Medical Devices

Thousands of patients rely on life-saving medical devices every year.  But when medical device manufacturers put profits over safety, these devices can also be deadly and cause terrible injuries.  Unfortunately for injured patients, justice may not be an option.

Many people believe medical devices are safe if they have been approved by the U.S. Food and Drug Administration (FDA).  However, FDA approval does not guarantee that these devices will not cause harm.  The FDA itself does not test medical devices before approving them for sale. Instead, they rely on medical device manufacturers to conduct the safety testing and report their findings in an honest manner. But because manufacturers stand to make billions of dollars from the sale of these devices, there can be a strong motivation to hide any potential dangers from the FDA.

The U.S. Supreme Court ruled that manufacturers of medical devices approved by the FDA’s strict review process, known as premarket approval or PMA, are shielded from accountability in court even when the devices are known to be dangerous. 

The Court’s decision gave complete immunity to manufacturers who knowingly sold dangerous devices, leaving thousands of patients injured by corporate misconduct unable to seek justice.  

To add insult to injury, patients, their insurers, and taxpayers are forced to pick up the tab for any additional treatment they may need to either remove the dangerous devices from their bodies, or heal the injuries they caused.

The bottom line is that the Supreme Court’s decision makes medical devices less safe for patients by limiting important checks and balances of the civil justice system when government systems alone do not adequately protect Americans.

 The Facts:

  • Medical device corporations were given a get-out-of-jail free card in the U.S. Supreme Court decision Riegel v. Medtronic.  [U.S. Supreme Court]
  • A report from the Government Accountability Office (GAO) stated that the FDA has failed in testing many medical devices. This study found that in a five year period, the FDA did only minimal testing before approving 228 high-risk medical devices. [Government Accountability Office]
  • In a U.S. District Court in Minnesota, 1,400 individuals with same defective heart device had their cases thrown out by the judge who cited Riegel. The judge stated that manufacturers are immune from liability lawsuits because the FDA has approved the medical device.  The court found that patients' only remedy lies “with Congress and not with this court.”  [U.S. District Court in Minnesota]
  • Medicare will pay up to $1 billion dollars in additional claims as a direct result of the damage caused by Medtronic’s defective heart device called a Sprint Fidelis lead.  And this is only ONE medical device.  [Examining the Sprint Fidelis Effect on Medicare Costs]

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