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FDA Reviewing Drug Labeling Charges

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

The FDA hasn’t bothered to confirm or deny these reports.

Just 2 weeks ago, the Government Accountability Office (GAO) released a report of federal agencies that were in need of major improvement. The FDA was included in the list, and part of the reason was its sloppy approval procedures for medical devices that have resulted in unsafe and defective devices being rushed into the market. The GAO’s findings correspond with the claims made by the CDRH scientists, and should be enough reason to us to worry about any preemption doctrine that would snatch away a consumer’s rights in case he suffers an injury from a defective device approved by the FDA. The entire premise of preemption is based on the logic that the FDA can be trusted to guarantee the safety of the devices it approves. However, as we are beginning to see in the increasing numbers of defective drugs and devices being released into the market, as well as evidence from the agency’s own scientists that the approval processes are being several compromised, the FDA stamp of quality is hardly something we can rely on.

Taking away a patient’s right to hold a company responsible for injuries caused by its defective product would finish off the last hope that consumers have for safety and reliability in the medical devices they use. The FDA fails the American consumer far too often – let’s hope the Supreme Court doesn’t.