IVC Filters Lead to Severe Injury
Two manufacturers of inferior vena cava filters (IVC filters) have begun facing numerous lawsuits brought by patients who suffered serious injuries due to defective IVC filters. Specifically, manufacturers C.R. Bard and Cook Medical are defendants in a growing group of lawsuits coordinated in Arizona and Indiana.
What is an IVC Filter?
An IVC filter is a small medical device that is surgically inserted into the inferior vena cava (a large vein that brings blood to the heart). The device is intended to prevent blood clots from traveling to the lungs or heart in patients who are at risk of clotting and cannot take anticoagulants (blood thinners).
The devices are typically placed in patients who recently underwent bariatric or orthopedic surgery or who have undergone surgery related to a traumatic event.
IVC filters have been on the market for years for permanent implantation. However, the retrievable type of IVC filter has come under significant scrutiny by the U.S. Food & Drug Administration after the agency has received numerous reports of injuries or even death caused by the defective devices.
What types of injuries do IVC Filters cause?
Retrievable IVC filters such as the Bard Recovery, Bard G2, Bard G2X, Cook
Gunther Tulip, and the Cook Celect can lead to severe injuries.
Specifically, these filters can cause the following:
• IVC Filter migration
• IVC Filter fracture
• IVC Filter perforation
• Tilting of the IVC Filter
• The inability to retrieve the IVC Filter
• Pulmonary embolism
The filters have a set of struts which can fracture and migrate, which can lead to an embolism or other serious events. Further, the struts or the filter can perforate through the inferior vena cava and surrounding organs. Although some retrieval attempts are successful, if the filter or the struts migrate to particular parts of the body, a doctor may not be able to retrieve the devices, which can lead to further complications.
Defective IVC Filter litigation
In October 2014, the Judicial Panel on Multidistrict Litigation agreed
to consolidate claims against Cook Medical related to its defective IVC
filters in the Southern District of Indiana. Similarly, in August of this
year, the panel coordinated claims against C.R. Bard in the District of Arizona.
Numerous claims remain pending in Indiana, Arizona, and in other jurisdictions across the country. For more information, contact us.
FDA Warns of Defective IVC Filters
The U.S. Food & Drug Administration has recently provided new safety warnings to patients who have inferior vena cava filters (IVC filters), as well as the physicians caring for them. This is the third time the FDA has issued safety information about the popular medical devices.
2015 FDA Warnings
On July 13, 2015, the FDA issued a warning letter to C.R. Bard—the manufacturer of a variety of retrievable IVC filters—outlining a series of safety concerns regarding the devices.
The most concerning involves Bard’s Recovery Cone Removal System, which is the device that is intended to be used to retrieve the IVC filters once the risk for a pulmonary embolism is resolved. According to the FDA, Bard never obtained FDA approval for the removal system, meaning that Bard has violated FDA regulations and federal law by marketing and selling an unapproved medical device for use in the United States.
Equally concerning, the FDA’s warning letter indicated that Bard filed to establish and maintain procedures for receiving, reviewing, and evaluating adverse event complaints for its G2, G2x, and Eclipse IVC filter products.
The company was also cited as failing to submit 30-day reports as soon as Bard became aware of information “that reasonably suggests that a device that your firm markets had malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”
To read the FDA’s July 13, 2015 warning letter regarding defective IVC filters, click here.
Prior FDA Safety Communication
The 2015 warning letter is not the first time the FDA has issued safety information regarding retrievable IVC filters, which have been on the U.S. market since the early 2000s.
In August 2010, the FDA issued guidance to IVC filter physicians alerting them to the fact that over 900 adverse events had been reported to the FDA involving device migration, embolizations (detachment of the device pieces), perforations of the IVC, and filter fractures. The agency advised that due to increased risk of these complications over time, physicians should consider removal of the devices as soon as the risk for a pulmonary embolism is diminished.
To read the FDA’s initial safety communication concerning IVC filters, click here.
Subsequently, in May 2014, the FDA issued another safety update, encouraging physicians involved in the treatment and follow up of patients with IVC filters to remove them as soon as protection from a pulmonary embolism is no longer needed. The FDA advised that physicians should consider removal when the risk/benefit profile favors removal and the patient is healthy enough to undergo the removal.
To read the FDA’s May 2014 safety update regarding IVC filters, click here.
The attorneys at Shrader & Associates L.L.P. are currently evaluating defective IVC filter cases. For more information, contact our team.