Bard IVC Filters
On August 9, 2010, the FDA released a safety communication stating that inferior vena cava (IVC) filters, which are inserted into the body to help prevent blood clots from reaching the lungs, had been linked to serious injuries, including deep vein thrombosis and organ perforation.
In May 2014, the FDA updated that communication to state that IVC filters should be removed as soon as they are no longer needed, to protect patients from serious side effects. More specifically, they recommended removal within 29-54 days after implantation, as long as the patient’s risk of pulmonary embolism (blood clot in the lung) had subsided.
Meanwhile, many patients who were implanted with Bard IVC filters suffered from serious injuries. Because Bard failed to provide adequate warnings about the risks, and because the devices are defectively designed, a number of these patients filed Bard IVC filter lawsuits against manufacturer C.R. Bard (“Bard”).
In response to the increasing number of Bard IVC filter lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federal cases into a multidistrict litigation (MDL) and transferred all Bard IVC cases to the District of Arizona on August 17, 2015. U.S. District Judge David G. Campbell was appointed to oversee pre-trial proceedings.
What is a Bard IVC Filter?
Bard IVC filters were originally designed to help patients who were at risk for a blood clot in the lungs (pulmonary embolism or PE). Though patients usually take blood-thinning drugs to reduce risk of clots, there are some patients who can’t take these drugs, or who have not experienced improvements while taking them. IVC filters are meant for them.
These devices are small, cage-like devices inserted into the inferior vena cava, which is a large vein that carries de-oxygenated blood from the lower body back to the heart. It comes from the legs and lower torso and empties into the right atrium of the heart. The filter, once implanted, traps blood clots so they can’t flow through the vein and lodge in the lungs. Once trapped, the clots may eventually dissipate.
The idea of interrupting blood flow to stop blood clots from causing problems is an old one, with the first IVC filter reaching the market in the late 1960s. Since then, manufacturers have created smaller, less invasive filters, some of which are meant to be temporary and others meant to permanent, but these newer designs have been plagued with problems.
Types of Bard IVC filters most associated with increased risk of injury include:
• Bard Recovery Filter
• Bard G2 Filter
• Bard G2 Express Filter
• Bard Eclipse Filter
• Bard Meridian Filter
• Bard Denali Filter
FDA Warns About IVC Filter Risks of Injury
The FDA first warned about the risks associated with these filters in August 2010. In that safety communication, they stated that the use of these filters had increased rapidly between 1979, when 2,000 were used, to 2007, when nearly 167,000 were implanted.
Between 2005 and 2010, the FDA stated they had received 921 adverse event reports involving these filters. Of these:
• 328 of those involved device migration
• 146 involved detachment of device components that moved to other parts of the body
• 70 involved perforation of the IVC
• 56 involved filter fracture
The FDA noted at the time that the problems could be related to temporary filters that were supposed to be removed after a certain amount of time, but hadn’t been. “The FDA is concerned that these retrievable IVC filters,” they stated, “intended for short-term placement, are not always removed once a patient’s risk for PE subsides.” They recommended that physicians consider removing the filters as soon as they were no longer needed to prevent PE.
In May 2014, the FDA issued an update to that communication, reiterating their advice to remove the filters as soon as protection was no longer needed. They noted that the filters had been linked to all the problems listed above, and stated that an analysis of the data showed that the risk/benefit profile favored removal of the device between 29 and 54 days after implantation.
They added that they were requiring additional clinical data for all IVC filters currently marketed in the U.S., to further examine their safety. Manufacturers like Bard were required to either participate in the PRESERVE (PREdicting the Safety and Effectiveness of InferioR Vena Cava Filters) study, or to conduct postmarket surveillance.
Studies Show Bard IVC Filters are Associated with Serious Side Effects
A number of scientific studies have found safety issues with IVC filters. Among them are the following:
• 2010: A study published in the Archives of Internal Medicine looked at patients who received a Bard Recovery or Bard G2 IVC between April 2004 and January 2009. Out of a total of 80 patients, they found that 16 percent of the filters fractured. A total of 25 percent of the Bard Recovery filters fractured and embolized. In five cases, patients had at least one fragment embolize to the heart (71 percent), presenting life-threatening complications. A total of 12 percent of the Bard G2 filters fractured.
• 2012: A study published in the American Journal of Medicine looked at data from patients who had received a vena cava filter, and compared it with in-hospital fatality rates. They found that the filters did not reduce mortality rates for stable patients. They did reduce mortality rates for unstable patients, but these are a small minority of patients receiving these filters. The researchers noted that the study results raised questions about whether widespread use of the filters is beneficial. Results also showed a number of complications associated with the filters, including migration, perforation of the vena cava, edema, other injuries caused by slow blood flow through the filter, and filter fracture.
• 2013: An editorial published in JAMA Internal Medicine questioned the safety of IVCs, with researchers noting that though the devices “should” work in theory, the results had “never been validated by empirical studies.” They stated that the history of the filter provided “valuable insights into the shortcomings of medical device approval in the United states.” In addition, they noted that the devices were plagued with high rates of occlusion (blockage of the inferior vena cava), PE, and migration.
• 2013: Another study published in JAMA Internal Medicine noted that there were no standards in place concerning when to implant IVC filters, with hospitals varying widely on their recommendations.
• 2013: Yet another study in the same journal raised additional concerns, with researchers noting that of 679 IVC filters, only 8.5 percent were successfully removed. Other cases involved unsuccessful attempts at removal and blood clot events (including PE). The researchers concluded that low retrieval rates and inconsistent use of blood-thinning drugs resulted in “suboptimal outcomes due to high rates of venous thromboembolism.”
• 2014: A study published in the Journal of the American College of Cardiology looked at 344 patients treated with a filter and 344 treated without a filter. They found that those who received a filter had a lower risk of PE-related death, but a higher risk of recurrent blood clots, which can be serious enough to cause death.
• 2015: A study published in JAMA compared patients with pulmonary embolism who received a filter and blood-thinning therapy, and those who received blood-thinning therapy alone. Researchers followed all patients for at least six months. Results showed that among hospitalized patients with severe acute pulmonary embolism, the use of an IVC didn’t reduce the risk of recurrent PE at three months. In other words, the filter seemed unnecessary in patients who could use blood-thinning drugs.
Bard IVC Filter Lawsuits
After the FDA released its 2010 safety communication, patients began to come forward seeking compensation for the injuries they suffered.
Plaintiffs involved in IVC Filter lawsuits claim that Bard failed to provide adequate warnings about the risks associated with its products, and failed to thoroughly study the devices before releasing them on the market. Plaintiffs point to the many studies that have raised questions about the safety if IVC filters, and claim that the manufacturers should have taken action much sooner to protect patients.
In August 2015, a total of 22 federally filed Bard IVC filter lawsuits were centralized in the District of Arizona. The lawsuits include cases concerning the Bard Recovery, Bard G2, and Bard G2 Express filters—all of which are designed to be retrievable.
Other cases are pending in various courts across the country. Some have already proceeded to settlement:
• Philips: Bard agreed to settle a Bard Recovery IVC filter lawsuit filed by Kevin Philips. The plaintiff claimed the filter broke inside him, with one of the small metal legs perforating his heart. He had to go through open-heart surgery to correct the problem. The trial was held in the U.S. District Court for the District of Nevada.
• Davis: Lisa Davis filed a Bard IVC lawsuit against the manufacturer after she claimed that her Bard G2 filter fractured and lodged in her heart. She claimed that the Bard G2 was defectively designed.
• Vlasvich: Kelly Vlasvich filed a Bard IVC lawsuit in the Northern District of Illinois, claiming that her Bard G2 filter had fractured, with pieces migrating to her heart.
These are only a few examples. There are many other cases pending, and more are expected to be filed now that the Bard IVC Filter MDL has been established.
Plaintiffs have presented evidence in early trials that Bard started receiving complaints about their filters as early as 2004, yet failed to take appropriate action to protect the public. Internal company tests also revealed that the Bard Recovery did not meet safety specifications, yet the company failed to withdraw it from the market until 2005, when the new G2 filter was ready to market.
Types of Injuries Associated with Bard IVC Filters
Bard IVC filters have been linked with the following serious injuries:
• Device fracture
• Migration to other body sections or organs
• Perforation of the inferior vena cava
• Perforation of the heart and/or lungs
• Severe pain
• Blood clots
• Pulmonary embolism
• Inability to retrieve the filter
A Bard IVC Filter Lawyer Can Help
Chaffin Luhana LLP is prepared to help patients who received Bard IVC filters and then suffered serious injuries. Bard had a responsibility to be sure their products were thoroughly tested and safe before releasing them on the market. They failed to protect patients as expected.
We can help evaluate the facts of your case to guide you in your legal options. A serious injury such as one caused by a Bard IVC filter can devastate an entire family. You may be entitled to compensation to help you deal with skyrocketing medical costs, therapies, prescriptions, and lost wages.
Call today for a free and confidential case evaluation at 1-888-316-2311.