Posted On April 04, 2023

How Long Does a Faulty Medical Device Lawsuit Take?

Whether the case proceeds to a court trial or is settled out of court will determine how long a faulty medical device lawsuit takes. If you suffer injuries due to a faulty medical device, you are entitled to seek compensation for your injuries through a civil lawsuit. 

Understanding the Injury Risks of Defective Medical Devices

Scientific advances in medical procedures, medical devices, and pharmaceuticals have played a significant role in saving the lives of millions of Americans. However, every month, federal regulators receive thousands of reports from consumers and patients undergoing medical treatments detailing how medical devices and drugs caused them significant injuries. According to the Federal Drug Administration (FDA), medical devices account for more than 200,000 injuries each year.

The FDA states that medical devices are not put through the same rigorous testing procedures as pharmaceutical drugs and medicines. In fact, new medical devices are never tested on humans before they are used on patients. 

Medical devices can be awarded FDA clearance through something called the 510(k) process. It’s a loophole process that allows pharmaceutical companies to market a new medical device if the manufacturer can show the device is “substantially similar” to another product that is already on the market. This process poses serious dangers for patients, because problems with these devices may not show up for years after they hit the market.

Between 2008 and 2017, the FDA received over 5 million reports of health complications and serious injuries linked to defective medical devices. In 2018, the FDA received more than 83,000 reports of deaths linked to defective medical devices. Over 25% of serious injuries and deaths were linked to 6 types of medical devices commonly used for patient procedures and treatments:

  • Implantable devices used for hip and knee replacements
  • Sensor-equipped insulin pumps
  • Implanted insulin pumps
  • Spinal cord stimulators
  • Hernia mesh implants
  • Defibrillators

Device Recalls

When medical devices are faulty or defective, the FDA oversees voluntary recalls issued by device manufacturers. The FDA may step in if a manufacturer ignores dangers and fails to order a recall on its own, but this is rare. Manufacturers and importers are required by law to notify the FDA when they issue a recall, then the FDA announces the recall to the public through its recall database. Common reasons for device recalls include manufacturing defects, software problems, high device failure rates, lack of sterility, and mislabeled packages or instructions.

As a patient, you can reduce your risks of injuries from medical devices by talking to your doctor prior to undergoing any medical procedure, especially one that involves high-risk medical devices. You can also find out if a medical device or drug has been recalled by visiting the FDA’s webpage on Recalls, Market Withdrawals, & Safety Alerts.

When Can You Sue for a Faulty Medical Device?

If you are injured by a faulty medical device, you can file a civil lawsuit through an unsafe product injury attorney to recover compensation for your injuries. Your attorney can gather important medical records, investigate defective medical devices that caused your injuries, and build a case that supports a successful lawsuit. Your attorney can also talk to you about how long a faulty medical device lawsuit takes and explain your options for receiving fair compensation through a court trial or a settlement agreement.

Medical devices have the potential to diminish pain, restore mobility, and even prolong life. When they are defective, however, they can cause serious health complications, long-term or permanent injuries, and even death. Like product liability claims, faulty medical device lawsuits are meant to hold device manufacturers liable for three major types of product defects:

    •    Design Defects – problems caused by defects in the product’s design

    •    Manufacturing Defects – problems caused during the manufacturing process

    •    Marketing Defects – problems with product instructions or warning labels

Design Defects

A design defect is a problem that occurs during the actual design process, but it doesn’t necessarily mean the device is harmful to a patient. For example, a newly designed defibrillator may have an on-off switch in an uncomfortable position for the operator, or a universal knee joint may not fit as many patients as it was designed to fit. These design defects do not make the device dangerous. If, however, the defect causes injury or exacerbates an existing injury or illness, you will likely have cause to file a product liability lawsuit. 

Manufacturing Defects

Most medical devices are manufactured in large plants owned and managed by medical corporations. Generally, the manufacturing process goes smoothly, but on occasion, the manufacturing process may become flawed due to aging machinery, machinery breakdown, faulty components, or human error.

Manufacturing defects are often invisible to the naked eye because they are hidden within the device. For instance, if a defective scalpel caused your newborn’s injury, the defect could cause serious harm to the newborn or the mother during a Cesarean birth. In such cases, the defect and harm caused to the infant or mother would be grounds for a medical device product liability claim.

Marketing Defects / Failure to Warn

While the design and manufacturing processes of a medical device may be flawless, the device may still have the potential to cause harm or death to a patient. Medical devices are distributed and sold by marketing representatives that are trained in the device’s intended use, and its potential for misuse and injury to a patient. Marketing representatives must be knowledgeable and skilled when explaining a device’s intended uses to medical professionals. Failure to provide a complete and accurate description of the device or its potential to cause patient harm can result in misuse of the device, lack of knowledge about its medical contraindications, or both.

According to the law, a defective product is any product that does not work the way it’s supposed to work. In the context of product liability lawsuits, such products cause injuries and damages to people who use them. Under product liability laws, it doesn’t matter if the responsible party (the manufacturer) intended for anyone to get hurt, or if the responsible party was negligent. The fact that the product is defective and caused harm is enough to file a civil lawsuit. This is because product liability cases fall under an element of tort law known as “strict liability,” which holds companies or distributors liable for consumer injuries, regardless of intent. 

If you suffer harm caused by a medical device, you have the right to file a civil action, or lawsuit, to recover damages caused by the faulty device. Those damages can include your present and future medical bills, out-of-pocket medical expenses, lost wages, and pain and suffering. In cases of intentional harm, or willful disregard for patient health and safety, the lawsuit may include punitive damages, which are intended solely to punish the at-fault party for egregious conduct.

How Long Does a Faulty Medical Device Lawsuit Take?

How long a faulty medical device lawsuit takes depends on the circumstances of the case. Factors, such as how your injury occurred, the type and severity of your injury, your medical treatments, and your medical prognosis will have a significant impact on the timeline of your case. The time frame of your lawsuit will be significantly impacted by whether you and your attorney choose to file a civil lawsuit and go to court, or pursue a settlement agreement out of court with the at-fault party.

Court trials are often time-consuming and complicated, depending on the nature of patient injuries. While some cases may resolve in a few weeks, others may take months or even years. If your case involves birth injuries like a brachial plexus injury or Erb’s palsy, your case may be complicated because these types of birth injuries are often due to errors made by a physician or medical professional during the delivery process. Rather than a defective product liability lawsuit, you may be looking at a medical malpractice lawsuit. Your attorney can explain the differences and how they will impact the time frame of your lawsuit and your award for damages.

If you decide to pursue a settlement agreement, the timeline of your case will likely be shorter, but you should talk to your attorney about the pros and cons of proceeding to a court trial versus settling your case outside of court. Although a settlement agreement may be faster, the compensation awarded for your injuries may be less than the award you receive by going to court.

Before you can determine how long your lawsuit will take, you must understand your legal options and choose the option that best suits your circumstances. This is not something you can do without a product liability attorney who understands the pros and cons of a civil trial versus a settlement agreement. Your attorney will help you make the right decision that gets you fair compensation for your injuries.