In 2002, C.R. Bard hired a regulatory specialist to help push their new device through FDA regulatory hoops and out to market as quickly as possible. The IVC Recovery blood filter was a one-and-a-half inch metal trap that was designed to sit inside the vena cava vein and block blood clots from traveling to the heart or lungs, where the clots could be deadly.
What are Bard IVC Filters?
IVC filters are used to prevent pulmonary embolism (PE), a potentially preventable cause of death in hospitalized and other high-risk patients. The probability of PE increases with the development of deep vein thrombosis (DVT), and treatment for both PE and DVT is anticoagulation, but in instances when blood thinners are not appropriate, an IVC filter is used instead.
There are currently no guidelines on the time frame during which IVC filters must be retrieved from the body, and according to the FDA, the majority of IVC filters are not retrieved, despite the perceived risk of increased fracture, embolism, and IVC wall penetration.
Common complications with IVC filters left in the body for long periods of time include:
- The progression of DVT
- Recurrent PE
- Filter migration
- Tilt, break, or embolism
- IVC perforation or occlusion
In addition to the risks associated with IVC filters, the benefits are also now being questioned. According to a study published on April 28, 2015, edition of the Journal of the American Medical Association, IVC filters provide no significant advantage over anticoagulant drugs that thin the blood to prevent clots.
A five-year, 2,100 patient, multi-center study of inferior vena cava (IVC) filters has begun enrollment, signing up its first nine patients at 10 initial medical sites.
The objective of the PRESERVE study is to determine the safety and effectiveness of IVC filters that are implanted in deep vein thrombosis (DVT) patients to prevent life-threatening blood clots from reaching the heart or lungs. It is being conducted by the IVC Filter Study Group Foundation, which is sponsored by the Society for Vascular Surgery and the Society for Interventional Radiology.
The study will follow 300 patients on seven different devices at 60 different medical sites around the U.S., with physicians operating as they would in day-to-day treatments to accurately assess typical outcomes in patients implanted with IVC filters.
Bard IVC Filter Lawsuits Move Forward
Dr. Kay Fuller, the regulatory specialist hired to help C.R. Bard secure FDA clearance, had serious concerns about the Recovery filter in 2002 and would not sign the FDA document she had been hired to prepare. She resigned from C.R. Bard after expressing her concerns and has just learned through NBC investigations that her signature was used on FDA documents to secure FDA clearance, more than 12 years ago. Dr. Kay Fuller claims that her signature was forged and C.R. Bard issued a statement denying any forgery. The FDA is not confirming an investigation of C.R. Bard IVC filters, but they noted in a statement to NBC News “that the FDA takes very seriously any complaints about 510(k) forgeries and device safety issues.”
Despite the questionable way in which C.R. Bard entered the IVC filter device market with FDA approval of the Bard Recovery filter in 2003, C.R. Bard continues to be a leader in the highly profitable IVC filter device market
Today, the IVC filter market is worth $190 million and is growing at a compound annual growth rate of 11% per year. It is expected that the IVC Filter market will be worth close to $320 million in several years.
Millennium Research Group notes that C.R. Bard was the market leader of IVC filters in 2008 with an estimated 36.9% of market share. After getting FDA approval for the Bard Recovery device in 2003, Bard gained clearance for the G2 (2005), G2X (2008), Eclipse (2010), Meridian (2011) and Denali (2013) Vena Cava filters.
Has there been a Bard IVC Filter Recall?
Experts continue to question the widespread use of IVC filters in recent years but as of today, there has not been a Bard IVC filter recall. Lawyers pursuing lawsuits on behalf of individuals harmed by the Bard G2 IVC filter, the Bard Recovery IVC filter and other Bard IVC filters, are hopeful that lawsuits and financial settlements will put pressure on Bard to restrict the use of these Bard IVC filters.
Bard IVC Filter Lawsuits Continue to be filed
Individuals claiming personal injury or the death of a loved one as a result of being implanted with a defective and unreasonably dangerous Bard IVC filter device continue to file lawsuits. Most of the Bard IVC filter lawsuits have been consolidated for pre-trial proceedings into a multidistrict litigation in the U.S. District Court for the District of Arizona assigned to the Honorable David. G. Campbell.
Is there a Bard IVC Filter Class Action?
We find that many people confuse class actions with mass torts. Class actions are generally filed on behalf of a “class” of individuals with the same or similar injuries. On the other hand, a mass tort is filed on behalf of individuals whose injuries are treated differently but the product and defendant are the same.
Mass Tort cases are often very complex and result in consolidation into a “multidistrict litigation” in order to move these cases through the courts in the most efficient way possible. It is generally to the benefit of the injured individuals to consolidate these cases.
The last Bard trial to make it through the court system prior to the consolidation of the cases ended with settlement in January of 2015. After 11 days of trial, Bard made a confidential offer accepted by the plaintiff.
In part one of the NBC News investigation “Did Blood Clot Filters Used on Thousands of American Have Fatal Flaw?” NBC questions whether C.R. Bard was upfront with the public and the FDA about the Recovery filter’s higher relative risk for death, filter fracture and movement than competitor filters.
In 2004, more than a year after the Recovery IVC filter was on the market, Bard became aware of 27 reported deaths and hundreds of injuries associated with failures of the Recovery IVC filter. Individuals started to go public with their claims of the Recovery filter failings, but instead of recalling the device, C.R. Bard made the decision to hire an outside consulting firm to formulate a crisis management plan as well as an outside doctor, John Lehman, MD to conduct a confidential study of the failures reported to the FDA.
Dr. Lehman compared the Recovery IVC filter to other IVC filters on the market for death, fracture, perforation, movement, embolization and other adverse events, and concluded “that further investigation of the Recovery IVC filter performance in relation to migration and fracture is urgently warranted.”
Bard still did not recall these devices and instead sold 34,000 more Recovery IVC filters until replacing Recovery IVC filters with a modified version of the filter, Bard’s G2 IVC filter. In February 2012, a retrospective review of 363 Recovery IVC filters implanted between 2003 and 2006 showed that 40% of these filters fracture after 5.5 years. According to internal Bard documents, as of 2006, there were still more than 20,000 people walking around with a Recovery IVC filter.
NBC News uncovered internal memos that show Bard was also concerned with failures with the G2 filter, their filter meant to replace the Recovery IVC filter. Again, instead of recalling the G2 IVC filter, Bard continued to market them for five more years, selling more than 160,000 of the G2 filters. At least 12 deaths and hundreds of injuries have been reported and more are expected to surface as reports and lawsuits are made public.
In a June 2014 abstract that analyzed patients who underwent Bard G2 IVC filter placement between October 2005 and February 2010, an estimated 38% of filters fragmented within 5 years.
According to Dr. William Kuo, an interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic, “The number of complications, the frequency of severe failures makes it obvious that it (Bard IVC Filter G2) was never safe to be implanted.” Dr. Kuo has removed thousands of flawed filters and believes the Bard G2 IVC Filter should be pulled from the market.