Personal Injury Law

Defective Medical Devices Protected By Regulators

Dangerous and defective medical devices pose a real and present danger to patients everyday in the Unites States. In many cases the results are debilitating injuries or death. Recently, the United States Supreme Court, at the urging of the Bush administration, provided cover to the companies that manufacture such devices.

The St. Petersburg Times newspaper has printed an editorial in which it exposes the hypocrisy of the current administration in granting federal approval to such devices thereby preempting consumer action.

The newspaper describes it as ?an old story.? A federal agency within the Bush administration is embroiled in controversy over the manipulation of science. A group of scientists and physicians within the Food and Drug Administration (FDA) has written Congress accusing top FDA officials of misconduct in the approval of medical devices. The scientists warn that unsafe or ineffective devices that were improperly approved may be threatening public safety, and the full extent of the danger may not be known for years.

In the letter to Michigan Democratic Rep. John Dingell, chairman of the House Committee on Energy and Commerce, professionals from the FDA Center for Devices and Radiological Health said that senior managers at the "ordered, intimidated and coerced FDA experts" into altering their scientific evaluations and conclusions regarding medical devices. The scientists say some within their ranks were told to use unsound evaluation methods and to make safety and effectiveness determinations that violated standards.

The scientists and physicians accuse senior administrators of overriding the judgment of trained experts to benefit manufacturers regardless of the implications for public health.

Full post as published by Georgia Injury Lawyer Blog on January 07, 2009 (boomark / email).