FDA Whistleblower Case Moving Ahead

//FDA Whistleblower Case Moving Ahead

FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration.

Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were victims of surreptitious surveillance and a violation of their rights to privacy.

MDND Background story is  here and here.

Judge James Boasberg found about 1,500 documents, which the NWC had sought from the FDA, were properly withheld or redacted because they did not contain information on “government impropriety.”

The NWC had been fighting to obtain the documents, but the FDA argued they might contain trade secrets of the companies they monitor.

The Freedom of Information Act (FOIA) allows documents to be withheld when they contain company trade secrets, any attorney-client privileged information, and personal information that could be considered a violation of privacy. These types of documents can be withheld, but only if there is no evidence of government wrongdoing.

Boasberg wrote the documents “Do not approach the level of misconduct contemplated by these cases with respect to either improper approval of medical devices or retaliation against FDA employees.”

The employees, who were in the medical devices division, wrote to Rep. John Dingell in an October 14, 2008 letter (these are excerpts) :

“The U.S. Food and Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.

“Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).

“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.

“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.”

Meanwhile the case, now in its 14th month continues. NWC had obtained thousands of documents related to the case and the Department of Justice, on behalf of the FDA, has filed a motion to dismiss the case which will be heard in December.

The case is filed as Hardy et al v. Shuren et al here.

Here is the letter October 14, 2008 by 11 whistleblowers to Rep. John Dingell concerning mismanagement at the FDA’s CDRH. It’s a pretty interesting read.

By | 2012-11-13T22:43:22+00:00 November 13th, 2012|FDA News|1 Comment

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

One Comment

  1. All Meshed Up September 3, 2013 at 2:18 pm - Reply

    Although I am glad that The TVT/Gyno/Vaginal Meshs are finally getting the attention needed, as a Hernia Mesh recipient x2 I would like to think that there is no difference between us as Mesh Victims. But as a Hernia Mesh Victim I cannot get an attorney to listen to me or take my case. I am almost disabled but because it is a “Hernia” the Social Security won’t even consider me. I hear the Lawyer advertisements talking about the pain and suffering of women because of TVT and I have the same exact symptoms but no chance of a Lawsuit. My life as I knew it is gone but no one gives a damn about a guy with a Hernia Mesh. We are ALL VICTIMS OF MESH! But we are not equal in the eyes of the court or public opinion. We as Hernia Mesh Victims have been left behind and forgotten. How long will it take for the TVT Victims to be in the same boat? We can count the successful lawsuits against the Mesh Manufacturers on one hand but there are tens of thousands of us out here with no recourse or a chance at some compensation for what has been done to us. I will never be same after the Prolene went bad, was removed and then replaced by a Kugel patch with the ring. I have sent report after report to the FDA and their Criminal Investigative Unit about these products. I have received the obligatory letter from them Thanking me for my report and assuring me that with 2 or 3 more solid reports they will issue an advisory. I am still waiting for them to issue that advisory after the several thousand reports they have. But I doubt that it will happen because there is too much money involved and we as Guinea Pigs do not count one iota.

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