Bard IVC Filters
Pittsburgh residents and others in the Ohio Valley area who have been implanted with a Bard IVC filter and then experienced serious side effects like migration and perforation may be eligible to file a personal injury lawsuit in an attempt to recover damages.
In 2010, the FDA warned that IVC filters had been associated with 921 reports of adverse events, and recommended doctors remove them as soon as the risk for pulmonary embolism had passed. Since then, a number of studies have linked these devices with serious problems, including migration of the device into other areas of the body, and perforation of the inferior vena cava vein.
The IVC filter lawyers at Chaffin Luhana have been following developments with Bard IVC filters, and stand ready to help victims who have suffered because manufacturer C. R. Bard failed to conduct appropriate safety studies on its products before releasing them onto the market. Families severely affected by hospitalizations and other medical procedures required because of defective IVC filters could receive compensation in the courts for their medical costs and pain and suffering.
What is a Bard IVC Filter?
Bard IVC filters are tiny devices designed to look like cages or spiders, with legs or “struts” that capture blood clots and hold them until they dissipate. Patients at risk for pulmonary embolism (PE)—a life-threatening condition involving a blood clot lodged in the lungs—who are unable to be treated with anticoagulant drugs, may be implanted with one of these devices to help reduce risk of PE.
The physician implants the IVC filter in the inferior vena cava—the main vein that takes deoxygenated blood from the lower legs back to the heart. It is this vein that can carry a blood clot from the lower legs into the lungs, in patients with deep vein thrombosis (DVT), or in other patients at risk for blood clots.
Most IVC filters, including the Bard Recovery, Bard G2, and Bard G2 Express, Bard Eclipse, Bard Meridian, or Bard Denali, were designed to be temporary, which means they can be retrieved and removed after the risk for PE has passed, or when the patient is able to go on a different therapy, such as anticoagulant medication.
Guidelines for when to remove the devices, however—or even when to implant them—have been lacking. Unfortunately, in many cases, the filters were not removed as soon as they should have been, and were left to create problems inside the body.
FDA Tackles Question of When to Remove Bard IVC Filters
When the FDA issued their safety communication in 2010, they noted that they believed many of the problems associated with IVC filters could have come about because the devices were left inside the body for too long. Among the 921 adverse event reports they received:
• 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
After releasing the initial safety communications, the FDA began to tackle the job of figuring out how long these devices should remain in the body. A 2013 study reported that the decision for when to implant the devices ranged widely among hospitals.
In May 2014, the FDA released an updated communication stating they had “developed a quantitative decision analysis” based on available data in the medical literature. They published the analysis in the October 2013 issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders. The conclusion: after the risk of PE has passed, benefit/risk profile favors filter removal between 29 and 54 days after implantation.
Though the analysis provided some guidance for retrieving Bard IVC filters, the FDA noted that there remained unanswered questions concerning the safety of the devices. They required manufacturers to either participate in the PRESERVE study, which is examining the safety of IVC filters, or to conduct postmarket surveillance to further understand the patterns of use and improve patient care.
Studies Indicate Bard IVC Filters May Provide No Additional Benefit
Studies over the past several years have raised serious concerns about the risks linked to Bard IVC filters, and of IVC filters in general. In 2010, for example, researchers looked at both the Bard Recovery and the Bard G2 IVC filters in 80 patients. The results showed the following:
• Thirteen (16 percent) of the patients suffered at least one strut fracture, which means one of the “legs” or struts of the device came off.
• At least one strut in 7 (25 percent) of the Bard Recovery filters fractured and embolized, meaning it caused an obstruction in the blood vessel.
• In five of these 7 cases, patients had at least one fragment embolize to the heart.
• Three patients experienced life-threatening symptoms, including one who experienced sudden death at home.
• Six of 52 (12 percent) Bard G2 filters fractured.
The researchers concluded that the Bard Recovery and Bard G2 filters had “high prevalences of fracture and embolization, with potentially life-threatening” consequences.
A 2012 study on IVC filters in hospital settings found that the devices did not reduce mortality rates for stable patients, causing the researchers to question the widespread use of the devices. Doctors published an editorial in 2013 questioning the safety of the devices on the whole, noting that the scientific literature did not support their efficacy, while another study that same year found that out of 679 IVC filters, only 8.5 percent were successfully removed as they were supposed to be.
More recent studies have done nothing to improve the reputation of these devices. In 2014, researchers looked at patients treated with a filter and those without one, and found that the devices did reduce of PE-related death, but also increased risk of recurrent blood clots. Finally, a 2015 study reported that in patients who had experienced a pulmonary embolism, the IVC filters, when combined with anticoagulant therapy, didn’t reduce the risk of recurrent PE at three months. They concluded that the devices were unnecessary in patients who could be treated with blood-thinning drugs.
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
Sample Bard IVC Filter Lawsuits
The 2010 FDA safety communication regarding IVC filters brought to light a problem that many were unaware of until that time and that the IVC Filter manufacturers have known for a long time. Patients who had experienced injuries with these devices were often in the dark as to what had caused the problems.
After the FDA noted that Bard and other IVC filters were associated with several serious health issues, patients began to come forward seeking compensation for their medical expenses. So far, a couple of those lawsuits have already been settled.
In January 2015, for example, Bard settled the case of a plaintiff for an undisclosed amount. The IVC lawyers in the case were able to show that Bard was aware of issues with the Recovery filter as early as 2004, but failed to take appropriate action to protect the public. Evidence revealed during the trial showed that the company also performed their own tests on the device that revealed it failed to meet safety specifications, and that it was more likely to migrate to other areas of the body than other similar IVC filters, and more likely to fracture.
In another Bard IVC lawsuit, the plaintiff had filed in June 2012, and went to trial in 2015 in the District of Nevada. He claimed that the IVC filter had broken off and perforated his heart. After ten days of trial, both sides revealed that they had come to a settlement agreement.
Panel Agrees to Consolidate Federal Bard IVC Lawsuits
With the growing number of Bard IVC lawsuits filed across the country, it became evident that pre-trial proceedings could be handled much more efficiently in one court. In June 2015, plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal cases in the Eastern District of Pennsylvania, the Northern District of Texas, or the District of Nevada.
In August 2015, the panel responded by transferring all federal Bard IVC lawsuits—22 at the time—into the District of Arizona, under the guidance of U.S. District Judge David G. Campbell. According to the transfer order, all cases involved common questions of fact arising from allegations that defects in the design of Bard filters “make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.”
The JPML added that centralization would reduce the risk of duplicative discovery and inconsistent rulings, and would conserve the resources of the parties and the courts. The District of Arizona was the best location, they stated, because Bard is headquartered there, which means most of the pertinent documents and witnesses would be found there, and because the district was not burdened by many other MDLs.
Bard argued against the MDL, arguing that informal coordination among the limited number of counsel was a better solution than formal centralization.
A Bard IVC Filter Lawyer Can Help
Those living in Pittsburgh or the surrounding areas of the Ohio Valley who were implanted with a Bard IVC filter and then suffered from serious side effects could potentially recover medical costs and lost wages in a personal injury lawsuit.
Patients who are suffering because of Bard’s failure to provide adequate warnings about the risks associated with their products, or to properly test them for safety, should not have to pay for additional surgeries and other medical procedures out-of-pocket. The IVC filter lawyers at Chaffin Luhana are extremely knowledgeable about these filters and the litigation surrounding them, and can help you evaluate the facts of your situation to see if you may have a case.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Pennsylvania, and Eastern Idaho. Call today for a free and confidential case evaluation at 1-888-316-2311.