Red Flags of a Defective Medical Device

Successfully representing clients harmed by defective medical devices demands a deep understanding of the intricate world of medical technology and the legal framework surrounding product liability.

The medical device manufacturing sector is a global behemoth, generating annual sales exceeding $200 billion, solidifying its position as one of the most lucrative segments within the healthcare industry. It is a marvel of modern technology, constantly pushing the boundaries of what’s possible in healthcare. However, even the most sophisticated devices can have flaws, leading to serious injuries and even death. For legal professionals whose practice includes product’s liability, understanding the red flags of a defective medical device is crucial for effectively representing clients who may have been harmed.

Common Symptoms of a Defective Medical Device

• Malfunction
• Unexpected Heating
• Unexplained Pain or Discomfort
• Device Failure
• Allergic Reactions

One of the most obvious signs of a defective medical device is malfunction. The device may fail to function as intended, completely cease operation, or exhibit erratic behavior. Another red flag is unexpected heating. Excessive heat generation can signal a short circuit, overheating components, or underlying design flaws. Furthermore, if a patient experiences new or worsening pain, discomfort, or other adverse reactions after receiving a medical device, it could indicate a potential defective issue. Device failure can manifest in various ways, such as broken parts, leaks, movement, or the device simply disintegrating. Finally, some patients may experience allergic reactions to materials used or emitted from the device, such as certain metals, plastics, or toxic fumes.

Patients involved in hernia mesh litigation, for example, claim to have suffered a range of debilitating complications following hernia repair surgery involving mesh implants. These complications include but are not limited to, infections, persistent pain, bowel blockages, and mesh displacement.

Product Recalls and Safety Alerts

The device manufacturer must test its devices for safety before selling to the public and must continue to monitor its medical devices after sale to ensure continued safety. The FDA does not test the devices but does play a role in monitoring the safety of medical devices. When a device is found to pose a significant health risk, the FDA may issue a recall. The FDA can become aware of safety issues in various ways including reports of patients, doctors, or the reports by the device manufacturer.  Medical device recalls range from Class I (most serious) to Class III (least serious). Each year the FDA publishes a comprehensive list of medical devices recalled for the public’s knowledge. For example, the list for 2024 can be found here: https://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls.

Legal professionals practicing in the area of defective medical devices should stay informed about medical device safety by regularly monitoring the FDA’s website and subscribing to their email alerts for the latest information on recalls. When a recall is issued, it is crucial to conduct a thorough investigation into the specific device involved, the nature of the defect, and the harm caused to patients.

Resources for Staying Informed

• FDA Website: The FDA’s website is an invaluable resource for information on medical device safety, including recalls, safety alerts, and guidance documents.
• Manufacturer Websites: Many medical device manufacturers maintain websites with safety information and instructions for use.
• Professional Organizations: Organizations like the American Medical Association (AMA) and the American Bar Association (ABA) offer resources and publications on medical device safety and legal issues.
• Academic Journals: Staying current with the latest research on medical device safety through peer-reviewed journals is essential for any legal professional.

A Word of Caution

While it’s important to be vigilant about potential device defects, it’s equally important to avoid becoming a “medical device malpractice” alarmist. Not every adverse medical outcome is the result of a defective device. A thorough investigation of the facts is always necessary. 

Ways To Investigate A Potentially Faulty Device

This may involve reviewing medical records, consulting with medical experts, and interviewing witnesses. It’s also incredibly important to rule out other potential causes of the patient’s harm, such as medical error, patient factors, or underlying medical conditions.

Investigating whether an injury caused by a medical device was due to a defect in the device itself or user error requires a thorough and multi-faceted approach. The process often begins with a detailed review of the injured patient’s complete medical records, carefully examining all notes, test results, and other documentation to piece together a timeline of events and identify potential issues with how the device was used. Consulting with medical experts specializing in the device in question is a crucial next step, as their knowledge and experience can provide invaluable insights into common problems, proper usage techniques, and the likelihood of a defect.

Interviews with witnesses present during the incident, including medical staff, the patient, and family members, can fill in missing details and corroborate or contradict information gleaned from records. If the device is available, a thorough physical examination and testing can often definitively answer whether a defect was present. In complex cases, re-creating the conditions of the incident using an exemplar device may be necessary. Ultimately, arriving at a conclusion requires carefully analyzing all available evidence and often significant medical and technical expertise.

A Call to Action: Vigilance and Advocacy

Successfully representing clients harmed by defective medical devices demands a deep understanding of the intricate world of medical technology and the legal framework surrounding product liability. This includes staying abreast of the latest safety advisories, conducting meticulous investigations that delve into the specifics of the device and the patient’s situation, and approaching each case with a healthy dose of skepticism. By diligently fulfilling these responsibilities, legal professionals can effectively advocate for their clients and play a crucial role in enhancing patient safety within the evolving landscape of medical technology.