Medical devices serve a vital role. When operated effectively, they preserve patient health, minimize suffering and reduce cost of care. But they don’t always work as intended. In fact, devices fail far more often than most people realize. And these malfunctions cause injuries, accidents, and far too many deaths. Manufacturers insist, doggedly, that their products are safe, even when compelling evidence to the contrary is presented. And although device recalls occur with regularity, they come too late for thousands of patients.
Which Devices Are at Risk for Failure?
- Any device that relies on blood or body monitoring is prone to malfunction, but certain categories of equipment fail more than others. In May 2018, a Class 1 Recall came out for HeartMate 3 devices. Some machines would—without warning—stop pumping blood, which caused blood clots and heart failure.
- Research conducted by Dr. Zian Tseng and his team found that pacemakers and other electronic defibrillators fail far more frequently than manufacturers acknowledge.
- Relatedly, earlier this year, Cook Medical successfully defended a lawsuit alleging that the company’s blood clot filters were defective. They won because the plaintiff waited too long before pressing charges. But plaintiffs have filed over 3,000 cases against Cook to date for similar issues.
- Electronic devices, along with implants like stents and filters, cause catastrophic harm when they fail. But patients face risks even from benign-seeming devices like breast implants, which have been linked to rare cancers.
FDA Recall Rules May Soon Change—for the Worse
The FDA, which controls product recalls and safety, admits that device malfunction is underreported. Nevertheless, the agency is seeking to loosen restrictions on reporting. Currently, known issues must be reported within 30 days of discovery. Proposed changes would allow manufacturers an entire quarter to alert the public. Consumer advocacy groups are alarmed; they argue that the public deserves more a more robust alert system, not a more lenient one.
Contact our Washington D.C. medical malpractice attorneys if someone you love suffered injury due to a defective or poorly monitored medical device.