Defective Product Claims Involving Medical Devices

When a patient is injured by a defective medical device, a product liability claim may be made against the manufacturers or sellers of the device. Read on to learn more.

Some injuries that occur in the health care setting can be attributed to defective medical devices, implants, and other products. Unlike medical malpractice claims, which are made against a health care professional, product liability claims are made against the manufacturers or sellers of the products. Read on to learn more.

What is Products Liability?

Products liability (or strict liability) differs from medical negligence in that medical negligence focuses on whether the defendant’s actions were reasonable when measured against the medical standard of care, while products liability focuses on whether the product was reasonably safe or not.

Different states have different laws on products liability, but generally a product manufacturer or seller is liable under products liability law if the product contains an inherent defect that is unreasonably dangerous and that causes injury to a foreseeable user of the product.

Three Types of Products Liability

Under products liability law, a product can be defective in three different way. A product can have a design defect, a manufacturing defect, or a marketing defect.

  • design defect is when the product is simply dangerous and defective. Cigarettes and asbestos products are examples of products with design defects.
  • manufacturing defect is when the defect occurred during the manufacturing process.
  • marketing defect usually refers to a problem with the product’s instructions or advertising. One example of a marketing defect would a failure to warn the purchaser about hidden dangers in a hip implant device.

Who Can Be Sued in a Products Liability Case?

Any entity in the chain of manufacture and sale of a defective medical device can be sued. Products liability law holds not just the manufacturer of the product liable, but also the manufacturers of the product’s component parts, the wholesaler, and the retailer.

What are Medical Devices?

Medical devices are any kind of physical equipment or instrument that is used in the course of medical treatment. A thermometer is a simple medical device, while a prosthetic knee or a pacemaker would be a more complicated medical device.

Examples of Defective Medical Devices

To stay with our thermometer example, a thermometer model that always breaks in people's mouths would be an example of a product with a design defect. There is nothing wrong with the manufacturing process; it is the design that is terrible.

If, on the other hand, the manufacturer sold a million excellent thermometers, but one broke in your mouth the day that you bought it, that is probably due to a manufacturing defect.

An example of a marketing defect with a thermometer might be a baby's rectal thermometer. It is reasonable to think that a rectal thermometer should have very explicit instructions as to how far it can be inserted without causing danger to the baby. There is nothing wrong with the product per se; babies cannot use oral thermometers, but not everyone understands exactly how to use a rectal thermometer.

Regulation of Medical Devices

Medical devices are regulated by the U.S. Food and Drug Administration (FDA). The intensity of the regulation depends on the complexity, usage, and potential danger of the device. A thermometer, for example, might have rather minimal regulations, while a pacemaker is very heavily regulated.

Challenges with Medical Device Products Liability Cases

The most important element of any products liability case is the product itself. If you believe that you were injured by a medical device, you must keep the device in the same condition that it was in at the time that you were injured, if at all possible. If the device is a piece of equipment that is used externally, like a thermometer, that is a very easy task. Put the device in a drawer and don’t touch it, play with it, take it apart, or otherwise fiddle with it until you give it to your lawyer.

It is just about impossible to win a products liability case if the product disappears or is tinkered with before the lawsuit is filed. In a products liability case, the defendant has a right to have its experts inspect the product in the condition that it was at the time of the incident. If the plaintiff interferes with that right, even unintentionally, the judge may dismiss the lawsuit.

If the medical device is an internal device, the procedure is somewhat more complicated. When a surgeon removes a medical device, they do not usually give the device back to the patient. In fact, the device may be considered to be medical waste and may be disposed of almost immediately. If that occurs, there is a very good chance that you have lost the opportunity to file a products liability lawsuit with respect to the device unless the surgeon happened to take photographs of it and/or made extremely detailed records of what the problems with the device were.

If your doctors believe that you have an internal medical device that is failing, and they plan to remove it, you should make sure to speak with your doctor and surgeon well before the operation to tell them that you would like them to save the device. This situation is not too unusual, and you may find that your doctor knows exactly what you have in mind. The key is to make this request enough in advance so that the doctor and hospital can plan for saving the device. Do not make this request as the anesthesiologist is putting you under.

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