When Medical Devices Make Matters Worse
Imagine struggling to breathe. Can you picture the feeling of panic that comes as each grasp for air becomes a greater struggle? Now imagine that a prescription medical device designed to reduce—or even eliminate the problem—is introduced to address the issue. What a relief, right? Sure, unless the device results in horrendous harm instead.
Philips Respironics
When Philips Respironics marketed and sold their medical devices as an aid to those struggling to breathe, patients were likely thrilled to have an intervention for their breathing issues. CPAP machines and respirators were prescribed for patients across the country. Unfortunately, millions of them were defective, and even though the risks were well known and documented, the products were not recalled.
FDA Fails
Investigative reporting reveals that, although the FDA was aware that the breathing machines sent the fumes and particles of industrial foam embedded in the machines directly into patients’ lungs, they did nothing to alert doctors or their patients. For over a decade, complaints about black powders and loose foam in the ventilators were reported to no avail. As far back as 2011 concerns about particulates and dust were submitted, yet there is no clear evidence that anyone at the agency read the reports, and certainly it’s evident that no one acted on them.
Dire Consequences
While the profits rolled into Philips Respironics, patients who were using the product were experiencing horrendous and inexplicable health consequences, including liver problems, respiratory infections, kidney issues, various cancers, and more. In fact, deaths associated with the devices have been reported, although those reports arrived long after the events in question. Experts in the medical field believe the deteriorating foam could be the cause of these and other ailments. In 2021 Philips admitted that the risks associated with their ventilators include exposure to toxic, carcinogenic materials, and they began the recall process. That is years after thousands of complaints had been filed with the FDA (something that is required for companies that provide medical equipment. In defending the tardy reporting, Phillips claimed that they didn’t think the complaints were serious enough to report at first, and they did ultimately turn them into the FDA (with dates modified after the fact to keep them in compliance with government regulations.) Despite both Phillips and the FDA claiming to have the same goals of protecting patient health as a top priority, millions of these dangerous machines were out in homes, hospitals, or care centers, causing untold suffering to Americans.
Legal Recourse
If you or a loved one used a CPAP device by Philips Respironics and have since suffered ill-effects that could be a result of the deteriorating foam, you may be entitled to significant damages to address the medical costs, lost wages, pain and suffering and more. To discuss your situation, schedule a confidential consultation with an experienced Kissimmee personal injury attorney at Salazar & Kelly Law Group in our office today.
Source:
propublica.org/article/how-the-fda-failed-to-protect-millions-of-people-tainted-breathing-machines
