Unfortunately, each year, thousands of people in Texas who are supposed to have their medical or health issues addressed by medical devices are injured by or as a result of those medical devices. Defective medical products and devices can often lead to serious injuries, but regardless of how bad the injury is, you may be entitled to compensation.
What Constitutes a Defective Medical Device Claim in Texas?
A lot of people rely on medical devices on a daily basis to be able to live and function normally. The definition of a medical device is very broad, but generally speaking, it is anything that is used in the diagnosis, treatment, or prevention of a disease or something that helps to affect any function or structure of the body.
There are many types of medical devices, ranging from things like artificial hips or walkers to something as simple as an electric toothbrush. Examples of recent types of medical devices that have had defects include:
- Hernia mesh
- Inferior vena cava filters
- Contraceptive devices
Every year, the Food and Drug Administration (FDA) recalls dozens of dangerous medical devices due to defects that pose risks to patients. The risk of harm can sometimes be substantial. In fact, courts have found that defective medical devices have caused thousands of deaths over the last few decades.
To claim damages from a defective medical device, a victim must show that the device in question was defective and that the defect is the cause of their injuries. The strategy for dealing with each case can be vastly different, but some common explanations to prove a defective medical device case could include inadequate product testing, faulty manufacturing, or a poor design.
Potential defendants include anyone from the manufacturer of the medical product or device to the doctor who used or inserted the device to the hospital or clinic where the operation occurred and to the supplier (pharmacy, drug store, or another retailer) who distributed the product.
Examples of Recalled Defective Medical Devices in Texas
The FDA is the government agency charged with making sure that medical devices marketed and sold to the public are designed and manufactured in safe and effective ways, and then thoroughly tested before being used in, on, or for the bodies of patients.
The FDA also catalogs product recalls when the above processes fail. The FDA database is a good way to search for your specific product. Three recent examples of recalled medical devices are described below.
In February 2019, GE Healthcare recalled a line of radiant infant warmers used in hospitals. The warmers were found to have broken side panels or latches that could open when the warmer was being moved. As a result, two babies fell from their warmers and sustained fractured skulls.
Faulty Test Strips
CoaguChek test strips were recalled in 2018 due to inaccurate test results. The strips were designed to measure patient response to warfarin, a blood thinner prescribed to prevent and treat blood clots. While a faulty test strip will not cause any injuries, an inaccurate test result can cause a doctor to take unwarranted action or leave serious medical issues untreated.
Many people with Type 1 diabetes use an insulin pump to monitor and manage their glucose levels. The MiniMed insulin pump was recalled in 2020 due to tens of thousands of complaints from users that the pump was either over- or under-distributing insulin due to a missing or broken retainer ring. These issues led to over 2,000 cataloged injuries and one death.
Defenses to Defective Medical Device Claims in Texas
There may be many defenses opposing attorneys may try to use in a defective medical device claim. Defenses most commonly put forth by defendants include:
- Outside the statute of limitations, where the personal injury claim or wrongful death claim was filed outside the statutory deadline––each jurisdiction imposes their own deadline, but it is typically between one and three years.
- Lack of standing, you must be the injured party (unless you are a parent of the injured minor child)
- Not duty owed, meaning if there was no duty owed to the victim, then you cannot recover, but it can also mean that the alleged duty was beyond what could be considered reasonable
- Modification, where the medical product was somehow modified by the customer or another person or entity and the modification was the actual cause of the injury
- Misuse, meaning the victim used the medical device in a way that the device was unintended and that the situation could not have been reasonably foreseen
- Assumption of risk, where the product was dangerous only because it is inherently a dangerous product and a reasonable person would expect and avoid the danger when purchasing the device
- Comparative negligence, meaning in jurisdictions adhering to a form of comparative negligence, the victim may have contributed to the injury and, therefore, compensation would be reduced accordingly
- Contributory negligence, meaning in jurisdictions adhering to this type of negligence, if the victim contributed to the injury in any capacity, the victim may be unable to collect any amount of compensation.
At f, our personal injury attorney will build a strong case that addresses and counters each of these defenses.