We rely on technology every day. Cell phones keep us connected to loved ones and coworkers. Automobiles help us commute to our jobs and run errands. The internet helps us track what’s happening in the world or our communities. Computers process data faster, and now pattern-recognition AI is being trained to help doctors diagnose patients. And like those AIs, many technological marvels have steadily innovated the medical field.
So what happens when medical devices that we have come to heavily rely on…don’t work? Who is responsible, and how do we hold them accountable? Many Chicago patients are turning to experienced personal injury lawyers for help with justice and compensation— Let’s take a closer look together.
When people hear the phrase ‘medical device’, their minds often go to specific items like wheelchairs, walkers, insulin pumps, blood pressure monitors, and more. But the term is far more broad than they realize. A ‘medical device’ can be anything from a bandage to an MRI machine. The FDA defines a medical device as follows:
“Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”
Medical devices, as noted in section B, are used for all stages of a disease or injury. This can include artificial joints, surgery tools, repair meshes, blood sugar monitors— the list goes on. When a patient is harmed by a failure, a lawyer can help them determine who or what is at fault and the party that is liable for the harm. This allows the patient to pursue the correct legal path to get help with medical bills and future aid, as well as to hold the offending party accountable for the harm they caused.
When harm is caused by a doctor, it falls under medical malpractice. The doctor, their clinic, or their insurance provider would be liable for compensation. However, when a medical device fails, the manufacturer is more likely to be held liable as the case falls under product liability.
Product liability refers to a manufacturer’s and distributor’s legal obligations to ensure the safety of their products for consumers. Companies that create products for public use are held to strict standards, none more so than medical and pharmaceutical companies. There are strict requirements to gain federal approval, especially through the FDA. And if there are dangerous side effects, the manufacturer is required to provide a proper warning— as are distributors, stores, and medical teams. But sometimes, companies don’t think of certain things to test— or they know the product is dangerous and fudge their results. When this happens, products slip through that aren’t as safe as they appeared.
Take, for example, Tylenol. While there are stringent regulations for medication and Tylenol has passed several clinical studies, pregnant women were told it was safe to take for pain. However, we’ve come to find that high quantities of acetaminophen in umbilical cord blood can lead to neurodivergence diagnoses like autism and ADHD in children. With this revelation, a federal judicial panel is creating a mass lawsuit against stores that distributed acetaminophen without proper warnings.
Many things can go wrong when medical devices fail. These can lead to lasting harm to patients. Imagine if you had a mammogram machine that failed to detect cancerous cells, allowing the disease to develop unhindered. Or if a blood glucose monitor gave improper readings, leading to diabetic shock. What happens when the hernia repair mesh doesn’t work, or medication has severe consequences on newborns?
Medical bills pile up, and the victims suffer. You could miss work, losing out on wages while going into medical debt. In worst-case scenarios, you could die. We literally put our lives at stake with certain medical devices; we need to be able to trust them. So it’s incredibly important to hold manufacturers accountable when something goes wrong. That’s where experienced defective medical device lawyers come in.
If you are a loved one has suffered harm due to a defective medical device, rest assured that Chicago lawyers are here to help. You will want to choose a lawyer who has experience in product liability and medical malpractice so that they can help you get to the bottom of who is liable and gather the correct types of evidence. They can also help you meet any deadlines, represent you during negotiations, and, if necessary, handle a lawsuit.
Product liability and medical malpractice fall under personal injury law. Chicago is home to highly experienced and successful personal injury attorneys who can help you maximize your compensation to cover all costs resulting from the defective medical device. Your lawyer will be your strongest ally for your claim, helping you build a strong case so that you don’t have to go into debt over a company’s failure. They will do everything in their power to hold manufacturers accountable for device failures and help you cover the resulting costs.
If a medical device has failed you or your family, it’s time to reach out to a lawyer for justice, closure, and peace of mind.