No Accountability

Millions of Americans trust their lives to medical devices but they may have no legal recourse if those devices fail.  When that happens, no one is held responsible.  There is no justice.

Katie M. of Cambridge, Minnesota, had a bright smile and a bright future when she died.  She was engaged to be married.  She had beaten bone cancer several years earlier.  And she was about to turn 31 years old.  

But Katie had been implanted with a medical device made by Medtronic, Inc. called the Sprint Fidelis “lead.”  It was a thin wire connected to a heart defibrillator.  

The problem is, the devices were prone to fail.  So the FDA ordered a recall of more than a quarter of a million Sprint Fidelis leads implanted in patients around the world.  

Katie was one of them.

The surgery was a disaster.  The lead fractured, causing three electrifying shocks to radiate throughout Katie’s body.  Additional errors made during the procedure quickly turned into an emergency open heart surgery.  Katie’s heart went into cardiac arrest.  Her brain was damaged by a loss of oxygen.  

Despite her promising future, Katie spent nearly eight months hospitalized until complications from the surgery ended her life.  

None of it needed to happen if the product was safe in the first place.  The FDA had given the device its “approval” before it went on the market.  And even though the very same government agency later recalled the devices because of their danger to patients, Katie’s family will never be fully compensated by Medtronic to cover almost $1,500,000 in medical bills.   Why?  Because the Supreme Court in a case known as Riegel v. Medtronic ruled that she and other victims cannot sue if a device was approved by the FDA’s premarket approval process (PMA) – even if the device is flawed, unsafe and widely recalled.  The sad part is the premarket approval process is supposed to be the FDA’s most stringent review of a medical device.  

It is a terrible miscarriage of justice, and another example of the need to Take Justice Back.