On January 25, 2012, six FDA “whistleblower” scientists filed a suit in federal court, accusing the U.S. government of illegally spying on them and using the ill-gotten evidence to retaliate against them.
The scientists say the government violated their constitutional rights and protections against reporting government corruption. And most importantly, claim the illegal spying activity will chill future federal employees from reporting official misconduct.
According the lawsuit, on January 29, 2009, the FDA “commenced a covert and secret search and seizure operation” on the “FDA 9” to intercept private communications sent by the scientists to Congressional representatives created on government issued computers, sent through government networks, or remotely connected to government networks.
Sources: FDA Complaint/RRY Publications, LLCThe electronic communications included email sent from private, third-party, non-governmental, password protected, and encrypted email accounts such as Google’s email service, “Gmail, ” or Yahoo’s email service, “Yahoo! Mail.” The information was capable of capturing private and intimate communications between private citizens.
The scientists say they had a reasonable expectation of privacy. The FDA says it had every right to monitor their employees’ government-issued computers. They say that employees are warned each time they log on that the information can be monitored.
Whistleblowers Arise: Corruption, Misconduct and Danger
But why did the FDA begin to spy on their scientists in the first place?
As far back as 2008, when the FDA was still being run by Commissioner Andrew von Eschenbach, scientists and reviewers began blowing the whistle on senior managers for clearing devices over their objections.
On November 17, 2008, the Chairman of the House Energy and Commerce Committee sent a letter to the Commissioner stating that FDA scientists had made well-documented allegations to the Committee that senior managers within CDRH (Center for Devices and Radiological Health) “ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.”
On January 7, 2009, nine FDA employees (The “FDA 9”) sent a letter to John Podesta of the Obama Transition Team. The letter raised issues of “public concern, including, corruption within the FDA device review process, managerial misconduct, dangers to public health, welfare and safety, and retaliation against whistleblowers.”
As an example the letter stated 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.”
Congress Warns FDA
The next day, The Wall Street Journal published an article about the letter and the FDA 9. That same day, according to the lawsuit, Senator Charles Grassley warned the FDA Commissioner in a letter that senior officials should assure their employees that it is both acceptable and within their rights to speak to Congress, should they feel compelled to do so.
Senator Grassley reminded the Commissioner that “FDA employees have a right to talk to Congress without interference and/or threats from the Agency [and] they have a right to talk to Congress confidentially.”
By January 23, 2009, the scientists say the FDA learned the identities of the persons who signed the Obama Transition Team letter.
Disclosure of Proprietary Information
According to the scientists, the FDA began the spying program six days later after complaints from companies that the whistleblowers were revealing confidential information to Congress and the media from their FDA submission documents.
Industry has to submit proprietary scientific, medical and technical information to FDA reviewers in order for the applications to be processed. The FDA assures people who submit applications to the FDA that those documents are safe and private.
The FDA acknowledges that it began the surveillance program to make sure no proprietary information was being leaked to anyone outside the agency. The spying program allowed agency managers to capture every key stroke on the scientists’ computers as well as save screen images on the monitors.
Source: MorgueFile and wax115 The scientists claim the agency then used information gathered during the surveillance program to retaliate against them.
The “FDA 9” and a “Short-Pant Communist”
Who are the FDA 9? What’s their beef and what Iron Curtain country did FDA leaders think they were emulating by spying on their employees, journalists, private citizens and members of Congress.
The FDA 9 include: Paul T. Hardy, Ewa M. Czerska, Robert C. Smith, Julian J. Nicholas and two others with names redacted from the Complaint. Their suit is against 12 individuals, the FDA, the U.S. Public Health Service, HHS (Department of Health and Human Services) and the U.S. of A. Some of the named individuals include Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health; William Maisel, the FDA’s top scientist; Regina Benjamin, the U.S. Surgeon General; and FDA Commissioner Margaret Hamburg and HHS Secretary Kathleen Sebelius.
Paul T. Hardy is a former officer of the U.S. Public Health Service Commissioned Corps, with a B.S. degree in biomedical engineering from Marquette University.
Ewa M. Czerska, M.D., Ph.D. is a former FDA employee. She received an M.D. following completion of medical studies in Poland in 1971, and a Ph.D. in genetics in 1978. She performed extensive research in nonionizing radiation, resulting in several publications and presentations in local and international meetings. From 2007-2009, she was president of the Bioelectromagnetics Society.
Robert C. Smith, M.D., J.D., is a former FDA employee. He received his M.D. from Yale University.
Julian J. Nicholas, M.D., Ph.D. is a former FDA employee and former federal contractor who worked for the FDA under the Oak Ridge Institute for Science and Education program. Nicholas holds an M.D. from the University College of London and a Ph.D. from Oxford University in Neurosciences.
Their lawyer is a whistleblower rock star named Stephen Kohn, chairman of the National Whistleblower Center.
While at Boston University (BU) in the ’70s, Kohn was one of the founders of the B.U. Exposure, a student-run independent newspaper dedicated to exposing the ethical irregularities of the administration of BU President John Silber. In an interview with Mike Wallace on 60 Minutes, Silber denounced the B.U. Exposure staff as “short-pants communists.”
Accusations
The FDA 9 is accusing the FDA of:
Taking and converting private emails without due process or just compensation in violation of the Fifth Amendment of the Constitution
Initiating searches and seizures in violation of the First and Fourth Amendments
Violating the First Amendment by chilling free speech with searches and seizures
Violating the First Amendment by chilling Plaintiffs’ and the public’s right to associate with whistleblowers
Violating Plaintiffs’ right to representation
Chilling Plaintiffs’ protected First Amendment right to free speech
Whistleblowing Round 2
The scientists weren’t done blowing their whistles in 2008.
Another round began in March 2009 when Nicholas began reviewing a CT colonography device for FDA clearance. General Electric, the device manufacturer, wanted to use the device for population screening. Nicholas concluded that the device was neither safe nor effective for that purpose.
In spite of his objection, the FDA indicated on April 13, 2009, that they would clear the device anyway.
According the FDA 9 lawsuit, “Within the FDA, a Branch Chief, two Deputy Division Directors, a Division Director, and four to five scientists in the Office of Science and Engineering Laboratories all opposed the approval in writing, emails, or at internal meetings.”
They also claim that two to three staff members had complained in emails about Dr. Tillman’s [Donna-Bea Tillman, the FDA’s top device reviewer at the time] mismanagement.
Nicholas asked Smith to independently review the submission the following month. Smith concluded on May 29 that the device posed a serious public health risk. He also sent an email to Dr. Joshua Sharfstein, then Principal Deputy Commissioner at FDA, blowing the whistle on FDA managers regarding the review of the GE device.
Off to Congress, Confronting Shuren
Smith then sent an email on June 11, 2009 to the House Energy and Commerce Committee regarding his and Nicholas’ concerns surrounding the device. By September the whistleblowers, including Nicholas and Smith, met with members of the House Committee.
On September 28, 2009, Nicholas participated in a joint email to Jeff Shuren with the subject line “Accountability, Transparency, and Enforcement at CDRH.” The email outlined the group’s concerns about dangers to the public health, safety and welfare. Specifically, Nicholas and Smith explained to Shuren how they tried to prevent the approval of the CT colonography devices.
Three days later, Nicholas sent Shuren another email describing his concerns over his management’s misconduct and fears that he may be retaliated against. On October 6, Congressman Chris Van Hollen informed Commissioner Hamburg that he was “deeply concerned” that Nicholas faced termination as a consequence of bringing forward major concerns.
Terminations
On October 31, 2009, the FDA let Dr. Nicholas’ employment contract expire. On July 31, 2010, the FDA did not renew Smith’s employment contract. Almost two years later, Hardy was informed by the Public Health Service on September 9, 2011 that his commission would be terminated on October 9, 2011.
Various federal agencies considered requests from the FDA and the FDA 9 to charge the other with crimes or misdeeds. Nothing was settled. So now we go to federal court.
Device companies should be paying close attention to how their proprietary information is handled. You don’t want to find out that your scientific data was found in Maxwell Smart’s shoe.
