IVC Filter Lawsuit

Medical device manufacturer, Bard is facing multiple IVC Filter Lawsuits filed by people or loved ones of those who suffered blood clots, pulmonary embolism, heart failure, hemorrhage or who died after receiving a Recovery or G2 IVC filter.

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Should I file an IVC filter lawsuit because the device malfunctioned?

People with IVC filters, especially those made by the Bard company, are filing lawsuits because of problems they experienced. Plaintiffs with the Recovery and G2 IVC filters have been injured and needed follow-up care to correct the damage caused by these filter. According to claims, the devices were poorly designed and Bard failed to warn consumers and the medical community about the risks.

Inferior vena cava (IVC) filters are medical devices that block blood clots from traveling to the lungs, which can be fatal. IVC filters are implanted in the body’s largest vein (the vena cava) when a person has an increased risk for blood clots. These metal filters catch the clot and hold it in place until it disintegrates naturally, so it cannot cause any damage.

Temporary IVC filters, like those made by Bard, are supposed to be removed as soon as the danger for clotting has passed. However, many people who were implanted with temporary filters still have them in place, despite the danger.

FDA Receives Adverse Event Reports

Many of the IVC filters on the market were approved via the FDA’s shortcut approval process known as 501(k). This allows medical products similar to those already on the market to be approved for sale without the usual tests required for new products.

By 2010, the FDA had received nearly 1000 adverse event reports related to IVC filters. These reports include:

  • Device embolism: detachment of parts traveled throughout the body
  • Device migration: entire device moved from original site
  • Filter perforation or fracture: device broke and/or punctured tissue in the body

In response to the numerous reports, the FDA issued an advisory warning to doctors. The warning alerted doctors to the fact these retrievable devices should be removed and if left in place too long, would cause serious complications.

Medical studies confirmed the danger and showed a high failure rate for Bard’s Recovery and G2 filters. Data showed complications that included:

  • Venous wall puncture
  • Venous thrombosis
  • Pulmonary embolism
  • Device removal failure

According to one of the studies, only nine percent of the retrievable devices had been removed – leaving 91 percent of IVC filter recipients at risk.

FDA Updates Warning

In 2014, the FDA issued an updated warning about IVC filter. The warning called for doctors to remove retrievable IVC devices within 29 to 54 days of implantation.

Patients who are left with devices beyond the encouraged removal date are at risk for:

  • Severe pain
  • Blood clots
  • Hemorrhaging due to perforation
  • Pulmonary embolism
  • Heart failure
  • Death

IVC Filter Lawsuits

As a result of the problems with IVC filters many users have filed lawsuits against Bard. The first case to go to trial settled in 2015 after just 10 days of litigation. The plaintiff in the case was forced to undergo open heart surgery following device embolism that perforated his heart.

Additional lawsuits included claims of:

  • Device fracture and migration to the renal vein
  • Device embolism in the heart
  • Devices migration to the pulmonary artery
  • Device migration that triggered cardiac tamponade
  • Vena cava puncture from device migration

According to information listed in the complaints, Bard began receiving complaints in 2014 and knew there were issues with the IVC filters, but chose not to disclose the reports to the FDA or the medical community.

As a result of Bard’s negligence and their experience with a faulty medical device, IVC filter recipients might be eligible for compensation. In addition to money for pain and suffering, medical treatments, and lost wages, some might receive punitive damages because the company hid issues with its product.

If you or a loved one has been injured because of problems with an IVC filter, you should speak to an attorney as soon as you can.

View Sources

  1. Berczi, V., (15 September 2007), Long-Term Retrievability of IVC Filters: Should We Abandon Permanent Devices?, Cardiovascular and Interventional Radiology, Accessed on 05 May 2015 http://www.osti.gov/scitech/biblio/21090787
  2. Burns, M., (22 March 2012), A brief history of inferior vena cava filters and analysis of current devices, Which Medical Device, Accessed on 05 May 2015 http://www.whichmedicaldevice.com/editorial/article/104/a-brief-history-of-inferior-vena-cava-filters-and-analysis-of-current-devices
  3. Cleveland Clinic, (2015), Inferior Vena Cava (IVC) Filter Retrieval, Accessed on 05 May 2015, Retrieved from http://my.clevelandclinic.org/services/heart/services/vascular_surgery/ivc-filter-retrieval
  4. EV Today, (07 May 2014), FDA Updates Safety Communication on IVC Filter Retrieval, Endovascular Today, Accessed on 05 May 2015 http://www.evtoday.com/2014/05/07/fda-updates-safety-communication-on-ivc-filter-retrieval
  5. Food and Drug Administration (06 May 2014), Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, U.S. Food and Drug Administration, Accessed on 05 May 2015 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
  6. Nicholson, W., (08 November 2010), Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade, JAMA, Archives of Internal Medicine, Accessed on 05 May 2015 http://www.ncbi.nlm.nih.gov/pubmed/20696949
  7. O’Riordan, M., (11 August 2010), FDA Warns of Adverse Events With Inferior Vena Cava Filters, Medscape, Accessed on 05 May 2015 http://www.medscape.com/viewarticle/726711
  8. Sarosiek, S., et al., (08 April 2013), Indications, complications, and management of inferior vena cava filters, JAMA, Accessed on 05 May 2015 http://archinte.jamanetwork.com/article.aspx?articleid=1669107#RESULTS
  9. Tam, MD, (February 2012), Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications, Journal of Vascular Interventional Radiology, Accessed on 05 May 015 http://www.ncbi.nlm.nih.gov/pubmed/22188776
  10. University of Michigan Health System, Vascular Surgery, (07 March 2013), Inferior Vena Cava filters, U-M Med School, Accessed on 05 May 2015 http://surgery.med.umich.edu/vascular/patient/treatments/ivc_filters.shtml
  11. Walsh, J., (2013), Safety and Effectiveness of Inferior Vena Cava Filters Used to Protect Against Pulmonary Embolus: A Technology Assessment, California Technology Assessment Forum, Accessed on 05 May 2015 http://www.medscape.com/viewarticle/744331_1
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