Medical Device Defect? Know Your Options

In the world today, many people use a medical device to improve their daily lives or in the case of emergency. People with heart conditions may have a pacemaker, and people with mobility problems may rely on a walker or wheelchair to get around. Usually, the devices function exactly as they should; they improve the life of the person using them, allowing them to live healthier and have more independence. But what happens when something goes terribly wrong?

If a device malfunctions, and causes and injury or even death, what can you do to get relief?

Alerting the FDA to Medical Device Defects

When a medical device malfunctions, it’s a serious event. According to the Federal Food and Drug Administration, however, medical device issues are not all that uncommon. Each year, the FDA receives hundreds of thousands of reports of suspected malfunctions, many of them resulting in death and serious injuries.

The federal government mostly issues fines and pushes manufacturers to make recalls. If you believe a medical device has malfunctioned, the FDA asks doctors, patients, caregivers and others to submit information on problems with medical products to MedWatch for investigation. Letting the FDA know about product malfunctions helps them hold manufacturers and importers responsible. It can also save lives, helping the agency alert others to this problem so they don’t fall victim.

While the FDA may eventually investigate the manufacturers, it’s unlikely that victims will receive any significant compensation from this. However, if you plan on filing a lawsuit, there is a chance that the outcome of the FDA’s investigation can help your lawyer prove that the manufacturer was liable.

Who is Legally Responsible for Injuries or Death Caused by Defects?

The medical industry is usually held to the highest standards when it comes to working with patients. Doctors take a pledge to do no harm. However, they’re not usually the ones to blame when a medical device malfunctions. In the US, medical device goes through a rigorous testing process and adhere strictly to government regulations before putting they go to market.

Medical device manufacturers of medical devices are legally required to warn doctors of any potential risks associated with medical devices. Sometimes they fail in this duty, causing doctors to recommend medical products without the ability to weigh the benefits against the risks.

Even with the testing process required by the government, sometimes faulty devices slip through the cracks. In many cases, product defects do not become apparent until the product has been in circulation for many years. Market approval from the FDA only requires the short-term testing.  Although the FDA monitors medical devices once they are on the market, many people who use the device are not always notified when a device is recalled or pulled from the market due to defects or other risks.

More one person or entity can be held responsible for injuries due to medical device defects. When a device is proven defective or dangerous, it’s important that you speak to a competent lawyer to determine a course of action.

What is Considered a Medical Device?

The term “medical device” refers to almost any device recommended by doctors or other medical professionals to treat or assist with a medical problem. Typically, this means a device used to treat disease, illness, injury, or disability. That covers a lot of ground!

There are many types of medical devices on the market that have gotten into legal troubles over the years. Hip replacements and other bodily implants, defibrillator machines, and companies that make walkers or crutches have been held responsible for injuries caused by defective products. Medical devices such as patches to control pain or stitches to hold a wound closed can also have defects. Almost any device that’s meant to help people has the capacity to malfunction.

If a medical device has caused harm to the person it is meant to help or doesn’t function in the way it is advertised, talks to an attorney. A competent legal professional can help you make your case and get justice for some of the harm done.

How Can I Document Medical Device Defects?

If you’ve been injured or suffered other health problems because of a faulty medical device, you’ll need to keep track of paperwork. Hospital bills, ambulance trips, physical therapy and doctor visits often involve a lot of paperwork. Make sure to get a few folders to keep this paperwork organized. Document your out-of-pocket expenses as diligently as possible.

Your medical records will also be an important part of any legal efforts. You may need to get copies of photos, MRI’s, and x-rays as well as other documentation related to the injury.

In some cases, a medical device defect can result in injuries that lead to death. If a person dies due to the medical device, there may be a criminal inquiry into the death as well. If you want compensation for pain and suffering, you will need to document the circumstances surrounding this claim. You or other family members may have missed days from work, required counseling, or needed to hire assistance as a result of your loss.

An Attorney Will Fight for Your Rights

Medical device defect lawsuits are often confusing and time-consuming, which is one reason it is always best to seek out an attorney experienced in personal injury lawsuits. Depending on the nature of the injury, your attorney can negotiate a settlement or even take your case to court. If the injury resulted in death, your attorney will probably recommend a wrongful death lawsuit.

Do you want more information on your legal options? Please feel free to contact us and we can set up a time to speak in detail.