IVC Filter Lawsuits Expose Holes in FDA Oversight and Public Communication

Unsealed court documents from lawsuits over inferior vena cava (IVC) filters expose a big gap between what manufacturers and regulators know about the safety of a medical device and how much of that information is conveyed to physicians and the public.

In an article published in Annals of Internal Medicine, Kushal T. Kadakia, MSc (Harvard Medical School, Boston, MA), and colleagues say that patients and their physicians should not have to turn to litigation—in this case, over the Celect IVC filter (Cook Medical)—to gain access to knowledge they need to make informed decisions.

“The fact that there were risks associated with this device does not necessarily mean the device is a bad device,” he said. “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.”

Their detailed look at unsealed court records involving the Celect IVC filter revealed numerous information gaps, including safety concerns that were voiced as far back as the animal testing phase, data quality concerns, and failure to do further testing or design modifications between the first denial of authorization and resubmission under the 510(k) pathway that led to authorization. Moreover, there also was no action taken on the part of the US Food and Drug Administration for a postmarket study of the device.

“We think this is a cautionary tale for medical device safety and medical device regulation,” Kadakia told TCTMD. “The FDA authorizes thousands of devices annually, and most of those processes are not completely transparent to the public, and so it begs the question of what else is going on behind the scenes.”

The Celect device, which was never removed from the market, has been embroiled in ongoing IVC filter litigation. To date, there are over 7,500 lawsuits pending against Cook for IVC filter injury and/or wrongful death related to Celect or other Cook IVC filters, according to Drugwatch. Among the causes of injury and complications cited are deep vein thrombosis, device migration, device perforation, filter fracture, IVC occlusion, and pulmonary embolism.

Safety communications from the FDA in 2010 and 2014 indicated that some of those adverse events may have been the result of how long the devices were left in place. Most recently, the SAFE-IVC study done in conjunction with the FDA found that only 15% of patients have their IVC filters taken out despite recommendations they be removed as soon as feasible.

We think this is a cautionary tale for medical device safety and medical device regulation. Kushal T. Kadakia

Riyaz Bashir, MD (Temple University Lewis Katz School of Medicine, Philadelphia, PA), who studied temporal trends in IVC filter use following the FDA safety communications, told TCTMD that Kadakia and colleagues’ paper, taken together with SAFE-IVC, sends a clear message that filter utilization rates are higher than they should be and that the data to support their use needs a rethink.

“More than a million of these devices have been implanted in the United States and many patients don't even know they have an IVC filter in them,” he noted. “We have been implanting them at rates much higher than what is seen in Europe.”

Bashir said the transparency issues highlighted in the paper should at the very least prompt the FDA and manufacturers to consider revising their protocols and standard operating procedures for new device approvals and pathways.

In a statement to TCTMD, Cook Medical said they disagree with how the authors characterized the data in the article.

“Their portrayal of the data is a litigation-driven representation of a technology that has helped countless patients around the world,” the company said. “We believe in filter technology and will continue to vigorously defend clinician and patient access to these devices. Cook Medical worked together with physicians to develop vena cava filters to help patients and reduce the risk of deadly pulmonary embolisms. Physicians choose to use IVC filters based on each patient’s need, knowing that every patient’s situation is different and individual factors and risks must be considered when evaluating treatment options.” 

‘A Public Health Necessity’

To TCTMD, Kadakia said evaluating the case of Celect is less about pointing fingers or casting blame on a device or company and more about using it as an example to learn from what happened.

In the unsealed documents, they found evidence of complications seen in animal testing and human testing that had been not fully made public. As for the initial device rejection, the documents also show that FDA reviewers identified perforation in 15% of the filters despite the company saying that there was no evidence of perforation in their animal studies. Additionally, the company used a definition of perforation that Kadakia and colleagues say is not in line with how societies like the Society of Interventional Radiology and the American College of Radiology define it.

There are many good suggestions that have come out of this [situation] that hopefully will help both regulators and manufacturers, and also contribute to patient safety. Riyaz Bashir

“If there were concerns that were raised within the agency, those should be documented and we shouldn't be relying on summaries that are largely written by manufacturers, not by agency officials,” Kadakia said. On the other hand, “sometimes you may not become aware of some of these issues until litigation actually happens and even then, courts often impose these protective orders, which we had to countersue to get lifted so we could release this information.”

Kadakia and colleagues also maintain that it is “a public health necessity” to ensure that companies and legal authorities don’t use a liberal estimate of “trade secrets” to lock down information pertaining to their devices, noting that it impedes even the FDA, which has about 30% of its Freedom of Information Act requests denied for this reason.

The publicly available summary regarding an expanded indication for Celect gave no details except top-line findings of a 95% retrieval success rate with no adverse events. In contrast, the court documents describe previously undisclosed issues related to study design, conduct, and analysis. The 2009 study that supported the expansion was conducted outside of the US with no control group and reported two device-related deaths, though the FDA’s summary does not mention any adverse events or deaths.

Bashir said while the deaths may not have been suspicious, they still should have been part of the regulatory record since they were reported in the supporting study.

Similar oversights by the manufacturer and/or FDA that Kadakia and colleagues note include a lack of core laboratory to verify perforations on imaging and lack of autopsies in study patients with suspected filter complications, both of which were part of the FDA’s recommended guidance.

Lessons for the Future

Going forward the researchers recommend revising the structure of publicly available FDA summaries to include standardized and more comprehensive information about the device’s regulatory history and development, including disclosure of any deviations from regulatory guidance during premarket testing. Kadakia et al say they would also like to see broadening of postmarket surveillance requirements to “enforce timely adherence to study conduct, and ensure complete reporting at regular intervals.”

Other suggestion include:

• Clarifying what constitutes protected information
• Ensuring accurate and complete reporting to the FDA of premarket data
• Improving public availability of clinical data
• Making timely updates to manufacturer-generated materials if discrepancies arise between premarket testing and real-world use
• Developing language for protective orders to avoid overly broad decisions limiting dissemination of public health information
• Developing standard processes for adjudication of confidentiality designations to enable selective disclosure of information from discovery that is in the public’s interest

Another thing that that Bashir said is a commonly acknowledged problem is the lack of premarket comparison data when it comes to devices like IVC filters.

“Before we get devices approved and utilized in clinical practice, studies need to show that this approach is better than the conventional approach, which in this case is anticoagulation,” he said. “Bypassing that step can cause overutilization of therapies that may not ultimately be beneficial.”

Federal and public funding for RCTs might help since some larger manufacturers could bear the brunt of paying for the trials themselves, but many smaller startups, which Bashir noted often are the companies who come before the FDA with novel devices, cannot.

“The FDA needs resources, too, because they’re stretched thin,” he added. “There are many good suggestions that have come out of this [situation] that hopefully will help both regulators and manufacturers, and also contribute to patient safety.”

Regarding transparency, Cook Medical said they have been, and continue to be, “committed to working alongside the FDA to get clinicians and patients the data necessary for them to make informed decisions relevant to patient care.”