IVC Filter Lawsuits
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Retrievable inferior vena cava filters (IVC filters) are small, spider-shaped medical devices which are designed to help prevent pulmonary embolism. Pulmonary embolism (PE) occurs when a blood clot forms in the body, travels through the heart and becomes lodged in one of the branches of the pulmonary artery in the lung. The inferior vena cava is where deoxygenated blood enters into the organ. A PE often is life-threatening. This filter serves as a form of a blood thinning medication, since not all people can’t take blood thinning medication. The primary role of the filter is to capture blood clots before they even occur.
IVC filters are designed to prevent pulmonary embolism by being placed in the vein of a patient so it will catch any blood clots before they are able to reach the lungs. The device is then placed into the inferior vena cava, which returns blood to the heart from the lower half of the body. The device’s purpose is to catch or filter clots before they reach the heart.
Manufacturers of IVC Filters
The two largest manufacturers of IVC filters are C.R. Bard and Bard Peripheral Vascular (Bard) and Cook Medical. Other manufacturers include Johnson & Johnson, Boston Scientific, B. Braun Medical, ALN, Rex Medical and Rafael Medical.
Complications with Retrievable IVC Filters
When the filter is first implanted the vein can become damaged or blood clots can form and bypass the device. However, more serious complications can occur because of the filters themselves. These complications include:
- Device migration – The device moves into a dangerous position
- Filter fracture – A piece of the device breaks off, causing injury
- Embolization – The entire filter or fragments move into the heart and lungs
- Perforation – The device perforates the inferior vena cava or other internal organs
- Difficulty removing the device – The patient may need surgery to remove the device, but the IVC filter cannot be safely removed due to the risks associated with removal.
In 2010, the FDA issued an initial communication expressing concerns about the long-term use of IVC filters. At this point, the FDA had received 921 device adverse event reports involving IVC filters. Those reports included:
|Type of Adverse Event||No. of Reports|
|Perforation of the IVC||70|
The FDA stated that these events may be related to the IVC filter remaining in the body for long periods of time – beyond the time when the risk of pulmonary embolism has subsided. As a result, 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 pulmonary embolism is no longer needed.
Updated FDA Warning: 2014
On May 6, 2014, the FDA released an updated warning about these devices. The FDA continued to warn of the risk of retrievable IVC filters. Based on the FDA’s research, if a patient’s risk for pulmonary embolism has passed, then it is better to remove the IVC filter between 29 and 54 days after implantation, or else the risk of serious side effects would be higher.
Bard IVC Filters
While there are many manufacturers of IVC filters, the FDA has expressed specific concern with Bard IVC Filters. The FDA expressed those concerns in a warning letter sent to the company in July 2015. The FDA stated that it had found the following violations in its inspection of the Bard facility:
- The Bard Recovery Cone Removal System had never been approved or cleared by the FDA
- The methods used to manufacture, store and package did not conform to GMP
- The “Denali” filter had been misbranded due to failing or refusing to provide material and information
- Bard failed to properly establish and maintain procedures for reviewing and evaluating complaints related to the G2, G2X and Eclipse Filters
- The company also failed to report information that reasonably suggested that its device had malfunctioned and was likely to cause death or serious injury.
Current litigation: Bard and Cook
Approximately 102 cases have been filed against Cook for its IVC filters and more than 400 cases have been filed against Bard. Have the manufacturers disclosed all they know about the risks or potential dangers of these devices? Regardless, the manufacturers have decided to not issue a recall of their devices.
Bariatric patients were potentially targeted as patients to receive the IVC filter. So, if you are a bariatric patient, we suggest you consult with your physician if you received such a device.
Contact Our Raleigh IVC Filter Attorneys
If you or a loved one received an IVC filter and experienced any complications as a result of the filter, contact us by calling or emailing us on the form on the right of the screen for a free consultation today.