Restore Your Right to Hold Medical Device Manufacturers Accountable

Safety First: Support the Medical Device Safety Act

In 2008, a young mother from Pennsylvania named Bridget Robb was woken up by a series of agonizing shocks to her heart. The defibrillator in her chest was misfiring. Bridget was shocked 31 times in just 13 minutes.

Bridget underwent two expensive surgeries to fix the defibrillator and stop the misfirings. It turns out the device had been recalled for 'faulty wiring' by the manufacturer two months earlier - but nobody had bothered to tell her.

Bridget was shocked once again when she learned that a Supreme Court ruling stripped her of the right to take the manufacturer to courtr for damages, or even to recover compensation for her surgeries.

Medical device manufacturers think they do not have to be responsible for repeated device failures simply because their device has been approved by the Food and Drug Administration.

The Medical Device Safety Act would correct the flawed Supreme Court decision that is allowing manufacturers to hide behind FDA approval in order to avoid accountability for their own medical devices. The FDA approval process is flawed. Manufacturers who produce implanted defibrillators, heart pumps, hip and knee replacements, and other devices should be making safe, risk-free products - not hiding behind the FDA as a shield for accountability.

Let's tell Congress that the responsibility for making safe medical devices should remain with the device maker. The Medical Device Safety Act (S. 540) will restore injured patients' rights to seek to hold manufacturers accountable.

January 16, 2019


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