Is Advice Provided by Food and Drug Lawyers Legal Advice Protected from Discovery?

A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice.  The court concluded that “[d]ocuments created in the context of seeking FDA approval, an inherently legal process, present ‘a circumstance virtually necessitating legal representation,’ as the FDA approval process requires close supervision by legal counsel.” 

Our colleague, John Fleder, wrote in a recent article for FDLI Update that “[t]he Magistrate Judge’s decision was a fundamental ruling on whether food and drug lawyers provided legal advice.”  Of course, not all advice provided by food and drug attorneys may automatically qualify as “legal” advice.  As such, Mr. Fleder notes that “[t]o maximize the protection of confidentiality, it is important that companies and/or their outside counsel timely document that counsel are rendering legal advice to the client when the purpose of the advice sought is, as it normally should be, legal advice.”