Healthcare Investigations and Enforcement Litigation
WilmerHale has been involved in some of the most significant healthcare-related criminal and civil investigations and litigation during the last decade. We frequently represent clients in investigations, leveraging the knowledge of our deep bench of former Justice Department officials.
Healthcare industry clients regularly come to us for representation in government investigations and litigation alleging conspiracy, fraud and abuse, including violations of the Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, the False Claims Act (FCA) and the Foreign Corrupt Practices Act. Our lawyers have represented clients in criminal, civil and administrative investigations and in criminal and civil litigation brought by federal and state authorities, both at trial and on appeal. On behalf of our corporate clients, we also have conducted hundreds of internal investigations and provided compliance advice.
Clients depend on our assistance to demonstrate why the government should not pursue any charge or claim, to negotiate civil resolutions of allegedly criminal conduct, and, where appropriate, to globally resolve criminal, civil and administrative claims to avoid potential collateral consequences. We have successfully resolved grand jury investigations of allegations of criminal wrongdoing prior to indictment. We also have obtained the early dismissal or resolution of FCA suits brought by qui tam plaintiffs and the government by focusing on precedent-setting legal defenses. When cases have gone to trial, our experienced courtroom advocates have tried them and won.
Public Policy and Congressional and Executive Branch Investigations in Healthcare
Companies in the healthcare industry rely on our representation in high-stakes congressional and executive-branch investigations. They also depend on us to help them shape legislation and regulations, and guide them through the political and media mazes that often accompany public policy controversies.
WilmerHale’s public policy team has extensive experience representing clients engaged in complex, high-stakes congressional and executive branch investigations, as well as those facing attorneys general and other regulators from multiple states that have banded together to investigate a corporation or industry. In the healthcare sphere, for example, we advised a director of a major US healthcare corporation in a House Energy and Commerce Committee investigation, and shepherded a medical device company through its response to congressional inquiries about its marketing practices. We also regularly guide companies through the complex legislative process, such as when we advised a major insurance company on constitutional, substantive and strategic issues associated with efforts to achieve a global legislative solution to the national asbestos crisis.
Our comparative advantage in handling these matters derives from three key strengths. First, we are skilled at complex policy analysis that grasps the intersections among law, policy and politics. Second, as experienced advocates, we understand how to frame arguments tailored to the audience in question—be it Congress, the administration, the business community or the public. Finally, we have a deep bench of lawyers with significant experience at the top levels of government, so we know how to get things done in the executive branch and in Congress.
Healthcare Transactions and Corporate Counseling
WilmerHale’s lawyers are renowned for their work on mergers and acquisitions, IPOs, private equity deals, strategic alliances and corporate governance matters both domestically and in the EU and China. Healthcare clients, which include Medtronic and PerkinElmer, know us as a one-stop source for solutions to the diverse array of corporate issues they face.
For clients that range from public and private companies to individual entrepreneurs, our corporate lawyers have:
- Served as issuer counsel or underwriters’ counsel in more than 400 public offerings and Rule 144A placements raising nearly $150 billion since 2006. We have a wide array of capital markets experience, as well as significant commercial finance knowledge.
- Advised on more than 1,000 M&A deals with a total value in excess of $400 billion since 2006. Our experience ranges from public-public mergers and related SEC, disclosure and fiduciary duty issues to the unique issues presented by sales of private equity and venture-backed private companies.
- Handled hundreds of strategic alliances, joint ventures, outsourcing and licensing transactions each year, including several strategic alliances that have received industry recognition for their importance. The complexity of these deals often demands deep experience and close collaboration among our corporate, licensing, intellectual property and tax lawyers, as well as our lawyers in the United States, Europe and Asia.
Healthcare Patent and Trademark Prosecution and Litigation
WilmerHale’s top-tier patent litigation practice has garnered numerous national awards for consistently winning headline-grabbing cases. Our patent prosecution team has filed thousands of US and foreign patent applications. We also have substantial experience in patent interference and reexamination proceedings, opinions, counseling, due diligence and audits. And our trademark lawyers are equally adept at registration and litigation.
Healthcare clients benefit from the industry experience, scientific knowledge and courtroom know-how of our more than 200 lawyers, including more than 120 who hold scientific or technical degrees. Our teams have achieved business-critical victories for numerous healthcare and medical device companies. For example, for Roche Molecular Systems, we prevailed against Stanford University in a closely watched case regarding the effect of the Bayh-Dole Act on patent rights to inventions developed using federal funds (the first patent case in which the US Supreme Court affirmed the Federal Circuit, despite the fact that the solicitor general urged reversal). We also represented Medtronic in its appeals of adverse judgments in three cases, obtaining rulings reversing the district court’s judgments against the company and awarding sanctions in two of the cases.
Healthcare Data Security and Privacy
WilmerHale brings significant experience navigating the complex waters of data security and privacy laws, including HIPAA, the HITECH Act and Federal Trade Commission (FTC) medical data breach notification requirements. From advising on domestic and global regulatory issues to litigating nuanced questions of first impression, to shaping compliance regimes, our lawyers provide soup-to-nuts counsel to clients around the globe.
Our healthcare data experience encompasses the HIPAA privacy, security, transaction and breach notification rules; requirements for de-identification and research; the additional requirements of the HITECH Act; FTC medical data breach notification requirements; state security breach laws; and the interplay of HIPAA, Gramm-Leach-Bliley and state security breach response requirements. In our health data regulatory work for covered entities, business associates, information technology companies, online content providers, device manufacturers, healthcare providers and health plans, we participate in rulemaking processes, provide regulatory compliance advice, develop compliance and training programs, assist in internal audits, facilitate product and technology sales and licensing, and support major corporate transactions. Working with our technology transaction and licensing group, we provide guidance on data analytics, clinical research and technology transactions, including research covered by HIPAA and human research protection regulations.
Antitrust and Healthcare
WilmerHale has one of the leading antitrust and competition practices in the United States and Europe, as consistently recognized by publications such as Chambers and Global Competition Review. With more than 70 competition lawyers in the United States, Europe and China, we can advise healthcare providers and payers on the full spectrum of antitrust issues in the jurisdictions where they do business. We regularly counsel on the issues associated with a company’s operational activities, we have secured antitrust clearance for hundreds of complex mergers and joint ventures, and we have won numerous victories for clients in private and government litigation. Our deep knowledge of securing merger clearance should put us at the top of the list for any healthcare company facing acquisition decisions.
Some of our recent successes in the healthcare sector include representing a major insurance carrier in the Insurance Brokerage Antitrust Litigation, where we successfully secured dismissal of all federal antitrust, RICO and ERISA claims in the consolidated class action complaint against employee benefits insurers, as well as the related state law claims. We also recently represented the second-largest provider of regulated medical waste services in obtaining clearance for its acquisition by the largest provider of those services.
Commercial Litigation and Healthcare
Our philosophy is simple: Consistent courtroom excellence is essential to client satisfaction in the resolution of high-stakes commercial disputes like the ones we litigate. We have extensive experience handling complex civil cases for clients—including hospitals, medical billing systems companies, pharmacy benefits providers and medical device manufacturers—in areas that include commercial contract disputes, licensing, bankruptcy, business torts, consumer fraud, employment, insurance, trade secrets and ERISA. Our litigators also regularly handle class actions and multidistrict litigation. In addition to our trial experience, we resolve cases through arbitration, mediation and complex settlements.
While we recognize that most high-stakes commercial cases should be and are resolved by settlement and pride ourselves on the creativity we bring to the settlement process, we firmly believe that the best settlements result not only from creative lawyering throughout pretrial, but also from a demonstrated trial capability and a readiness to take any case to trial. Members of our practice have tried literally hundreds of commercial cases to judgment involving nearly every major industry in state and federal courts throughout the United States.
Healthcare in the European Union and Germany
Advising on regulatory, public policy and legal strategy questions in the German healthcare arena as well as in the rest of the European Union, our partners offer healthcare clients a full-service approach to tackling questions of public law, privacy, transactional, licensing and other types of law, as well as public policy and legal strategy advice.
Our EU and German healthcare practice advises on regulatory, public policy and legal strategy, as well as on antitrust, public procurement, privacy, transactional and licensing matters both in Germany and in the rest of the European Union. We provide legal know-how, technology knowledge, industry insight and internationally oriented advice from a commercial perspective. Our approach also considers the public sector, including in niche matters of public law. JUVE nominated WilmerHale as the “Law Firm of the Year for Regulated Industries” in Germany particularly because of our healthcare and pharmaceutical industry practice.
We have advised on the inclusion of innovative medical devices and future-orientated e-health solutions in public reimbursement schemes, and have assisted with tender procedures, negotiations and litigation concerning agreements between healthcare funds and pharmaceutical companies, associations of physicians and other healthcare providers.
Clients also regularly seek our counsel on the reforms of the public healthcare system in Germany and other major EU member states. We help them overcome regulatory and legislative obstacles when launching new products, and enable them to benefit from initiatives such as the introduction of e-health systems. In addition, we have handled a broad range of complex regulatory and legislative issues and new directives and regulations on the EU level in the field of health, safety and product standards applied to life sciences companies.
Healthcare in China
Companies around the world rely on our extensive experience with and understanding of the Chinese legal and policy systems and the impact of those systems on the healthcare industry. We also handle a wide range of acquisitions and other corporate transactions, and provide acute insight on market access questions.
We regularly advise our clients on the Chinese healthcare and medical device industries, and have extensive experience in transactions involving foreign-invested healthcare institutions in China, including:
- Advising on the development of seniors housing and healthcare facilities;
- Advising a Beijing-based owner and operator of private hospitals and clinics;
- Advising an operator of specialty-care hospitals on the provision of services in China; and
- Advising on the restructuring of a Chinese hospital management company to facilitate foreign investment.
Leading an independent compliance monitorship for a major healthcare provider in the wake of a Department of Justice settlement.
Secured an arbitration award of more than $100 million on behalf of a major medical device manufacturer asserting breach of contract.
Advised in a landmark court proceeding in the European Union regarding commissioned data processing of patient data.
Healthcare Investigations and Enforcement Litigation
- Represented medical device companies, senior executives, and sales and marketing personnel in numerous criminal and civil False Claims Act investigations of alleged off-label marketing and kickbacks.
- Represented a medical device manufacturer in the defense and resolution of government claims that it had breached a deferred prosecution agreement.
- For a lab company, provided counsel in a government investigation of allegations of Medicare and Medicaid fraud.
- Represented a company in an inquiry by Senator Chuck Grassley into whether several companies in a particular healthcare sector engaged in Medicaid fraud or otherwise failed to comply with applicable laws.
- For an internet search and technology company, handled a grand jury investigation of alleged aiding and abetting of unlawful conduct by Canadian online pharmacies and the negotiation of a non-prosecution agreement that resulted in the closing of the investigation and a release of claims.
- Defended a company in a grand jury investigation of alleged kickbacks and obstruction in which the government declined prosecution.
- Defended a medical device manufacturer in a grand jury investigation of allegations that it had violated the Anti-Kickback Statute, and negotiated a global resolution of the government’s criminal, civil and administrative claims.
- On behalf of a healthcare company, persuaded the Justice Department not to proceed against the company in an False Claims Act matter, and negotiated a favorable settlement with the Department of Health and Human Services.
- Represented a third-party billing company in the civil resolution of parallel criminal and civil investigations of alleged Medicare and Medi-Cal fraud.
- For a medical device manufacturer, obtained a global civil resolution in an investigation by a US attorney’s office arising from a former employee’s allegations that the company had maintained an inadequate complaint reporting system under the Food, Drug, and Cosmetic Act and had misrepresented the quality of numerous medical devices.
- Secured the government’s dismissal of all criminal charges against a biomedical sales manager after opening statements and less than one day of trial testimony.
- Represented a device manufacturer in a grand jury investigation in which the government ultimately declined to pursue any criminal charges.
- Handled numerous internal investigations—including internal investigations of activities in the United States, China, Korea, India, Japan, Mexico, Russia and Poland—on behalf of medical device and other life sciences companies facing alleged violations of the Food, Drug, and Cosmetic Act; the Anti-Kickback Statute; and the Foreign Corrupt Practices Act.
- Offered compliance counseling to multiple clients, including a clinical research organization and a health insurance company, regarding anti-bribery risk assessments, compliance policies and compliance training.
- Represented a global medical device manufacturer in an Foreign Corrupt Practices Act investigation by the Justice Department and the Securities and Exchange Commission.
Public Policy and Congressional and Executive Branch Investigations
- For a major insurance company, advised on constitutional, substantive and strategic issues associated with efforts to achieve a global legislative solution to the national asbestos crisis.
- Assisted in a successful effort to obtain legislation protecting the confidentiality of sensitive business information provided to the government to assist in the protection of critical infrastructure.
- For a director of a major US healthcare corporation, advised in an investigation by the House Energy and Commerce Committee.
- Guided a medical device company in its response to congressional inquiries about its marketing practices.
- Represented a medical device company in hearings concerning dual-use technology issues.
Healthcare Transactions and Corporate Counseling
- Represented TransMedics, a medical technology company dedicated to improving quality, assessing viability and increasing the utilization of donor organs for transplantation, in its closing of $51.2 million growth equity financing.
- For healthcare IT provider Caradigm, provided licensing and general corporate advice.
- Represented aesthetic laser treatment developer Cynosure in its acquisition by Hologic for $1.6 billion.
- Represented the underwriters in the initial public offering for IT security company Imprivata and represented medical equipment company Medtronic in a Rule 144A placement of convertible note offerings, among many other transactions handled for life sciences companies.
Patent and Trademark Prosecution and Litigation
- For Roche Molecular Systems, argued and won against Stanford University in a closely watched case regarding the effect of the Bayh-Dole Act on patent rights to inventions developed using federal funds (the first patent case in which the US Supreme Court affirmed the Federal Circuit, despite the fact that the solicitor general urged reversal).
- Represented Medtronic in its appeals of adverse judgments in three cases (DePuy, Spine Solutions and Brainlab), obtaining rulings reversing the district court’s judgments against the company, including awards of sanctions in DePuy and Brainlab. We also represented Medtronic at the trial level in Globus Medical, where we obtained a ruling, affirmed on appeal, that Globus Medical had infringed two Medtronic patents.
Data Security and Privacy
- Negotiate data-sharing agreements among collaborators in life sciences research projects.
- Advise covered entities and business associates on HIPAA privacy, security and breach notification compliance requirements.
- For a provider of a direct-to-consumer personal health record solution, advised on the regulatory considerations affecting such entities that operate outside of the HIPAA regulatory regime.
- Counseled a state-sponsored operator of a health information exchange on its federal Department of Health and Human Services grant funding agreement and related compliance requirements.
- Advise biotech clients on licensing of data and technology from federal agencies, such as the Centers for Medicare and Medicaid Services and the National Institutes of Health.
- Counsel software developers operating as business associates on the contractual, intellectual property and regulatory considerations involved in conducting data aggregation and de-identifying and using health information for secondary purposes.
- Have advised on the patent eligibility of algorithms, software and methods of analysis relating to genetic data.
- For software startups in the healthcare sector, developed standards for ensuring that HIPAA-covered information is secured, while ensuring that information is de-identified in accordance with HIPAA standards.
- For a large account servicing organization, conducted regulatory due diligence review in the acquisition of a health claims processing company.
- For a nonprofit healthcare provider, investigated and coordinated the remediation, individual notification and regulatory reporting stemming from a loss of computer media containing unsecured health data.
- Represented a major insurance carrier in the Insurance Brokerage Antitrust Litigation, successfully securing the dismissal of all federal antitrust, RICO and ERISA claims in the consolidated class action complaint against employee benefits insurers, as well as the related state law claims.
- Represented the second-largest provider of regulated medical waste services in obtaining clearance for its acquisition by the largest provider of those services.
- Prevailed on all issues in a three-week trial before the American Arbitration Association involving license rights to molecular diagnostic probes.
- For affiliates of an internet-based health information firm, provided representation in several consumer class actions brought by physicians.
- Representation of a national medical billing system company in arbitration against developers of software.
- For a pharmacy benefits manager, provided representation in numerous litigation matters.
- Represented a medical device manufacturer in arbitration against a European distributor.
- Represented several hospitals in billing disputes with the Commonwealth of Massachusetts.
European Union and Germany
- For a Boston-based medical device producer, advised on a contract with DSO, the German federal foundation for organ transplantation, regarding the financing of a heart transplant device.
- Counseled US companies in medical devices industries on market access and reimbursement in the EU, as well as on regulatory product approval and labeling and requirements.
- For associations of German physicians, negotiated selective agreements on standards for primary medical care and doctor’s fees, including the groundbreaking first selective agreement affecting approximately 5,000 general practitioners, almost 4 million patients and a major public health insurance fund. According to the German Federal Minister of Health, the arrangement serves as a role model for similar agreements.
- Advised and represented associations of general practitioners in more than 350 arbitration proceedings with public health insurance funds and 155 litigation proceedings before the social courts in connection with various arbitral awards in Germany.
- Advised on the development of housing and healthcare facilities for seniors.
- Counseled a Beijing-based owner and operator of private hospitals and clinics.
- For an operator of specialty care hospitals, advised on the provision of services in China.
- To facilitate foreign investment, advised on the restructuring of a Chinese hospital management company.