Every Breath You Take . . . FDA is Watching You!

By Robert A. Dormer –

Every breath you take
Every move you make
Every bond you break
Every step you take
I'll be watching you

Every single day
Every word you say
Every game you play
Every night you stay
I'll be watching you

Our apologies to Sting and The Police, but we were reminded of the lyrics from “Every Breath You Take” the other day when we learned about the “Automated Litigation Tracking System” being run by the Office of General Counsel of the Department of Health and Human Services, the parent agency of FDA.  As a law firm that is involved in litigation with FDA on a fairly regular basis, we are certainly not surprised that HHS and FDA would want to know relevant information about companies or individuals who are suing the government or who are defendants in cases brought by the government. We were, however, surprised to learn about the Automated Litigation Tracking System that is located at the old Parklawn Building in Rockville, Maryland where many of us FDA alumni used to work. With recent disclosures about National Security Agency surveillance and the report last week [http://oversight.house.gov/wp-content/uploads/2014/02/FDA-Staff-Report-final.pdf] from Senator Charles Grassley (R-IA) and Congressman Darrell Issa (R-CA) about FDA monitoring of employee emails we thought this might be a timely topic.

According to the government’s description of the litigation tracking system, records are maintained on individuals “who are involved in litigation with the Department [of HHS] or the United States (regarding matters within the jurisdiction of the Department) either as plaintiffs or defendants in both civil and criminal matters.”  Also included are individuals who “either file administrative complaints[s] with the Department or are the subject of administrative complaints initiated by the Department …” and individuals “who are named parties in cases in which the Department believes it will or may become involved ….”  What is not clear is the type or extent of records that are automatically tracked.  We hope that only publicly available information is tracked and maintained but does that include for example court records from divorce proceedings or child custody cases?  What about financial contributions to political candidates?  The government’s description says only that the records contain information to identify “the people involved in each case.”  We are aware, for example, that FDA is tracking company websites using this system.  What else is FDA tracking?

Among the “routine uses” of this information are communications “with, among others, Federal, State, and local law enforcement agencies, private individuals, public and private hospitals, allegedly negligent parties, private attorneys, insurance companies, the United States Attorney and other Federal officials and agencies, individual law enforcement officers and tribal officials.  These communications are all for the purpose of investigating, settling, or denying claims and subsequent litigation action.”

Although we don’t pretend to know the extent to which FDA is tracking companies it regulates, it is prudent to assume that if your company is (or may be) in litigation with FDA – or is potentially subject to enforcement action – FDA is watching every move you make, every step you take.