Rachael G. Pontikes

Rachael is a nationally recognized authority in the FDA’s Drug Quality and Security Act (DQSA) Compounding Quality Act (CQA), and participated in various discussions with the Senate HELP Committee staffers as the law was drafted. She is frequently invited to speak on the DQSA-CQA and its implications for compounding pharmacies, most recently by the Food Drug Law Institute (FDLI) for their enforcement conference and the American Pharmacist Association (APhA) for their annual conference.

Her deep experience with the laws governing compounding pharmacies stems from her role as trial and appellate counsel for two seminal cases that shaped the legal landscape. Rachael served as trial counsel in Medical Center v. Mukasey through defeat of the motion to dismiss, and trial and appellate counsel in Wedgewood Village Pharmacy v. United States. She also has an active commercial and appellate litigation practice, acting as lead counsel in representing companies in a broad range of business disputes.

Fluent in Italian and a former resident of Milan, a core focus of Rachael's commercial practice involves assisting companies in litigating or arbitrating cross-border disputes, both as counsel for international entities doing business in the United States, and also as a liaison for American companies in disputes abroad. She served as lead trial counsel for an Italian vineyard sued for $18 million in Palm Bay Int'l, Inc. v. Marchesi DiBarolo S.p.A. After a month long federal jury trial, she obtained a defense verdict of $500,000 and successfully defended this win in the Second Circuit.

Rachael also maintains an active civil action and pro bono practice, focusing on assisting clients affected by sexual exploitation and domestic violence.

In each of these contexts, Rachael approaches client problem solving creatively, from crafting beneficial settlements to creating novel legal theories on matters of first impression. She distills complex legal theories to an essence that anyone can understand. Rachael passionately advocates her clients' positions in a manner tailored to her audience, whether it be regulators, trial or appellate judges, or juries.