Key Takeaways:
- The FDA oversees recalls of medical devices and ranks them by classes (I, II, and III).
- Patients who are not alerted by their healthcare providers about recalls can take legal action against them and possibly the manufacturer for injuries.
- Defective medical devices can cause serious harm or impairment that may be entitled to legal compensation.
- A personal injury or product liability attorney can help you explore your options and build a strong claim against a negligent manufacturer or healthcare provider in South Dakota.
What Are Medical Device Recalls?
Medical devices can be taken off the market when they are found to be unsafe or ineffective. These recalls can be issued to medical suppliers or healthcare facilities, or directly to patients who have been sold or prescribed the device for treatment.
A medical device is recalled because it violates the Food and Drug Administration’s laws [1].
The device can be recalled for correction or removal depending on the situation.
- A correction addresses issues with a medical device where it is currently in use or sold.
- A removal pulls the medical device where it is used or sold to due to the risks it poses to users’ health.
Classes of FDA Recalls
The FDA divides medical recalls into three classes. Class III has the lowest risk to someone’s health; class II recalled products pose a moderate risk; class I recalled products post severe risk and may even be life-threatening to use.
- Class I: The medical device could cause serious harm, permanent injury, or death.
- Class II: The medical device may cause a temporary health problem or injury with continued use, and there is only a slight chance of severe harm or death.
- Class III: The medical device is unlikely to cause any serious injury or harm.
Who Initiates Recalls?
Many manufacturers recall their devices when they become aware of their products’ defects. If the manufacturer is unwilling to recall their device, someone can alert the FDA, and the FDA can request the recall.
In rare but serious cases, the FDA can legally order a manufacturer to recall a medical device under 21 CFR 10, Medical Device Recall Authority [2].
Common Reasons for Medical Device Recalls
- Design Defects: Flaws in the device’s design that make it inherently unsafe or ineffective.
- Manufacturing Defects: Errors in the manufacturing process that result in a defective product.
- Labeling Issues: Inadequate warnings, instructions, or misleading information on the device’s labeling.
- Software Problems: Errors in the software that controls the device.
- Component Failure: Malfunction of a specific part or component of the device.
- Contamination: The presence of harmful substances in the device.
In 2022, FDA Class I recalls hit a 15-year high [3]. Mislabeling was the leading cause of these recalls. Recently, there have been major medical recalls such as Philips heart monitoring software, which has caused a reported 109 injuries and two deaths [4].
Earlier, in 2019, the FDA took action against transvaginal mesh to treat pelvic organ prolapse; the organization completely banned the sale of the material that can cause organ perforation, bleeding, severe discomfort and pain, and recurring pelvic issues, among other symptoms [5].
Whether the recall is instigated by the manufacturer or the FDA, patients have the right to seek justice if they are harmed by a defective product in South Dakota.
Our personal injury attorneys will help you recover damages if you’ve been harmed by faulty manufacturing. Learn more about ourpersonal injury lawyers in Sioux Falls, SD.
How Do You Find Out if a Medical Device Has Been Recalled?
You can visit https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls to review medical device recalls from the FDA. Medical device manufacturers and suppliers generally do not notify patients directly; they alert healthcare facilities who are then responsible for alerting patients.
Under the Safe Medical Devices Act (SMDA) of 1990, manufacturers have a legal obligation to alert the FDA of any recalls [6].
If a healthcare provider fails to notify you about a recall, they could be held liable for any harm you experience or be held accountable in a wrongful death lawsuit.
Connecting Recalls to Personal Injury Claims
If you are considering legal action due to a recalled medical device, you will have to take careful measures to establish a link between the device and any harm that you experienced. This includes medical notes, doctors’ written statements, and medical reports that support your claim.
Product Liability Law
In South Dakota, manufacturers are not always liable for damages a person sustains from using their product. It depends on whether the product was negligently made or produced up to the standard of care.
The standard of care is the highest standards of safety at the time the product was made. Most recalls reveal a defect in the product, but that defect may not inherently fall under product liability laws [7].
It is important to ensure you discuss your case with an attorney to determine fault. This can save you money and time pursuing legal action if your case does not qualify. If it does, then you can rely on the attorney to properly inform you of South Dakota product liability laws and build a strong case that supports your personal injury claim against the responsible party.
Establishing a Link: Explain that a recall, by itself, does not automatically entitle someone to compensation. They must prove they were harmed by the defective device.
Product Liability Law: Introduce the concept of product liability: the legal responsibility of manufacturers and sellers for injuries caused by defective products.
Types of Claims
Negligence: The manufacturer failed to exercise reasonable care in the design, manufacture, or marketing of the device.
Strict Liability: In many jurisdictions, manufacturers are held strictly liable for injuries caused by defective products, regardless of negligence. This is a key concept.
Breach of Warranty: The device failed to meet the manufacturer’s express or implied warranties.
Types of Damages You Can Recover in a Product Liability Case
In South Dakota, you can pursue economic and non-economic damages for an injury. This includes medical expenses, lost wages, pain and suffering, disability, loss of a spouse or family, and punitive damages.
Punitive damages come into play when a plaintiff (the person filing the lawsuit) can prove that the product manufacturer acted with gross negligence. Gross negligence is a reckless regard for consumer safety that may include producing a public without failure to notify of its risks despite knowing that it posed danger to others.
A personal injury or product liability attorney is the best person to consult with about determining appropriate damages and compensation. The team at Alvine Law Firm includes both types of lawyers to ensure you have the most aggressive and effective litigation on your side. Meet our team.
Connect With a Sioux Falls Personal Injury Attorney
Reach out to us today to schedule a free consultation call with one of our attorneys. We will listen to your case, explain what we could do to help, and ensure you know your possible next steps to recovering any compensation you deserve.
Contact us online or call 605-275-0808 to schedule your free call.
Sources:
[1] What is a Medical Device Recall? | FDA
[2] Recalls, Corrections and Removals (Devices) | FDA
[3] FDA Class I recalls hit 15-year high in 2022 | MedTech Dive.
[4] Philips recall of heart monitor software tied to 109 injuries, 2 deaths | MedTech Dive
[6] H.R.3095 – 101st Congress (1989-1990): Safe Medical Devices Act of 1990