Can I File an Injury Lawsuit Over a Medical Device?

Lawsuits for injury caused by defective medical devices hinge on the legal concept of "product liability."

Updated by , J.D. · University of San Francisco School of Law

Many patients rely on a variety of medical devices (from hernia mesh to pacemakers and CPAP machines) in order to maintain their health and improve their lives. In most instances, use of these devices brings only positive results. But when a medical device fails or doesn't perform the way it should, the patient can suffer serious harm, and a "product liability" lawsuit might be in order.

What Are Medical Devices?

The term "medical device" refers to just about any implant, device, monitor, or machine used by medical practitioners to treat a disease, illness, injury, or disability. Examples include:

  • defibrillators (small electronic devices implanted in the patient's chest that deliver electric shocks to maintain normal heart rhythm)
  • stents (tubes, sometimes drug-coated, inserted into an artery to prevent blockage)
  • implants (synthetic devices implanted to restore function to the patient's disabled body part, such as a hip or shoulder)
  • hernia mesh
  • inferior vena cava filters
  • CPAP machines and ventilators, and
  • contraceptive devices.

Product Liability Claims Involving Medical Devices

A personal injury lawsuit over a dangerous or defective medical device is typically brought under a fault theory known as "product liability." And these kinds of claims typically come in three varieties:

  • defectively manufactured medical devices
  • medical devices with a defective design (even though properly manufactured), or
  • defectively marketed medical devices.

Defectively-Manufactured Medical Devices

These are devices that were improperly manufactured or otherwise damaged before reaching the patient, through a manufacturing error, a shipping problem, or damage that occurs at the hospital or doctor's office.

In other words, the defect can occur at any point between the factory and the place you received the medical device.

Defectively-Designed Medical Devices

These are medical devices that were properly manufactured but have an unreasonably dangerous design that results in injury.

Sometimes, a medical device will have been on the market for a long time before causing serious injuries, typically because the device breaks down in some way over time. In some cases, the plaintiffs may claim that the manufacturer knew of the danger but deliberately concealed it or delayed taking the product off the market.

Defectively-Marketed Medical Devices

The "marketing" of a medical device refers to any recommendation, warning (or lack of a warning), or instruction concerning the use of that medical device.

This category of claims involves:

  • failure to provide adequate or accurate warnings regarding the danger posed by the medical device, and
  • failure to provide adequate instructions regarding its safe and appropriate use.

The "bad advice" may have been given by the manufacturer or by a doctor, hospital, sales rep, or other medical provider. Or the "defective" marketing may involve sophisticated sales pitches targeting the medical profession, meaning the patient may never have seen the ad.

Learn more about types of defective product liability claims.

Who Can Be Sued for a Defective Medical Device?

Defendants in a product liability case can include almost any person or entity involved in the "chain of distribution" of a medical device—that is, the path the medical device took from the manufacturer to the patient. Learn more about who can be sued in a product liability case.

Manufacturer. Because of the huge market for medical devices and the technical challenges involved in developing new medical equipment, device manufacturers are typically large companies. This is generally good news if you're seeking compensation for your injuries, although it is also true that these companies inevitably retain teams of high-priced lawyers to defend such cases.

Doctor. The doctors who recommended the medical device may be liable based on their failure to warn you about potential dangers or to provide adequate instructions regarding the proper use of the medical device. (More about potential liability of doctors and other care providers in the next section.)

Hospital or clinic. Any company, including a hospital or a clinic, that was part of the chain of distribution between the manufacturer of the medical device and you may be liable for your injuries.

Retail Supplier. Although most medical devices are delivered to the patient directly by a doctor or a hospital, if you obtained the medical device that injured you from a pharmacy, drug store, or other retail supplier, that retailer is the final point in the chain of distribution of the medical device from the manufacturer to you and may also be liable.

Defective Device or Medical Malpractice?

When a medical device fails, it's not usually obvious what went wrong. Did the device not perform as intended, or did the surgeon or another health care provider make a mistake? For example, when implanted hernia mesh fails and a patient is harmed, the problem could lie with a defect in the device itself (giving rise to a product liability lawsuit) or in the way the surgeon implanted it in the patient (which could mean medical malpractice).

Next Steps

If you've been harmed by a medical device, it's never a good idea to try taking legal action against the manufacturer (or any other potential defendant) on your own. The legal complexity of these cases—including the need to bolster your position with qualified expert witnesses—make it crucial to have an experienced legal professional on your side. Learn how to find the right personal injury attorney for you and your case.

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