Life Sciences

Morgan Lewis lawyers represent companies across the entire pharmaceutical and biotechnology product life cycle, from emerging growth to established multinational entities. This encompasses start-ups with a single promising research and development (R&D) candidate to diversified global conglomerates seeking to augment broad internal operations with new technologies from other industry players, academia and research institutes.

Corporate and Finance

To optimize capabilities for research, development, and commercialization of investigational compounds and biologics, and to provide a mechanism to share risks and rewards, expertise, and IP, our lawyers structure, negotiate, and implement corporate partnering, financing, and M&A, ranging from early-stage research platform deals to manufacturing and other operational agreements and later-stage development and commercialization collaborations.

Our firm’s market-leading corporate, finance, and investment practices, and our strong contacts and presence in the global centers for finance and research, help us craft strategic capitalization solutions that connect companies with venture capital funds, investment and commercial banks, institutional lenders, and other investors at critical points in the business/product life cycle. Our depth and scope in this sector often involves us in multinational drug development, manufacturing, licensing, and related transactions in the United States, North and South America, Europe, Asia, and the Middle East.

In the M&A arena, our lawyers regularly handle transactions valued from several million dollars to billions of dollars, including product acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers (friendly and hostile), proxy contests, restructurings, leveraged buyouts, and “going private” transactions. Our financing transactions on behalf of pharma companies, venture capital and private equity firms, and investment banks include senior secured credit facilities, acquisition financings, refinancings and royalty monetizations.

Throughout the business/product life cycle, the technical insight of our team members with advanced degrees in science and engineering is a significant advantage as they help both innovators and investors assess (and litigate) IP and evaluate R&D and commercial pathways to success.

Securities

Our securities lawyers apply their skills to complex transactions, corporate governance issues, and public issuer reporting. We represent pharma and biotech issuers on the full range of US and global public offerings of securities and stock exchange listings on all US and alternative markets. Our corporate and securities lawyers and our securities litigators advise and represent boards of directors, board committees, and company executives on a broad range of situations, extraordinary and routine, arising from the current financial disclosure and regulatory environment.

Outsourcing

We structure a full range of outsourcing transactions for our pharma and biotech clients, from start-ups to diversified multinationals to academic/research institutes. In addition to the traditional information technology outsourcing and business process outsourcing (e.g., human resources, finance and accounting, procurement, logistics, and call center) transactions, we also counsel clients on the outsourcing of industry-specific processes, such as clinical trials and development, US Food and Drug Administration (FDA) documentation and submissions, manufacturing and supply, and sales and marketing. Together with our FDA and healthcare practices, we work closely with clients to identify and allocate responsibility for FDA- and pharma-specific compliance obligations, including validation and documentation.

FDA Regulatory

Morgan Lewis counsels early-stage biotech to global pharma companies on issues ranging from clinical trial design through all aspects of FDA regulation and enforcement, from approval to manufacture, to promotion and marketing, including pricing and distribution, compliance, and enforcement matters. The firm’s FDA and healthcare practices also counsel these clients on the regulatory implications of corporate transactions.

At the development stage, we advise on pathway strategies; clinical trial design and negotiation processes; orphan drug submissions; Investigational New Drug applications, New Drug Applications, and Biologics License Applications; biosimilars and Hatch-Waxman strategies; preparation for FDA/advisory committee meetings; approval; negotiations; and dispute resolution. We also represent biopharma companies on all aspects of government sales and contracting and related disputes.

Additionally, we assess reimbursement strategies and provide advice regarding any available market exclusivity for a product. Once pharmaceutical products are introduced in the marketplace, we help our clients develop promotional, reimbursement, marketing/distribution and pricing strategies, and advise on good manufacturing processes, recall, product supply chain, comparative effectiveness research, export/import, post enforcement, and social media and privacy/data security issues.

Several of our lawyers have held past positions at key regulatory and enforcement agencies—including the FDA, the US Department of Agriculture, the CMS, and the Office of Inspector General (OIG)—and incorporate a nuanced understanding of the goals and procedures implemented by these bodies to help clients achieve their business and legal strategies.

Intellectual Property

Our firm’s lawyers, patent agents, and technical specialists provide capabilities in a diverse array of life sciences technologies. We offer assistance on the full range of issues involving biopharma, therapeutics, diagnostics, vaccines and medical devices. Our clients include every type of company regulated by the FDA and Centers for Medicare and Medicaid Services. All of our patent lawyers and patent agents have science or engineering backgrounds, and many have advanced degrees in the life sciences. Many have held positions as patent examiners at the US Patent and Trademark Office (USPTO). We appear regularly before the USPTO and other relevant government agencies, as well as before the US Court of Appeals for the Federal Circuit, combining the technical capabilities of our patent lawyers with the courtroom skills and strategies of our patent litigators. We also regularly counsel clients on all matters under the Hatch-Waxman Act and with respect to biosimilars, from developing patent procurement strategies to defending those strategies in litigation.

Our service to our life sciences clients extends throughout the complete product life cycle. Our teams are customized according to each client’s needs, extending across practice areas as needed, including our IP, FDA and healthcare, product liability litigation, commercial litigation, and corporate and business transactions practices.  We assist clients in a broad range of industries, including immunology, virology, pharmaceutical chemistry, molecular biology, bioinformatics, and medical devices.

Litigation and Dispute Resolution

Our compliance and government investigations team includes lawyers with litigation and regulatory backgrounds to assist clients with a range of criminal and civil healthcare fraud investigations and related litigation, including some of the most significant recent pharmaceutical industry–related matters in the United States. We advise clients at every stage of government enforcement activity, including responding to federal and state grand jury subpoenas and all federal government civil investigative demands and administrative subpoenas (e.g., those issued by the OIG of the US Department of Health and Human Services (HHS) and other agencies). This includes representing clients through the document production and investigation phase, settlement discussions, Corporate Integrity Agreement (CIA) negotiations, pretrial proceedings, trial, and appeal.

We routinely handle parallel criminal, civil, and administrative proceedings that occur simultaneously in multiple jurisdictions involving claims under the Anti-Kickback Statute, Healthcare Fraud Statute, HHS-OIG exclusion authorities, Civil Monetary Penalties Law, Responsible Corporate Officer Doctrine, federal and state false claims acts, and suspension and debarment authorities. Likewise, we routinely deal with state Medicaid Fraud Control Units (that are usually components of the state attorneys general) and multijurisdictional Medicaid Fraud Task Forces organized by the National Association of Medicaid Fraud Control Units.

Additionally, we regularly advise clients on all aspects of the design, negotiation, and implementation of government-mandated compliance agreements, such as CIAs, Deferred Prosecution Agreements, and state consent decrees. Morgan Lewis lawyers have negotiated and assisted dozens of large and small life sciences and healthcare companies with their most important CIA matters and have extensive knowledge of best practice compliance controls within the life sciences sector.

White Collar Litigation

Our white collar litigators regularly represent life sciences companies in Foreign Corrupt Practices Act (FCPA), UK Bribery Act (and all other forms of UK investigations and prosecutions), and other anticorruption matters, as well as US grand jury and civil investigations and criminal trial defense, state attorneys general investigations and litigation, civil False Claims Act litigation, third-party payor class action litigation, civil antitrust class action litigation, and state Bureaus of Consumer Protection actions.

In addition, Morgan Lewis insurance recovery lawyers represent policyholders on a US-wide and international basis and provide a seamless, cross-border, and cross-disciplinary solution to clients’ needs.

Commercial Litigation

We regularly represent pharmaceutical clients in the full range of business disputes, including trade secrets and noncompete litigation, supplier/purchaser and post acquisition disputes, and consumer class actions and other consumer-related litigation. Whether they are plaintiffs or defendants in such matters, our clients benefit from our experience in these types of cases. Our work in this area has not gone unnoticed – Morgan Lewis was named a “Class Action Practice Group of the Year” by Law360 for 2013 and 2014. This accolade is in addition to two consecutive years on BTI Consulting Group’s 2014 and 2015 Litigation Outlook, which ranked us as one of four “powerhouse” firms for class actions and mass torts.

Labor and Employment

Our labor and employment practice has been at the forefront of many of the employment law issues facing pharmaceutical companies. For example, when industry-wide litigation was initiated by pharmaceutical sales representatives challenging their classification as overtime-exempt employees, numerous pharmaceutical companies turned to Morgan Lewis. We have successfully defended industry employers against high-stakes systemic employment litigation alleging discrimination on the basis of gender, race, national origin, and other claims. Our litigation and counseling experience with industry employers—which includes individual employee, Employee Retirement Income Security Act (ERISA), Fair Labor Standards Act (FLSA)/wage and hour, and systemic employment discrimination claims—informs our ability to provide industry-specific preventive counseling in all aspects of labor and employment law.

Employee Benefits

For life sciences clients, our Employee Benefits and Executive Compensation lawyers assist with all aspects of benefit offerings, including helping to design, implement, and administer qualified and non-qualified retirement plans, health and welfare plans, and executive compensation and equity plans, as well as employment agreements, and severance and retention arrangements. We also have extensive experience with ERISA fiduciary and prohibited transaction issues. We advise on the executive compensation and employee benefits aspects of mergers, acquisitions, spin-offs, and other transactions. In transactional settings, we have advised pharmaceutical companies regarding the design and implementation of equity incentive plans; the treatment of outstanding equity awards, and deferred compensation and profit sharing plans in connection with a transaction; the application of Internal Revenue Code Sections 280G and 162(m) to certain covered executives; drafting and negotiation of executive compensation agreements; and preparation of related representations, disclosures, and filings. We also have experience working with U.S. subsidiaries of foreign parent companies (especially those based in the U.K., Japan and Germany).

Real Estate

Our real estate lawyers represent major life sciences and biotechnology companies in connection with their ownership, use, and financing of real estate. We efficiently handle transactions of all sizes and degrees of complexity, both locally and internationally. We are experienced in acquisitions, dispositions, financing, workouts and restructurings, land assemblage, development, investments by global entities, sale-leasebacks, leasing and taxation. Morgan Lewis has a deep understanding of our life sciences clients’ business models’ and provides innovative advice as these clients deploy real estate as a key strategic asset. Our real estate lawyers frequently advise life sciences clients on a variety of industry-specific transactions, including those involving laboratory space and vivariums.

Tax

Our firm’s tax lawyers provide life sciences companies and clients of all sizes with an integrated approach to the delivery of tax advice with a focus on four major disciplines: advising on transactions, providing day-to-day consulting on myriad substantive and tax compliance issues, resolving disputes with taxing authorities and in court, and helping clients obtain private or public guidance from the Internal Revenue Service (IRS) and the US Department of the Treasury. We coordinate these disciplines by working together as teams and across offices, producing practical and efficient solutions to often highly complicated tax problems. We have advised extensively on global transactional tax planning matters and we regularly work with life sciences clients on a wide variety of M&A, reorganizations, spin-offs, joint ventures, and strategic alliances, as well as equity and debt securities offerings.

Antitrust

Morgan Lewis has a thorough understanding of antitrust issues in the life sciences industry. Our antitrust lawyers handle investigations and cases for pharmaceutical clients in a broad range of areas, including US Federal Trade Commission (FTC) investigations of Hatch-Waxman settlements, claims arising from the filing of allegedly sham citizen petitions, antitrust counterclaims arising from patent infringement suits, multidistrict class actions alleging horizontal conspiracies, Robinson-Patman Act price discrimination claims, and antitrust challenges to IP licenses and standard-setting activities. Additionally, we have acted as antitrust counsel in several of the industry’s most high-profile mergers, acquisitions, and joint ventures.

Our team comprises sought-after and trusted advisers to the life sciences industry, including a former general counsel to the FTC with unique insight into the agency’s enforcement priorities in the life sciences sector, a former attorney adviser to two FTC commissioners who focuses on the application of the antitrust laws in the pharmaceutical industry, and the former deputy general counsel of a global pharmaceutical company. In addition to these resources, our antitrust team partners closely with our healthcare and FDA lawyers to understand the regulatory challenges facing our life sciences clients and to provide complete, business-focused antitrust advice.

 Morgan Lewis seamlessly combines full-service regulatory, transactional, and litigation counsel for medical device developers, manufacturers, and wholesalers and other distributors—as well as technology companies newly entering the medical device market. We represent a full range of business entities, from start-ups to midsize companies and diversified global enterprises. 

FDA Regulatory

Our pre- and post-market support through all phases of the FDA regulatory process includes both strategic and day-to-day compliance activities. In the premarket arena, we advise on regulatory pathways to market and clinical and nonclinical study design, as well as jurisdictional issues for both devices and combination products. We prepare investigational device submissions and humanitarian use device exemptions, and prepare and negotiate 510(k) and premarket approval applications.

In a device’s post-market phase, we advise on product modifications, medical device reporting, Quality System Regulation issues, recall, correction, removal and supply chain issues, labeling, advertising and promotion, import/export issues, Medicare and Medicaid coverage and reimbursement, and device compliance with sunshine, state distribution, and related laws. We prepare responses to 483 observations and warning letters. We also represent device companies on all aspects of government sales and contracting and disputes.

Intellectual Property

Our IP lawyers regularly prepare and prosecute patent applications, including reexamination, reissue, and interference cases for medical device clients. Through the development and commercialization of technology, we help clients avoid infringement of third-party rights, and enforce patent rights against others.  This includes negotiating and drafting patent and technology licensing agreements, and enforcing and defending against patent infringement claims. To help avoid litigation and enforcement actions, we perform IP audits and due diligence investigations. Our lawyers also render opinions on patentability, infringement, and validity, and coordinate the filing and prosecution of patent applications in the United States and worldwide, particularly in Asia and Europe.

Our patent practice has a significant medical device litigation component that combines the specialized technical capabilities of our patent lawyers and patent litigators with the broad-based court presentation and strategy skills of our general practice litigators. Morgan Lewis represents patent holders and defendants in district courts throughout the United States, the US Court of Appeals for the Federal Circuit, and the US International Trade Commission.

Corporate and Finance

To optimize capabilities for research, development, and commercialization of investigational devices and to provide a mechanism to share risks and rewards, expertise, and IP, our lawyers structure, negotiate, and implement corporate partnering, financing, and M&A transactions, ranging from early-stage research platform deals to manufacturing and other operational agreements and later-stage development and commercialization collaborations. 

Within the medical device arena, the firm focuses on service throughout the product life cycle. The firm’s market-leading corporate, finance, and investment practices, and our strong contacts and presence in the global centers for finance and research, help us craft strategic capitalization solutions that connect companies with venture capital funds, investment and commercial banks, institutional lenders, and other investors at all critical points in the business/product life cycle. Our depth and scope in this sector often involves us in multinational device development, manufacturing, licensing, and related transactions in the United States, North and South America, Europe, Asia, and the Middle East.

In the M&A arena, our lawyers regularly handle transactions valued from several million dollars to billions of dollars, including product acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers (friendly and hostile), proxy contests, restructurings, leveraged buyouts, and “going private” transactions. Our financing transactions on behalf of device companies, venture capital and private equity firms, and investment banks include senior secured credit facilities, acquisition financings, and refinancings. 

Throughout the product life cycle, the technical insight of our team members with advanced degrees in science and engineering is a significant advantage as they help both innovators and investors assess (and litigate) IP and evaluate R&D and commercial pathways to success.

Securities

For medical device clients, our securities lawyers apply their skills to complex transactions, corporate governance issues, and public issuer reporting. We represent medical device companies on the full range of United States and global public offerings of securities and stock exchange listings on all United States and alternative markets. Our corporate and securities lawyers and our securities litigators advise and represent boards of directors, board committees, and company executives on a broad range of situations, extraordinary and routine, arising from the current financial disclosure and regulatory environment. 

Product Liability Litigation

We routinely represent our clients in medical device industry litigation, including product liability, fraud and abuse, and commercial litigation. Our long-standing, well-recognized product liability practice includes more than 50 lawyers across our US offices. For decades, we have successfully represented clients in class actions, individual lawsuits, multidistrict matters, and mass and toxic tort litigation.

When enforcement concerns have arisen, we have assisted in some of the largest and most complex government investigations and settlements of the last decade. As the FDA, Department of Justice (DOJ), Health Care Financing Administration, and HHS-OIG continue to take an aggressive enforcement stance, we regularly assist clients in responding to civil and criminal enforcement and compliance actions, including FDA Form 483 and Warning Letter responses, Import Alerts, consent decree issues, FDA’s integrity policy, OIG suspension and exclusion authority, and debarment penalties from government contracting agencies. Our white collar criminal litigators regularly team with us on investigations, negotiations, and litigation and other defense strategies.

Our deep bench of seasoned trial lawyers is capable of trying the most high-risk cases against the most aggressive adversaries, and frequently serves as US national coordinating and trial counsel to medical device companies in large-scale serial litigation. This experience consists of cases involving pacemakers, cardioverter defibrillators, neurostimulators, drug pumps, insulin pumps, therapeutic blood derivatives, breast implants, femoral knee components, and many other devices.

Commercial Litigation

Our lawyers regularly represent medical device clients in the full range of business disputes, including trade secrets and noncompete litigation, supplier/purchaser and post acquisition disputes, consumer class actions and other consumer-related litigation, and third-party payor cases.  Whether they are plaintiffs or defendants in such matters, our clients benefit from our experience in these types of cases. Our work in this area has not gone unnoticed—Morgan Lewis was named a “Class Action Practice Group of the Year” by Law360 for 2013 and 2014. This accolade is in addition to two consecutive years on BTI Consulting Group’s 2014 and 2015 Litigation Outlook, which ranked us as one of four “powerhouse” firms for class actions and mass torts. 

White Collar Litigation

Our white collar litigators have been involved in life sciences for more than three decades, bringing together the trial skills, industry experience, and legal knowledge needed to handle the wide range of proceedings that may arise from a white collar investigation in any jurisdiction. Our medical device experience includes successfully defending numerous enforcement actions such as alleged violations of antikickback and illegal marketing statutes, FCPA, and federal and state false claims acts, as well as related qui tam litigation.

Real Estate

Our real estate team of lawyers represents medical device companies in connection with their ownership, use, and financing of real estate. We efficiently handle transactions of all sizes and degrees of complexity, both locally and internationally. We are experienced in acquisitions, dispositions, financing, workouts and restructurings, land assemblage, development, investments by global entities, sale-leasebacks, leasing, and taxation. Morgan Lewis has a deep understanding of our life sciences clients’ business models and provides innovative advice as these clients deploy real estate as a key strategic asset.

Tax

We provide an integrated approach to the delivery of tax advice to medical device clients of all sizes. Our focus covers four major disciplines: advising on transactions, providing day-to-day consulting on myriad substantive and tax compliance issues, resolving disputes with taxing authorities and in court, and helping clients obtain private or public guidance from the IRS and the US Department of the Treasury. We coordinate these disciplines by working together as teams and across offices, producing practical and efficient solutions to often highly complicated tax problems. We have advised extensively on global transactional tax planning matters and we regularly work with medical device clients on a wide variety of M&A, reorganizations, spin-offs, joint ventures and strategic alliances, as well as equity and debt securities offerings.

Antitrust

Morgan Lewis has a thorough understanding of antitrust issues for medical device clients. Our antitrust lawyers handle matters for medical device clients in a broad range of areas, including government investigations, antitrust counterclaims arising from patent infringement suits, multidistrict class actions alleging horizontal conspiracies, Robinson-Patman Act price discrimination claims, and antitrust challenges to IP licenses and standard-setting activities. Additionally, we have acted as antitrust counsel in several of the industry’s most high-profile mergers, acquisitions, and joint ventures.

Our team comprises sought-after and trusted advisers to the life sciences industry, including a former general counsel to the FTC with unique insight into the agency’s enforcement priorities in the life sciences sector, a former attorney adviser to two FTC commissioners who focuses on the application of the antitrust laws in the pharmaceutical industry, and the former deputy general counsel of a global pharmaceutical company. In addition to these resources, our antitrust team partners closely with our healthcare and FDA lawyers to understand the regulatory challenges facing our life sciences clients and to provide complete, business-focused antitrust advice.

Employee Benefits

For medical device clients, our Employee Benefits and Executive Compensation lawyers assist with all aspects of benefit offerings, including helping to design, implement, and administer qualified and non-qualified retirement plans, health and welfare plans, and executive compensation and equity plans, as well as employment agreements, and severance and retention arrangements. We also have extensive experience with ERISA fiduciary and prohibited transaction issues. We advise on the executive compensation and employee benefits aspects of mergers, acquisitions, spin-offs, and other transactions. In transactional settings, we have advised medical device companies regarding the design and implementation of equity incentive plans; the treatment of outstanding equity awards, and deferred compensation and profit sharing plans in connection with a transaction; the application of Internal Revenue Code Sections 280G and 162(m) to certain covered executives; drafting and negotiation of executive compensation agreements; and preparation of related representations, disclosures, and filings. We also have experience working with U.S. subsidiaries of foreign parent companies (especially those based in the U.K., Japan and Germany).

Morgan Lewis advises the full spectrum of the healthcare sector, including healthcare service providers, insurers, product manufacturers, health IT companies, and investors in the sector with sophisticated, integrated, and cost-effective counsel covering all of their unique needs—in business and finance (including transactions and joint ventures); federal, state, and local regulation; litigation and dispute resolution, coverage, and reimbursement; and fraud and abuse and compliance counseling, including CIAs. Likewise, we represent clients in payment disputes and US False Claims Act (including qui tam matters) and Antikickback and Physician-Self Referral (Stark) Law litigation; antitrust litigation; IP; public policy advocacy; real estate; and labor and employment issues.

Our healthcare provider clients include hospitals and health systems; long-term care, home health and hospice providers; retail and specialty pharmacies; suppliers; distributors; physician practices; medical societies; and all of the vendors that help support these providers.  Our work in privacy and information security (HIPAA/HITECH as well as state privacy laws) is acclaimed. 

Our team includes some of the most respected healthcare law practitioners in the United States and a number of former senior US government officials. Leveraging our lawyers' intimate knowledge of the inner workings of the government's executive branch, and the regulatory agencies most critical to healthcare businesses, we bring special insight and savvy to the complex challenges and opportunities that our healthcare industry clients confront in the posthealthcare reform era.

Corporate and Finance

Our lawyers regularly handle mergers, acquisitions, and other transactions in the healthcare space, from several million to billions of dollars. Our experience includes business acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers (friendly and hostile), proxy contests, restructurings, leveraged buyouts, and "going private" transactions. We also advise on a variety of healthcare joint venture transactions and service agreements between and among healthcare providers and payors with sophisticated consideration of applicable regulatory, fraud and abuse, and tax law implications.

Our transactional clients in this sector include a wide range of healthcare enterprises, private equity firms, investment banks, venture capital firms, institutional lenders, independent directors committees, and management groups.

Securities

For healthcare clients, our securities lawyers apply their skills to complex transactions, corporate governance issues, and public issuer reporting.  We represent healthcare companies on the full range of United States and global public offerings of securities and stock exchange listings on all United States and alternative markets. Our corporate and securities lawyers and our securities litigators advise and represent boards of directors, board committees, and company executives on a broad range of situations, both extraordinary and routine, arising from the current financial disclosure and regulatory environment.

Litigation

Morgan Lewis has litigated matters for healthcare industry clients for more than a quarter century, offering the combination of trial experience, intimate knowledge of the healthcare sector, and legal prowess required to resolve lawsuits and government investigations to the greatest possible advantage of our clients, among them both payors and providers. Our experience includes payment disputes, and disputes relating to the development, production, sale, and distribution of medical services and products.

Our lawyers handle litigation for clients in all facets of the healthcare delivery system, including managed care companies and insurers, hospitals and health systems, long-term care and postacute care facilities, pharmacies, and other healthcare providers. We assist our clients at every stage of these investigations and litigations, from responding to grand jury subpoenas through trials and any appeals. We routinely handle the government investigation and any parallel civil or administrative proceedings, including False Claims Act actions and negotiation and implementation of CIAs. Our capabilities in US False Claims Act (including qui tam matters) and Anti-Kickback and Physician-Self Referral (Stark) Law investigations and litigation are recognized by Chambers USA, and our defense team includes former criminal and civil fraud prosecutors, as well as former HHS-OIG senior lawyers.

Coverage and Reimbursement

Our experience with regulations and subregulatory guidance from the CMS, including local coverage decisions and national coverage determinations, provides our clients a critical advantage on coverage and payment issues under Medicare, Medicaid, and other federal healthcare programs.  We also advise and defend clients on audits and investigations related to alleged fraud and abuse in billing and coding practices by Medicare and Medicaid and their growing number of regional contractors.

On Medicare reimbursement appeals, we represent clients at the redetermination and reconsideration stages before administrative law judges and the Medicare Appeals Council and in federal courts. We also represent Part A providers before the Provider Reimbursement Review Board and with appeals at the state level on a variety of Medicaid reimbursement issues.

Privacy and Data Security

Morgan Lewis lawyers advise clients across virtually all healthcare sectors on privacy and security compliance matters, including those related to the US Health Insurance Portability and Accountability Act (HIPAA), the Gramm-Leach-Bliley Act, the US Health Information Technology for Economic and Clinical Health (HITECH) Act, state security breach notification laws, FTC privacy and security standards, state medical privacy laws, and the Red Flags Rule, as well as international privacy rules.

We also advise on the development of privacy and data security policies and procedures, the structuring of healthcare information technology ventures, responses to security breaches, and data transmissions to state and federal healthcare agencies. Additionally, we help train employees on the disclosure of information and ongoing compliance monitoring.

We assist clients with monitoring, influencing, and interpreting federal rules and regulations, congressional legislation, and other policies issued by the executive branch. Many of our lawyers have government backgrounds in healthcare oversight agencies, and this experience translates into astute analysis of rapidly evolving developments and timely guidance on matters critical to our clients' businesses.

Compliance, and Fraud and Abuse

Morgan Lewis provides compliance guidance, fraud and abuse counseling, and corporate defense in government investigations and proceedings to manufacturers and suppliers, vendors, group purchasing organization, hospitals and health systems, academic medical centers, pharmacies, hospices, specialty and long-term care providers, health plans, contract research organizations (CROs), medical societies, private equity funds, and physician practices.

Most of our lawyers represent healthcare industry clients every day in compliance and enforcement matters. Those who previously served as government lawyers and officials bring added value to clients confronting compliance program assessments, corporate integrity agreements (CIAs), and government monitor oversight matters. We also regularly provide government self-disclosure advice involving Medicare and Medicaid, the False Claims Act, Anti-Kickback and Stark Law, and excluded persons.

Labor and Employment

Morgan Lewis has a long history of assisting healthcare industry clients in virtually every area of labor and employment law. Our labor relations lawyers assist with union campaigns and union avoidance programs, corporate campaigns, and representations before government agencies and multiemployer bargaining groups. We have successfully solved novel and difficult labor-management problems, and advised companies on long-range planning to build strong and effective employee-management relationships.

Our working knowledge of US union organizations is a critical differentiator in our representations of healthcare providers. We counsel on and litigate all matters regarding US Department of Labor compliance, particularly wage and hour issues, leave laws, and Occupational Safety and Health Administration (OSHA) compliance, as well as Equal Employment Opportunity Commission (EEOC) charges and related discrimination matters. Our immigration practice offers I-9 compliance, executive transfer visa programs, global visas, and comprehensive immigration strategic planning.

The firm also has played a leading role shaping public policy regarding healthcare industry employment and labor issues. For example, we represented employer coalitions during rulemaking on healthcare reform laws enacted in 2010; and in amicus brief filings in Specialty Healthcare, we negotiated the important US National Labor Relations Board case dealing with bargaining units in nonacute care facilities. Our workforce change practice provides strategic advice and counseling on important structural issues such as layoffs, restructurings, spin-offs, and acquisitions.

Antitrust

Our antitrust experience in the healthcare industry includes defending healthcare systems, physician groups, and other industry participants against government and private antitrust claims arising out of alleged exclusive dealing and improper pricing practices, as well as handling multidistrict class actions alleging horizontal conspiracies. We have successfully defended M&A transactions before a wide range of antitrust authorities, including the US Department of Justice, the FTC, the European Commission, and other foreign competition authority agencies.

Real Estate

Our real estate lawyers regularly guide healthcare industry clients in the leasing, acquisition, development, sale, and financing of their real property, including patient care facilities, senior housing, medical office buildings, research and development facilities, clean rooms, and vivariums. We represent a variety of industry property owners, operators, and tenants, as well as real estate investment trusts (REITs), in sophisticated transactions across the United States, wherever their business needs may take them.