Answer: A company’s first priority is to deal with the FDA’s concerns in the Warning Letter. A Warning Letter that is addressed promptly and effectively is the most defensible later. The FDA requires verifiable information that demonstrates that the alleged violations have been addressed and corrected. Once your company makes such a showing, the FDA will issue a close-out letter. (The FDA began issuing close out letters in late 2009. Close-out letters will be issued in connection with Warning Letters dated after September 1, 2009.) However, as your question implies, it is wise to consider the Warning Letter’s possible implications for future or ongoing litigation.
The FDA puts every Warning Letter it issues on its website. A medical technology and life sciences company should expect that a plaintiff will find any Warning Letters that a company has been issued and try to connect the alleged violations enumerated in them to the lawsuit, if possible. Even before any lawsuit is filed, publicity generated over a Warning Letter might alert some potential plaintiffs to possible issues at a company or encourage other potential plaintiffs to come forward with claims.
Courts are split on the admissibility of Warning Letters as evidence in litigation because the FDA considers them “advisory” and not conclusive of any Food Drug and Cosmetic Act (FDCA) violation. Whether or not your company’s Warning Letter will be admissible into evidence probably will depend on whether the product and alleged violation that are the subjects of the Warning Letter are substantially similar to the product/defect at issue in the lawsuit.
A Warning Letter recipient should anticipate that the letter, the response, and any other correspondence and documents related to the Warning Letter may be discoverable in subsequent litigation and draft them accordingly. In any written communications regarding a Warning Letter, the recipient-company should carefully describe the alleged violation as specifically as possible and not make any admissions regarding the FDA’s claims. Being specific about the issues raised by the Letter may later help to show that the subject of the Letter is different from the claims asserted in the lawsuit.