FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

January 30, 2012 ~ What’s going on inside the FDA?

Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market. You may recall as President Obama was taking office on January 7, 2009, nine scientists alerted him to the internal problems, accusing the agency of acting illegally by approving flawed and defective medical devices for sale even when others within the FDA objected because of safety issues. One medical device cited as problematic was the computer-aided breast mammograms, “the FDA approved the devices anyway in a flawed process that ignored the science. This had led to significant harm to large numbers of women and significant unnecessary costs to the public.”

After that the staffers said the FDA spied on their private emails, harassed them and in some cases fired the whistleblowers. Internally the group was known as the “FDA Nine”.

The federal lawsuit filed in the District of Columbia charges the agency with 12 counts and names FDA chief Margaret Hamburg, M.D., Jeffrey Shuren, M.D., William Maisel, M.D., and HHS chief Kathleen Sebelius accusing them of retaliation, among other things:

"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."

Mass Device reports there is a question whether or not the government can surveil any private email activity if it is carried out on government-issued computers.

The complaint says that the plaintiffs, “had a reasonable expectation of privacy in their private, password protected, non-Governmental, encrypted email communications when these communications were sent from or received on computers or networks that the FDA had explicitly stated could be utilized for personal communications.”

The complaint points out that private email accounts were also used for personal banking, attorney-client privileged communications and other sensitive personal issues.

Whistleblowers Warned the President

As President Obama took office, the whistleblowers said that several staff scientists and managers should be held accountable for wrongdoing for allowing unsafe devices on the market.

They also wrote to Rep. John Dingell in October 2008. MDND has a copy of that letter (here) which says:

“There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices…… Managers at CDRH with no scientific or medical ex~_ devices, or any clinical experience in the practice of medicine.__, have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements. To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law. Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects."

And more

“At the same time, there is a need for new legislation that modernizes the regulatory structure of the 510(k) program so that complex medical devices are not allowed onto the market without a comprehensive (or in some cases, any) clinical evaluation of their safety and effectiveness. This is especially true for _ devices due to their markedly increased use in clinical practice and because" devices employ highly complex hardware and software, undergo rapid technological changes and touch the lives of so many patients on a daily basis. The current framework for medical device adverse event reporting does not work for many _ devices as the adverse effects of devices are rarely detected immediately, are not transparent on an individual patient basis, and can only be prevented by a rigorous pre-market evaluation process.”

Staffers of Sen. Charles Grassley (R-Iowa) reportedly warned the FDA against retaliating, but the Washington Post reports the FDA asked the HHS to investigate the whistleblowers for the disclosure of confidential manufacturer information. The Inspector General’s office failed to get involved.

Kohn, Kohn and Colapinto represent the whistleblowers on behalf of the National Whistleblowers Center, (here) which has the complete set of documents including the complaint (here) filed by the law firm:

Here is Washington Post on their set of documents including the original letter to President Obama.