Certain patient injuries are caused by defective implants (including IVC filters, hernia mesh, and artificial joints) and other medical devices. Unlike medical malpractice claims, which are made against a health care professional, product liability claims over defective medical devices are made against the manufacturers or sellers of these products.
Product liability in the health care setting differs from medical negligence in that medical negligence focuses on whether the defendant health care provider's actions were reasonable when measured against the medical standard of care, while product liability focuses on whether the product (the medical device) was defective or dangerous.
Different states have different rules when it comes to product liability, but generally a manufacturer or seller is liable if the product contains an inherent defect, or came with inadequate warnings, and someone was injured by the product while using it as the manufacturer intended.
A medical device can usually be considered defective in one of three different ways:
Learn more about how product liability works.
Almost any medical device can fail or cause complications, but that doesn't always mean the device is defective. A truly defective medical device may shift from its original position, disintegrate, cause discomfort or infection in the patient, or simply stop working. Often a defective medical device is the subject of a recall, meaning the product (or a certain manufacturing lot) is removed from the market and no longer used by health care providers. Learn more about how a recall affects a product liability claim.
Usually a defective device needs to be removed and replaced, and in most instances the patient needs to undergo additional care to treat complications.
Medical devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA often works with manufacturers to initiate and announce necessary medical device recalls.
The most important element of proving a medical defect case is often the product itself. If you believe you've been injured by a defective medical device, it's crucial to preserve it to the extent possible. If the device is used externally, like a thermometer, that's a pretty easy task. Put the device in a drawer and don’t take it apart or otherwise handle it until you give it to your lawyer.
It's just about impossible to win a product liability case if the product disappears or is tinkered with before the lawsuit is filed. In these cases, the defendant manufacturer has a right to have its experts inspect the product in the condition it was in at the time of the incident. If the plaintiff interferes with that right, even unintentionally, the judge may dismiss the lawsuit. (Learn more about manufacturers' defenses to a product liability lawsuit.)
If the medical device has been implanted, preserving it can be more complicated. When a surgeon removes a medical device, they don't typically give the device back to the patient. In fact, the device may be considered medical waste and may be disposed of almost immediately. If that occurs, any product liability lawsuit will be an uphill struggle, unless the surgeon happened to take photographs or make extremely detailed records related to the device and how it failed.
For example, in March 2020 a New Jersey court ordered the dismissal of a hernia mesh lawsuit based on the plaintiffs' failure to preserve the device and demonstrate that Johnson & Johnson (or its subsidiary Ethicon) actually manufactured it.
The lesson here: If your doctors believe you have an internal medical device that is failing, and they plan to remove it, make sure to speak with your providers well in advance of the procedure and ask them to save the device. Your next best step might be to discuss your situation (and your options) with a personal injury lawyer.