IVC Filter Manufacturers Ignored Safety Warnings

Defective medical devices pose serious health risks for patients who rely on safe medical proceedures performed in hospitals. Although all medical devices, especially when new on the market, pose some risks to patients, defective medical products can cause serious injuries and even death. Nevada patients who suffer injuries require assistance from a Reno defective medical device lawyer who can protect their legal rights.

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Law

What Does an IVC Filter Do?

An IVC filter (inferior vena cava filter) is a retrievable, metal device designed to entrap blood clots, so they can’t move to the heart or lungs. It has a number of thin wire legs that serve to catch blood clots. IVC filters are implanted in a large vein called the inferior vena cava that runs vertically through the torso and returns circulated blood to the heart. Filters are typically used in patients with deep vein thrombosis or those who are at risk for developing blood clots after surgery. Whenever possible, patients are given anticoagulant therapy, but patients who can’t use anticoagulants often require an IVC filter implant. Each year, about a quarter of a million blood clot filters are implanted in patients who can’t tolerate blood thinners.

IVC Complications and Injuries

IVC filters have made headlines recently as one of those defective medical products that are causing injuries. They have caused dozens of deaths and hundreds of serious injuries in patients who have had them implanted. Over the last ten years, IVC filters have been implanted in millions of Americans with rising numbers of complication and injury reports. Nevada patients injured by IVC filters consulted a Reno defective medical device lawyer who could defend their rights for personal injuries. Government data shows reports of 27 deaths and 300 non-fatal injuries in patients who received IVC filters. Since 2010, there have been over 900 reports of IVC filter injuries that include:

  • Filter Perforation – The filter cut through the inferior vena cava and punctured internal organs.
  • Filter Migration – The filter became displaced and moved to another part of the body.
  • Filter Tilt – The filter tilted inside the patient’s vein causing difficult removal.
  • Filter Fracture – The filter’s thin metal legs broke off.
  • Device Embolization – The filter or components traveled to the heart or lungs.
  • Device Removal  – The filter can not be removed due to movement or fracture.

IVC Safety Warnings Ignored

In 2010, the FDA (Food and Drug Administration) issued a safety alert regarding defective IVC filters after receiving hundreds of injury reports. They warned that the IVC filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA safety communication was reiterated in 2014, but the warnings came too late for many patients that suffered injuries from IVC filters. In Nevada, plaintiffs began filing lawsuits with a Reno defective medical device lawyer.

C.R. Bard, a major manufacturer of IVC filters, neglected to notify physicians or the public after they discovered ongoing risks associated with their devices. FDA reports indicate that Bard was aware of the malfunctions as far back as 2002, but they failed to take any actions. Instead, the company consulted with Dr. John Lehmann to compare newer models to older models to see if failure rates had improved. In addition, the FDA found that Bard had a number of quality system violations at their facilities that were never addressed. In August 2010, the FDA reported over 900 IVC filter injuries that included: 328 filter migrations; 146device detachments; 70 device perforations; and 56 filter fractures. In this report, the FDA expressed concerns about IVC filters, intended for short-term placement, being left in place too long, and they recommended that surgeons remove IVC filters as soon as possible.

IVC Filter Litigation

Manufacturers C.R. Bard and Cook Medical are now at the center of IVC filter litigation. In 2012, plaintiffs filed the first lawsuits against Bard in Pennsylvania and California state courts. In October 2014, the U.S. Judicial Panel consolidated Cook lawsuits from 11 districts to a Multi-district litigation panel in Indiana. Since then, the number of lawsuits against Cook has risen to more than 100. Various lawsuits across the country claim negligence; design defects; manufacturing defects; failure to warn; and breach of implied warranty.

In 2015, Kevin Phillips, a Nevada resident, filed a lawsuit with a Reno defective medical device lawyer. Mr. Phillips was fitted with a Bard Recovery Filter System in 2005. The device was not removed and migrated to his heart in 2010 causing life-threatening complications that required emergency open-heart surgery. Ten days into the February 2015 trial, C.R. Bard settled with Mr. Phillips for an undisclosed amount.