Health Care and
Life Sciences Litigation

Davis Polk has been advising clients – ranging from the world’s largest health care companies to startups – with a focus on pharmaceuticals, biotechnology, diagnostics, medical devices and health care equipment, genetics and other areas for decades. We consistently help our clients achieve their strategic objectives in a wide variety of matters through ever-changing market and regulatory conditions. Our lawyers have advised clients in hundreds of matters across a range of civil litigation, regulatory and enforcement matters. Through our broad experience, we understand the complex issues that health care and life sciences companies face in their line of business including:

  • Bribery and kickbacks
  • Consumer protection
  • False advertising
  • False Claims Act / qui tam actions
  • Health care fraud
  • Independent investigations and compliance reviews
  • Mass torts
  • Misbranding
  • Off-label promotion
  • Patent misuse
  • Price fixing
  • Products liability
  • Securities fraud
  • Securities and corporate governance 

Our litigators strive to keep up to date with the industry, our clients and their competitors. We integrate this awareness into every interaction, providing insight into where the industry is going and what health care and life sciences companies need to know in order to reach their strategic goals.   

RECOGNITION

Chambers USA

  • Commercial Litigation, Mergers & Acquisitions, Securities Litigation and White Collar Crime & Government Investigations, Band 1
  • Davis Polk is praised for its "superb expertise in a number of industries including pharmaceuticals."

NOTABLE MATTERS

Biotechnology and Pharmaceuticals 

  • AstraZeneca. We represented AstraZeneca in an investigation by DOJ and the SEC of the pharmaceutical industry in seven countries, including China. The broad-ranging inquiry, which spanned several years, focused on sales practices, internal controls, distributors, and interactions with health care providers, institutions and government officials. 
  • Prosensa. We represented Prosensa and several of its officers and directors, obtaining a total victory of a securities litigation related to its IPO. Plaintiffs alleged that Prosensa’s Registration Statement omitted material facts concerning its lead drug.
  • Orexigen Therapeutics. We represented current and former directors of Orexigen Therapeutics in connection with shareholder claims, successfully obtaining the dismissal of claims filed by the shareholder plaintiffs.
  • Pfizer. We represented Pfizer in connection with actions related to the anticonvulsant medication Neurontin, including federal and multistate investigations of off-label marketing practices, and the $430 million landmark global resolution with the U.S. Attorney’s Office for the District of Massachusetts and 50 states.
  • Forest Laboratories. We represented the Chairman, President and CEO of Forest Laboratories in connection with a proceeding by the HHS-OIG to exclude him from the pharmaceuticals industry.
  • AstraZeneca. We represented AstraZeneca in connection with the dismissal of a securities fraud class action in the Southern District of New York that alleged that the company defrauded investors by failing to disclose certain information regarding a drug for which AstraZeneca was seeking FDA approval. The Second Circuit affirmed the district court’s dismissal.
  • Eisai. We represented Eisai in connection with respect to the approval of new drugs by the Drug Enforcement Administration (“DEA”) and the FDA.
  • ImClone. We represented ImClone in connection with shareholder litigation and investigations by the SEC and DOJ arising out of the Food and Drug Administration’s decision refusing to file ImClone’s application for approval of ERBITUX, its highly anticipated cancer drug.
  • A major pharmaceuticals company. We represented a major pharmaceuticals with manufacturing operations in Puerto Rico in connection with a criminal investigation regarding violations of the Clean Water Act.
  • Roche. We represented Roche in all litigation arising out of its $47 billion acquisition of Genentech, its $3.4 billion acquisition of Ventana, and its $230 million acquisition of Anadys Pharmaceuticals.
  • Hoffmann-La Roche. We represented Hoffmann-La Rochein connection with civil and criminal antitrust investigations by DOJ of alleged price-fixing in the bulk vitamins industry. In a case before the U.S. Supreme Court concerning the extraterritorial reach of U.S. antitrust laws, the Court voted 8-0 in favor of our client. 

Health Care

  • A Fortune 50 managed health care company. We represented a Fortune 50 managed health care company and four current and former directors and officers in the dismissal of a multibillion-dollar securities class action. The dismissal, affirmed on appeal by the Third Circuit, created important law regarding the appropriate analysis for determining whether company statements should be viewed as subject to safe-harbor rules.
  • HCA underwriters. We represented all underwritersin class actions arising out of the IPO of Hospital Corporation of America (“HCA”). The parties reached a settlement before trial in which our clients paid nothing.
  • Health care Supplies Company. We represented a health care supplies company subsidiary in connection with a potential DOJ investigation into the endoscope industry under the Federal Food, Drug, and Cosmetics Act.
  • WellCare. We represented a special committee of the board of directors of WellCarein connection with its investigation into matters raised as part of a health care fraud investigation by certain federal and state agencies.
  • Abbott Laboratories. We represented Abbott Laboratories in connection with a California shareholder litigation relating to its $2.8 billion acquisition of Advanced Medical Optics.
  • A Fortune 50 managed healthcare company.We represented a Fortune 50 managed health care company and its board of directors in connection with proxy disclosure claims related to the disclosure of the company’s political contributions. In shareholder litigation that was among the first of its kind, a company shareholder sued the company and members of its board of directors for violation of the proxy disclosure laws for alleged misstatements in its proxy statements that supposedly rendered invalid prior shareholder votes concerning the disclosure of additional political contribution information.

 Medical Device

  • VNUS Medical Technology. We represented VNUS Medical Technology in connection with patent infringement litigation since 2005, in connection with the endovenous treatment for varicose veins. Litigation included a jury verdict of infringement and an award of $45.8 million in favor of VNUS, as well as several favorable settlements.
  • Smith & Nephew plc. We represented Smith & Nephew plc and its U.S. subsidiary, Smith & Nephew Inc., in connection with the SEC and DOJ settlements of their joint FCPA investigation.
  • Global Medical Device Company. We represented the board of directors for one of the world’s largest medical device companiesin connection with allegations by the SEC and DOJ of corruption in China and other markets, including in relation to M&A transactional issues, distributor relationships and product registration issues, among others.
  • Affymetrix. We represented Affymetrix and its CEO in connection withsecurities litigation relating to its 2016 acquisition by Thermo Fisher Scientific. We obtained dismissal of state court suits and settled federal securities claims. We also represented Affymetrix in connection with state court bond holder litigation challenging the company’s proposed acquisition of eBioscience.
  • Smith & Nephew plc. We represented Smith & Nephew in connection with shareholder litigation related to its $1.7 billion acquisition of ArthroCare Corp.
  • Smith & Nephew. We won dismissal of a putative nationwide class action brought in New Jersey federal court against our client, Smith & Nephew, a manufacturer of orthopedic devices, and a second orthopedic device manufacturer.