Powerful Tool to Ensure Medical Device Safety is Rarely Used
As the US population ages, more medical devices like artificial hips and knees are being surgically implanted. If defective, patients can suffer a lot of harm as a result, including chronic pain, physical limitations, and additional surgery. The federal government can recall dangerous medical devices, but it rarely does so. That may mean more people needlessly suffering injuries and harm from medical devices that never should’ve been sold.
You may have a valid compensation claim if you suffered an injury due to a dangerous or defective medical device. Call Satterley & Kelley, PLLC at 855-385-9532 or contact us online to learn more.
Overworked and Understaffed Safety Agency Not Up to the Job
The federal Food and Drug Administration (FDA) regulates medical devices and can remove defective devices from the market if the risk of serious harm is great enough. But the agency is so poorly staffed that it may be unable to ensure companies take critical steps to protect patients, according to a report by the federal Government Accountability Office (GAO) released in December.
ProPublica reports that GAO was asked nearly two years ago by US Senate members to investigate FDA’s ability to recall medical devices after an investigation into the 2021 recall of breathing machines that endangered the health of millions of Americans.
Senators wanted to know why the FDA didn’t do more to protect users of Philips Respironics devices after receiving reports that the devices used a hazardous industrial foam that could break down and be inhaled. Philips’ tests showed foam in the machines released dangerous chemical compounds.
Philips received thousands of complaints before it recalled the device and didn’t notify the FDA. Customers who used the continuous positive airway pressure (CPAP) machines and other devices reported that they suffered cancer, respiratory illnesses, kidney, and liver conditions.
One of the Senators involved, Richard Durbin, stated the GAO report detailed that the problem was the result of “drastic staffing cuts” and that “weakened enforcement authority has made it even more difficult for FDA to carry out critical oversight activities.”
The GAO found that the FDA rarely requires manufacturers to recall defective devices from the market, though it has the legal authority to do so. It’s recalled medical devices four times, most recently in 1992. There’ve been about 900 voluntary recalls by manufacturers in each of the past five years.
If companies start the process, FDA staff can’t ensure the following:
- Recalls aren’t delayed
- Whether mistakes are made when defective devices are taken off the market
- Whether companies miscommunicate with consumers
The FDA regulates more than 190,000 medical devices, an increase of about 15,000 since 2016. ProPublica and the Pittsburgh Post-Gazette found patients who hadn’t learned about the 2021 recall of their possibly toxic CPAP machines for months or years afterward.
Since 2021, the FDA has received more than 500 reports of deaths connected to the devices, according to the FDA’s most recent update. A cardiologist quoted by ProPublica stated the FDA’s recall notification system is “primitive by today’s standards” and that improvements have been urgently needed for years. She cited the agency’s reliance on fax machines because it lacks a comprehensive, modern recall system.
FDA employees told the GAO they often can’t complete basic tasks, such as reading reports from companies written while they recall their products. These reports state the following:
- How many people are notified
- The number of products repaired
- The estimated time to finish the recall
The FDA’s staff has been reduced since the GAO investigation, so the problem may be worse.
The Department of Health and Human Services, the FDA’s parent agency, in response to the GAO report, stated that it would determine whether it needs additional staff and additional statutory authority to improve recall management.
Company Denies Dangers, Then Settles Lawsuits for More Than $1 Billion
Philips claimed the original foam in the devices caused no “appreciable” harm to users. The company later entered into an agreement with the Justice Department over the issue, promising it would hire an independent safety monitor and regularly inspect its facilities.
Philips also agreed to pay more than $1 billion to settle thousands of lawsuits by those claiming the devices injured them. Not surprisingly, Philips didn’t admit fault or liability in the terms of the agreement.
Injured Patients May Receive Compensation for the Harm They Suffer
There are various government agencies charged with making our lives safer, including the FDA. The reality is they’re not up for the job. They lack the resources, and politicians who create and fund these agencies may not want to take on major industries that profit from defective and dangerous products. In theory, products like CPAP machines should be universally safe, but that’s not always the case.
As a result, patients get hurt. You’re told a medical device is safe and effective for its intended use, but it may not turn out that way. Instead of government spending resources to prevent the sale of dangerous medical devices or quickly take them off the market if they’re not, Americans are Guinea pigs engaged in real-world testing.
Medical device companies would rather deal with lawsuits filed by law firms like ours, representing injured people like you, and profit from a defective medical device than make the necessary investments early in the process to make it safer.
Schedule A Free Consultation by Contacting Us Today
You might have a valid compensation claim if a dangerous or defective product injured you, killed a family member, or caused extensive property damage. Schedule a free consultation to discuss your case with an experienced Satterley & Kelley, PLLC product liability lawyer. Call 855-385-9532 or contact us online to reach our Louisville office.