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Rockford & Moline, Illinois

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Nick Avgerinos
Nick Avgerinos
Contributor •

Faceless Foibles: Who’s To Blame For Medical Device Mishaps?

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A lot of people see the legal arena as a battlefield. The goal? The attach blame to the enemy faction and extract compensation. But behind those battle lines, there are people. Mistakes have been made and everyone just wants to move on. What makes matters trickier is when there is no one to blame. No, I’m not talking about those rare “Act of God” cases; rather, I’m referring to medical devices gone wrong. Here are some common problems:

  • Prescription drugs
  • Heart valves and pacemakers
  • Implantable contraceptives and intrauterine devices
  • Prostheses
  • Latex gloves
  • Silicone implants
  • Surgical and physical therapy equipment
  • Respiratory devices
  • Contact lenses and dental care products
  • Laser and orthopedic tools

You assume that just because you’re treated at a well-respected hospital by a well-trained doctor, you’ll be safe. Unfortunately, that’s not the case. Sometimes it’s not about human error. Instead, machines are to blame. And that makes your situation more difficult all around. There’s “no one” to blame, no face to attach to your pain. So what now? Do you have a personal injury claim? Are you the victim of medical malpractice? Well, it depends.

Of particular interest to patients is the recent Supreme Court decision of Riegel v. Medtronic, Inc. As Injury Board member Dan Firth discussed in May, this case involved the bursting of a balloon catheter, manufactured by Medtronic, during angioplasty surgery. The result: Medtronic was not held liable. The suit was dismissed on grounds that the malfunctioning device had pre-market FDA approval and, thus, was barred by the Food, Drug, and Cosmetic Act.

The Court reasoned that the FDA has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use. Thus, they should take the blame for the mistake. And while that may make legal sense to some, it doesn’t make much common sense to most. Why? The FDA approves devices for sale, but it does not guarantee that a particular product is safe. Seems like a game of hot potato, passing the buck as to who’s to blame.

So, where does that leave you? We don’t know yet. The legal landscape is still growing up around this fresh decision. But there’s little question that patients deserve more protection. Keep up-to-date on the latest recalls and always question your care. Until someone is forced to take responsibility for these faceless foibles, you’ll have to be extra aware of choices affecting your health.