Defective medical devices can cause horrendous injuries, permanent disabilities, hospitalizations, and even death. According to the U.S. Food and Drug Administration (FDA), a medical device is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. In other words, these devices are intended to ease pain, help with disabilities, and save lives, but different forms of negligence can make them downright dangerous.
Medical device manufacturers have a duty to make safe products, test those products, meet the FDA’s standards and approvals for products, and issue warnings for any risks associated with their products. Physicians and pharmacists also have a duty to relay the manufacturers’ warnings to their patients or consumers to ensure they are aware of risks and side effects. A device manufacturer can be held responsible for defective manufacturing, negligent design, failure to warn of serious risks they knew about but did not disclose, and failure to follow the FDA’s rules.
A device manufacturer can be held liable for:
- Design defects
- Manufacturing defects
- Deceptive marketing
- Failure to warn
Design defects are part of the basic product design and render the medical device unsafe for use. Sometimes the medical device will have been on the market for a long time before causing injuries. This is usually because the defective design causes the device to break down in some way over time. The manufacturer may have also concealed the defective design.
Competition among medical device companies can lead companies to design products quickly and rush them to market. This speed can lead to design flaws. If a device is similar enough to a company’s existing device, the FDA allows a fast-track approval process that can lead to key dangers being missed.
Manufacturing defects can occur as unintended consequences of the manufacturing process such as the product deviating from design specifications or performance standards of the manufacturer or deviating from otherwise identical units of the same product line. The FDA requires medical device manufacturers to perform adequate tests on their products; however, there are ways to bypass more thorough testing to get the product to market quicker.
Marketing includes any recommendation, warning (or lack of warning), or instruction about the use of the medical device. Medical device manufacturers have a duty to follow the FDA’s labeling requirements and to warn doctors of the potential risks associated with the devices. The risks must be updated when manufacturers learn of new additional risks–even after the product has been approved by the FDA and enters the market.
Failure to Warn
Device manufacturers may be held liable if they failed to warn consumers of serious risks they were aware of with the medical device. This can include failure to provide accurate warnings regarding the danger posed by the medical device or failure to provide adequate instructions regarding its safe and appropriate use.
Who Can Be Liable in a Product Liability Case?
The typical defendants in a product liability case will be one or more of the following parties:
- Device designer
- Device manufacturer
- Device distributor
- Testing facility
- Medical supplier
- Medical facility or hospital
FDA & Medical Devices
The FDA has mandatory medical device reporting requirements. Medical device manufacturers are required to report to the FDA if they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report when they become aware that their device has malfunctioned, and another incidence of the malfunction could cause or contribute to a death or serious injury.
Importers are required to report to the FDA and the medical device’s manufacturer when they learn that a device may have caused or contributed to a death or serious injury. However, the importer must only report to the manufacturer if the imported device malfunctioned and a recurrence of the malfunction would likely cause or contribute to a death or serious injury.
Device user facilities include hospitals, ambulatory care providers, surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities. These facilities must report suspected medical device-related deaths and serious injuries to both the FDA and the medical device’s manufacturer.
The FDA handles reporting medical device recalls. Manufacturers frequently issue medical device recalls for products, even if they were originally approved by the FDA. You can access the FDA’s database to see if your medical device has been recalled. The FDA also posts summaries of information about the medical device recalls that could cause serious health problems or death.