In recent months, the IVC filter has been in the news about whether the medical device is safe for use. Recently, NBC news reported about the problem surrounding IVC filters and the catastrophic injuries caused by IVC filters, including 27 deaths that have been caused by medical device failure. Click link to read more… Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?
In this report, lawyer Matthew Sharp, explains the IVC filter lawsuits.
What Is The IVC Filter Lawsuit?
The IVC filter lawsuit involve CR Bard and Cook Pharmaceuticals. The lawsuits allege that: (1) Bard and Cook failed to provide necessary warnings to patients and physicians regarding the risk of the IVC filter; (2) the IVC filter is unreasonably dangerous, especially given the limited medical benefit the device provides; (3) Bard and Cook withheld adverse safety information from consumers; and (4) Bard and Cook knew the IVC filters were being misused creating catastrophic risks to patients.
What Is The IVC Filter?
The IVC filter is a medical device. It is installed into a patient’s inferior vena cava, a major vein that carries deoxygenated blood from the lower body to the heart. An IVC filter is supposed to be used in a patient who has a deep vein thrombosis (“DVT”) but cannot take an anticoagulant like heparin.
What Are the Injuries and Risk from the IVC Filter?
An IVC filter can fracture, splinter, migrate, or explode. The pieces from the IVC filter can lodge or pierce the heart, lung, liver, or kidney. Injuries include:
- Death
- Organ injury
- Stroke
- Chest pain, shortness of breath
- Internal bleeding or hemorrhaging
- Pulmonary embolism
What Did the Pharmaceutical Industry Do?
The pharmaceutical industry initially designed the IVC filter as a permanent medical device. The problems began when Bard and Cook started selling a retrievable IVC filter.
A retrievable IVC filter was intended to be a temporary device. The Journal of the American Medical Association has reported that the IVC retrievable filter provides no medical benefit but poses a significant risk to the patient. The risk includes cardiac injury and death. For example, the IVC filter can break. The pieces can migrate to the heart and pierce the heart. Medical journals report that 40% to 100% of the IVC filters will fracture or migrate.
Although the IVC filters were designed as a temporary medical devices, Bard and Cook knew the filters weren’t being used as intended and that physicians were not removing the devices from the patients. According to the Federal Drug Administration (“FDA”) warning in 2010, retrievable filters were causing injuries like pulmonary embolisms from the migration of the filter, the fracture of the filter, or even from the filter itself. Bard and Cook failed to take steps to assure these temporary devices were being removed.
In 2013, the FDA sent a second warning letter that the retrievable filters were not being removed. It recommended the IVC filter be removed as soon as possible after implantation. Bard and Cook still failed to take steps to reasonably assure their product was being used as intended.
In the face of known dangers to the patient, Bard and Cook have aggressively marketed the IVC filters. They encouraged using the IVC retrievable filters for use in patients who could take an anticoagulant. The medical community reports that these off label uses of an IVC filter creates a needless risk to the patient while providing no medical benefit.
The IVC filters are also difficult to retrieve. In July 2015, the FDA issued a letter that the medical device sold by Bard to retrieve the IVC filter has not been approved by the FDA for use in patients, thereby, increasing the risk that the filter will fracture or break during removal.
What Can I Do to Protect My Rights?
The Law Offices of Matthew L. Sharp is reviewing cases involving IVC Filters. We provide a free consultation. We work on a contingency fee, and we never charge any fees or costs unless we recover money on your behalf.
Every state has a statute of limitation when an injury claim must be filed. Without first reviewing your case, we cannot tell you when the statute of limitation runs. We know every day you wait to consult a lawyer, the more likely your statute of limitation has run.
IVC Medical Articles:
Indications, Complications, and Management of Inferior Vena Cava Filters: The Experience in 952 Patients at an Academic Hospital with a Level I Trauma Center by Shayna Sarosiek, MD; Mark Crowther, MD; and J. Mark Sloan, MD. Published in Journal of the American Medical Association Internal Medicine Journal (April 8, 2013).
Indications, Complications, and Management of Inferior Vena Cava Filters: The Experience in 952 Patients at an Academic Hospital With a Level I Trauma Center.
The Inferior Vena Cava Filter by Hiroshi Wada, MD; Junya Ako, MD; and Shin-ichi Momomura, MD. Published in Journal of the American Medical Association Internal Medicine Journal (October 14, 2013).
Complications of temporary vena cava filter placement
The Inferior Vena Cava Filter: How Could a Medical Device Be So Well Accepted Without Any Evidence or Efficacy? Vinay Prasad, MD; Jason Rho, MD; and Adam Cifu, MD. Published in Journal of the American Medical Association Internal Medicine Journal (April 8, 2013).
Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurring Pulmonary Embolism: A Randomized Clinical Trial by Patrick Mismetti, MD, PhD; Silvy Laporte, PhD, MS; Olivier Pellerin, MD, MS; Pierre-Vladimir Ennezat, MD, PhD; Francis Couturaud, MD, PhD; Antoine Elias, MD, PhD; Nicolas Falvo, MD; Nicolas Meneveau, MD, PhD; Isabelle Quere, MD, PhD; Pierre-Marie Roy, MD, PhD; Olivier Sanchez, MD, PhD; Jeannot Schmidt, MD, PhD; Christophe Seinturier, MD; Marie-Antoinette Sevestre, MD; Jean-Paul Beregi, MD, PhD; Bernard Tardy, MD, PhD; Philippe Lacroix, MD; Emilie Presles, MS; Alain Leizorovicz, MD; Hervé Decousus, MD; Fabrice-Guy Barral, MD; and Guy Meyer, MD. Published in Journal of the American Medical Association Internal Medicine Journal (April 28, 2015). JAMA
Inferior Vena Cava Filters by Ido Weinberg, MD; John Kaufman, MD; and Michael Jaff, DO. Published in Journal of the American College of Cardiology (June 2013).
No Advantage to Adding Inferior Vena Cava Filters to Anticoagulation in PE Patients by Larry Hutson. Edited by David Fairchild, MD, MPH and Lorenzo Di Francesco, MD, FACP, FHM. Published in NEJM Journal Watch (April 29, 2015).
No Advantage to Adding Inferior Vena Cava Filters to Anticoagulation in PE Patients
FDA Letters:
Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication
If you have been injured by an IVC Filter, you would be well served talking to a product liability lawyer who can advise you on what options are available.
