Covington has one of the world's most active and respected Pharmaceutical Litigation and Investigations Practices, with over 110 firm lawyers engaged in this work. Drawing on the expertise of the firm's pre-eminent FDA regulatory practice, our litigators have helped guide some of the world's leading pharmaceutical companies through all aspects of difficult investigations and lawsuits. Covington represents more pharmaceutical companies in more criminal and civil investigations by federal and state government agencies, including high-profile congressional inquiries -- such as the Food & Drug Administration, the Department of Justice, Congress, and State Attorneys General -- than any firm in the country. Our litigation experience is broad, encompassing many areas including, suits under the False Claims Act, product liability litigation, patent litigation, pricing and antitrust litigation, litigation with federal agencies, and insurance coverage disputes.
Pharmaceutical Investigations
As investigations often precede litigation, our firm has deep experience serving as national coordinating counsel, handling document-intensive litigation, working with experts, and managing multi-jurisdictional and class action proceedings for pharmaceutical manufacturers. The firm regularly advises pharmaceutical clients on a wide array of enforcement and regulatory proceedings, including the Anti-Kickback Statute, the Medicaid rebate statute, the Prescription Drug Marketing Act, the False Claims Act, the Stark physician referral statute, and state anti-fraud and consumer protection laws. With the assistance of our offices in London and Brussels, we also handle investigations under the Foreign Corrupt Practices Act.
In addition to Executive branch investigations, Covington has also assisted numerous pharmaceutical manufacturers in preparing for high-profile congressional inquiries. We have a team of lawyers with experience on both sides of the aisle in the House and the Senate. Covington’s team of former government lawyers, includes a Deputy Associate Attorney General, a U.S. Attorney (EDNY), two Assistants to White House Counsel, eight AUSA's (including one from Boston), a DOJ Civil Fraud Section Attorney, and three DA's. Through our numerous legislative representations, we have developed a deep appreciation of the benefits of being forthcoming in these investigations, the value of developing a positive relationship with both majority and minority staff and educating them on the substance of their inquiries, and the importance of effectively preparing witnesses for congressional hearings. Our lawyers are also experienced at handling the public relations and media relations challenges that often accompany political investigations, including preparing and implementing "crisis management" plans that dovetail with our legal strategies.
The Practical Law Company (PLC) ranked Ethan Posner, Mark Lynch, and Geoffrey Hobart as being leading lawyers in the Pharmaceutical Fraud & Abuse Investigations field. These rankings reflect our lawyers' superior industry knowledge and proven ability to protect clients' interests in a broad range of investigations and related litigation.
Pharmaceutical Litigation
Covington is one of the most active firms in the country on a broad range of pharmaceutical litigation. Our litigators draw on the expertise of the firm's preeminent Food and Drug Practice, which comprises 40 lawyers, including two who served as Chief Counsel of the Food and Drug Administration. Our lawyers serve as regulatory and legislative counsel for numerous manufacturers and also industry groups such as PhRMA (Pharmaceutical Research and Manufacturers of America); CHPA (Consumer Healthcare Products Association); EFPIA (European Federation of Pharmaceutical Industries and Associations); NPC (National Pharmaceutical Council); and AHI (Animal Health Institute).
False Claims Act: In today's world, government investigations often proceed in tandem with private class actions and qui tam lawsuits under the False Claims Act. We have experience with investigations alleging wrongdoing during clinical research, violations of the Prescription Drug Marketing Act, billing fraud, kickbacks and violations of the Stark self-referral law, and violations of good manufacturing practices. We represent companies in all phases of an investigation, from subpoena compliance to trial. Our experience includes handling the private class actions that arose out of two of the largest health care matters in history -- the cases involving overbilling allegations against National Medical Enterprises/Tenet Healthcare Corporation and SmithKline Beecham Clinical Laboratories.
Products Liability Litigation: Covington has defended many product liability claims on behalf of clients in the food, drug, and chemical industries, and has played a central role in defending against actions seeking to establish new scientific theories of causation and novel theories of liability. We presently serve as national coordinating counsel for Hoffmann-La Roche in Accutane product liability litigation; national coordinating counsel in all pharmaceutical products liability litigation for the Consumer Healthcare Products Association (CHPA), the Washington, DC based trade association for nonprescription drug manufacturers; and we are responsible for economic injury cases involving OxyContin.
Patent Litigation: The firm successfully combines its regulatory and antitrust expertise in handling Hatch-Waxman and other patent cases and associated antitrust litigation. Representative litigation work includes: coordinating Monsanto's litigation of several cases involving interrelated biotechnology patents, as well as antitrust and trade secret issues; defending SmithKline Beecham against claims of patent infringement; defending GlaxoSmithKline for alleged patent antitrust violations; prosecuting suits for patent infringement on behalf of clients such as Key Pharmaceuticals, Caliper Life Sciences, and Monsanto Company; and a pending ANDA case for Johnson & Johnson.
Pricing and Antitrust Litigation: We have successfully litigated many complex civil and criminal antitrust and consumer protection matters, including nationwide class actions, consolidated multidistrict cases, short-fuse preliminary injunction proceedings, and appeals up through the U.S. Supreme Court. Our experience encompasses jury and bench trials in state and federal courts and before administrative agencies. Representative matters include: Boehringer Ingelheim in pending Canadian import litigation; GlaxoSmithKline and Purdue Pharma in patent/antitrust litigation; a major Rx client in a Department of Justice criminal grand jury investigation; Warner-Lambert in the In re Brand Name Prescription Drugs Antitrust Litigation; and, related state court lawsuits. We also serve as antitrust counsel to the National Pharmaceutical Council, Consumer Healthcare Products Association, Pharmacogenetics Working Group (EU and US scientific representatives from 22 major pharmaceutical companies), and well over a dozen other trade associations in the food and drug area and related fields.
Litigation with Federal Agencies: Our litigators have extensive experience representing pharmaceutical manufacturers that challenge FDA actions and those that intervene to defend agency actions. For example, we have both overturned FDA decisions denying pediatric exclusivity to our clients and defended FDA decisions granting pediatric exclusivity. We also have deep expertise in handling "reverse" Freedom of Information Act cases, where manufacturers assert their interests in the confidentiality of proprietary information sought by competitors, watch-dog groups or others.
Insurance: The firm has a leading national practice in litigating insurance coverage disputes for policyholders, and has handled many cases for pharmaceutical manufacturers both in court trials and in private arbitrations, including both domestic and international proceedings. We recovered approximately $1.5 billion in coverage for Dow Corning breast implant liabilities, and are currently representing several major pharmaceutical manufacturers in confidential arbitrations seeking coverage for major product liability cases.
Representative Matters
- Lead counsel to Pfizer on numerous investigations into physician interaction practices and the marketing and promotion of various prescription drugs by the Department of Justice, multiple state Attorneys General, Congress and the Securities and Exchange Commission.
- Lead counsel to GlaxoSmithKline in a Department of Justice investigation into physician payments, sales and marketing issues and good manufacturing practices, as well in federal and state lawsuits challenging AWP drug pricing.
- Lead counsel to Boehringer Ingelheim in the Canadian import antitrust litigation.
- Representation of Procter & Gamble Pharmaceuticals, Inc. in a California antitrust and unfair competition case challenging a contract authorizing the sale of an "authorized generic" version of P&GP's Macrobid.
- National coordinating counsel for Hoffmann-La Roche and Roche Laboratories Inc. -- Covington managed all aspects of a nationwide lawsuit alleging that Accutane causes depression, psychosis, suicide, violence, and other psychiatric side effects. Covington also managed all political aspects of this controversy. Drawing on the substantial experience of our lawyers in dealing with the House Energy and Commerce Committee, we worked closely with the committee staff over an 18-month period to provide documents and other requested information. The Committee ultimately held a day-long hearing in December 2002, and we prepared company executives to testify, including Roche's President and CEO, George Abercrombie.
Accolades
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2009)
- PLC - Life Sciences, Which Law Firm? (2006-2009)
- Leading: Government Enforcement & Investigations, USA
- Highly Recommended: Product Liability, England
- Recommended: Product Liability, USA
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