Bards IVC filters are supposed to protect patients from dangerous blood clots. But the devices are potentially deadly themselves.

IVC Filters; such as Bards IVC filters, Bard G2 filter, and the Bard G2 Express filter, are implanted into the inferior vena cava to limit where blood clots can travel in the body. The Bard IVC Filters were designed to prevent blood clots from forming, preventing stroke and other life-threatening events. Unfortunately, a number of studies show that shards can break from the filter and may be just as deadly as a stroke.

  • A study conducted by the New England Society for Vascular Surgery noted a 31% fracture rate in IVC filters. Most of the splinters found their way to patients’ right ventricles of the heart.
  • Another study conducted by Dr. Nicholson of York Hospital, showed that 25% of the group had splinters that broke off, most of which migrated to an end organ, such as the heart, lungs and the hepatic vein.

 

Know the Risks of a Defective IVC Filter

The IVC filter is a wire device that looks something like a spider, set snugly against the walls of the inferior vena cava. Any one of the metal extremities on the device can fracture and be carried away by the blood stream, finding its way to the heart or lungs. The likelihood of splintering increases the longer the device remains in the body.

The use of an IVC filter may cause the following problems:

  • IVC Filter migration
  • IVC Filter fracture
  • IVC Filter perforation
  • Tilting of the IVC Filter
  • The inability to retrieve the IVC Filter
  • Pulmonary embolism
  • Compromised respiration
  • Stroke
  • Death

 

Did IVC Filter Manufacturers Know About the Danger?
Over 100,000 IVC filters have been in use since the 1960’s. These devices were not intended for permanent placement. Manufacturers made the devices retrievable so that doctors could remove the devices once the danger of blood clots or pulmonary embolism passed and the filters were no longer needed. Bard, however, allegedly petitioned for the device to be approved as a permanent implant. Based on the above noted studies and others, the FDA now recommends the devices be removed as soon as the risk of pulmonary embolism subsides. A number of other manufacturers make IVC filters with similar risks, including Bard, Cook, and B. Braun.

It is alleged that as early as 2003, Bard’s own research showed that the IVC filters posed an unreasonable danger to patients from splintering. The company did not tell the FDA about their findings, or warn patients or doctors, and continued to sell and market the deadly Recovery IVC filter until it could create a suitable replacement for the market. Bard only removed the Recovery IVC from the market when it had a new filter, the G2, ready in 2005. Since 2005, the FDA has received 921 device adverse event reports involving IVC filters.

Long History of Attempts to Dismiss Defective IVC Filter Case
Bard has tried, on multiple occasions, to have cases alleging injury from their devices dismissed. However, plaintiffs’ efforts to thwart these attempts have been repeatedly upheld as courts across the country find cause to allow testimony and have the cases decided by a jury.

Late last year, California Superior Court Judge Edward Sturgeon denied a motion by Bard for summary judgement. In what was the second attempt by the medical device manufacturer stop the case from going to trial, the Court stated that enough evidence existed that Bard had acted negligently and that the case should be allowed to proceed.

Bard’s attempts to dismiss an IVC filter lawsuit were derailed again in late 2014. United States District Court Judge Robert C. Jones denied yet another motion for summary judgement by C.R. Bard attorneys. Judge Jones’ decision is notable as it also upheld the plaintiff’s right to seek punitive damages in the case. Punitive damages are generally used as punishment for acts deemed to be extraordinarily negligent or deliberate.

While none of these decisions hand a victory to the plaintiffs in the cases, they do show that courts are not willing to simply dismiss the accusations against Bard and that the facts of the cases should be brought to light.

What Can I Do If I Have Been Injured By An IVC Filter?
The Pisanchyn Law Firm is investigating these and other allegations about IVC filters. If you or someone you love suffered serious injury or died due to complications from an IVC filter, contact our office by using the form on the right or call (800) 444-5309 to discuss your legal options. You may be entitled to compensation for your injuries or loss. There is no obligation when contacting us but we encourage you to give us a call because every state has deadlines for bringing claims.