Drug and Medical Device Litigation

Overview

Navigating the complexities of product liability litigation can be daunting for pharmaceutical and medical device manufacturers. Because of the sector’s stringent regulations and high stakes, securing tenacious, industry-savvy legal representation to protect your interests is not just a recommendation, it's a necessity.

This is why pharmaceutical and medical device manufacturers turn to Epstein Becker Green's Drug and Medical Device Litigation Group. Our seasoned lawyers possess extensive experience litigating product liability matters unique to these manufacturers.

An Industry-Specific Strategy

Every product liability matter presents its own challenges. How a company responds to those challenges is a function of its business model and the nature of its industry.

Epstein Becker Green's Drug and Medical Device Litigation Group seeks to become keenly aware of your company's specific business goals, needs, and economics and the impact of potential liability on your company. The group uses the resources of Epstein Becker Green's Health Care and Life Sciences practice, which has a special focus on the pharmaceutical and medical device industries, and the firm's Litigation & Business Disputes practice to help your company manage risk. We represent pharmaceutical and medical device manufacturers not only in product liability matters but also in a wide range of civil and criminal matters, including class actions and government investigations.

Litigation Avoidance

Epstein Becker Green does not accept the premise that the role of the lawyer is simply to react to bad events—such as the filing of a lawsuit against a client. Rather, an integral aspect of the Drug and Medical Device Litigation Group is to take proactive measures through direct interface with clients to avoid lawsuits in the first place. Many of the most important decisions to minimize risk and exposure are often made before the company is a litigation target.

Pharmaceutical and medical device manufacturers address a significant number of regulatory requirements associated with the research, development, pricing, promotion, marketing, and selling of medical devices and ethical drugs. As scrutiny on the pharmaceutical and medical device industries from the public, federal and state regulators, and enforcement agencies continues, companies operating in these industries must remain even more vigilant and knowledgeable about the regulatory parameters that affect them. Members of the Drug and Medical Device Litigation Group, in conjunction with our health care regulatory lawyers in the FDA Inspections and Enforcement Group, provide comprehensive legal services relating to all aspects of product development, the FDA regulatory approval process, label development, and post-approval marketing and advertising. We provide FDA counseling to manufacturers relating to promotional matters and off-label distribution issues. We provide counseling with regard to all aspects of post-market clinical trial research programs and grant administration. The regulatory areas in which we counsel our pharmaceutical and medical device clients often are crucial to the defense of product liability litigation.

The Medicine

Epstein Becker Green lawyers have extensive experience litigating cases that require a thorough knowledge of epidemiology, toxicology, and medical sciences. In deposition and at trial, we demonstrate a firm grasp of the scientific and medical issues critical to the defense of the case. We routinely use Daubert and Frye hearings to attack the credibility of adversarial experts and limit the effectiveness of those experts in court.

The Courtroom

Epstein Becker Green aggressively defends its clients in product liability litigation in state and federal courts throughout the United States. Members of the Drug and Medical Device Litigation Group are seasoned trial lawyers who bring a combination of extensive preparation and creativity to the courtroom. While we strive to prevail by summary judgment where possible, we have no qualms about trying jury cases to verdict.

Complex, Class Actions, and Multi-District Litigation

Epstein Becker Green lawyers represent companies in both federal and state class actions, multi-district litigation, and mass actions. Our clients' first (and often best) opportunity to successfully defend a class action is to defeat certification of the putative class or prevent the amassing of dissimilar claims. We have been victorious in opposing class certification and claims aggregation for many clients across many industries through thoughtful and comprehensive pre-certification discovery and investigation, coupled with the development of creative, case-specific strategies.

Crisis Management

Because of the potentially significant impact of product liability claims on a company's reputation, we also assist our clients with developing legally and operationally sound internal and public communications throughout the discovery, management, and resolution of adverse events.

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