On September 3 and 4, 2015, NBC Nightly News aired a two-part report on an IVC filter (Recovery Filter System) manufactured by C. R. Bard and approved for market in 2003. In part 1, NBC reported that Bard’s Recovery filter had been associated with 27 deaths and 300 other adverse effects. Bard responded to problems with its filter by hiring a public relations firm and conducting a confidential study, which found that the risk of death, filter fracture and filter movement were all significantly higher for the Recovery filter than its competitors. According to the NBC report, even after it became aware of the serious risks associated with its filter, Bard sold 34,000 Recovery filters before replacing it with a new model, the G2, in 2005.
The second part of NBC’s investigation focused on a 510(k) application submitted by Bard to gain FDA clearance to sell its Recovery filter. The FDA had rejected an earlier application and Bard turned to regulatory specialist Kay Fuller for help. Fuller, however, raised concerns about the safety of the device. Bard’s response, she says, was to threaten her with removal from their team. She told her boss she would not sign an application unless her concerns were addressed. Nevertheless, a second application that appeared to bear Fuller’s signature was submitted and approved. Fuller says she never signed the application. An image of the application and Fuller’s actual signature can be seen here. FDA officials and Bard executives both denied requests to be interviewed for the NBC story.
In December 2015, NBC News published a follow-up report on the Bard’s G2 IVC filter (approved via 510[k] process after the Recovery filter). According to the story, Bard was aware of problems with the G2 shortly after its release, but continued to sell the device and a similar filter, the G2 Express. (The Express was released in 2008.) By 2010 Bard had sold over 160,000 G2 and G2 Express IVC filters. Dr. William T. Kuo is an interventional radiologist and the director of Stanford University’s IVC Filter Clinic. He told NBC News, “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” Kuo believes that a Bard IVC filter recall should have been issued.
In September 2015, a New York woman filed a Bard IVC filter lawsuit after imaging tests revealed that the filter had punctured her inferior vena cava. Struts (or legs) of the device were protruding toward her lumbar spine, but doctors have advised her that surgery to remove the device would be too risky.
Here are several other Bard IVC filters are the subject of at least one IVC filter lawsuit:
- Eclipse IVC Filter
- Meridian IVC Filter
- Denali IVC Filter
Cook Medical, Inc. IVC Filters
High Perforation Rates with Cook “Günther Tulip” and “Celect” IVC Filters
The other filter manufacturer playing a major role in the IVC filter litigation is Cook Medical, Inc. Nearly 200 IVC filter lawsuit cases were recently consolidated in the U.S. District Court for the Southern District of Indiana (see below). Cook makes two filters, the Günther Tulip, which received FDA approval in 2003, and the Cook Celect, which was approved by the FDA in 2008, under the 510(k) process.
Doctors at the University of California, San Francisco investigated the Celect and Günther Tulip filters and published their results in 2012 in the medical journal Cardiovascular Interventional Radiology. They found that 86% of the Günther Tulip and Celect filters had perforated through the IVC. After 71 days all of the filters showed “some degree of vena caval perforation, often as a progressive process.” Surprisingly, the newer Celect filter actually had higher perforation rates than the Günther Tulip and the most severe penetrations—those in which the filter passed through the inferior vena cava and contacted or perforated an outside structure—were more frequent in the newer Celect filter.
The progressive nature of the perforation was confirmed in an April 2013 study published in the Journal of Vascular and Interventional Radiology (JVIR). In that study researchers compared patients with the Günther Tulip filter (GTF) to patients with another similar device, the Option IVC filter. They found that “only GTFs showed time-dependent penetration, with penetration becoming more likely after prolonged indwelling times.” A June 2015 study comparing the same two filters, also published in the JVIR, found, “The incidence of strut perforation was 43% for Celect ﬁlters versus 0% for Option ﬁlters.”
The Cook filters appear to be uniquely prone to perforation problems. Did Cook properly warn patients and physicians of the defects associated with its filters? The plaintiffs in each Cook IVC filter lawsuit will argue they did not.