A medical device refers to any instrument, machine, apparatus, or implant used for a medical purpose. According to the World Health Organization there are approximately 2 million different medical devices. Medical devices have been used for centuries to help improve the quality of life for people or even save their lives. Unfortunately, there are instances when these devices malfunction. A medical device failure can be catastrophic, proving fatal in some instances.
Individuals who suffer harm as a result of a defective medical device may be ableto pursue compensation by taking legal action against the manufacturer. This article will discuss what a medical device is, why medical devices fail, and how to file a lawsuit for a medical device malfunction.
What is Considered a Medical Device?
A medical device is any device that is used for a medical purpose. Devices can range from test kits to pacemakers. The US Food and Drug Administration regulates medical devices. A product may be named a medical device if it is used in the diagnosis, treatment or prevention of disease. This means that millions of products are considered medical devices in the US, classified into 7,000 different groups.
Types of medical devices:
- Implantables
- Diagnostic devices
- Prosthetics
- In vitro diagnostic products
- Life sustaining devices
- Life support devices
- Medical testing tools
- Therapeutic devices
- Medical instruments
- Rehabilitation equipement
Medical device manufacturers must notify the FDA at least 90 days in advance of going to market about their device. Known as 510(k) clearance, the premarket notification is designed to determine whether a similar device already exists on the market and that new devices are properly classified. It is also done to ensure that the device is safe and effective.
Some medical devices may be exempt from the process or may bypass rigorous testing and still receive 510(k) clearance. Unfortunately, just because a medical device was approved by the FDA does not mean that it was safe and the lack of a recall does not mean that the device does not contain a dangerous defect. When a medical device fails, a person may be eligible to file a medical device injury lawsuit.
Why Do Medical Devices Fail?
According to a study published in Cureus, there were 61 medical device recalls in 2023, representing a marked increase from the 33 recalls in 2020. Medical devices are recalled for a number of reasons including manufacturing errors, improper labeling, inadequate testing, design defects, and a lack of sterility. While these recalls highlight concerns over the safety and efficacy of devices, many dangerous or defective products continue to be sold. It can take years before the FDA initiates a recall of a device, meaning that millions of people can be harmed without knowing the dangers associated with a particular device. A device does not need to be recalled in order for it to cause harm.
Some reasons a medical device may fail:
- Lack of FDA clearance
- False results
- Design defect
- Risk of explosion or burn injury
- Unanticipated system shutdown
- Exposure to toxic substances
- Lack of sterility
- Software malfunction
- Alarm failures
- Improper labeling
- Risk of bacterial/fungal contamination
- Risk of device separation or failure
- Electrical failure
These failures can cause serious, irreparable harm, particularly when the device is implanted or used for life-sustaining purposes. Individuals harmed by a medical device failure are encouraged to consult with an attorney to determine whether they may qualify for a defective medical device lawsuit.
What Are Common Device Medical Device Malfunctions?
According to the FDA, each year it receives over two million reports of suspected device-related deaths, injuries, or malfunctions. A malfunction is any product problem that may cause physical injury or financial strain to a patient.
Manufacturers are required to report to the FDA if they learn that their device may have caused or contributed to a serious injury or death or if they become aware that the device malfunctioned and would be likely to cause or contribute to serious injury or death if the malfunction recurred.
Common medical device malfunctions:
- Design defect
- Manufacturing flaw
- Improper labeling
- Inadequate instructions
- Lack of quality control
- Performance failure
- Inadequate testing
- Contamination
What Devices Have Flaws, Defects, or Malfunctions?
While any medical device could have a flaw, defect, or malfunction, some products may be more prone to problems compared to others. Defects can be minor or may cause life-threatening problems requiring surgery to repair. Individuals affected by a medical device failure are encouraged to seek legal representation. Even without a recall, injured parties may be able to file a medical device malfunction lawsuit.
Well-documented medical device malfunctions resulting in lawsuits:
- Port catheters
- CPAP breathing machines
- Glucose monitoring devices
- Insulin pumps
- Metal on metal hip implants
- Transvaginal mesh
- IVC filters
- Pacemakers and defibrillators
- Infusion and heart pumps
Wisner Baum is investigating claims related to a potential defect in the Dexcom G6 and G7 continuous glucose monitors or sensors. It is believed that these monitors, sold between January and November 2024 may contain a dangerous defect which caused them to have inaccurate readings. Additionally, patients may have missed critical alerts and had diabetic emergencies or other severe complications. Attorneys with Wisner Baum are currently accepting Dexcom lawsuits.
How To Identity the Device Malfunction
Individuals who are using a medical device or have one implanted are encouraged to look out for warning signs of a malfunction. Any new or worsening symptoms should immediately be reported to a healthcare provider. Additionally, alarms or error codes may provide guidance about the performance of the device. Patients should report any abnormal functioning along with signs of a physical reaction to the device. A healthcare provider can use diagnostic imaging and other evaluative processes to check the health of the device.
In addition to working with a healthcare provider, patients using a medical device can access FDA’s MedWatch to determine if any safety alerts have been issued. MedWatch is a database where adverse events are reported and tracked. Users may also search the Manufacturer and User Facility Device Experience (MAUDE) Database to see if a mandatory or voluntary reporter has submitted any information about the device.
How to Prove a Medical Device Malfunction Claim
If you were injured by a medical device malfunction, it is important to gather evidence to help support your claim. Documents including medical records, usage logs, and FDA safety communications can help to strengthen your case. An attorney, experienced in medical device failure lawsuits can provide additional details about what evidence may be needed throughout the process, including expert testimony to help prove causation.
It is essential to preserve any physical evidence related to the device, including broken pieces. Take pictures and document adverse reactions such as swelling or bruising at the implantation site and keep any medical bills, receipts or insurance communications to provide to the attorney assisting with the case.
Process of Filing a Lawsuit
Individuals harmed by a defective or malfunctioning medical device may be eligible to file a lawsuit. The process of filing a medical device malfunction lawsuit involves several key steps. It is important to work with a medical device failure attorney throughout the process to ensure the best chance at a successful outcome.
Recognizing and Documenting the Malfunction
The first step in a medical device malfunction lawsuit is recognizing and documenting the malfunction. It is important to discuss any adverse events related to the device with a healthcare professional. Additionally, individuals can also consult FDA’s MedWatch or the MAUDE Database to determine if reports have been filed related to the device or its malfunction.
Consulting with a Medical Device Attorney
As early in the process as possible, potential plaintiffs should consult with an attorney well-versed in medical device malfunction lawsuits. Wisner Baum has extensive experience working with individuals harmed as a result of corporate negligence or wrongful conduct. Consulting with an attorney early in the process, can help to ensure all legal deadlines are met, such as the statute of limitations, and the case is properly filed.
Gathering Evidence
Next, individuals harmed by defective medical devices will need to gather evidence to help strengthen their claim. This evidence may include medical records, lost wages, out-of-pocket expenses, documentation showing how the defect impacted their quality of life, and proof of pain or suffering.
Determining Liability
Prior to filing the lawsuit, an attorney can help ensure eligibility and determine what parties can and should be held liable or legally responsible for the harm caused by the device. Expert testimony, FDA safety alerts, and reports of adverse events can help establish liability in a medical device malfunction lawsuit.
Filing the Lawsuit
With the necessary evidence collected, the lawsuit can be filed. An experienced attorney will help determine what jurisdiction the lawsuit should be filed in and whether there is existing litigation that can be joined.
Entering the Discovery Phase
After filing, the case may enter the discovery phase. During this phase, parties gather and review information that may be relevant to the case. Attorneys may also depose witnesses and subpoena additional evidence to help prepare for trial.
Accepting a Settlement or Going to Trial
Throughout the process, attorneys from both sides may try to negotiate a settlement. If a settlement cannot be reached the matter may go to trial. If a settlement is reached or a verdict is returned against the defendant (typically a manufacturer or retailer of the defective device) then compensation may be distributed. An attorney can provide guidance on how and when a payout may be received.
Medical Device Lawsuit Settlements and Verdicts
Medical device lawsuit settlements and verdicts vary substantially depending on the circumstances of the case. It is important to discuss a potential claim with a qualified attorney to determine the potential value of the case. Factors that may influence a settlement include injury severity, strength of the evidence, ability to prove causation, jurisdiction, and conduct of the defendant.
Previous defective medical device settlements and verdicts:
- IVC Filters: While litigation continues against certain manufacturers, other cases have resulted in multi-million-dollar settlements. It is alleged that these devices, particularly those manufactured by C.R. Bard and Cook Medical, contain a dangerous defect making them prone to breakage.
- Phillips CPAP Lawsuits: Legal claims allege that the breathing machines increased a patient’s risk for developing certain kinds of cancer and other serious health issues. In 2024, Phillips announced a $1.1 billion settlement to resolve some claims.
How a Wisner Baum Lawyer Can Help
Individuals harmed by defective medical devices are encouraged to contact an attorney immediately to determine eligibility for filing a lawsuit. Wisner Baum has extensive experience holding corporations who put profits over people accountable for their negligence and wrongdoing when their products cause harm. Contact Wisner Baum today to schedule a free, no-obligation consultation.
Frequently Asked Questions Regarding Medical Device Lawsuits
Who is liable for a defective or malfunctioning device?
Multiple parties may be liable for a defective or malfunctioning medical device, including the manufacturer, importer, retailer, or distributor. An attorney can help determine what parties may be held legally responsible for the harm caused by the device.
How to report faulty medical equipment?
There are several ways to report faulty medical equipment including to FDA’s MedWatch and the MAUDE database. It is also recommended that patients affected by a faulty medical device consult with an attorney as soon as possible.
What should you do if medical equipment fails?
If your medical equipment fails, you need to contact your healthcare provider immediately. Once you are able, you should also consider consulting with an attorney who can help determine whether you are eligible to take legal action.
Can you sue a medical device company?
Under certain circumstances, individuals harmed by a defective medical device may sue the manufacturer or maker of the device. The best way to determine eligibility is by consulting with a defective medical device attorney.
What should you do if you notice that a piece of equipment is damaged or malfunctioning?
If you notice that a piece of equipment is damaged or malfunctioning it is important to preserve the evidence and contact your healthcare provider. As soon as possible, you should also contact an attorney who can assess whether there is the potential for litigation.
Does a device need to be recalled in order for there to be a lawsuit?
While there are many medical devices recalled each year, there does not need to be a recall to initiate a lawsuit.
