FDA Medtronic Recall Updates | Medtronics Lawsuit News

Following the latest court decision involving preemption in the Medtronics lawsuit for the recalled Sprint Fidelis leads it is interesting to see the increasing number of reports regarding the inner-workings at the Food and Drug Administration. According to a recent New York Times article, nine government scientists complained to the FDA commissioner regarding FDA managers and their lenient relationship with corporations seeking approval for medical devices.

Internal documents and medical reviews reveal that the agency scientists were critical of the medical device approval process that they felt lacked adequate testing of medical devices. In one specific example, the scientists alleged that an agency supervisor pressured them to change reviews of a breast imaging device among others. The increasing information regarding the inability of the FDA to adequately evaluate medical devices such as the recalled Medtronic Sprint Fidelis leads and drugs is especially disturbing considering that the medical device and pharmaceutical industry has been using the FDA approval process as a shield from any liability for products that turn out to be dangerous.

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronics leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Sprint Fidelis leads recall was due to the potential for lead fractures. After reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

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