Introduction

• Jurisdiction: United States

Introduction

If there has been one constant of the regulatory landscape in which pharmaceutical and medical-device companies operate, it has been consistent growth—both in complexity and interconnectedness. In today's environment, a warning letter or other enforcement action from the Food and Drug Administration can spawn litigation across diverse areas, from product liability to securities fraud (for public companies) to everywhere in between. Private and governmental third-party payors may also seize on regulatory actions and file claims seeking to recoup money spent on medications they now characterize as inefficacious. At other times, just the opposite occurs: private civil litigation catalyzes heightened scrutiny from state and/or federal regulators. At still other times, actions by a competitor seeking to challenge or invalidate a drug patent can trigger both patent and antitrust litigation, from competitors, and direct as well as indirect purchasers of the product. Beyond this, perhaps nothing commands greater attention among litigants of all stripes than an investigation by the U.S. Department of Justice that results in a criminal plea, civil fine, or indictment. Such investigations, to be sure, add not only to a company's litigation docket, but also impact virtually every aspect of its operation. In the worst-case scenario, the government can exclude the company from sales—which, as a practical matter, could put the company out of business.

Against this backdrop, the provision of sound legal advice to the makers of products regulated by the FDA has never been more challenging and fraught...