For decades, our lawyers have skillfully represented public and private corporations, boards of directors, and individuals in high-stakes white collar cases and government investigations. We handle a broad range of matters, including internal investigations, enforcement inquiries and litigations, compliance advice and counseling, and corporate governance. Within this arena, Arnold & Porter has a tremendous track record and has become a "go to" firm for clients in the life sciences arena.
The Federal Food, Drug, and Cosmetic Act is enforceable through criminal prosecution, injunction proceedings, civil money penalties, and a variety of administrative actions, as well as through the False Claims Act and general federal criminal statutes. We have significant experience both in the courtroom and in helping avoid the courtroom altogether through effective early intervention to prevent inappropriate or unnecessary enforcement actions. Our attorneys are experienced advocates before the FDA, the DOJ, and other federal agencies with related jurisdiction, including the Drug Enforcement Administration, the Inspector General of Health and Human Services (HHS), and the CPSC, as well as state regulatory agencies. The firm also has advised clients during intensive government investigations and audits. We have, for example, successfully defended several manufacturers of medical devices in so-called Section 305 hearings that resulted either in no criminal referral by the FDA or in no subsequent action by the DOJ.
Our team is recognized for our experience in complex health care fraud and abuse matters, including off-label promotion matters and False Claims Act litigation. Additionally, we have extensive experience representing clients in FCPA, UK Bribery Act, and other anti-bribery investigations and compliance matters in more than 85 countries. We have built a strong reputation in dealings with the US DOJ, the SEC, the UK's SFO, and other US and international government authorities. Many of our partners joined the practice from former high-ranking government positions. Together, our lawyers bring in-depth knowledge and insights to potential criminal issues and build long-standing credibility with prosecutors to resolve matters effectively for our clients.
Areas of Focus
- Government Investigations and Enforcement Actions
- Qui Tam Litigation
- Securities and Accounting Fraud Investigations and SEC Enforcement
- Internal Investigations
- Compliance Advice and Counseling
- Corporate Governance
False Claims Act Investigations and Litigation
We often represent companies not only in the initial investigation by DOJ and/or state Attorneys General, but also in the parallel internal investigation and any subsequent litigation, most commonly in the form of qui tam litigation brought by relators under the False Claims Act. Our teams are closely coordinated and work together to develop strategies to: respond to agency and criminal grand jury subpoenas or federal and state Civil Investigative Demands; conduct internal investigations regarding the subject of the government's inquiry; address potential whistleblower or shareholder litigation; defend companies and seek early dismissal of claims in the event of an FCA suit; and vigorously defend these claims in the event of a trial. We have extensive experience litigating the unique issues that arise from these suits and developing defenses to FCA allegations. Our lawyers have not only defended large corporate clients in FCA suits, pursued either by federal and state governments or by relators themselves following declinations, but also have extensive experience as federal prosecutors investigating and bringing FCA cases on behalf of the government. Our experience on both sides of the aisle provides our clients with valuable insight and strong capabilities in defending against FCA allegations and helps our clients to fully assess all of the direct and collateral consequences that could result from such claims.
The breadth and depth of our practice, as well as the skills and insights of its individual attorneys, is also recognized through the demand for our comprehensive White Collar Deskbook. Published annually by Practicing Law Institute, the Deskbook is the nation's leading single-volume treatise on white collar representation and includes definitive chapters on health care fraud and the False Claims Act, among many other chapters.
Select Representative Matters
- Novartis (NPC) in connection with a well-publicized qui tam suit filed in the Southern District of New York (SDNY) regarding speaker and other promotional programs with doctors conducted by the company over a 10-year period. In their complaints, the US and New York state assert claims under the federal and New York False Claims Acts, respectively, alleging that NPC submitted false claims resulting from alleged kickbacks arising out of tens of thousands of promotional programs that the government contends were "shams" based on the identities of the doctors who attended, the location of the program, and various other factors. NPC is vigorously defending the action, which is pending before Judge Paul Gardephe in the SDNY.
- Novartis Pharmaceuticals Corporation and Novartis Corporation in the successful defense of a qui tam suit brought in District of Massachusetts by multiple relators, alleging off label and kickback claims in connection with the asthma medication, Xolair®. On a motion to dismiss, obtained dismissal with prejudice of all claims. United States ex rel. Garcia et al. v. Novartis Pharmaceuticals Corporation et al., 06 Civ. 10465 (WGY). Dismissal with prejudice of all federal claims was affirmed by the First Circuit. United States ex rel. Kelly et al. v. Novartis Pharmaceuticals Corporation et al., 827 F.3d 5 (1st Circuit 2016).
- Novartis in connection with another high-profile qui tam suit filed in the S.D.N.Y. in which the US and 11 states alleged that discounts, rebates, and other incentives to specialty pharmacies were kickbacks, including incentives tied to medication adherence programs. The case concerned interactions with pharmacies regarding Myfortic, a drug that prevents kidney rejection in transplant patients, and Exjade, a drug that treats chronic iron overload. The case proceeded through fact and expert discovery and pre-trial submissions before resolving with the federal and state governments prior to trial.
- Alcon Laboratories and Alcon, Inc. in the successful defense of a qui tam suit brought in District of New Jersey by relator, alleging off label and kickback claims in connection with ocular medication, Vigamox®. On a motion to dismiss, obtained dismissal with prejudice of all claims. United States ex rel. Lampkin v. Alcon Laboratories, Inc., et al., 08 Civ. 05362 (JAP).
- Led investigation and negotiated resolution with DOJ of qui tam case involving allegations that company submitted false reports involving regulatory status of Nitroglycerin.
- AstraZeneca in state AG unfair trade practice/consumer fraud actions alleging off label marketing and minimization of product safety risks regarding Seroquel antipsychotic medication.
- Pfizer in litigation brought by Nevada AG alleging DTPA violations relating to the promotion of hormone replacement therapy products.
- Pharmaceutical company in an investigation by S.D.N.Y. Civil Division regarding agreements with, and payments to, PBMs. Previously represented a different pharmaceutical company by S.D.N.Y. Civil Division of similar subject; the US closed its investigation less than a year after document production and interviews.
- Federal and state criminal and civil government investigations and internal investigations involving: allegations of off-label promotion; AKS and FCA violations; "best price" and bundling; and other issues related to sales, marketing, pricing, clinical trials, and GMP.
- Pharmaceutical companies on compliance with Anti-Kickback Statute issues in connection with commercial agreements and agreements with government programs, including compliance with the safe harbors for discounts, personal services, and group purchasing organizations.
- Pharmaceutical companies in structuring adherence/disease management, outcomes research, discount and service agreements, quality-based programs, reimbursement support, patient assistance programs, coupon/co-pay assistance programs, free trials, sample programs, and voucher programs.
- Providing advice and analysis to numerous companies on the federal transparency requirements under the Affordable Care Act and state legislation, and assisting in the implementation of required policy and procedural changes.
- Routinely defend pharmaceutical clients in state and federal litigation and governmental investigations by the FBI, FDA OCI, HHS-OIG, and numerous US Attorney's Offices and Attorney General offices involving alleged promotional violations, allegations of violations of the Anti-Kickback Statute, and Medicare and Medicaid fraud.
- PhRMA on major rulemaking initiatives and thought leadership in the Anti-Kickback area, including on exclusion authorities, development of safe harbors, and other issues.
- Several manufacturers on OIG advisory opinion requests, including the requestors for AO 13-7, 13-10 and 14-5, which create key precedents in the commercial space under the Anti-Kickback Statute.
- Seven major pharmaceutical companies with their responses to the OIG survey on co-pay assistance programs and with implementation of the OIG's recommendations.
- Large national healthcare entity in an investigation by FBI, HHS-OIG, Main Justice, and US Attorney's Offices across six districts involving alleged Medicare and Medicaid fraud. The matter involves parallel criminal, civil, and administrative investigations into qui tam allegations related to alleged violations of the Anti-Kickback Statute, Stark Laws, and False Claims Act.
- More than two dozen Medicare/Medicaid providers or suppliers in criminal and civil False Claims Act cases arising from government allegations such as: lack of medical necessity, services below standard of care, unbundling, upcoding, receipt of kickbacks, invalid certificates of need, and violations of the Stark Law. One investigation focused on treatment for vertebral injury.
- Multiple clients on state and federal Anti-Kickback issues arising out of contracts with group purchasing organizations, specialty pharmacies, wholesalers, pharmacy benefit managers, and other customers.
- Healthcare company regarding provision of free goods and payment to physicians for performing clinical trials.
- Major pharmaceutical manufacturer in connection with allegations of misbranding and violations of the False Claims Act asserted by the US Attorney's Office in Boston.
- Pharmaceutical manufacturers on various fraud and abuse issues relating to contractual relationships with distributors, specialty pharmacies, pharmacy benefit managers, managed care organizations, group purchasing organizations, retail pharmacies and other customers.