A subpoena is a court order telling someone to appear at a legal proceeding or to produce certain documents. Generally, if someone is subpoenaed, that person must comply. In other words, the person must appear at the place and time designated in the subpoena, and if the subpoena requires the production of certain documents, the person is legally bound to produce them.

Courts’ subpoena power comes from Federal Rule of Civil Procedure 45 which states that ‘‘[e]very subpoena shall . . . command each person to whom it is directed to attend and give testimony or to produce and permit inspection . . . of designated . . . documents.’’

Generally, if one fails to appear as ordered by the subpoena, or fails to produce the requested documents, he or she will likely be found in contempt of court and sanctioned with jail time and fines. Of course, there are a few well known exceptions to this rule that one must testify or produce documents if subpoenaed.

First, one may have the right to refuse to answer questions or produce documents if doing so might incriminate oneself in a crime. Second, one may also refuse to testify if answering the question or producing the document violates a legally-recognized privilege, such as a marital privilege, an attorney-client privilege, or a doctor-patient privilege.

However, there is another, less commonly known exception to the “subpoena rule.” If one is a federal employee, he or she may avoid testifying or producing requested documents due to something called “Touhy regulations,” named after the landmark case, United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).

Under federal Touhy regulations, federal employees generally cannot be compelled to testify or produce documents even when they have extremely relevant information. Such employees testify and disclose information only if the federal agency ultimately agrees it is in the agency’s best interest. Awfully convenient for the federal agency—and awfully inconvenient for the party trying to establish facts by having federal employees testify or disclose certain documents.

Since the FDA is a federal agency, Touhy regulations are a good thing to be aware of if you bring a lawsuit involving pharmaceutical companies and defective medicines. Since federal employees of the FDA may be key witnesses to your claims, Touhy regulations can certainly present a challenge. Every agency has its own Touhy regulations, and therefore it is important to check the FDA’s specific regulations to determine what steps need to be taken to overcome the regulations and acquire the testimony or documents that you need.

Typically, an agency’s Touhy regulations’ first step requires you to submit a formal written request identifying which federal employees you want as witnesses and the areas of testimony. Despite the obstacles that Touhy regulations may present, our firm remains determined to help you navigate the steps involved in your potential case and successfully serve a subpoena on a federal agency if need be.  Please call us for a free consultation.