Phillips Lytle’s Life Sciences & Health Effects Team has decades of experience in high-stakes, complex product liability and other health effects litigation. From our early days in the DES and silicone gel breast implant litigation to more recent drug and device multidistrict litigation, Phillips Lytle has been at the forefront of cutting-edge product liability issues, including defending pharmaceutical manufacturers in cases involving antidepressants, antidiabetic medication, sleeping medication, vaccines, antiemetic therapy, ulcer treatments, cough and cold remedies, denture adhesives and hormone replacement therapies. We have also brought our expertise to bear in newer industries with evolving federal and state regulatory frameworks, including the vaping product industry. Our Team of experienced mass tort litigators, lawyer/scientists, and scientific analysts with advanced scientific degrees coordinates strategic scientific defenses for litigation involving pharmaceuticals and medical devices, consumer products and chemicals.
Companies, small and large, including several among the Fortune 100, have trusted us for successful defense in the most complex product liability matters, often with billions of dollars at stake. In addition to litigation and developing and coordinating the scientific defense in thousands of cases, we focus on risk assessment, risk mitigation, and regulatory compliance and investigations.
Our Team brings its expertise to bear in successfully defending clients facing health effects claims regarding products ranging from pharmaceuticals and medical devices to consumer products, food products and chemicals. We are often at the forefront of legal challenges to unreliable science in the courtroom, achieving defense victories under Daubert and Frye, and successfully advocating to require competent dose assessment for causation testimony under Parker v. Mobil Oil Corp., 7 N.Y.3d 434 (2006). Our deep knowledge of the scientific issues regarding causation of birth defects, cancer, heart attack, stroke, cardiovascular disease, autism, neurological damage, pulmonary disease and vaccine side effects has served our clients well.
We have been called “the experts on experts” because we have a proven track record of identifying and working with the top experts in the country to develop scientifically strong and sound defenses to mass torts, class actions and other litigations. We take incisive depositions of our opponents’ expert witnesses to develop key admissions to challenge the admissibility of expert testimony under Daubert/Frye. With a team of scientific specialists and an infrastructure that includes a unique expert database and scientific library, the numbers speak for themselves:
We also conduct smart, thorough preparation for company scientists and executives with high-level regulatory compliance responsibility who are called to testify in various settings.
Advising our clients on risk management strategies to avoid litigation is an important aspect of our role as trusted advisors. We are adept at taking scientific data and other developments and interpreting them through a business risk and litigation risk lens for our clients. We effectively and efficiently analyze the science relevant to a given product, understand its legal ramifications, and advise our clients how to navigate the intersection of litigation risk and regulatory obligation. Our dual expertise in law and science allows us to provide advice and early risk assessment, informed by a deep understanding of developing science and medicine, to help mitigate legal risk from the earliest stages of product development and regulatory approval through post-marketing safety surveillance.
We are experienced in regulatory compliance matters, especially for entities that are regulated by the FDA and other federal and state agencies. We assist clients with good clinical practices; product labeling, marketing and promotion parameters; product recall and reformulation issues; site inspections by regulatory agencies; and other regulatory and compliance issues. We assist in all issues that may affect a product’s lifecycle, whether in preparation for seeking regulatory approval, labeling and content claims, in post-marketing surveillance and adverse event reporting requirements, or defending against regulatory enforcement actions.
We advise our clients in conducting internal investigations to ensure regulatory compliance, and defend them with respect to whistleblower claims and governmental investigations and actions by the U.S. Department of Justice, State Attorneys General and Offices of Inspectors General, among other entities. We have successfully defended clients in a variety of industries with respect to investigations and enforcement actions under federal and state False Claims Acts.
With a depth of knowledge and legal experience surpassing the capabilities of many larger firms, the Phillips Lytle Life Sciences & Health Effects Team can provide unparalleled counsel to companies facing challenges at the intersection of law and science, including:
We know how to harness and effectively communicate scientific issues to adversaries, regulatory bodies, judges, juries, consumers and stakeholders to achieve our clients’ goals inside and outside the courtroom.
We are eager to put our unique combination of legal and scientific expertise to work for you. Please contact Life Sciences & Health Effects Team Co-Leaders Eric M. Kraus or Lisa L. Smith for further information.