The safety and trustworthiness of medical devices are important aspects of a society with a well-operating healthcare system. While the United States can largely rely on the Federal Drug Administration (FDA) to keep the population out of harm’s way, some faulty products still slip through the cracks. Recent news has shown the public that medical device recalls have been especially prevalent in 2022.
Such recalls have also been quite serious in the risk they pose to the populace. Using the FDA’s classification system (with Class l being the most severe and Class lll the least severe) and recent statistical data, it may seem irrelevant that only 21 of the 268 recall events in the second quarter of 2022 were Class l. Even so, this was the highest number of Class l recalls in a single quarter in over a 15-year timeframe. Furthermore, 234 of the recalls were in the second-most severe classification.
Potential Fallout of Device Malfunctioning – The Philips Case
Issues pertaining to the proper functioning of medical devices can have profound effects on individuals throughout the US. Philips, a Dutch device-making company, received 48,000 complaints between May 1st and July 31st, 2022, for a respiratory device it has on the market. This number is expanded to over 69,000 complaints, including those received from August 2021 and onward. The issues experienced with the device in this complaint has ended the lives of 44 people to date.
Most of the recalled medical devices are those with a polyester-based polyurethane foam piece. This addition’s purpose is to suppress the sounds and vibrations of many of Philip’s breathing-assistance machines as they can be quite annoying. The broken-down foam was known to enter into peoples’ airways and digestive systems, causing them an array of health issues.
The devices experiencing issues include CPAP (Continuous Positive Airway Pressure) machines, ventilators, and other respiratory devices. Altogether, however, they have caused 168 known deaths and potentially more. This goes without saying that other potential side-effects of the devices include asthma, infection, pneumonia, headaches, cancer, and more.
Despite the severity of the recalls, the FDA claims that Philip’s is doing little to solve the issues it has caused. As the FDA mandated that Philips immediately alert those using their respiratory devices of their potentially harmful effects, its efforts were classed as “inadequate,” according to the federal agency. This has led to an aggressive uptick in class action lawsuits against the company.
In a stroke of good news for consumers, Philips expanded the number of products it would recall to include all of those using the foam substance produced from 2009 to 2021 – nearly 5.5 million products across the world. Although it has initiated a type of repair and replace program, many critics point at the shortcomings of Philips and the number of people it has affected in all corners of the globe.
Liability and Faulty Medical Devices
As is the case with Philip’s respiratory machines, it is not the fault of the consumer for the faulty nature of the medical devices. Manufacturers rushing to push items to the market and make a profit still have an obligation to produce quality, non-harmful products. As is the case when a distributor shoves a device onto the market without the approval of the FDA, they may be subject to pay damages in a court case should they be found responsible.
These types of cases usually fall under one of two categories. Defectively manufactured medical devices are those that are unique to a single unique unit or set of closely-related units. Whether it be accidents involving those made in shipping or at the factory, the fault is not that of the consumer. A case involving defectively manufactured medical devices can be the fault of a number of actors involved in the making, supplying, and transporting of the device before it reaches the consumer.
The case of Philip’s is one that is an example of a medical device with a defective design. Philip’s respiratory devices had innate faults that resulted in the deaths of many people, in addition to long-lasting health problems. This is almost always the fault of the distributing company as it is their design teams who are directly responsible for the design.
Individuals suffering from issues caused by faulty medical devices can take a number of legal routes. Depending on the circumstances, attorneys may recommend filing a personal injury lawsuit. Usually, this type of claim falls under product liability. Certain cases, especially those that are already in motion and affecting a large number of people, may require that the plaintiff join a class-action lawsuit. A manufacturer, doctor, retail supplier, hospital, clinic, or other type of healthcare facility may be responsible for their role in a product liability case, depending on the situation.
Safety Concerns
The Federal Drug Administration has reported an array of medical device recalls for a few particular reasons. One of the leading concerns is regarding safety, potentially posing a risk to the health and well-being of Americans of all backgrounds. The second quarter of 2022 saw 48 recalls initiated due to safety concerns alone. In fact, only once since 2016 have there been more safety-related recalls of medical devices in the United States. Safety concerns also topped out as the biggest reason for recalls in the same quarter. The Philips respiratory issues fall under the umbrella of safety concerns.
Software Concerns
In addition to safety concerns with the devices themselves, software concerns have proven to be a growing area of anxiety for regulatory agencies. With 47, software concerns trail safety concerns by a slim margin. This area of device failure is particularly worrying considering the gravity of the problem that it poses to patients and their care providers alike. Software failure is a leading cause of medical device recalls and may cause serious injury or even death.
Additional types of software concerns include malicious remote hacking and interoperability issues (computer reasoning capabilities). Not only do many of these concerns have immediate consequences on the lives of those who depend on the software for care, but lasting effects impact victims, as well as their physicians, who may make medical decisions based on long-term information provided by this software. All in all, those manufacturing and supplying medical devices have a legal obligation to ensure their safety.
