Product Liability Claims Involving Medical Devices

“Product liability” is a legal principle that holds manufacturers, designers, and sellers accountable for putting defective and/or unsafe products on the market.  When these defective devices are trusted to save people’s lives day in and day out, it becomes a grave safety concern.

Product liability is generally divided into three categories:

Design Defects occur when the original design of the product is faulty. These defects are the result of poor research, poor planning, or negligence on the part of the designer or design company involved. A defective design can mean a number of things, including failure to account for wear and tear, which causes the device to break down unexpectedly, and failure to make the device an appropriate size or weight.

Manufacturing Defects occur when the device is designed correctly but not manufactured according to the design specifications. These defects can occur at the manufacturing plant, during the shipping process, or another point in the supply chain.

Manufacturing defects are often the easiest to prove because one simply has to review the original design specifications to see that the product was manufactured incorrectly. Further, plaintiffs in a manufacturing defect case are typically not required to prove negligence on the part of the manufacturer; the court assumes that, because the product was manufactured incorrectly, negligence must have occurred somewhere within the process.

Marketing Defects occur when a device does not have the proper instructions, warnings, or recommendations for use. Manufacturers are required by law to label all medical devices with instructions for safe use and warnings against misuse (and its potential consequences). It is important to note that the inclusion of a product warning does not rule out a product liability case; if the warning is not adequate or substantial, there could still be grounds for a marketing defect claim.

Before pursuing your claim, it is important to identify the guilty party in your situation. Depending on the situation, liable parties can include a manufacturer, designer, medical sales representative, doctor, testing laboratory, medical facility, or retailer.

In order to prove a defective medical device case, you must prove that:

  1.     You were injured
  2.     The medical device was defective in one of the ways mentioned above
  3.     The defect was the proximate cause of your injury

More than 125 million Americans visit the emergency room every year, each one depending on some sort of medical device. With so many lives in their hands, manufacturers, designers, and suppliers of medical devices should be held to an extremely high standard of excellence.

Medical devices that have been subject to recent recalls include:

  • Stents
  • Implants
  • Contraceptive devices
  • Defibrillators
  • Anesthesia machines
  • Ventilators

However, this is far from a complete list of medical devices covered by product liability. The Food and Drug Administration defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar [object]…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Under this definition, everything from a doctor’s stethoscope to an expensive MRI machine can be subject to a product liability claim.