Morgan Lewis has purposefully developed our capabilities to serve the complete life sciences product life cycle and all aspects of the healthcare and life sciences industry. We understand and work creatively to solve the business, transactional, regulatory, intellectual property (IP), litigation, and related issues that our clients face along the product life cycle, from innovation protection and emerging business issues, through regulatory development and approval, to reimbursement, marketing, and distribution. Our lawyers handle litigation in all relevant areas (including government enforcement, fraud and abuse, product liability and IP), labor, employment, and benefits, and antitrust, and work closely with clients on mergers and acquisitions, collaborations and licensing agreements, and outsourcing.
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.
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.
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 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.