IVC (Inferior Vena Cava) Filters
Patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication, often have IVC (inferior vena cava) filters implanted. These small, cage-like or spider-like devices (as seen in the picture to the right) are implanted in the inferior vena cava — the main vessel moving blood from the lower body to the heart. IVC filters may be implanted permanently or removed after a doctor decides that the risk of pulmonary embolism has passed.
In 2010, the FDA issued a safety communication about IVC filters, stating that close to 1,000 adverse events had been reported since 2005 and that the delayed removal of IVC filters intended for short-term use could cause serious side effects.
What Are The Side Effects, Problems And Risks Of IVC Filters
There have been reports of the IVC blood clot filter falling out of place or fracturing. The metal filter, or pieces of it, can then migrate through the vascular system, working its way through a vein wall and puncturing an internal organ. There are also reports of embolisms at the insertion site — the same clotting that the device is intended to prevent. To date, the recovery IVC filter has been implicated in at least 30 deaths and 300 nonfatal injuries.
If pieces of the IVC filter fragment and migrate to the heart or lungs, symptoms may include:
- Chest pain
- Heart rhythm problems
- Neck pain
- Shortness of breath
- Hemorrhaging or internal bleeding
In severe cases, injuries can lead to:
- Hemorrhaging or internal bleeding
- Pulmonary embolism
If you or a loved one had an IVC filter implanted and have suffered serious side effects, you may have a potential claim. Contact us for a free and confidential consultation to determine if you may have a case related to side effects from an IVC filter.
Creation Of MDL For Both Cook And C.R. Bard
Lawsuits against both Cook Medical and C.R. Bard regarding IVC filters have been consolidated into multidistrict litigation (MDL): In re Cook Medical, Inc, IVC Filters Marketing, Sales Practices and Products Liability Litigation (MDL No. 2570) in the Southern District of Indiana and In re Bard IVC Filter Products Liability Litigation (MDL No. 2641) in the District of Arizona.
The cases in a MDL are joined for purposes of discovery and investigation, and hopefully settlement. However, as part of a MDL, each individual case is separate, and no one client is forced to settle his/her case as part of a class action group, and no one is bound by the trials of others. Each client gets to make his/her own decision whether to go to trial or not.
Troy A. Brenes of Brenes Law Group, P.C. was instrumental in the consolidation of these lawsuits and continues to have a leadership role in the cases going forward.
IVC Trial against C.R. Bard
On January 26, 2015, Troy A. Brenes as lead trial counsel represented a plaintiff in the second lawsuit in the nation to proceed to trial against Bard for its defective inferior vena cava (IVC) filters. The case involved a recovery filter that migrated to and punctured a hole in the plaintiff’s heart, leading to emergency open heart surgery. After 11 days of trial, Bard made a confidential settlement offer that was accepted by the plaintiff.
At trial, Mr. Brenes presented evidence that Bard knew the recovery filter was not reasonably safe for human use and exposed patients to significantly higher risks than other available IVC filters. This evidence included:
- By early 2004, Bard was aware that failures of the recovery filter were causing patient deaths and severe injuries.
- Multiple internal tests in early 2004 revealed the recovery filter failed to meet its own minimum safety specifications.
- Bard’s testing also revealed that the filter was substantially more likely to dislodge and migrate within the body when impacted by blood clots compared to other available IVC filters.
- In March 2004, two of Bard’s own physician consultants warned Bard that the recovery was a “wimpy” filter that needed a better design to assure patient safety.
- In July 2004, Bard’s own internal analysis revealed that the recovery filter was reported to fracture at a rate 28 times higher than all other devices combined.
- In December 2004, Bard’s own internal analysis revealed that the recovery filter was reported to cause death, fracture, migrate and perforate the vena cava at rates that were substantially higher than all other available IVC filters.
- According to Bard’s internal safety procedure, the recovery filter posed an unacceptable risk to human health and required corrective action by no later than December 2004.
- That if the device tilted or fractured such that just one strut was no longer properly engaged with the wall of the vena cava, the device could not be expected to remain in place if challenged to perform its purpose of stopping clot challenges.
- Instead of revealing these facts to the public or issuing a recall, Bard created a task force to systematically and intentionally conceal and misrepresent these dangers from the public.
- Bard’s own experts acknowledged that Bard misrepresented the safety and efficacy of its device in marketing and labeling messages.
Mr. Brenes has taken the testimony of dozens of treating physicians and former Bard sales representatives who testified under oath that they never would have used or agreed to sell these devices had then been made aware of these facts.
This evidence and testimony raises a safety concern that may affect thousands of consumers who have one of these filters. Bard continues to withhold important safety information about their IVC filters from physicians and patients despite there being several hundred thousand of these devices still implanted in patients. Medical literature and recent safety alerts from FDA reveal that every one of these patients are at significant risk of serious complications from the defective design and manufacture of these products.