Medical device recalls can be a catastrophic event for any one of a number of reasons. The largest concern when a recall is issued is for the health and safety of the patient. Over a ten-year span, roughly 83,000 deaths and 1.7 million injuries have been linked to defective medical devices. Moreover, there is a large financial cost as the company that sold the device faces both lost sales and the prospect of significant legal liability for any injuries or damages caused.
Medical devices can fail for a variety of different reasons. It does not take much for a large catastrophic product failure to occur. Even the slightest of defects or malfunctions can cause a life-threatening event for the patient who must experience the consequences. Here are some examples of medical device failures in recent years:
- A surgical stapler did not properly work and either failed to close the incision or fired malformed staplers into organs. This resulted in over 50,000 lawsuits against the manufacturer.
- Numerous hip implants needed to be recalled because their design resulted in metal-on-metal, causing toxins and chemicals to enter the bloodstream. As a result, several device makers entered into one of the largest medical device recall settlements ever.
- Hernia mesh, which is considered a medical device even though it is just a small piece of synthetic material, has frayed and migrated after it has been implanted in surgery. Several manufacturers are not facing thousands of product liability lawsuits as a result.
One of the major ways that medical devices may fail is because of a design defect in the product. The legal definition of a design defect is that the product has an inherent flaw in the design that makes it unreasonably dangerous. Note that not every design flaw is legally actionable. The key is that it must be dangerous. In a product liability context, the plaintiff would have to show that there is an alternative design that was safer. An example of this would be that the battery in a defibrillator was designed in a way that it drained faster than usual, placing the patient at risk that the defibrillator would stop working suddenly. Battery failure is actually a common instance of design defect as many medical devices are powered by batteries.
Sometimes, the medical device can be designed without any error, but it will still fail. In some cases, this is because it was just not properly made. The defect can occur at any point between the time that the product’s maker began to make the device all the way through shipping. Sometimes, the product can even be manufactured well, but the product breaks while it is being shipped.
To extend this to the pacemaker example, the product would be defective if the wires were frayed or if the actual battery simply failed and did not work. In this case, there is nothing wrong with the design, but there was simply an error in the parts that were used or how the product was assembled. As long as the plaintiff can show that there was a manufacturing mistake or that something happened to the medical device along the way that caused it to break, they can hold the device maker accountable for the error.
Some medical devices have no defects and were designed properly. Still, the device fails to work and the patient is injured. Sometimes, the blame for the failure can be placed on the doctor who inserted the device. They may have made a mistake during the surgery and improperly put the stent or pacemaker into place. Alternatively, the doctor may have made the error of selecting the wrong medical device for the patient.
Medical devices are often complicated pieces of equipment that come with a long and detailed checklist of instructions. The surgeon may make an error by failing to follow even one of the directions.
Another possible error that can cause a medical device to fail is the fact that it is stored improperly. Medical devices may require maintenance even before they are used in surgery, and the medical practice may have failed to pay the proper attention to the complicated piece of equipment.
In that case, the manufacturer of the medical device will usually not be the one that is at fault for the injury. Instead, the plaintiff would file a medical malpractice suit against the doctor instead of a product liability claim against the device maker.
However, in some cases, it is the patient themselves who makes a mistake in how they use the device. For example, they could use their own insulin pump incorrectly which results in the wrong amount of insulin being administered. In this case, the focus would be on the instructions that the patient received on how to operate the medical device.
Marketing or Labelling Failures
Sometimes, the device would work perfectly well on its own. However, the medical device does not do what the manufacturers have promised it would. They may have made promises in the marketing literature or have given representations that the device would function a certain way or accomplish a certain purpose. When that happens, the manufacturer is responsible when the medical device does not work in the promised way.
The label is also another crucial piece of the medical device, even if that part is not implanted in your body. The label is where the manufacturer warns of any possible side effects. The manufacturer may be able to escape responsibility for some device failures if they warn about them on the label. However, when there is a failure to warn, it is as if the device itself failed, and the maker is subject to possible liability.
Proving that either the medical device itself failed or that someone made a mistake with the device is not always an easy task. To carry this burden, you will need scientific evidence on your side along with extensive documentation. This is where you need a medical device lawyer on your side. The attorney at Sadaka and Associates will fight for you to receive the compensation that you deserve for the medical device injury you have suffered. Call us today to set up your free initial consultation.