When a medical device or drug is considered to be defective or dangerous, it will likely be recalled. Recalls are issued either voluntarily by the device or drug manufacturer or by the U.S. Food & Drug Administration (FDA). Notifications are then sent to doctors, patients, and the public by emails, faxes, letters, or announcements on FDA.gov or other sites like RecallGuide.org.


When a dangerous medical product causes a patient harm, it is common for the affected patient to file a product liability suit directly against the product manufacturer. But are there ever instances in which a healthcare provider may be named in a medical malpractice suit? What effect do recalled medical products have on malpractice claims?


Dangerous Medical Devices: When a Healthcare Provider Commits Malpractice


In some cases, the manufacturer of a recalled product may not be the only one who is liable for a patient’s harm caused by that product; a medical professional may be held responsible, too. This is the case when a healthcare provider a) knows that the product has been recalled, or b) knows that the product has been associated with adverse patient events, and c) uses the medical device or drug despite known risks. (As a note, a lawsuit may be brought forth anytime that a healthcare provider uses a device with known dangers that results in patient harm, regardless of whether or not that device has been recalled. The fact that the device has been recalled can be used as evidence, and adds clout to a claim). Doing so is considered to be an act of malpractice if it is a breach of the standard of care, or if another healthcare provider in a similar circumstance would have refrained from use of the medical device or drug. A healthcare provider may also be named in a medical malpractice suit involving a recalled product if the healthcare provider incorrectly used that product, incorrectly prescribed the product, or made another similar error that breached the standard of care.


Who Can Be Named in a Lawsuit Involving a Recalled Product?


A patient who is harmed by a defective medical device or drug is not limited to filing a lawsuit against the manufacturer of that product alone, nor the healthcare provider who used that product alone; rather, there are multiple parties that may be named in a single suit. In addition to a product manufacturer and healthcare provider, a marketer, a hospital, pharmacist, nurses, operating room staff, distributor, and more may all be named if these parties contributed to the patient’s harm through acts of negligence.


Find Out More About Recalled Medical Products & Take Action if Harmed


It is important to stay abreast of recalled medical products – using a recalled medical device or drug could be dangerous. Refer to the FDA’s website – Medical Device Recalls – to learn more.


If you have been treated with a recalled medical product and have suffered harm as a direct result, you may have a claim for damages against both the manufacturer of the product and your doctor. It is important that you meet with a medical malpractice attorney to learn more about your legal options – if you wait too long, the statute of limitations for filing a claim may expire.