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.
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:
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.
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 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.
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