IVC Filter Lawsuit: FDA Issues Safety Communications
In 2010, the FDA issued its first safety communication regarding IVC filters. Safety communications are the FDA’s primary means of alerting health care professionals to safety risks associated with drugs and medical devices. The FDA warned of serious adverse events associated with the filters and expressed its concern that the filters, which are designed to be retrievable, were being left in place too long. The agency recommended that doctors consider removing the filter as soon as the need for protection from a pulmonary embolism is no longer needed. The problem with that is that the longer a filter is left in place, the more difficult it becomes to remove.
Unfortunately, it appears that the FDA warning had little effect. It was reported that at one large Boston medical center, less than 10% of the filters were being removed, even though they were no longer needed. In 2014, the FDA issued a new safety communication. The FDA’s own analysis had found that if the filters were not removed between 29 and 54 days after implantation, the risks associated with having the filter in place began to exceed all the possible benefits.
“… if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”
-FDA Safety Communication, May 6, 2014
Part of the problem is that the filters can be very difficult or impossible to remove. In one study of 978 patients, nearly 20% of the attempts to remove the filters were unsuccessful. In over a seven and a half year period, only 8.5% of the filters were successfully removed.
IVC Filter Lawsuit: A Failure to Warn
Central to each IVC filter lawsuit is the question of whether or not the manufacturers have taken adequate steps to warn consumers of the risks associated with their filters. Considerable evidence shows that certain manufacturers failed to warn the public about the dangers of IVC filters.
C.R Bard IVC Filters
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.
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 that have been the subject of at least one IVC filter lawsuit:
- Eclipse IVC Filter
- Meridian IVC Filter
- Denali IVC Filter
Cook Medical, Inc. 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.
IVC Filter Lawsuit: Multidistrict Litigation
In many cases, those who have filed an IVC filter lawsuit will be grouped together with other similar cases in what is known as multidistrict litigation (MDL). Instead of trying each IVC filter lawsuit separately, multidistrict litigation brings all the cases before one judge to avoid having conflicting pretrial rulings and to conserve resources of both plaintiffs and defendants in the discovery process. The MDL process gives both sides a chance to see how courts and juries view the evidence.
In August of 2015, 16 cases against Bard were transferred to the U.S. District Court for the District of Arizona. By the end of January 2016, the Bard IVC filter lawsuit count in Arizona was up to 90. More than 200 cases against Cook Medical have been consolidated in the United States District Court for the Southern District of Indiana (MDL No. 2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation), and the pace of the IVC filter lawsuit filings against Cook increased significantly in the latter half of 2015.
Types of IVC Filters:
- Bard Recovery IVC Filter
- Bard G2 IVC Filter
- Bard G2 Express / G2x Filter
- Bard Eclipse
- Bard Meridian
- Bard Denali IVC Filter
- Cook Günther Tulip
- Cook Celect IVC Filter
- B Braun Tempofilter IVC Filter
- Cordis OptEase IVC Filter
Do I Have an IVC Filter Lawsuit?
If you or someone you know has been injured by an IVC filter, the IVC filter lawsuit team at Baum Hedlund Aristei & Goldman would like to hear from you.
Based in Los Angeles, our firm has successfully represented thousands of clients against many of the largest drug and medical device manufacturers in the world. For over several decades, we have developed unique and very effective techniques to uncover evidence that device makers would prefer remains hidden from consumers and even physicians.