Can I Sue Over A Defective Medical Device?

Sean T. Keith
Sean T. Keith

Personal Injury Lawyer for 30+ years. Nationally recognized Top 100 Trial Lawyer. Top Car Accident Lawyer & Motor Vehicle Accident Lawyer in Arkansas.

Defective Medical Devices: Can You Sue?

Yes, there are defective medical device lawsuits that allow patients or their representatives to file liability lawsuits.

There are three classes within which medical devices are classified under the Federal Food, Drug, and Cosmetic Act.

These three (3) classes are:

  • Class I: Under this, medical devices that pose minimal danger to the user and are simplistic in design are included. Such devices include enema kits, bedpans, elastic bandages, etc.
  • Class II: Around 43% of the medical devices are under this category. Class II medical devices include wheelchairs, pregnancy kits, etc.
  • Class III: Only 10% of the medical devices fall under this category, including essential life-sustaining devices like pacemakers, breast implants, prosthetic devices, and teeth implants etc. These are usually implanted within the body form part of this class.

defective medical device
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What Defects In Medical Devices Are Liable For Compensation?

Three (3) medical device defects make the user liable to receive compensation – these are:

Design Defect

A design defect potentially cannot harm a patient but arises out of fit issues.

For instance, a defibrillator has an on/off button placed in an awkward position or when a universal knee joint isn’t fit for as many people as it was made to fit to.

Such cases are sort out on two rules, namely the ‘consumer expectations rule’ and ‘risk-utility balancing rule’.

Manufacturing Defect

Medical devices are manufactured with the help of big machines.

A manufacturing defect in a medical device can be caused because of human error, faulty components or wear and tear of machines, etc.

Such defects can sometimes be visible to the naked eye and sometimes not.

If such a defect has caused undue harm, the patient can receive a medical device product liability claim.

Marketing Defect

Once a medical device is manufactured, it includes required labels that make users aware of its dangers (if any).

As every medicine comes with a side effect warning, so do medical devices.

Failure of the manufacturer to provide rightful information to the users about its harm can result in wrongful death lawsuits.

Even the distributors and medical professionals using the device should provide sufficient knowledge to its users regarding its intended use.

Also, the manufacturers should provide proper guidelines for using the device to the doctors.

Failure to do so can even allow the doctors to sue the manufacturer for providing a lack of information.

What Parties Are Liable For A Medical Device Defect?

Many parties are involved, upon which the liability for a medical device defect can fall under different circumstances.

A few of the possible liable parties are:

Physicians/Medical Practitioners/Doctors

The burden of liability can fall over physicians, doctors, and medical practitioners when they recommend installing medical devices to help patients.

Improper installation of medical devices can blame such parties.

Also, the inability (negligence) of the doctors and physicians to provide rightful information regarding the use of the device to its patients can hold them liable for the injury.


Most of the medical device distributors must first convince the doctors of the organization to get them installed.

In certain instances, distributors, being wary of the product defects and harm, suggest surgeons and doctors get them installed and face the product defect liability.

Treatment Facilities/Hospitals

Even treatment facilities like hospitals can be liable for a defective medical product.

Medical devices like implants are highly profitable for hospitals.

They even urge patients to get them implanted even without dire need.

Hospital facilities also allow surgeons to recommend them to patients as part of professional care cooperation.

Other medical staff, like nurses, are required to be cooperative in the process.

Under such circumstances, the treatment facilities can be sued for getting defective medical devices installed on the premises.

Sometimes, mistakes happen due to the negligence of someone in the hierarchy.

The liability falls on the treatment facility when they are running treatment facilities over their capacity.

What Does A Medical Defect Product Liability Attorney Do?

To win a medical defect product liability case, the attorney must be able to:

  • Establish the consequences as a result of using a defective medical device
  • Prove that the immediate and proximate cause of the injury was due to negligence
  • List the details of the medical product liability claims in case more than one part are found negligent
  • Prove the failure of the doctor to warn the possible risks of using the medical device
  • Establish the relationship between doctor and manufacturer of receiving advantages
  • Get compensable damages caused as a result of defective medical device

That said, you can surely sue over a defective medical device.

To learn more and to get any legal assistance, contact us today.

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