Product News and Recalls

Lawsuit: FDA whistle-blowers faced retaliation

A group of six doctors and scientists who worked for the U.S. Food and Drug Administration have sued the agency, claiming their personal e-mail was monitored after they warned Congress that the FDA was approving faulty medical devices, The Washington Post has reported.

All of the doctors and scientists who filed suit in federal court had worked in the office responsible for reviewing medical devices. They claim information gathered from the surveillance was used to harass and dismiss them, and their constitutional privacy rights were violated.

The scientists and doctors claim they first made internal complaints beginning in 2007 that the FDA had approved or was about to approve at least a dozen devices of unproven effectiveness that could jeopardize millions of patients. They also brought their concerns to Congress, the White House and the Department of Health and Human Services inspector general.

The Washington Post report mentions that the plaintiffs were by no means the only ones to raise concerns about the process by which the FDA approves medical devices.

Congress’ auditing arm, the Government Accountability Office, warned in 2009 and 2011 that risky medical devices win approval through a lax approval process. And last year, the Institute of Medicine published a study concluding that the FDA needed to overhaul its approval process.

Of particular concern is a FDA policy that allows devices to be approved without testing in humans, because of their alleged similarity to other devices already on the market.

Thousands of people have filed lawsuits over two devices allowed on the market as a result of that policy.

Transvaginal mesh, used to treat urinary incontinence and pelvic organ prolapse, has generated widespread complaints of health problems for patients including perforated organs and debilitating pain. And a type of metal-on-metal hip implant manufactured by DePuy Orthopaedics was recalled over its high early failure rate, and complaints of metal particles breaking off and getting into patients’ soft tissues.

See the whistle-blower report here: