Pharmaceuticals and Medical Devices

Representing pharmaceutical and medical device companies on the complex and diverse legal challenges they face.

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Decades of Experience in Pharmaceutical and Medical Device Representation

Phillips Lytle represents pharmaceutical and medical device companies, from startups to multinational corporations, on a myriad of issues affecting the lifecycle of a medication or the evolution of a device through treatment and clinical use.

We are trusted advocates for global pharmaceutical companies, medical device manufacturers, research institutions, healthcare facilities, investors, serial entrepreneurs and startups. Indoctrinated from early days in the DES and silicone gel breast implant and over 10 years as national science counsel to GlaxoSmithKline, our seasoned attorneys, including lawyer/scientists and scientific specialists, possess a level of knowledge and legal expertise that surpasses many larger firms.

We have successfully represented clients in the medical device and pharmaceutical industry for decades in high-stakes, complex product liability and other litigation. Our work is 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, and hormone replacement therapies.

Wide-Ranging Representation for Pharmaceutical and Medical Device Clients

Robust Support and Counsel

With a depth of knowledge and legal experience surpassing the capabilities of many larger firms, Phillips Lytle 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.

Extensive Litigation Experience

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.

Pharmaceutical and Medical Device Regulatory Compliance

We are experienced in regulatory compliance matters, especially for entities that are regulated by the Food and Drug Administration and other federal and state agencies. We provide guidance on product labeling, marketing and promotional guidelines, product recalls and reformulation in addition to 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.

Meet Our Pharmaceuticals and Medical Devices Team


Thomas K. Caraher Associate
Joshua Glasgow Partner
George Hajduczok Counsel
Eric M. Kraus Partner
Julia M. Markov Science Specialist
Dorothy Shuldman
Dorothy E. Shuldman Associate
Lisa Smith
Lisa L. Smith Partner
Joshua Wallace
Joshua S. Wallace Associate
Meet the Team
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