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How Do I Prove that a Medical Device is Defective?

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It can feel like your worst nightmare…you seek help for a medical issue and are given a treatment plan by medical staff that requires using a medical device. The very medical device that was supposed to help you get back to your life is what actually caused further damage to your health.

It is an overwhelming feeling to have to navigate these complex cases. You are not alone. Through this article, we will discuss factual information regarding some common issues that we see and how we can help you and your family. Read on to learn more about how your circumstances may apply.

What Makes a Medical Device Defective?

There are typically three ways a medical device can be considered defective. They are through Manufacturing Errors, Failure to Warn Errors, and Design Errors. 

Manufacturing Errors can be some of the most common errors in medical devices. These types of errors occur when the product, although intended for a specific purpose, suffers a manufacturing flaw that alters the device’s ability to perform its intended purpose. This can have devastating effects on patients. Consider if the defective device was a surgical instrument used in a lifesaving surgery, a pacemaker, or a stent that attributed to issues with the patient’s heart. 

Design Errors include those determined as unreasonably dangerous to the consumer through the initial design. These cases are more complex due to proving that an alternative design would have had a different outcome and would have avoided an unreasonably dangerous circumstance for the patient. 

Failure to Warn, sometimes called Marketing Defects, includes a claim that had the patient been provided a warning or an adequate one, they would have avoided unnecessary harm by using the product. The burden of proof in these cases can become complex due to having to prove that the defendant knew about the defect in the product and proceeded anyway or that they chose not to disclose adequate warnings in using the product accurately. 

What Can I Do to Protect Myself and My Family?

One of the first things we strongly suggest is seeking medical care. Some will choose to wait to seek care, and this can prolong your case being resolved or possibly lower your chances of having a compelling case in the first place. It is essential to have a starting point documented when you start noticing symptoms and what may be causing the problem.

Gather past documentation of all medical care, from the original injury through treatment received, and anything else you may feel is pertinent to your situation. Gather medical records, journal symptoms, when the symptoms began or when they seem to worsen due to certain activities, and what, if any, relief you can find. All these can be important to building a plan for you and your family.

Seek legal representation. These cases can be complex, and having a sound, knowledgeable and experienced attorney on your side can help in various ways. They can help you to ascertain what you are facing, how to put together a plan to protect yourself, allow you to gain perspective on the next steps, and be your advocate.

Is There a Statute of Limitations on Defective Device Cases?

The statute of limitations on these types of cases will follow the same guidelines as wrongful death or personal injury, as there isn’t a specific statute of limitations on defective devices. Wrongful death or personal injury cases have a time limit of three years from the issue’s discovery date.

This can pose an issue to those affected as, in some cases, the effects of the defective product may not show up immediately. The moment that you realize there is an issue if you suspect it has to do with a defective device, it is imperative that you seek medical care and reach out to a legal team for advice. They can help to ensure that you avoid missed opportunities due to the statute of limitations.

Is the Burden of Proof on Me?

In product liability cases, the burden of proof will rely on you. You must work with your attorney to prove that a few things occurred to build a reasonable claim.

Firstly, you must be able to prove that an injury was sustained as a direct result of the product in question. In some cases, the injuries sustained aren’t as immediate or apparent, such as an infection or other physical symptoms, making this difficult to prove.

You must be able to prove that you didn’t alter the product, essentially making it defective yourself. This can be straightforward in the case of a stent or pacemaker but not as black and white in dealing with other medical devices.

Third, you’ll need to prove that the device was unreasonably dangerous, making it defective and the cause of your injuries/illness.

How Can an Attorney Help?

No one should have to navigate these cases on their own. It can be intense and scary to have lost your trust in the medical community and now be hesitant to trust the legal world. We are here to support you, help you understand the following steps, and work with you to develop a plan that will get you the justice you deserve.

We have years of experience helping clients and their families in defective medical device cases, and we are confident that we can be your advocate while you proceed with this process. Call our offices today at (803) 500-0000 to get your specific questions answered a formulate a plan.

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