Medical Device Safety Act Protects Patients
Let’s imagine your doctor has diagnosed a serious heart condition that requires a defibrillator to prevent a fatal arrhythmia.
Imagine then, the horror when this life-saving device malfunctions and instead of helping save your life, sends multiple dangerous, life-threatening shocks to your heart and throughout your body. Now your health has been seriously compromised and you face more medical bills due to hospital stays and medications to monitor and repair the damage caused by this malfunctioning medical device.
Imagine that this medical device that was approved by the Food and Drug Administration (FDA) was known by the manufacturer to have problems. In fact there was a recall issued on this supposedly life saving medical device just weeks before this horrific incident.
This is the really story of Bridget Robb and many others like her. Ms. Robb, a single mother, recently testified before the US House Energy and Commerce’s Subcommittee on Health in support on the Medial Device Safety Act (MDSA).
Last year, the Supreme Court ruled in Riegal vs. Medtronic that medical devices approved through the Food and Drug Administration are immune from lawsuits filed at the state level. Typically, states laws are stricter in their degree of accountability for the manufacture of medical devices and prescription drugs. What the Supreme Court ruling means for patients’ is, that if you are injured or a loved one suffers a fatality from a defective medical device, the manufacturer can not be held liable for the malfunction of their device.
In the case of Bridget Robb, Medtronic knew of the malfunction problems with the leads in their defibrillators. According to Heart Rhythm, the Official Journal of the Hearth Rhythm Society, Medtronic recalled the lead in their defibrillator in 2007, only after there were 665 failures and five reported deaths.
In addition, the Journal reports that in a study of 3,037 cardioverter-defibrillator leads, 72 (8.5 percent) of 848 Sprint Fidelis leads failed, while only 94 of all 3,037 defibrillator leads studied failed. According to the Journal article, “the cumulative hazard of Sprint Fidelis failure was significantly greater compared to 2,189 other defibrillator leads.”
In a 2008 landmark case, the Supreme Court ruled in Wyeth vs. Levine that drug companies will be held accountable for content on the labels of their prescription drugs. The Medical Device Safety Act (MDSA) would restore this same protection to patients who need medical devices.
We’d all agree, Ms. Robb included, that medical devices save lives. The Medical Device Safety Act would protect patients’ rights by forcing the manufacturers of these medical devices to put consumer protection over profit by holding these manufactures accountable for their defective products.
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