IVC Filters May Fracture If Not Removed In Established Time Frames Parker Waichman

IVC Filters May Fracture If Not Removed In Established Time Frames

Posted on

C.R. Bard May Have Known About Issues with Recovery and G2 Filters

At least 27 deaths have been tied to a C.R. Bard blood clot filter named the Recovery. Allegedly, C.R. Bard replaced the device with a modified version. Soon after the modified medical device was approved, C.R. Bard allegedly knew that it had similar problems to the initial version of the device, according to NBC News.

Despite that C.R. Bard was aware of complications associated with its blood clot filter, the device maker continued to sell the medical devices. According to NBC News, just four months after C.R. Bard released the G2 Bard blood clot filter, the device maker was concerned about failure reports. The G2 was created to replace the Recovery Bard blood clot filter and, since that time, the device has been tied to more than one dozen deaths and many injury reports.

Dr. William Kuo, a specialist in removing blood clot filters that have failed, told NBC, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications.” The Stanford radiologist also said that, “[t]he number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

The attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

C.R. Bard Recovery Filter Background

According to a prior NBC News report, IVC filters—sometimes known as blood clot filters—are implanted in approximately 250,000 Americans annually. In the last decade or so, millions of filters have been implanted in Americans.

C.R. Bard is one of 11 makers of IVC filters and had hoped to gain traction in the profitable filter market when it introduced the Recovery filter, receiving FDA clearance to market the device in 2002. It was then that reports of deaths and injuries tied to the device moving and breaking steadily mounted, according to NBC News. A confidential study commissioned by C.R. Bard revealed that the Recovery filter had increased rates of relative risk for death, filter fracture, and movement when compared to its competitors. An outside doctor hired to conduct the study wrote that “further investigation … is urgently warranted.”

C.R. Bard opted against recalling the Recovery from the market and, in 2005, after the device had been sold for three years, Bard finally replaced the Recovery with a similar device, the G2 series of filters. Internal Bard records and hundreds of reports to the U.S. Food and Drug Administration (FDA) reveal that that the G2 series did not resolve the IVC device’s issues.

A confidential memo written in December 2005 by a Bard vice president after the G2 was cleared by the FDA reveals his concern about “problems with … migration,” “tilting,” and “perforation.” He noted that Bard had another filter on the market with virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he questioned. Another later document includes data through 2010 that reveals that the G2 series filters experienced even more fractures, migrations, and reported problems than any of its competitors, according to NBC News. The C.R. Bard G2 series filters remained on the market until 2010.

In 2010, a man underwent implantation with the Bard G2 Express due to his body’s propensity to develop blood clots. The patient, 69, asked his physician in October 2015 to check on how the filter was doing and learned it had moved. His physician told him that the Bard filter was “dangerously close to your heart,’” according to NBC News. Two surgeons declined to remove the filter given its precarious position. The patient asked Dr. Kuo, whose team developed an advanced technique to remove failed filters and filter pieces. During emergency surgery, Dr. Kuo found that three legs broke off the filter, traveling to the patient’s lungs. Dr. Kuo said that two partially broken legs completely broke away during the operation. One, he said, could have killed the patient. “It floated off right in front of our eyes,” said Dr. Kuo. “First into the right atrium and then into the right ventricle. He’s very lucky.”

Kuo told NBC News that, in the prior 10 years he has removed 1,000 failed filters and noted that he has removed more Bard filters than any other single make of filter. Dr. Kuo said that, the Recovery and G2 series filters should have been pulled from the market and that, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.” In addition with device companies, the FDA must take stronger action to protect patients. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” he said, according to NBC News.

What is an IVC Filter?

The FDA approved inferior vena cava (IVC) filters in 1979. The human body has large veins known as inferior vena cavas; these veins carry deoxygenated blood from the legs to the heart. The filters are “spider shaped” medical devices that look similar to a small cage, are approximately one-and-a-half-inches, are constructed of metal, and are inserted into the IVC. Once inserted, the filters are meant to capture blood clots that may travel to the heart, lungs, and brain.

IVC filters are typically prescribed for patients unable to take anticoagulants; when a patient is diagnosed with a recurrent pulmonary embolism (PE); a blood clot, especially a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); or if a patient suffered a significant accident or injury. Blood clots from the lower body may take place after knee or hip replacement surgeries.

For the most part, IVC filters are only meant to remain in the body on a temporary basis and should be removed when the threat of clots is over. Previously, some IVC filters were left in patients’ bodies permanently or for extended time periods, which may lead to life-threatening complications.

In 2010, the FDA warned that long-term use of IVC filters should be discontinued given risk of IVC filter damage, noted that IVC filters are intended as a temporary measure, and warned physicians to consider risks when discussing removal of these devices with their patients. The agency updated its warning in 2014, recommending that retrievable IVC filters be removed 29 – 54 days following implantation. Research shows that IVC filter risks outweigh their benefits when the filter remains in the body for more than two months. In one FDA warnings, it indicated that IVC implants may break in a patient’s body, potentially traveling through the bloodstream and into vital body areas with fragments potentially puncturing veins and organs. Pieces may become lodged in high-risk areas, according to NBC News.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/ivc-filters-may-fracture-not-removed-established-time-frames/

Advertisements