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The Supreme Court gave the manufacturer immunity for their responsibility for Avery’s injuries just because the FDA approved the medical device.
Avery was born with a hereditary heart defect that put her at risk for arrhythmia. When she was only two years old, her doctor recommended she have a defibrillator implanted in her chest. A year later she was playing when her implanted defibrillator began unnecessarily shocking her. Terrified and unsure what was happening, Avery screamed that monsters were attacking her. When Avery’s mother picked her up she felt electric shocks jolt through her daughter’s body.
Avery had Medtronic’s Sprint Fidelis defibrillator wire that was prone to fracture, causing unnecessary electrical shocks. The wire was later recalled, but not before injuring thousands of people. However, because the Medtronic product was approved by the FDA’s pre-market approval process, the PMA process, the company has immunity from any lawsuits. The Supreme Court decided in Riegel v. Medtronic that any medical device approved by the FDA’s most stringent approval process (PMA) cannot be sued for the injuries caused by the defective product. Even when the product has been recalled or kills or injures someone. There is no justice as Avery’s parents are stuck paying for most all of Avery’s hospital bills to replace the bad product.
See more about Avery’s story from her local NBC TV station.