The medical device industry is a crucial part of the healthcare system. With a growing prevalence of surgical procedures in the US, the demand for devices such as implants, pacemakers, and catheters is ever-growing. Since patient health and safety depend on these devices, manufacturers and distributors are responsible for ensuring compliance with the FDA standards.
Unfortunately, defective device and product recall cases are common in the country. The FDA gets several hundred thousand medical device reports highlighting suspected device-associated malfunctions, serious injuries, and deaths each year. The medical device recall list for 2023 alone has dozens of leading brands, such as GE Healthcare, LivaNova, and Philips.
Software issues, design defects, mislabeling, contamination, and product quality and safety concerns are the leading reasons for recalls. As a patient, you need to be aware and vigilant about device recalls and your rights if you experience damage due to defective medical devices.
Let us highlight a few significant facts in this context.
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All Medical Device Recalls Are Not the Same
Medical device recalls happen for different reasons and have diverse implications. The FDA classifies them as follows:
- Class I recalls refer to defective devices likely to cause severe health issues or even death
- Class II recalls happen when a device may (i) cause a temporary or reversible health issue (ii) has a slight chance of leading to a severe health issue or death
- Class II recalls apply to devices that are not likely to result in a health problem or injury despite being defective
FDA data suggests that approximately 92 percent of medical device recalls are Class II, while the remaining numbers are split evenly between Class I and Class III. Recalls, in most cases, lead to the removal of the product from the market or correction of the defect. The FDA can compel removal or correction if a manufacturer refuses to implement appropriate action.
Patients Can Legally Claim Compensation
Patients have the legal right to claim compensation for the damage caused by a defective device. The Bard PowerPort lawsuit is an instance where people who have sustained injuries due to a device can file a claim even when there is no active recall. The FDA announced a Bard PowerPort recall in March 2020, but it ended in May 2022.
TorHoerman Law notes that the device is prone to a fracture inside the patient’s body, leading to fragments of silicone and polyurethane traveling in the circulatory system. Catheter migration is an even more serious complication, where the device may get dislodged and migrate to another organ. It may require surgical removal.
Victims can hold the manufacturer responsible for breaching their duty of care or failing to mention the risks related to a defective device. These lawsuits come under the law of product liability and ensure fair verdicts for patients. The compensation includes the cost of medical treatment, pain and suffering, and lost wages.
Recalls Often Happen Too Late
Unfortunately, for patients, medical device recalls are not always timely. They happen only when many patients report damage or injuries due to a defective product. In a recent event, Medtronic pulled back 350,000 implantable cardiac devices from the market after 22 reported injuries. In most cases, many patients already sustain damage through defective devices before it gets flagged.
When issuing a recall, the FDA and manufacturers provide guidance for patients. It may include monitoring for potential symptoms, getting medical advice, and considering revision surgery (in the case of an implantable device). Your legal rights as a patient come in handy at this point, and you shouldn’t hesitate to bring up a claim against the manufacturer.
Manufacturers May Conceal Facts
A medical device recall will include essential technical information about the defects in the device. But manufacturers often conceal facts from patients. You have to read between the lines and be proactive about getting more information to deal with the concern effectively.
For instance, the recall notice will recommend that patients reach out to the company to get a refund or a replacement device. But a defective medical device can leave patients with substantial physical, psychological, and financial costs. The best option is to enforce your legal rights and claim the rightful dues from the manufacturer.
The Bottom Line
Besides knowing these key facts about medical device recalls, you must understand that recalls may not happen for all defective devices. As a wise consumer, you must dig deep into the performance and safety statistics to ensure the right decision before going ahead with an implant. Also, seek guidance from your doctor to be aware of the potential defects and risks.