Lawsuit Claims Bard IVC Filter Migrated & Perforated Vein

A North Wales, PA man has filed an IVC filter lawsuit against C.R. Bard, Inc. and Bard Peripheral Vascular, Inc., claiming the faulty device caused him to suffer serious and permanent injuries.

An IVC filter is a small, cage-like device that is inserted into the inferior vena cava — the main vessel returning blood from the lower half of the body to the heart — to trap blood clots and keep them from reaching the lungs.

In 2012, Kevin Gross underwent surgery for the placement of a Bard IVC filter. Shortly after, in 2013, it was discovered that the IVC filter had tilted in a direction not consistent with initial implementation and that it had migrated within the vein and perforated it, causing him to sustain an injury. According to the claim, he was forced to undergo extensive medical treatment and care, including technically difficult surgery in an attempt to remove the IVC filter. The attempt failed and the device remains inside his body.

Details of IVC filter lawsuit

According to his lawsuit, the plaintiff has suffered and will continue to suffer vast damages from the IVC filter, including pain and suffering, costly medical bills, disability, loss of enjoyment of life and more. He will require ongoing care to monitor the G2 IVC filter to make sure it doesn’t cause any further injury.

The claim states the defendants should have known that no clinical testing had been conducted to determine whether the RECOVERY filter would perform safely once inside the human body. It notes that Bard and BPV received a growing number of adverse event reports from 2003 to September 2005, reporting numerous failures and injuries. Consequently, they knew or should have known that the failure rates associated with the device were much higher than similar products on the market.

The plaintiff is suing Bard on seven counts, including:

• Strict Products Liability — Design Defect
• Breach of Implied Warranty of Merchantability
• Negligence
• Strict Products Liability — Failure to Warn
• Punitive Damages
• Strict Products Liability — Manufacturing Defect
• Negligent Misrepresentation

FDA alerts public about IVC filter complications

On May 6, 2014, the U.S. Food and Drug Administration issued a safety communication noting the receipt of adverse events and product problems linked to IVC filters. Issues with the device included migration, embolization, filter fracture, difficulty removing the device and perforation of the IVC. The agency noted that incidents may be related to the length of time the filter has been implanted.

“Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion,” said the FDA safety communication. “For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”

The FDA advises medical professionals responsible for the ongoing care of patients with retrievable IVC filters to consider removing them as soon as protection from pulmonary embolism is no longer needed. The FDA developed a quantitative decision analysis using publicly available date from medical literature to determine that if a patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile starts to favor removal of the device between 29 to 54 days after implantation.

In October 2013, these results were published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

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