Healthcare organizations face increasing government scrutiny and private whistleblower activity, and frequent regulatory and policy changes—all of which pose greater financial and reputational costs than ever before. We offer unmatched guidance in navigating this complex legal environment to help our clients minimize risk while reaching their goals.
If an investigation or litigation is unavoidable, our healthcare defense team efficiently and effectively achieves the best possible result for our clients, so they can focus on what they do best—innovating and revolutionizing the healthcare industry.
We anticipate problems and proactively develop solutions.
We understand you have a business to run, and we can help by minimizing the distraction that comes with subpoenas, investigations and litigation. Our healthcare litigation, regulatory, compliance and transactional practitioners work together to address every aspect of a legal problem in a layered approach that includes leveraging our industry-leading experience, following trends and staying on top of ever-changing laws, rules and guidance.
Our unrivaled understanding of the business of operating hospitals, health systems, healthcare providers, life sciences and technology companies—down to the complicated reimbursement structure and rules, at both the federal and state level—is critical in a world where billing government payors is a source of constant scrutiny. And our skilled team works tirelessly to help clients on many fronts, including identifying and avoiding unnecessary risks, responding quickly and effectively in a crisis, efficiently defending any investigation or qui tam complaint, and negotiating the best possible outcomes with the government and private parties. We routinely handle matters under the False Claims Act, the Stark Law, the Anti-Kickback Statute, HIPAA, corporate governance, cybersecurity, pharmaceutical marketing and pricing, and disputes among payers and providers.
Made up of well-respected and nationally renowned lawyers across the United States and around the world, our team includes:
Several former Assistant United States Attorneys and healthcare fraud lawyers from the US Department of Justice
Former senior advisors, lawyers and professionals from the HHS Office of Inspector General and the Centers for Medicare and Medicaid Services
A best-in-class regulatory and compliance team that wrote a leading treatise on the Stark Law and includes nationally recognized authorities on the Anti-Kickback Statute and its safe harbor regulations
Transactional lawyers experienced in negotiating healthcare transactions involving complex regulatory and compliance issues
Our team’s robust experience helps us deliver optimal results in healthcare litigation and investigations, and provide the necessary compliance guidance to help clients operate smoothly and avoid running into new issues.
While we are—and will continue to be—on the front lines of some of the largest and most important cases shaping the healthcare industry, our goal is to prevent problems from ever reaching the courtroom. Our clients come to us because they know they will get the best possible advice to minimize the likelihood of investigation or litigation. The comprehensive breadth and depth of our knowledge and experience enables us to spot issues before they become problems. Working as partners with our industry-leading healthcare regulatory and transactional lawyers, we help clients avoid investigations, litigations and crises. Yet, if litigation is unavoidable, our team of seasoned, first-chair trial lawyers is experienced in aggressively and effectively defending healthcare litigation.
As the only law firm to receive national Tier 1 rankings in healthcare from all of the industry’s top legal directories—Chambers USA, The Legal 500 USA and U.S. News – Best Lawyers—we’ve earned our reputation by leading the legal strategies on some of the most important cases in the healthcare industry and stand ready to help you take on yours.
The firm again awarded the nation’s only Band 1 healthcare firm by Chambers USA
FCA Update blog
Exploring recent developments in False Claims Act litigation, enforcement, and compliance
Results
Our team routinely wins for clients in their most high-stakes matters. Here are some of our recent results:
We persuaded the US Department of Justice (DOJ) to decline to bring charges after a two-year False Claims Act investigation of a medical device manufacturer. Because there was no whistleblower, the company was able to put the entire matter behind it.
We convinced the DOJ to decline to intervene in a False Claims Act case brought by a former employee alleging fraudulent billing for medical services that were part of clinical research. When the relator elected to proceed with the case in US district court, our team persuaded the court to dismiss the case.
We persuaded the government to decline to intervene in an False Claims Act action involving allegations against a specialty pharmaceutical company that develops, manufactures and markets generic and branded prescription and over-the-counter products.
We convinced the government to decline to intervene in an False Claims Act action against a health system alleging that physician financial relationships violated the Stark Law and Anti-Kickback Statute.
We defended a national healthcare provider against civil claims of a putative class of private health insurers arising from the provider’s $345 million settlement of Medicare fraud claims, successfully moving to compel arbitration and defeat a class certification motion, after which the plaintiff dismissed its claims.
We won a case against an aerospace and defense company in a whistleblower suit under the False Claims Act. The US Court of Appeals for the Seventh Circuit affirmed the district court’s finding that our client’s conduct did not give rise to False Claims Act liability.
We represented a regional health system in a qui tam case. The court excluded the relator’s expert after the Daubert hearing before trial, after which the case settled on terms favorable to our client.
We routinely negotiate favorable settlements for our clients in investigations and qui tam litigation, allowing them to revolve matters on a global basis, put their legal issues behind them and get back to business as usual.
Legislazione Americana per la lotta alla Corruzione Straniera
Effective anticorruption compliance is critical to any company operating internationally. We regularly conduct internal investigations of reported concerns under the Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws to determine the veracity of allegations and to advise companies on responding effectively, including taking steps to reduce opportunities for future misconduct. We also defend companies and individuals in government enforcement and regulatory investigations by authorities in the United Statesand other countries.
We leverage our investigations and defense experience to assist clients in developing effective compliance programs and with appropriate compliance policies, procedures and training designed to enhance rather than disrupt business operations. We conduct global compliance risk assessments to help our clients make informed decisions on how to allocate compliance resources. We assist clients in conducting anticorruption due diligence and drafting strong contracts in cross-border deals and engagements of third-party representatives in order to mitigate the significant anticorruption risks those relationships present.
Our team includes former senior lawyers from the US Department of Justice (DOJ), US attorneys' offices and the US Securities and Exchange Commission (SEC), and individuals with deep in-house compliance, computer forensics and accounting experience, who collaborate to provide clients with the multidisciplinary experience and counsel that anticorruption matters often require.
Difesa Valori Immobiliari (SEC)
Securities litigation remains an ongoing threat to businesses and financial institutions. Our SEC Enforcement group is composed of lawyers - including former senior members of the US Securities and Exchange Commission (SEC) Division of Enforcement - who possess substantial experience covering the full spectrum of securities enforcement activity. Our lawyers are knowledgeable about the SEC as an agency, including its rules, practices and customs, and maintain excellent relations with staff of the Enforcement Division and Office of General Counsel.
Clients rely on us to provide legal defense against securities litigation. We have secured favorable results stemming from investigations and enforcement proceedings, on behalf of public companies, their audit committees, officers, directors and senior management, as well as financial services firms, broker deals, investment advisors, hedge funds and accounting firms.
Our capabilities cover all aspects of SEC and other regulatory investigations, as well as parallel proceedings, private class actions and derivative litigation. We have been successful in deterring the SEC at various stages of enforcement investigations and frequently persuade the SEC either not to take any action against our clients or to reduce the nature and scope of the charges, including the elimination of fraud-based charges.
We have demonstrated success - civil and criminal - bringing trials to verdict in federal district courts and handling administrative proceedings at the federal and state level, and we possess substantial appellate experience in the appeal of administrative decisions to the SEC and to the US circuit courts.
As a testament to the mutual respect between our practice and the commission, we have successfully petitioned the SEC to appear as amicus curiae in favor of a client's position in private securities litigation. The SEC also has called upon members of our group to act as receivers in the SEC civil enforcement proceedings. This cumulative experience differentiates us from the competition, ultimately providing clients with the best legal representation to achieve a favorable outcome.
Colletti Bianchi
Today’s organizations and individuals need legal advisors who can help them navigate government investigations; defend qui tam actions, criminal charges, and parallel proceedings; and interpret and address complex regulations. We have the necessary global experience, deep insider knowledge of government processes, and business acumen to help our clients favorably resolve investigations, minimize legal risk, protect reputations, and achieve business goals.
Fortune 500 companies, executives, and board members rely on our global team of more than 60 lawyers to defend them in high-stakes government investigations and lawsuits. Among our key differentiators, we are one of the few law firms with experience handling white-collar proceedings involving digital assets like cryptocurrencies and NFTs, earning us a Band 1 ranking in Crypto-Asset Disputes by Chambers USA. Working in conjunction with our leading healthcare regulatory team, our white-collar lawyers are also uniquely positioned to handle the most sophisticated healthcare matters and to drive government investigations, agency inquiries, and litigation to the best possible results for our clients.
Our white-collar team includes dozens of former senior government officials from the US Department of Justice (DOJ), the Securities and Exchange Commission (SEC), the Federal Trade Commission (FTC), the Department of Health and Human Services (HHS), and other leading US agencies that investigate and prosecute white-collar crime. While serving in these roles, our lawyers led high-profile enforcement matters across every major industry. We combine insider experience with deep knowledge of white-collar law to help clients develop effective compliance programs, craft strong positions against government allegations, and minimize reputational damage.
Sanità & Scienze della vita
Lo Studio è leader mondiale nell’assistenza legale in ambito sanitario e opera con un team di professionisti di altissimo livello dislocati negli Stati Uniti, in Europa e in Asia.
Lo Studio, attraverso il team di professionisti dedicati, vanta una vasta conoscenza delle tematiche legali legate al settore health and life sciences. Una profonda competenza del mercato e del business di riferimento consente allo Studio di affiancare con successo clienti che operano in tutti gli ambiti del settore sanitario.
McDermott Will & Schulte è riconosciuto dalle principali directories del mercato legale quale indiscusso leader mondiale dell’assistenza legale in ambito sanitario.
Nel 2015 le riviste The Legal 500 USA e Chambers USA – quest’ultima per il sesto anno consecutivo – hanno attributo a McDermott il ranking più alto nelle classifiche di settore. In Europa, il team tedesco di McDermott è stato riconosciuto tra i top performer del settore health and life sciences da Chambers Europe.
Lo Studio assiste in molteplici giurisdizioni (inclusa l’Italia) società leader nel settore farmaceutico, nella produzione e distribuzione di dispositivi medicali, ma anche investitori nel settore delle infrastrutture ospedaliere (banche, investitori istituzionali, fondi di private equity), società che si occupano dei servizi connessi alla gestione di ospedali, case di cura e infrastrutture sanitarie in genere.
Il team italiano è in grado di offrire ai propri clienti che operano nel settore health and life sciences una consulenza multidisciplinare annoverando avvocati di riconosciuta esperienza nell’ambito di operazioni corporate, nel banking and finance, nel diritto tributario, nella normativa antitrust e nella tutela della proprietà intellettuale e della privacy. L’interazione costante con i colleghi che operano in altre giurisdizioni consente di fornire risposte efficaci alle specifiche problematiche affrontate, anche in caso di arbitrati internazionali o di progetti che richiedono una consulenza cross-border.
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