacturers covering a range of topics: government enforcement initiatives; innovative pharmaceutical marketing initiatives; government price reporting obligations; federal regulation of research; federal and state legislative developments in managed care reform laws; formulary management programs; reimbursement support programs; and patient assistance programs.
Avoiding & Resolving Whistleblower Employment Claims
- After the identity of a qui tam whistleblower in a sealed action was inadvertently disclosed, advised hospital chain of appropriate steps to protect itself against allegations of retaliation.
- Defended a federally funded research and development center against a False Claims Act retaliation action in U.S. District Court.
- Enforced against former employee a waiver of all claims and causes of action barring his qui tam action as whistleblower.