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Pharmaceutical and life sciences disputes

Consisting of more than 70 lawyers who devote their practices to the healthcare industry and act as partners to pharmaceutical and medical device manufacturers of all sizes, our pharmaceutical and medical device disputes team represents clients in contentious proceedings before the courts and regulatory authorities—including individual cases, consolidated cases, and multi-district litigations. Our litigators have extensive trial experience and the industry knowledge to handle disputes and regulatory cases on a national, regional and local level. Our pharmaceutical and medical device lawyers can provide integrated advice on both domestic and cross-border matters.

Our securities disputes team has extensive experience defending shareholder lawsuits and government enforcement actions against life sciences companies across the US. We have obtained recent dismissals of federal securities fraud suits on behalf of pharmaceutical and medical device companies over adverse FDA decisions and are defending ongoing securities litigation relating to problems with clinical trials. We have defended numerous clients in SEC enforcement actions and have obtained successful outcomes for life sciences clients in securities litigation and enforcement matters across the country.

The head of our securities disputes team, Gerry Pecht, was named as one of five national securities litigation MVPs in the US for 2015 by Securities Law360, while another of our team members oversaw all US securities litigation while in-house at one of the world’s largest pharmaceutical companies. We are well-positioned not only to defend life sciences companies in securities matters across the US, but also to counsel life sciences companies on how to manage their securities litigation and enforcement risks.

Our lawyers are experienced and skillful in defending against alleged antitrust violations, including restraint of trade, monopolization, and price discrimination, as well as bringing antitrust claims for our clients to ensure there is a level competitive playing field. We understand the significant cost of such disputes, including costs associated with document discovery and we are well-equipped to reduce that cost by staffing cases efficiently and employing efficiency-enhancing tools.

Our areas of work include

  • bellwether trial counsel in numerous cases across the country
  • lead counsel in securities class actions and in shareholder derivative actions
  • management counsel in multi-district litigation (MDLs) and state-coordinated proceedings
  • national coordinating counsel and regional counsel throughout the US and Canada, including cross-border coordination
  • pre-trial discovery counsel through trial to post-verdict appeals
  • managing discovery counsel creating cost-effective strategies
  • trial and regulatory team leaders
  • settlement strategy counsel
  • disputes readiness, settlement/mediation programs, clinical trials, Attorneys General investigations, internal investigations

Our recent work

Product liability

  • Served as national counsel for a pharmaceutical company in product liability disputes involving a colonoscopy preparation product. The plaintiff alleged that this product caused kidney failure in certain patients. We handled cases in state and federal court and opposed the plaintiff’s attempts to establish an MDL. We developed an early case assessment and settlement program that led to the resolution of many claims even before suit was filed. While we worked with local counsel in some states where cases were filed, we served as both national and local counsel in Texas, California, Virginia and Maryland.
  • Represented an international pharmaceutical company at the national level in defending a large mass tort disputes involving allegations that the company’s prescription pain medication was associated with an increased risk of serious cardiovascular events. The medication was withdrawn from the market and eventually over 40,000 claims were asserted. We participated in fact and expert witness development in the bellwether trials, served as trial co-counsel at the first case tried in the country, and achieved an appellate victory which reversed the jury verdict from this first trial. We developed and implemented a unique settlement program which essentially resolved the claims alleging serious injuries.

Securities

  • Defended a Canadian biopharmaceutical company, as well as its CEO and CFO, in two securities class action lawsuits after the company announced problems with a Phase III study for a monoclonal antibody cancer treatment.
  • Obtained the complete dismissal of a Rule 10b-5 securities class action filed against the CEO of an Australian pharmaceutical company in the Southern District of New York alleging material misrepresentations regarding the efficacy of a new drug and the likelihood of FDA approval.
  • Obtained dismissals on behalf of pharmaceutical and medical device companies, including federal securities fraud suits against a Houston pharmaceutical company and the CEO of a California medical device company over adverse FDA decisions.
  • Obtained a favorable settlement for a division of a global medical device company and successfully represented two global medical device companies in shareholder class actions.

Antitrust

  • Represented pharmaceutical company in putative class action disputes challenging the settlement of patent disputes on antitrust grounds, so-called "reverse payment settlement" cases.
  • Advised hospital system in an antitrust suit by a competing hospital and its investors.
  • Represented healthcare organization in defense of class action suit alleging conspiracy to lower compensation.
  • Defended a regional hospital group in an antitrust class action alleging conspiracy to depress wages in the US. As reported in New York Times and Wall Street Journal, this is one of several suits filed against hospitals in four US cities in a coordinated action.
  • Global pharmaceutical company as discovery counsel in a multidistrict antitrust litigation that combines eleven proposed class actions alleging a pay-for-delay scheme over a generic version of a stroke prevention drug with a damage claim expected to exceed US$120m.