Missing emails fuel whistleblower complaints against FDA and HHS

Missing emails are the latest flashpoint in an ongoing battle between whistleblowers and administrators at the Food and Drug Administration and its parent agency, the Health and Human Services Department.

The National Whistleblowers Center along with six current and former employees from FDA and HHS are suing three federal agencies and two agency chiefs, charging they withheld records and deleted emails related to the whistleblowers' complaints.

Deleting the emails would violate federal requirements to preserve them as official government records, said Kelly McClanahan, an attorney for the National Whistleblowers Center and the six plaintiffs.

In a suit filed in federal court in January, McClanahan said FDA scientist Ewa Czerska sent an email to HHS Secretary Kathleen Sebelius complaining that she was being pressured to reverse an adverse decision she had made about the safety of a medical device. She received an automated email response saying, "Your message was deleted without being read."

If so, the deletion violates a federal records regulation that prohibits deleting emails unless they already have been copied into a record-keeping system, McClanahan said in his lawsuit.

He also noted that deletions of whistleblower emails might explain the difficulty McClanahan and his clients have had obtaining documents from FDA and HHS through Freedom of Information Act requests.

In response to repeated FOIA requests for records, HHS has withheld records or said no records could be located, McClanahan's suit says.

The records sought include emails that the six plaintiffs sent to supervisors, agency lawyers, Sebelius and others spelling out wrongdoing and making other complaints, McClanahan said. The plaintiffs want copies of the records so they can demonstrate that they reported problems to FDA and HHS officials and then were punished for doing so, he said.

The plaintiffs "are current and former FDA or HHS employees and all are involved in whistleblowing," McClanahan said. The agencies seldom acted upon the employees' complaints except to retaliate, he added.

Two of the six, Drs. Julian Nicholas and Robert Smith, have been battling FDA since 2008, when they recommended that the agency prohibit expanded use of computed tomography, or CT, equipment used for cancer screening.

They warned that high levels of radiation from too many CT scans pose a cancer danger to patients, and Nicholas wanted to deny a manufacturer's request to market CT scanners for colon cancer screening.

Nicholas said in 2010 that he and other scientists at FDA "were pressured to change their scientific opinion" by agency managers.

When the whistleblowers refused to change their opinions, their FDA bosses retaliated, McClanahan said. Nicholas, who worked for FDA as a contractor, was dropped by the agency. Smith left the agency last summer.

In a similar situation at FDA, McClanahan said, a biologist who disagreed with the agency over the safety of another medical device was placed on administrative leave.

In addition to suing HHS and Sebelius, McClanahan is suing the National Archives and Records Administration and its chief archivist, David Ferriero, for failing to ensure HHS properly maintains its electronic records.

NARA and Ferriero are responsible for the preservation of federal records, McClanahan said in his suit. If the archivist discovers that federal records are being destroyed, he is required by law to take steps to preserve them, he noted.

And emails are, indeed, official records, said Patrice McDermott, director of OpenTheGovernment.org, and a former Archives employee.

Legally, an email is no different from a paper letter or a memo, McDermott said. And emails that agency employees send to their bosses on matters related to government business are clearly official records, she said. It is illegal to automatically delete them, just as it would be to destroy a paper letter when it arrives at the agency in the mail, she said.

Instant messages and messages delivered via social media also are official records in certain instances, McDermott said.

"Emails can be and often are federal records," Archives spokesman Paul Wester confirmed by email. Under federal rules agencies have "very limited authority" to delete emails, but they must have no value as documents or evidence, such as holiday notices and notifications of routine meetings.

HHS spokeswoman Dori Salcido declined to comment on the suit, saying, "we can't comment on pending litigation."

Deleted and missing emails have been controversial even at the top echelons of government.

Under pressure from a 2007 lawsuit, aides to President George W. Bush searched for and finally found 14 million emails from 2003 to 2005 that the White House said were missing from its computer files. They included information about such events as the invasion of Iraq.

Bush's predecessor, Bill Clinton, experienced similar legal problems when about 100,000 emails related to controversial fundraising practices, Clinton's impeachment and other matters were discovered missing. Congressional hearings and a Justice Department investigation followed, but the matter faded from view after Clinton left the White House in early 2001.

McClanahan said he will begin filing arguments in the whistleblowers' suit later in April. A decision could take a year or more.

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