Life Sciences and Health Effects

Phillips Lytle’s Life Sciences and Health Effects Team has decades of experience representing life sciences companies and other clients in the health effects and health care industry.

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Crafting Solutions for the Unique Needs of Our Life Sciences and Health Effects Clients

Our representation encompasses high-stakes, complex product liability and other health effects litigation at the national level. We have also brought our expertise to bear in newer facets of the life sciences industry with evolving federal and state regulatory frameworks, including the medicinal psychedelics and vaping products industries. 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.

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 litigation, often serving as national science counsel to develop strategic scientific defenses in mass tort litigation. We have defended global pharmaceutical manufacturers in cases involving antidepressants, antidiabetic medication, sleeping medication, vaccines, antiemetic therapy, ulcer treatments, and hormone replacement therapies. 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, including those alleging health effects such as birth defects, autism spectrum disorder, cardiovascular disease, cancer and neurological disorders.

We also counsel clients in the life sciences space on risk assessment, risk mitigation and the work necessary to maintain compliance with regulations and investigations.

Risk Mitigation

Advising our clients on risk management strategies to avoid litigation is an important aspect of our role as trusted advisors to life science companies. 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.

Regulatory Compliance and Internal Investigations

We are experienced in regulatory compliance matters, especially for entities that are regulated by the Food and Drug Administration (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 compliance issues and related regulations.

We advise our clients in conducting internal investigations to ensure regulatory compliance and defend them with respect to regulatory inspections and audits, 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.

When Science Matters

With a depth of knowledge and legal experience surpassing the capabilities of many larger firms, the Phillips Lytle Life Sciences and Health Effects Team can provide unparalleled counsel to companies facing challenges at the intersection of law and science, including:

  • Product liability litigation
  • Regulatory approval and compliance
  • Evidence-based regulatory rulemaking
  • Risk assessment and mitigation
  • Product labeling and content claims
  • Product recalls and reformulations
  • Regulatory warnings and enforcement actions

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.

Meet Our Life Sciences and Health Effects Team

Lisa Smith
Lisa L. Smith Partner
Eric M. Kraus Partner
Hannah E. Amundsen Associate
Thomas K. Caraher Associate
Joshua Glasgow Partner
George Hajduczok Counsel
William P. Keefer Partner, Governing Committee
Kenneth A. Manning Partner
Julia M. Markov Science Specialist
Dorothy Shuldman
Dorothy E. Shuldman Associate
Joshua Wallace
Joshua S. Wallace Associate
Meet the Team

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