How Do I Know If a Medical Device is Defective or Harmful?

Establishing liability for an injury lawsuit in Washington state

Each year, many Washington State residents suffer serious injuries due to dangerous or defective medical devices. When this happens, the injured person can seek damages against the manufacturer of the product. The Washington Product Liability Act (WPLA) establishes the legal requirements for bringing and proving such claims.

Types of Strict Liability

Under the WPLA, there are three broad categories of product liability: defective manufacture or construction, defective design, and failure to warn. These are all considered “strict liability” standards in Washington. This means that as the person bringing a lawsuit, you do not have to show the manufacturer of a medical device was negligent or acted with malicious intent, only that their actions caused your injury.

With that in mind, here is a brief rundown of each type of product liability cause of action and what it entails:

Defective Manufacture or Construction – The manufacturer of a medical device must ensure that all of its products leave the factory in “reasonably safe” condition in construction, meaning the product deviated in some material way from the design specifications or performance standards of the manufacturer, or deviated in some material way from otherwise identical units of the same product line when the product left the control of the manufacturer.

“In other words, it’s not a design defect,” says Seattle product liability attorney James Rogers. While most products may work as intended, one may come off the manufacturing line with some sort of defect. “And it has to be a material way that affects the product,” Rogers adds.

Defective Design – When hundreds–or even thousands–of patients report similar injuries from the same medical device, that is usually a sign that there is a defect in the design of the product itself. “The test overall is whether the likelihood of a medical product or any product causing the claimants harm and the seriousness of the harm outweighs the burden on the manufacturer to design a medical product or a product that would have prevented the harm,” Rogers says, "and the adverse effect that an alternative design that was practical and feasible would have on the usefulness of the product."

Under the WPLA, a manufacturer's design is not considered “reasonably safe” if it fails to meet either of the following tests:

  • The “risk/utility” test. If you can show that the design of a medical product was likely to cause your injury and outweighed the burden on the manufacturer to design a product that would have prevented the injury, and there was an alternative design that would have prevented said injury, the manufacturer can be held liable.
  • The “consumer expectation” test. Even when no alternative design was available, the manufacturer can also be held liable for defective design if the victim can show the product is found by the trier of fact to be unsafe to an extent beyond that which would be contemplated by the ordinary consumer.

Failure to Warn – A medical device may also be considered unsafe under the WPLA if it does not contain adequate warnings or instructions about the potential risk of injury to patients provided with the product, and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.

Similar to defective design, a patient can prove injury either by showing there were alternative warnings or instructions that could have been provided at the time of manufacture, or the product was “unsafe to an extent beyond that which would be contemplated by an ordinary consumer,” according to the WPLA.

One Negligence Standard in the WPLA

In Washington, there is only one type of situation where a manufacturer can be held to a negligence standard as opposed to a strict liability standard in the WPLA. “If after the product’s manufacturedit’s on the market—the manufacturer learns that there’s a danger with the product that's causing injuries, the manufacturer must provide adequate warnings or instructions,” Rogers explains. “This duty is satisfied if the manufacturer exercises reasonable care to inform product users—a negligence standard." 

What to Do if You Have a Case

If you believe your medical device or product caused you injury, there are a few things you need to do. First is to talk to an experienced product liability lawyer to see if there are any lawsuits involving the same product. “A lawyer would check and see what the status is of litigation on these medical devices,” Rogers says. “Because it’s very hard—although it can be done—to take a case of first impression.”

Another reason to contact a lawyer is the cost of these types of cases. “They are very expensive cases,” Rogers says. "The cost is very significant, primarily with experts. So it's not always good to reinvent the wheel."

While multi-district litigation can be cheaper, an individual case can run into the six-figure range, and higher if it goes to trial. But if you’re working with a lawyer, they’ll generally advance the cost. “I can’t speak for everybody,” Rogers says, “but anyone I know that’s a first-year lawyer doing this work, the clients don’t pay out of pocket in advance. The lawyers advance all costs, and are reimbursed at the end, out of the settlement, recovery or verdict.”

If you’re considering a lawsuit, you need to collect and preserve any evidence, including the device or product. In the course of your case, experts will inspect the device to determine if it was defective. You’ll also need your medical history and records to see if your injury is consistent with the device defect.

Can Other Parties Be Held Responsible

The WPLA primarily applies to manufacturers (in this case, of medical devices). It does not typically apply to sellers or distributors. But there are several exceptions. For instance, if the manufacturer is insolvent and cannot be sued, it is possible to bring a product liability claim against the seller instead. Similarly, if the seller is simply a controlled subsidiary of the seller (or vice versa), it can be sued. However, the mere fact a third party, such as a pharmacist or doctor, distributed a defective medical device does not make them liable under the WPLA.

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