Eight U.S. Food and Drug Administration (FDA) scientists have accused top FDA officials of serious misconduct in their approval of medical devices that the scientists say are unsafe or ineffective.

Dissention amongst the ranks

It's no secret that the FDA has seen better days. Although it is supposed to protect Americans against harmful foods, drugs and medical devices, consumer advocate groups say that the FDA has fallen short of its goals. If the FDA wasn't overly concerned about that in the past, it should be now.

Eight of the FDA's own scientists from the Center for Devices and Radiological Health sent a letter to FDA Commissioner Andrew C. von Eschenbach saying that their concerns about drug and medical device approvals have not only gone unheard, but that they were threatened with adverse employment actions if they did not modify and obscure scientific data.

The FDA's assistant commissioner for integrity and accountability, William McConagha, investigated the matter and found that the scientists' claims were "sufficient to justify … disciplinary actions." The Congressional House Committee on Energy and Commerce will now investigate matter, but representatives John Dingell and Bart Stupak, both Michigan democrats, have said that they are "deeply concerned" about the allegations.

Consumers lose

Whether or not the scientists' allegations are true, it's safe to say that consumers lose when drugs and medical devices are approved without the benefit of adequate scientific data obtained from clinical trials. In fact, the FDA bases much of its decision on whether to approve a drug on the clinical trials conducted by the manufacturer itself. Although it will sometimes require manufacturers to conduct additional testing before being approved, the FDA's scientists seem to be saying that drugs and medical devices are often approved without knowing their long term affects on users.

If you've been injured due to a defective drug or medical device, contact an experienced drug litigation attorney to discuss your situation and determine what options you might have. Consultations are free, without obligation and are strictly confidential.