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Cardiologist Warns of Lax FDA Regulations for New Implanted Defibrillator — St. Louis Defective Medical Device Lawyer

By December 19, 2008March 14th, 2022Defective Medical Device litigation

The Minneapolis Star-Tribune reported that a doctor from the Minneapolis Heart Institute Foundation expressed grave doubts this week about the safety standards for a new breed of defibrillators. In the Dec. 11 edition of the New England Journal of Medicine, Dr. Robert Hauser (writing with Dr. Adrian Almquist of the Heart Institute) warned that FDA regulations for the medical devices must be strict — or patients could suffer lethal consequences.
The defibrillators at issue are an improved version of existing implanted defibrillators (ICDs), which are implanted directly into patents’ chests. The devices work by monitoring patients’ heartbeats and sending electric shocks to the heart if they detect missing or irregular heartbeats. Unfortunately, some existing models of ICDs had to be recalled after a lead — the wire that leads from the device to the patient’s heart — turned out to be likely to break. This has caused at least five deaths and sent other patients to emergency rooms with uncontrolled and random electric shocks.
Dr. Hauser was among the first to blow the whistle on past ICDs; he and a colleague went public with concerns in 2005 after a patient died due to a defective implanted defibrillator. His current concern, according to the Star-Tribune, stems from the fact that new devices can be approved by the FDA with little testing or review if they’re similar to existing devices. He writes that the new design, which features more leads attached to the patient’s heart, is different enough to require new studies before the FDA can safely approve it. A representative from the FDA wrote that no final decision has been made.
A representative from the medical device industry also told the newspaper that the manufacturers themselves test the devices thoroughly before they reach market. Unfortunately, this is cold comfort for victims of defective medical devices and unsafe prescription drugs. As a Missouri medical device defect lawyer, I have seen many situations in which pharmaceutical companies know all about problems with a device or medication, but intentionally do not disclose them to the public in an effort to keep profits high.
When this irresponsible behavior kills or seriously hurts patients, victims and their families have the right to sue the manufacturer over their physical, financial and emotional injuries. My law firm represents victims of several defective medical devices, including the defective Guidant defibrillator Dr. Hauser warned of in 2005. If you believe you’ve been hurt by a defective implanted defibrillator and you’d like to learn more about defending your rights, please contact the Lowe Law Firm for a free initial consultation.