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September 25, 2018
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Morgan Lewis & Bockius
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.
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.
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.
Fast Facts
- 300+ partners recognized, Chambers, all publications (2016)
- Most Recognized for Client Service, BTI Client Service A-Team (2016)
- More than 250 international partners and counsel focused on the life sciences industry
- More than 1,000 active life sciences clients
Honors
- Law 360: Life Sciences Practice Group of the Year (2014)
- BioPharm Insight: Top five transactional firm (2015)
- Modern Healthcare: Ranked as the largest healthcare law firm (2016)
- Legal 500: Ranked as a top 10 firm for health insurers and life sciences (2016)
- Chambers USA 2016:
- National for Life Sciences – Band 3
- Washington, DC for Healthcare: Pharmaceutical/ Medical Products Regulatory – Band 3
- Law 360 MVPs for life sciences (2012 and 2014) and healthcare (2012)
- LMG Life Sciences Award – Healthcare Pricing and Reimbursement Firm of the Year (2013) and Lifecyle Firm of the Year (2015)
Clients
- 18 of the top 20 pharma companies
- 16 of the top 20 biotechnology companies
- 11 of the top 20 medical device companies
US
Antitrust
| Competition & Antitrust — Highly recommended |
|---|
| Arnold & Porter |
| Cleary Gottlieb Steen & Hamilton |
| Gibson Dunn & Crutcher |
| Goldman Ismail Tomaselli Brennan & Baum |
| Latham & Watkins |
| Sidley Austin |
| Weil Gotshal & Manges |
| White & Case |
| Competition & Antitrust — Recommended |
|---|
| Covington & Burling |
| Dechert |
| Morgan Lewis & Bockius |
| Patterson Belknap Webb & Tyler |
| Ropes & Gray |
Corporate
| Corporate — Highly Recommended |
|---|
| Cooley |
| Goodwin Procter |
| Latham & Watkins |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Sidley Austin |
| WilmerHale |
| Corporate — Recommended |
|---|
| Arnold & Porter |
| Covington & Burling |
| Dechert |
| Gibson Dunn & Crutcher |
| Hogan Lovells |
| Jones Day |
| Morrison & Foerster |
| Wilson Sonsini Goodrich & Rosati |
FDA: Medical Device
| FDA: Medical Devices — Highly Recommended |
|---|
| Hogan Lovells |
| Hyman Phelps & McNamara |
| King & Spalding |
| Sidley Austin |
| FDA: Medical Devices — Recommended |
|---|
| Arnold & Porter |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Ropes & Gray |
FDA: Pharmaceutical
| FDA: Pharmaceutical — Highly Recommended |
|---|
| Covington & Burling |
| Hogan Lovells |
| Hyman Phelps & McNamara |
| Sidley Austin |
| FDA: Pharmaceutical — Recommended |
|---|
| Arnold & Porter |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
General Patent Litigation
Healthcare Pricing & Reimbursement
| Healthcare: Pricing & Reimbursement — Highly Recommended |
|---|
| Arnold & Porter |
| Hogan Lovells |
| Sidley Austin |
| Healthcare: Pricing & Reimbursement — Recommended |
|---|
| Epstein Becker Green |
| King & Spalding |
| Latham & Watkins |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Reed Smith |
Licensing & Collaboration
| Licensing & Collaboration — Highly Recommended |
|---|
| Cooley |
| Covington & Burling |
| Goodwin Procter |
| Hogan Lovells |
| Latham & Watkins |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| WilmerHale |
| Wilson Sonsini Goodrich & Rosati |
| Licensing & Collaboration — Recommended |
|---|
| Dechert |
| Fenwick & West |
| Jones Day |
| King & Spalding |
| Mintz Levin Cohn Ferris Glovsky and Popeo |
| Sidley Austin |
| Wiggin and Dana |
Patent Prosecution
Patent Strategy & Management
Venture Capital
| Venture Capital — Highly Recommended |
|---|
| Cooley |
| Goodwin Procter |
| Latham & Watkins |
| Wilson Sonsini Goodrich & Rosati |
| Venture Capital — Recommended |
|---|
| Gunderson Dettmer |
| Hogan Lovells |
| Mintz Levin Cohn Ferris Glovsky and Popeo |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| WilmerHale |
White-Collar/Govt. Investigations
| White-Collar/Government Investigation — Highly recommended |
|---|
| Cleary Gottlieb Steen & Hamilton |
| Cooley |
| Covington & Burling |
| Gibson Dunn & Crutcher |
| Hogan Lovells |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Sidley Austin |
| WilmerHale |
| White-Collar/Government Investigation — Recommended |
|---|
| Arnold & Porter |
| Latham & Watkins |
| McDermott Will & Emery |
| Nelson Hardiman |
| Schulte Roth & Zabel |
| White & Case |
| Lawyer | Section | Practice Area | Location |
|---|---|---|---|
| Abernathy, Michael | Intellectual Property | General Patent Litigation, Hatch-Waxman Patent Litigation | Chicago |
| Buenafe, Michele | Regulatory | FDA: Medical Device | Washington, D.C. |
| Cooney, Gordon | Non-IP Litigation & Enforcement | Product Liability, Antitrust | Philadelphia |
| de Bodo, Richard | Intellectual Property | General Patent Litigation, Patent Strategy & Management, Hatch-Waxman Patent Litigation | Century City |
| Dodds, John | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Frank, Steven J | Intellectual Property | Patent Prosecution | Boston |
| Glazer, David G | Financial & Corporate | Corporate, Licensing & Collaboration, Mergers & Acquisitions | Princeton |
| Kraeutler, Eric | Intellectual Property | General Patent Litigation | Philadelphia |
| Leeds, Alan | Financial & Corporate | Licensing & Collaboration, Mergers & Acquisitions | Princeton |
| Mahinka, Stephen Paul | Regulatory , Non-IP Litigation & Enforcement | FDA: Medical Device, FDA: Pharmaceutical, Antitrust | Washington, D.C. |
| Mann, Jeffry S | Intellectual Property | Patent Prosecution, Patent Strategy & Management | San Francisco |
| McDermott, Kathleen | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
| Memmott, Scott | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
| Navarro, Steven A | Financial & Corporate | Corporate, Mergers & Acquisitions | New York City |
| Pensak, Benjamin | Financial & Corporate | Licensing & Collaboration, Mergers & Acquisitions, Venture Capital | San Francisco |
| Ragosa, Emilio | Financial & Corporate | Mergers & Acquisitions, Venture Capital | Princeton |
| Reed, Steven | Non-IP Litigation & Enforcement | Antitrust | Philadelphia |
| Ruskin, Andrew | Regulatory | Healthcare Pricing & Reimbursement | Washington, D.C. |
| Sanzo, Kathleen | Regulatory | FDA: Medical Device, FDA: Pharmaceutical | Washington, D.C. |
| Sitarchuk, Eric | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Sonnenfeld, Marc | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Stein, Mark B | Financial & Corporate | Corporate, Licensing & Collaboration, Mergers & Acquisitions, Venture Capital | Boston |
| Sunberg, Randall B | Financial & Corporate | Corporate, Licensing & Collaboration, Mergers & Acquisitions, Venture Capital | Princeton |
| Tom, Willard | Non-IP Litigation & Enforcement | Antitrust | Washington, D.C. |
| Young, Howard | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
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Financial & Corporate
Morgan Lewis & Bockius
Based in Philadelphia, Morgan Lewis & Bockius is a full-service firm with an exceptional life sciences practice equipped to handle various financial and corporate matters. The firm serves a diverse set of clients, from international life sciences entities to emerging businesses, and handles matters throughout all phases of growth.
The firm is particularly prominent in the licensing and collaborations area. Randall Sunberg, Benjamin Pensak, Alan Leeds and David Glazer handled numerous agreements, including multiple deals with a potential value of over $1 billion. The team has handled several agreements and collaborations for major pharmaceutical companies, especially seeking to develop or fund and conduct clinical trials. On the international front, Pensak represented a Singapore-focused venture fund in a licensing agreement between its portfolio company and a university. This licensing agreement brought together the firm's Singapore and San Francisco offices, showcasing the strength of the firm's international footprint.
In the corporate and venture capital space, the firm represents both investors and companies in financings and IPOs. Notable members of the group include Mark Stein and Steven Navarro, who both focus on corporate transactions as well as M&A. Stein recently represented a lead investor in a Series C financing, and Navarro's latest representation includes a private placement sale of common stock for a pharmaceutical company focused on cancer therapies.
Intellectual Property
Morgan Lewis & Bockius
Morgan Lewis & Bockius is an international firm with an expansive footprint in the United States, armed with a deep bench of attorneys able to provide legal services across the IP spectrum. The firm is notable for counseling life sciences clients in patent strategy, prosecution and general patent litigation. Its patent litigation capabilities grew last July with the addition of seven life sciences-focused IP litigators from McDermott Will & Emery.
Michael Abernathy serves as co-head of the firm's IP litigation and life sciences IP practice groups. He has experience leading patent-related jury trials and Hatch-Waxman disputes for pharmaceutical clients. Abernathy was successful in clearing an 11-patent district court dispute against client Praxair by invalidating five of the patents asserted by Mallinckrodt and securing non-infringement verdicts for the other six. Eric Kraeutler is global head of the firm's IP practice, and has spent nearly four decades with the firm. He is versed in handling patent disputes for life sciences companies in district courts. Richard de Bodo is one of the firm's standout litigators experienced in Hatch-Waxman disputes. He has also been involved in biosimilar and medical device suits.
Patent strategist Jeffry Mann splits his time between the firm's Singapore and San Francisco offices, where he counsels clients on portfolio management, prosecution, and IP transactions. He recently represented cell therapy company Medisix Therapeutics in a $20 million Series A funding led by Lightstone Ventures to be used for product development and pre-clinical studies.
Life Cycle
Morgan Lewis & Bockius
Morgan Lewis & Bockius has an all-encompassing practice in the life sciences. The firm receives top marks for its involvement in white-collar matters, licensing and collaboration, and general corporate work. The group is also notable for a significant regulatory team equipped to handle the full gamut of FDA issues, and a patent group active in litigation and counseling.
The firm receives top rankings in licensing and collaboration and general corporate work. One of the leaders in the licensing area is Randall Sunberg, who co-heads the life sciences transactions group. His specialties include complex collaborations, M&A, joint ventures and licensing agreements. Sunberg recently led a Morgan Lewis team acting for Shire in an agreement with biopharma company Novimmune, which granted the client rights to develop an antibody platform. Alan Leeds co-heads the transactions group with Sunberg. He recently assisted Regeneron in a collaboration with ISA Pharmaceuticals to fund and conduct clinical trials for cancer treatments. Mark Stein and Steven Navarro offer expertise in corporate transactions and mergers and acquisitions. Stein recently represented an investor in a Series C financing, and Navarro assisted in a private placement sale of common stock for a pharmaceutical company focused on cancer therapies.
Morgan Lewis is equipped to represent companies at all stages of a product's life cycle as it relates to regulatory matters. The firm receives national rankings in all three main regulatory practice areas, including FDA counseling in the pharmaceutical and medical device spaces, and pricing and reimbursement. The team includes Kathleen Sanzo, whose practice focuses on FDA compliance for companies both in the pre-market and post-market stage. One client says, "Kathy is an FDA and regulatory expert, and is my first point of call for the great variety of legal questions that confront us during clinical trials of new biotherapeutics." Michele Buenafe has recently handled and submitted 510(k) submissions for several medical device companies, and has further assisted the clients in responding to questions raised by the FDA. Andrew Ruskin concentrates on handling clients' healthcare pricing and reimbursement matters, providing advice and strategy to clients facing issues with Medicare and Medicaid especially.
In the litigation and enforcement area, Morgan Lewis receives top marks for its strength in investigations and white-collar matters, and is also notable for its antitrust practice. Stephen Paul Mahinka has a diverse practice focused on both antitrust and regulatory matters. He is the founder of the firm's FDA practice, and is versed in compliance issues. Kathleen McDermott is a top practitioner in the government investigations space, notably in matters related to the False Claims Act. She has recently been active for multiple life sciences clients in matters related to the statute. Eric Sitarchuk is another standout in the investigations and white-collar area, who recently represented Rite Aid in a False Claims Act suit filed in state court in California.
The firm's patent litigation group is supported by Michael Abernathy, Richard de Bodo and Eric Kraeutler, three seasoned trial lawyers with deep experience helming life sciences cases. Abernathy recently secured a favorable outcome for Mallinckrodt in an 11-patent suit against Praxair. Kraeutler is currently part of a team defending Acerta Pharma against patent infringement claims in the District of Delaware. Jeffrey Mann is a standout member of the firm's patent prosecution and counseling practice, with a specialty in IP transactions and portfolio management. He recently acted for cell therapy client Medisix Therapeutics in a $20 million Series A funding. Patent attorney Steven Frank offers expertise in the medical device area.
Non-IP Litigation & Enforcement
Morgan Lewis & Bockius
Morgan Lewis & Bockius is one of the life sciences industry's most dominant and deepest legal service providers, with a number of its extensive network offices throughout the US attending to both litigation, investigation and regulatory work.
Domiciled in the firm's Philadelphia office where the firm's genesis began, Eric Sitarchuk represented Rite Aid in connection with a US False Claims Act suit filed in state court in California with the threat of statutory penalties of up to $11,000 per claim and treble damages. A qui tam relator, a former claims processor for California Department of Health Care Services, alleged that Rite Aid had a policy of overcharging Medi-Cal by failing to report the prices offered to non-insured customers as its "usual and customary" price, and by not complying with regulations regarding when to dispense either generic or name-brand prescription drugs. The plaintiff, a former claims processor for California Department of Health Care Services, was a serial relator who had successfully filed "whistleblower" claims against other retail pharmacies. In January 2018, the appeal was dismissed on Rite Aid's motion, bringing the matter to a final and successful conclusion on behalf of the client.
Sitarchuk also successfully negotiated a settlement of a years-long FCA litigation against Cephalon in the US. The whistleblowers in the case alleged that Cephalon promoted two pharmaceutical products, Provigil and Nuvigil, for indications not approved by the FDA. Boston-based Jordan Hershman obtained a rare dismissal from the bench of a securities class action filed against Teva, with plaintiffs alleging that it had engaged in antitrust violations that also allegedly supported federal securities law claims. Nonetheless, at the conclusion of the Teva oral argument, the court granted the Morgan Lewis team's motions to dismiss, without prejudice, all claims asserted against all Teva defendants.
Regulatory
Morgan Lewis & Bockius
Morgan Lewis & Bockius provides a full suite of regulatory expertise to clients in the life sciences sector, with the capability to handle a product at all stages of the life cycle. The firm receives national rankings in all three main regulatory practice areas, including FDA counseling in the pharmaceutical and medical device spaces, and pricing and reimbursement.
The team includes Kathleen Sanzo, whose practice focuses on FDA compliance in for companies both in the pre-market and post-market stage. She primarily focuses on pharmaceutical and biotechnology clients. One client says, "Kathy is an FDA and regulatory expert, and is my first point of call for the great variety of legal questions that confront us during clinical trials of new biotherapeutics." Among the firm's longstanding practitioners is Stephen Paul Mahinka who originally founded the firm's FDA practice and co-founded the life sciences industry practice. Mahinka continues to on regulatory compliance, assisting clients throughout the life cycle. For medical devices, Michele Buenafe advises and represents companies dealing with the regulatory issues, frequently strategizing pathways to FDA approval for clients. Buenafe successfully handled and submitted 510(k) submissions for several medical device companies, and has further assisted the clients in responding to questions raised by the FDA.
Andrew Ruskin concentrates on handling clients' healthcare pricing and reimbursement matters, providing advice and strategy to clients facing issues with Medicare and Medicaid especially.
Articles
New content includes national firm rankings, life sciences stars and editorial reviews