FDA staffers sue agency over email surveillance


Six of the so-called "FDA 9" whistleblowers are suing the federal watchdog agency, alleging that the government violated their constitutional rights with surveillance of their private email accounts.

The staffers allege that the FDA spied on the private email accounts they accessed using their government-issued computers, after they warned Congress and the president that unsafe medical devices were being allowed onto the U.S. market.

The lawsuit, filed in the U.S. District Court for the District of Columbia, levels 12 counts against the agency, its chief Dr. Margaret Hamburg, medical device chief Dr. Jeffrey Shuren, the Dept. of Health & Human Services and its head, Kathleen Sebelius, and other government officials. It accuses them of enacting the secret surveillance after learning of a letter the staffers sent to then-President-elect Barack Obama’s transition team Jan. 7, 2009, and of using the information gleaned from the tapped email accounts to harass and, in some cases, fire the whistleblowers.

After learning of the letter, the FDA set up a secret file on its database labelled "FDA 9" to collect the surveillance data. The agency took screenshots of the staffers’ computers as they accessed their private Gmail accounts, according to the lawsuit. Although the government has the right to surveil any activity on the computers it issues, it’s unclear whether it’s legal to secretly gain access to private email accounts used on government-issued devices.

The staffers later wrote an open letter to Obama asking him to hold former and current officials accountable for their alleged wrongdoing. The Jan. 7 letter to John Podesta, the transition team leader, warned that potentially unsafe radiological devices were being allowed to hit the market.

"For example, in the January 7, 2009 letter to Mr. Podesta, the FDA scientists noted that in the past, computer-aided detection devices (‘CAD’) to be used with breast mammograms were not safe or effective, but the FDA approved the devices anyway in a flawed process that ignored the science. This has led to significant harm to large numbers of women and significant unnecessary costs to the public," according to the lawsuit. "After the defendants learned about the Jan. 7, 2009, letter to Mr. Podesta, FDA officials began to secretly refer to the signatories of the letter from the FDA scientists and including [the plaintiffs] as the ‘FDA Nine’ or ‘FDA 9.’"

The FDA staffers also communicated with aides of Sen. Charles Grassley (R-Iowa), who then warned the FDA not to retaliate against the whistleblowers.

But, "despite Senator Grassley’s warnings," the agency "commenced a covert and secret search and seizure operation on the ‘FDA Nine’ in retaliation for their protected speech, which included, but was not limited to, the interception of private communications sent by or on behalf of plaintiffs to congressional representatives," according to the lawsuit.

"The information secretly obtained by defendants included plaintiffs’ legally protected documents and information that was stored by plaintiffs in folders labeled ‘For Congress’ and other folders that clearly indicated the intent of plaintiffs to raise issues of public concern with appropriate authorities," according to the complaint.

"Defendants have taken and converted private emails without due process or just compensation in violation of the 5th Amendment of the United States Constitution. Defendants have initiated searches and seizures in violation of the 1st and 4th Amendments. Defendants have conducted searches and seizures of a scope that violates the 1st and 4th Amendments. Defendants have violated the 1st Amendment by chilling free speech with searches and seizures. Defendants have violated the 1st Amendment by chilling Plaintiffs’ and the public’s right to associate with whistleblowers. Defendants have violated plaintiffs’ right to representation. Defendants have chilled plaintiffs’ protected 1st Amendment right to free speech."

Documents obtained by the Washington Post show that the FDA twice asked the HHS inspector general’s office to investigate the whistleblowers, accusing them of illegally releasing confidential business information about the devices they believed were unsafe.

"We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," Shuren wrote, according to the documents.

But both times the IG’s office declined to intervene.

"Who would have thought that they would have the nerve to be monitoring my communications to Congress?" Robert Smith, one of the plaintiffs in the suit, told the Post. "How dare they?"

Michael Sussmann, a former federal prosecutor who is now a partner at the Perkins Coie law firm, told the newspaper that the FDA has the latitude to conduct extensive monitoring.

"Anything on this agency’s network is fair game by use of this banner, as long as they’re lawfully targeting their employee," Sussman said.

Federal investigators later cleared the FDA managers of criminal acts against the whistleblowers.

“We do have a zero tolerance policy for retaliation,” Shuren said at the time.

"The FDA has a huge responsibility to protect public health and safety," Grassley said in a statement to the Post. "It’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress."

RSS From Medical Design & Outsourcing

  • Emuge expands solid carbide thread mill program with new 3XD sizes
    Emuge is now offering an expanded line of Solid Carbide Thread Mills in their popular THREADS-ALL Program, to include new 3XD sizes designed for maximum reach. A total of 17 new sizes have been added, from miniature to standard size tools, providing maximum versatility in a wide range of thread milling applications. The 3XD THREADS-ALL […]
  • Start of helpful humanoid robots? CITEC uses compact LDS component as sensor array
    Editor’s Note: LaserMicronics, a service provider for laser-based manufacturing, has released the whitepaper “Robot hand with a sensitive touch: LDS tactile sensors for sensorimotor skills.” The paper describes a 2014 project from the CITEC department at Bielefeld University in Bielefeld, Germany, where researchers created a tactile sensor resembling a human fingertip. The sensor was then […]
  • Nature meets technology: Festo’s BionicANTs cooperate to solve a common task
    Editor’s Note: Festo, an industrial control and automation company, has released the whitepaper “BionicANTs: Cooperative behavior based on a natural model.” The paper describes the BionicANT, a creation of Festo engineers that duplicates the physical anatomy of its natural counterpart and reproduces the insect’s cooperative behavior. Festo engineers have used the delicate anatomy of an […]
  • Acorn Regulatory streamlines approval process drug-device manufacturers
    Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, is streamlining procedures for U.S. manufacturers of drug-device combinations with customized programs that successfully overcome challenges in meeting European regulatory approvals. Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical […]
  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]

Leave a Reply