EAST ST. LOUIS — District Judge David R. Herndon has granted summary judgment to defendants in a case in which a former FDA employee submitted numerous Freedom of Information Act (FOIA) requests and other correspondence over a three-year period regarding a glucose monitoring system.
The plaintiff was suing two FDA officials for violating the act.
In the case J. Donald Henson Sr. v. Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA), court documents show that Henson submitted 18 FOIA requests between November 2011 and August 2014. Additionally, according to the court’s summary judgment ruling, Henson “sent letters and emails seeking responses to questions and additional information, which FDA alleges were outside the scope of FOIA.” Additionally, Henson filed motions in court which were “repetitive in nature,” according to Herndon.
“The majority of the records sought by Plaintiff Henson were related to FDA’s premarket approval of a particular device, PMA P980022, and its supplements," Herndon wrote. "PMA P980022 is an application by Medtronic Minimed Inc. for a continuous glucose monitoring system, which is a Class III device which was approved by the FDA on June 15, 1999...All of these premarket approval records are located in FDA’s Center for Devices and Radiological Health.”
According to the March 23 order, defendants responded to the plaintiff's numerous FOIA requests. By November 2015, the defendants had produced 7,964 documents. In June 2016, more documents were produced. Altogether, since the case was filed, the FDA has produced 8,439 pages of Bates-stamped documents and 457 pages of Vaughn indices (which justify any withholdings made in a FOIA response).
Herndon wrote that summary judgment motions are "routine" in cases such as this.
In granting defendants’ motion for summary judgment, Herndon found that the FDA had properly produced all requested documents, properly redacting what was exempt from being disclosed. Also, the Vaughn indices properly explained what was redacted and why.
On March 28, the plaintiff filed a notice of intent to appeal.