Product Liability Claims Involving Medical Devices

Republished with Permission © 2009 Nolo.

Learn about defective product claims involving medical devices such as defibrillators, stents, implants, and contraceptive devices.

Many people have used a medical device (such as a defibrillator) in order to better their health, only to suffer injuries from that same device. Sometimes, these injuries can form the basis for a product liability claim.

The term "medical device" refers to just about any device used by medical practitioners to treat a disease, illness, injury, or disability. Some examples of medical devices that have run into medical and legal problems in recent years include:

- defibrillators (small electronic devices implanted in the patient's heart 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), and 

- contraceptive devices.     

Here are some of the special features of product liability claims arising from defective medical devices. Types of Defective Product Claims Involving Medical Devices All defective product liability claims come in three varieties. Product liability claims resulting from defective medical devices are based on one of the following:    

- 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. A defectively manufactured medical device can be created as a result of an error at the manufacturing facility, a shipping problem, or an error 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.

Medical devices with a defective design. These are medical devices that were properly manufactured but have an unreasonably dangerous design that result 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. In some cases, the victims may claim that the manufacturer knew of the danger but deliberately concealed it or delayed taking the product off the market. If the victims can prove this, they may get more money in the form of punitive damages .

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 by a potential defendant . This category of claims involves anything from a failure to provide adequate or accurate warnings regarding the danger posed by the medical device to a 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 -- you may never have seen the ad.

The Potential Defendants in Your Case

Make sure you include all potential defendants in your claim. Consider every 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 consumer. 

Manufacturer. Because of the huge market for medical devices and the technical challenges involved in developing new medical equipment, the manufacturer is typically a large company. 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.

Testing laboratory.  Include any testing laboratories that performed tests on the medical device, especially if they are independent of the manufacturer.

Medical sales representative. Medical device manufacturers often make use of "sales reps," who meet with doctors and other members of the medical community to tout the latest medical device and make recommendations regarding its potential applications. These representatives may be liable if they recommended the medical device that injured you.

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.

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.

Is It Products Liability or Medical Malpractice?

In any case in which you are suing a doctor or a hospital in connection with an injury caused by a medical device, you may also have a claim for medical malpractice . The legal basis for a medical malpractice claim is somewhat different from a defective product claim. 

Fortunately, you don't have to choose. As long as they have a reasonable legal basis, you should include every available type of legal claim in your complaint.

Proving Your Claim You will have to prove three things in order to win your lawsuit:     you were injuredthe medical device was defectively designed or manufactured or defectively "marketed" (as discussed above), andthe defect or improper marketing was the cause of your injury.  In medical device cases, the outcome usually revolves around the second and third issues.  How Long Do I Have To File My Lawsuit?

Every state sets certain time limits, called the "statute of limitations," on bringing product liability claims. Be sure to find out the statute of limitation in the state where you are bringing your claim.

Class Action Lawsuits

If others have been injured by the same medical device you used, you may be able to file a class action lawsuit. Sometimes, a class action has already been filed and you may be able to join in the lawsuit. Joining an existing class action has several advantages:

the lawyers for the class, who may have considerable experience and expertise in bringing big cases against big companies, will become your lawyers as wellthere will likely be little or no upfront cost to you, andyou will not have to sort out potentially complex legal issues, such as where to file your claim.

You may also bring your own lawsuit instead of joining the class action. This may be appropriate if your injuries are substantially different from those of the other people in the class action, or if there are special circumstances in your case.

Consider consulting with a lawyer to find out if there is an existing class action concerning the medical device that injured you, and if so, whether it is advisable for you to join. Such initial consultations are usually free of charge. You may also contact the lawyers for the class action directly -- they will most likely be interested in talking with you.