Who is Liable For Defective 3D Printed Medical Devices?

3D printing is revolutionizing the medical industry and offering new ways to treat patients. It also is raising new questions about who is liable if one of these devices injures a patient. When doctors are able to custom design and print devices, these cases can toe the line between medical malpractice and product liability cases.

The Design & Production Process

When a patient needs a 3D printed device custom made for then, someone will have to design an appropriate device for their needs. Often, the prescribing doctor will be involved in the design process, but there may also be design specialists and other technicians involved in the creation of a device.

Many hospitals are employing 3D printers to perform their own in-house printing jobs, allowing them to get devices faster than they would if they were ordered from a manufacturer. However, hospitals don’t have the same strict federal regulations on them that medical device manufacturers do. This creates a legal grey area for who is liable for injuries caused by these devices, and even what type of case it is.

The law is still catching up to technology and is trying to determine just who is responsible for a custom printed medical device. Several questions should be addressed when assessing liability, and the law hasn’t quite done so. These questions include:

  • Will there be patient contact for these devices?
  • Will the 3D printed product be sold?
  • Is there a skilled intermediary to handle the design and production of the product?
  • How cutting-edge is this technology?
  • Is this technology in the public’s hands already?

The Use of 3D Printing in the Medical Field

Liability can rely heavily on the exact use of 3D printing. This method can be used to create prototypes rapidly so that the finished design can be completed by a manufacturer. When used for the rough draft of a finished device, 3D printed devices will actually have very little contact with a patient, and the risk is minimal.

When these devices are used directly to treat patients, however, the risk can become far more significant. It is critical that medical devices meet control procedures and have been appropriately tested for safety. If the CAD file that instructs the printer is wrong, or the printer isn’t properly working, to the design is simply poor, patients can pay the price. With so many involved in the process, it can be difficult to pin blame on any one party.

3D printed medical devices has no one-size-fits-all solution from a legal standpoint. Each case needs to be handled individually. As courts and lawmakers work to find adequate solutions to the potential dangers of this new technology, injured patients can be left in limbo, waiting to learn who may be responsible for their suffering and injuries.

At The Gilbert Law Group, P.C., our experienced team is ready to fight for you. We have the experience and knowledge to advocate for you, no matter how complex your case may get. Our compassionate Denver product liability attorneys can help you recover the compensation you are owed. Don’t hesitate to get the help you need to protect your rights as an injured patient.

Contact our team today to learn more. Call (888) 711-5947 to schedule a free consultation.


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