The Food and Drug Administration (FDA) revealed on Friday that the use of Philips ventilators, BiPAP, and CPAP machines, which were part of a widespread recall, may have led to the death of an additional 40 individuals. Regulatory officials have been receiving new medical device reports, elevating the total death count linked with Philips’ devices to 385 since the recall was initiated in June 2021. Despite the increased reports, the FDA maintains the same guidelines set forth in the June 2021 safety communication concerning the use of the recalled products.
Over five million sleep apnea devices and ventilators produced by Philips are under repair or replacement due to the degradation of polyester-based polyurethane foam used for noise reduction in the machines.
In the most recent update regarding this matter, the FDA announced that it had received in excess of 6,000 medical device reports related to the recalled ventilators, bilevel positive airway pressure machines, and continuous positive airway pressure machines from the beginning of January to the end of March.
The prior update from the agency in February unveiled an additional 82 deaths from 8,000 reports associated with Philips devices during the final two months of 2022.
This latest data inflates the total number of medical device reports connected to Philips’ machines to beyond 105,000 since April 2021, as reported by the FDA.
Mario Fante, a representative for Philips, asserted that the information released by the FDA had already been disclosed and published by the company on April 24.
“The overwhelming majority (~94%) of the approximately 105,000 MDRs submitted from April 2021 up to and including March 2023 denote alleged technical malfunctions that do not involve serious injury,” Fante explained in an email.
Fante emphasized that the submission of a report to the FDA does not constitute “proof” that the device contributed to or caused the outcome, a stance echoed by the FDA. Nevertheless, the FDA has designated the recall as “Class I,” indicating that there exists a “reasonable likelihood that the use of, or exposure to, a non-compliant product will lead to severe adverse health effects or death.”
In the previous month, Philips publicized the findings of a third-party risk assessment of their recalled sleep apnea machines, stating that potential patient exposure to foam particles or volatile organic compounds from the devices is “not likely to result” in significant harm to the patient’s health.
Lawyers who represent patients currently suing Philips over the recalled devices have dismissed the company’s report findings as “PR manipulation disguised as research.”
Philips has announced its intention to lay off approximately 10,000 workers by 2025 in an effort to reduce expenses, streamline operations, and enhance its performance.
Pursuing a Lawsuit to Recover Monetary Compensation for Harm Caused by a Product
In situations where a product, such as the Philips ventilators, BiPAP, or CPAP machines, results in harm, you may have a legal right to pursue a lawsuit for monetary compensation for the damages suffered. This legal action falls within the wider scope of product liability law, which holds manufacturers, distributors, retailers, and suppliers responsible for providing defective or dangerous products to consumers.
Initiating such a lawsuit begins with consulting a product liability attorney who can guide you through the complicated legal process. They can evaluate whether your case is valid, based on the severity of the injury, your losses, and the causative relationship between the product and your injury. Evidence of the injury caused by the product, such as medical documentation, is vital in supporting your claim.
In relation to the Philips recall case, potential plaintiffs would need to prove that the devices were faulty and that the fault resulted in their injury. Given the FDA’s Class I recall designation, there may be a basis for a lawsuit if patients have suffered harm due to the malfunctioning of the devices.
If the lawsuit is successful, the awarded compensation may cover medical expenses, lost wages due to incapacity to work, and non-economic damages such as pain and suffering. In some cases, punitive damages might also be awarded to penalize the defendant and deter similar conduct in the future.
However, filing a product liability lawsuit can be intricate. The definition of a defective product can vary across jurisdictions, and demonstrating a clear causal link between the product and the injury can be challenging. This highlights the importance of speaking to one of Parker Waichman ‘s experienced product liability lawyers.
If you or a loved one has been affected by a defective product, it is crucial to seek legal advice promptly. A competent product liability attorney can assess your case, help collect necessary evidence, and guide you through the often complex process of filing a lawsuit. Your actions could lead to not only monetary compensation for your harm but also contribute to wider changes in product safety.
.svg){kind=small}
.avif)
.avif)
