Retrievable IVC Filters, including the C.R. Bard’s (unit of Johnson & Johnson) Recovery IVC Filter and C.R. Bard’s G2 IVC Filter System, have reportedly been fracturing and migrating inside of patients’ bodies, leading to serious injuries, including perforation of the interior vena cava (IVC). A fractured IVC filter may also perforate other organs, including the heart and lungs. When a retrievable IVC filter fractures and migrates, patients may experience severe pain, bleeding, further embolus, and other life-threatening complications.
The human body has two vena cavas, both are large veins that carry deoxygenated blood into the heart. The inferior vena cava is responsible for carrying blood from the lower body into the heart.
The defective medical device lawyers at Parker Waichman LLP are investigating potential lawsuit claims stemming from IVC filter injuries. While C.R. Bard’s Recovery IVC Filter and G2 IVC Filter appear to have the highest injury rates, other devices have been associated with similar complications.
IVC filters being investigated by Parker Waichman:
- B Braun Tempofilter IVC filter (retrievable)
- Bard G2x IVC (retrievable, unlimited indwell time)
- Bard G2 (retrievable)
- Cook Günther Tulip (retrievable)
- Cook Celect (retrievable)
- Cordis OptEase IVC filter (retrievable, 23 day indwell time)
- ALN IVC filter (retrievable)
- Rex Medical Option IVC filter (retrievable)
Parker Waichman is offering free lawsuit evaluations to victims of IVC filter injuries, including those caused by C.R. Bard’s Recovery IVC Filter and G2 IVC Filter System. If you or one you know suffered an injury due to the fracturing and migration of an IVC Filter, it is vital that you contact Parker Waichman LLP today to protect your legal rights.
About Bard’s Recovery IVC Filters & G2 IVC
IVC filters are placed in the inferior vena cava of individuals who have deep vein thrombosis in their legs to prevent blood clots that break off from traveling to the heart, lungs and brain. There are two types of filters: permanent and retrievable (meaning the filter is removed once the risk of emboli resolves). While most IVC filters currently on the market are permanent, the retrievable models appear to be associated with the most complications.
Both C.R. Bard’s Recovery IVC Filter and G2 IVC Filter System were approved for sale via the U.S. Food & Drug Administration’s (FDA) 510(k) protocols. This type of approval allows for clearance of a medical device without human clinical trials if a device maker is able to prove that the proposed device is substantially equivalent to another product already approved for sale and is on the market.
C. R. Bard removed the Recovery IVC from the market in 2005, but it is believed that there are still devices implanted in people. The G2, which was the replacement for the Recovery, is still being used.
Retrievable IVC filters have been associated with reports of fracturing and migration. Most often, the fractured portions of the device migrate to the heart and lungs of its victim. However, fragments of IVC filters can also migrate to other organs. Once the metal fragments from a retrievable IVC filter have deposited in the heart, lungs or another organ, grave injury, bleeding, severe pain, further embolus and other complications can occur.
In August 2010, the FDA issued an advisory, after it had received 921 adverse event reports involving IVC Filters. The reports to the agency included:
- Filter Migration (328 reports)
- Embolization (146 reports)
- IVC Perforations (70 reports)
- Filter Fracture(56 reports)
The FDA indicated in its alert that such complications may be related to a retrievable filter remaining in the body for long periods of time, well after the danger to the patient had subsided. The FDA recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from a blood clot is no longer needed.
Warning Signs and Complications of IVC Filter Failure
Warning signs that a Recovery IVC Filter or G2 IVC Filter System has failed include chest pain and shortness of breath. In most cases, victims end up in the emergency room. A CT scan or other test will be used to determine if the IVC filter system has failed.
The failure of the Recovery IVC Filter or G2 IVC Filter System may lead to serious and life-threatening complications. These include:
- Constant severe pain in the heart, chest, or elsewhere
- Pulmonary embolus
- Respiratory compromise
- Perforation of tissue, vessels, and organs
- Constant anxiety or worry over the fact that metal shards may be in the organs
Study Results: Medical Device Litigation and IVCFs
According to the June 2016 issue of Seminars in Interventional Radiology, the last several years have seen mounting lawsuits brought over inferior vena cava filters, prompting the United States Judicial Panel on Multidistrict Litigation (MDL) to centralize the lawsuits into two MDLs. One MDL involves Cook filters and one MDL involves C.R. Bard filters. Both MDLs share similar questions of facts, particularly if IVC filters’ design and manufacturing practices made the medical devices unreasonably prone to serious complications.
MDL case resolution will contribute to the larger legal debate that concerns how much legal protection the “1976 Medical Device Amendments” should provide firms from tort liability. This specialty typically relies on medical devices and it is, therefore, critical that interventional radiologists have at least a general understanding of medical device litigation and the ability to consider the approaches to informed consent regarding these IVCF devices.
Study Results: Evidence-Based Evaluation of IVCF Complications Based on Filter Type
A June 2016 study published in Seminars in Interventional Radiology found that many IVC filter types—as well as their specific risks and complications—are not recognized.
The study’s purpose was to evaluate the various FDA-approved IVC filter types to determine risks specific to the various devices studied so that there is a way to help determine patients who may benefit from ongoing follow-up without having to undergo filter retrieval.
An evidence-based electronic search—FDA Premarket Notification, MEDLINE, FDA MAUDE—was conducted to identify all IVC filter types and device-specific complications. The search period was from 1980 to 2014 and, of the IVC filter types, the 23 IVC filter types identified 14 retrievable and nine permanent. Device categorization included:
- Conical (14)
- Conical with umbrella (1)
- Conical with cylindrical element (2)
- Biconical with cylindrical element (2)
- Helical (1)
- Spiral (1)
- Complex (1)
The purely conical filters were tied to the greatest number of risks of penetration at 90-100 percent, while filters with cylindrical or umbrella elements were associated with the highest reported risk of IVC thrombosis at 30- 50 percent. Meanwhile, Conical Bard filters were tied to the highest reported risk of fracture at 40 percent. According to the researchers, “the various FDA-approved IVC filter types were evaluated for device-specific complications based on best current evidence.”
Study Results on Failed Optional Inferior VCFs
A single-center retrospective study conducted at the Louisiana State University Health, Shreveport, Louisiana in May 2016 evaluated causes of failed optional inferior VCF (IVCF) retrievals. Researchers concluded that filter duration and misalignment were significantly tied with IVCF retrieval failures.
The team attempted IVCF retrievals in 26 out of 211 individuals-12 percent-at a mean of nearly 43 days. Nine failures occurred and all of the failures involved the OptEase device. Failures were due to: inability to snare the hook, noncollapsible IVCF, and unusual pain associated with the procedure. The median duration of the retrieved IVCFs was 31, while the median duration was 53 days for failures. The researchers also noted that IVCFs aligned with VCFs cephalocaudal axis (long axis of the body) were retrieved in 13 of 16 cases; misaligned IVCFs were retrieved in four of 10 cases.
MDL Established for Bard IVC Filter Lawsuits
According to a United States Judicial Panel on a Multidistrict Litigation (MDL) Transfer Order dated August 17, 2015, cases brought over the Bard IVC filter have been consolidated in the District of Arizona. The MDL is In Re: Bard IVC Filters Products Liability Litigation (MDL No. 2641), the Honorable David G. Campbell is presiding. As of November 2015, more than 50 lawsuits were involved in this MDL.
Lawsuits in the MDL stem from common allegations that Bard’s retrievable IVC filters were defectively designed and prone to fracture, migration, tilt or perforation of the inferior vena cava. Centralizing common lawsuits to one court before one judge makes complex litigation more efficient because it eliminates duplicate discovery and avoids inconsistent pretrial rulings.
FDA Warning Letter Cites Federal Violations
In a letter dated July 13, 2015, the FDA cited eight violations of federal law regarding Bard’s IVC
filters, which include the Denali Filter, the Simon Nitinol Filter, and the Recovery Cone Removal Kit. The FDA identified the violations at the Bard Peripheral Vascular facility in Tempe, Arizona and the C.R. Bard Inc. facility in Queensbury, New York.
According to the FDA warning letter, Bard failed to correct violations at the two facilities. The violations were brought to light following Inspectional Observations that took place from November 18, 2014 through January 5, 2015 in Arizona and from October 6, 2014 through November 25, 2015 in New York.
At the Arizona facility, Bard was cited for manufacturing the Recovery Cone Removal System without marketing clearance or approval, making the device adulterated. The FDA also criticized Bard for failing to report a device malfunction that might likely result in serious injury or death. Additionally, the FDA letter indicated Bard misfiled several customer complaints, including the report of one patient’s death. At the Queensbury, New York facility, Bard was cited for failing to validate a procedure used to clean the IVC filters.
Bard IVC Filters Side Effects May Lead To Pulmonary Embolus Lawsuits
Bard’s Recovery IVC Filter and G2 IVC Filter System have been associated with serious injuries and even deaths.
The injuries allegedly caused by failure of the Bard Recovery IVC Filter and G2 IVC Filter System have already sparked lawsuits around the country. If you or someone you know has been injured by one of these allegedly defective medical devices, our Bard IVC Filter System injury lawyers want to hear from you today.
Bard Recovery IVC Filter and G2 IVC Filter System lawsuits allege that these devices were defective and caused life-threatening injuries to the plaintiffs. Such lawsuits seek damages for medical bills, lost wages, and pain and suffering. If you were injured by one of these devices, you may also be eligible for such compensation.
Bard Recovery IVC Filter and G2 IVC Filter System Injuries
IVC filters are meant to filter blood clots that travel from the lower portions of the body to the heart and lungs known as deep vein thrombosis, or DVT. If a DVT travels to the lungs, a life-threatening pulmonary embolism may occur. IVC filters were initially marketed to remain in the body for a finite period of time and, therefore, marketed as retrievable.
The Recovery IVC Filter and G2 IVC Filter System are manufactured and marketed by C.R. Bard and Bard Peripheral Vascular, Inc. The Recovery IVC Filter was approved by the FDA in 2003. The device was marketed as a retrievable device, but safe for permanent placement within the body.
Unfortunately, the Recovery IVC Filter proved troublesome from the start, as several studies published in medical journals pointed to a high failure rate for the device.
According to these studies, the Recovery IVC Filter systems were prone to fracture and migration. Most often, these fractured portions of the device may migrate to the heart and lungs of its victim; however, the pieces may migrate to other organs. Once the metal pieces have deposited in an organ, grave injury, bleeding, severe pain, further embolus, and other complications may occur.
One study, published in the Journal of Vascular and Interventional Radiology in November 2008, found the rate of fracturing and migration with the Recover IVC filter concerning. To conduct the study, all patients who received a Bard Recovery filter at a single institution were contacted for consultation and evaluation by noncontrast computed tomography. Fourteen of 16 patients with Bard Recovery filters were evaluated. Final images demonstrated filter arm perforations in all 14 patients, and there were a total of four fractures with migration in 21 percent of patients.
The Recovery IVC Filter was ultimately pulled from the market in 2005 and was replaced by the G2 IVC Filter system, which was modified to reduce filter fracture and migration. Unfortunately, studies have shown that the G2 IVC Filter system is also prone to fracturing and migration.
Once the Recovery IVC Filter or G2 IVC Filter system is found to have failed, patients must undergo surgery to remove the device, as well as any broken pieces. In some cases, it may be too dangerous to remove the fractured components due to the risk of further injury and/or death.