Congressional Inquiry into Medical Device Recalls and Patient Safety

The United States Government Accountability Office (GAO) is set to undertake a significant investigation into the Food and Drug Administration’s (FDA) procedures for recalling medical devices. This action follows the emergence of reports highlighting the FDA’s failure to issue timely warnings regarding certain Philips Respironics breathing machines, which were alleged to release dangerous particles and gases. Senators Dick Durbin of Illinois and Richard Blumenthal of Connecticut have prompted this inquiry, referencing investigative reports by ProPublica and the Pittsburgh Post-Gazette. These reports shed light on the FDA’s involvement in a health crisis impacting millions globally.

The investigative reports revealed that the FDA had received numerous complaints about the Philips Respironics breathing machines well in advance of the company’s substantial recall in 2021. Despite this, the agency did not take immediate steps to inform patients or healthcare professionals. Philips Respironics had allegedly kept back thousands of additional complaints over an 11-year period. During this time, users of the machines reported various health issues, including respiratory problems, kidney and liver conditions, and cancer.

Senator Durbin, chair of the Senate Judiciary Committee, emphasized the necessity for effective oversight of medical device manufacturers, highlighting the Philips case as an example of patient harm being known yet inadequately addressed. The senators’ request to the GAO underscores the need for more comprehensive information about the FDA’s supervision of the medical device industry, particularly regarding how the agency ensures that companies adhere to recall processes and what happens when manufacturers do not comply.

Philips Respironics claims to have evaluated early complaints regarding its sleep apnea machines and ventilators on an individual basis and initiated the recall upon discovering that an industrial foam used in the devices could degrade, potentially releasing toxic materials. The FDA, defending its response, stated that it had received complaints about general contamination issues but suggested that the debris could be attributed to external sources, not necessarily the foam. However, at least 30 complaints explicitly mentioned foam degradation, but the FDA reported that there was no clear indication of patient harm.

In response to these developments, Senators Durbin and Blumenthal have cited the need for a follow-up to a similar GAO investigation conducted in 2011, which called for changes to enhance patient protection. The urgency of this investigation is underscored by the fact that in 2022, the FDA received around 3 million reports of malfunctioning devices, a staggering increase from the numbers reported in 2005, with nearly a third of these describing injuries or fatalities.

This situation highlights the potential harm that patients can face from defective medical devices. Individuals who have suffered injuries or health complications due to such devices may consider legal action through product liability lawsuits. In these cases, plaintiffs must demonstrate that the product was defective or lacked appropriate warnings, leading to their injuries.

Navigating a product liability lawsuit involves several complex steps, requiring the expertise of a skilled attorney. Legal professionals can assist victims in gathering evidence, filing claims, and advocating on their behalf throughout the legal process. Successful claims can lead to compensation for medical costs, pain and suffering, lost income, and, in some instances, punitive damages.

Contact Parker Waichman LLP for a Free Case Review

For those harmed by defective medical devices like the Philips breathing machines, Parker Waichman LLP offers legal assistance. Victims can receive a free consultation by contacting 800-968-7529. The firm’s experienced attorneys are dedicated to helping clients navigate the complexities of product liability litigation and work towards securing the justice and compensation they deserve.

Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.