IVC Filter Lawsuits Reveal Gaps in FDA Oversight

IVC Filter Lawsuits Reveal Gaps in FDA Oversight

Introduction

Unsealed court documents from lawsuits over inferior vena cava (IVC) filters highlight significant gaps in the information available about the safety of medical devices.

Miscommunication between the manufacturers, regulators, physician and public

These gaps underscore discrepancies between what manufacturers and regulators know and what is communicated to physicians and the public. The litigation involving the Celect IVC filter, produced by Cook Medical, provides a detailed account of these deficiencies.

What did the research state?

In an article published in Annals of Internal Medicine, a Harvard Medical School researcher and colleagues emphasized that patients and physicians should not have to rely on legal cases to access critical safety data necessary for informed decision-making. The researcher noted, “The fact that there were risks associated with this device does not necessarily mean the device is a bad device. The story we’re trying to tell is that all medical devices offer both benefits and risks, but you can’t make an informed decision about whether the benefits outweigh the risks if you don’t have complete data about the risks.”

What does the unsealed record contain?

A closer examination of unsealed records for the Celect IVC filter revealed numerous issues, including safety concerns identified during animal testing, problems with data quality, and a failure to conduct additional testing or make design modifications between the initial denial of FDA authorization and a subsequent resubmission. Furthermore, the U.S. Food and Drug Administration (FDA) did not require a postmarket study of the device, despite its known risks.

Issues with the device

“This is a cautionary tale for medical device safety and regulation,” the researcher stated. The FDA approves thousands of devices annually, yet much of this process remains opaque, raising questions about potential undisclosed issues. The Celect device, never withdrawn from the market, has been the focus of over 7,500 lawsuits related to injuries and wrongful deaths attributed to IVC filter complications. Reported issues include deep vein thrombosis, device migration, perforation, filter fracture, IVC occlusion, and pulmonary embolism.

FDA safety communications in 2010 and 2014

FDA safety communications in 2010 and 2014 linked some adverse events to the duration the devices remained in place. A more recent study, SAFE-IVC, conducted with the FDA, revealed that only 15% of patients had their filters removed despite recommendations to extract them as soon as feasible. The unsealed documents show complications in both animal and human testing that were not fully disclosed. For instance, FDA reviewers identified a 15% perforation rate in the initial device rejection, contradicting the company’s assertion that no perforation evidence existed in animal studies. Furthermore, the manufacturer used a definition of perforation that diverged from standard definitions by medical societies like the Society of Interventional Radiology and the American College of Radiology.

FDA summary

The FDA summary for an expanded indication of the Celect IVC filter reported a 95% retrieval success rate with no adverse events. However, the court documents revealed issues with study design, conduct, and analysis, including two device-related deaths in the 2009 study, which was conducted outside the U.S. without a control group. These deaths were not mentioned in the FDA’s public summary. Additional shortcomings included the absence of core laboratory verification for imaging data, no autopsies for patients with suspected complications, and deviations from FDA-recommended testing protocols.

What do the researchers suggest?

To address these systemic issues, the researchers suggest revising FDA summary structures to include standardized, comprehensive information about a device’s regulatory history and development. This would ensure full disclosure of any deviations from regulatory guidelines during premarket testing. They also advocate for expanded postmarket surveillance requirements to enforce timely study conduct and ensure thorough reporting at regular intervals.

These recommendations aim to increase transparency in the medical device approval process, enabling patients and physicians to make more informed decisions and improving overall device safety.