Malfunctioning Medical Devices: Malpractice or Product Liability?

Normally, when a medical device like a pacemaker malfunctions, it is a matter brought to the courts under product liability law. However, depending on the facts of the case, there can absolutely be a malpractice component to such matters. It can take a dedicated and knowledgeable attorney to be able to tell the difference between the types of cases.

A medical device is any instrument or equipment used to treat, diagnose or prevent a medical condition that does not achieve its effect via chemical interaction (in other words, not a drug). Like any device, it may sometimes malfunction, and if/when it does, it may be actionable under a theory of product liability.

There are three distinct theories of California product liability law: design defect, manufacturing defect, and failure to warn. Design defect is when the process of creating the product in question was somehow flawed, while a manufacturing defect happens when something in the external process goes wrong. Failure to warn is the cause of action that results when consumers are allegedly not properly advised of potential dangers of a product, even if the product is not misused.

While these three theories are based in common law and thus used in many states, California’s somewhat unique twist comes from the fact that product liability is a strict liability issue within the state. The case of Greenman v. Yuba Power Products (1963) established that if a manufacturer puts a product on the market, to be used in a specific way, and that product causes injury while being used in that specific manner, strict liability is appropriate.

While a medical device may be inherently defective, it still may amount to medical malpractice instead of or in addition to the claims of product liability. It may matter little if a device is defective, if no doctor elects to use it. For example, if a pacemaker is found to be defective, but a doctor in a position to know the product was defective decided to implant it anyway, it would almost certainly be the doctor who would be liable, not necessarily the manufacturer - at least from the viewpoint of the patient-plaintiff. In this example, the pacemaker would be being used in the exact method it ought to have been used - namely, being implanted into a patient. If it malfunctioned and caused injury, it would be grounds for a product liability suit against the manufacturer by the doctor, but the patient would likely not become involved.

Even if a medical device is defective, a doctor or other medical professional still must exercise the appropriate standard of care - and while the standard will vary slightly depending on the nature of the complaint and the facilities available, there is no standard under which implanting a defective medical device without due diligence is considered acceptable. California law holds doctors to the same standard of care as a similar medical professional of like age, experience and talent would observe, and if it can be shown that the doctor did not adhere to that standard, liability may soon follow.

The interplay between product liability and medical malpractice can be complex, but the crux of the matter for patients is usually that the doctor’s negligence is actionable. The zealous San Jose medical malpractice lawyers at Corsiglia, McMahon & Allard, L.L.P. have many years of practice with these cases, which can be very confusing for the average person. We are happy to answer questions and offer advice that will hopefully set you going in the right direction. Contact our office by phone or on our website to set up an appointment. We serve San Jose, the Bay Area, and the counties of Monterey, Alameda, Santa Clara, San Benito and San Mateo.