IVC Filter Lawsuit Settlement Update

IVC filters have been linked to an increased risk of fracture which can cause serious injury or death.  The Bard IVC cases have settled do the focus here is on Cordis and Cook IVC filter cases.

The IVC filter lawsuits have been going on for a long time, too long.  Our lawyers frequently get calls from people who are frustrated that their lawyer has “done nothing” to advance their case toward settlement. Our attorneys also get calls from victims who cannot find a lawyer. This page gives you information if you have filed an IVC filter lawsuit or are thinking of filing such a claim.

Our lawyers are not taking new claims. But we do update this page to keep victims informed about the litigation because there is so little current information out there for victims.

UPDATES:

August 2024: The Seventh Circuit unfortunately upheld a decision favoring Cook Medical LLC in a lawsuit filed by a woman who claimed that the company’s Günther Tulip Mreye IVC filter caused her abdominal pain and fractured during removal.

Plaintiff’s case was dismissed because it was filed after the statute of limitations had expired. She was implanted with the filter in 2007, and discovered it had perforated her inferior vena cava in 2013. She filed her lawsuit in 2016, exceeding Ohio’s two-year statute of limitations. The court rejected her lawyer’ argument that she wasn’t aware of the defect until 2016, stating that the statute of limitations begins when the causal relationship between injury and product use is known.

July 2024: The Cook Medical, Inc., IVC Filters MDL, managed by Judge Richard L. Young in Indiana, had a marginal decrease from 7,717 active cases in June to 7,711 in July 2024.

June 2024: On June 25th, a status conference with Magistrate Judge Tim A. Baker was held for the Cook IVC filter litigation, with parties appearing by their lawyers. The discussion focused on the case status and the process of updating case categorization forms. Due to the time needed to complete this process, the Court has canceled the previously scheduled status conference on July 25, 2024, and rescheduled it for December 16, 2024.

May 2024: There will be a status conference next month.

August 2023: A $3.3 million verdict was awarded to Natalie Johnson by a Wisconsin federal jury in 2021 after she claimed that a piece of C.R. Bard’s vein filter broke and got embedded in her heart. C.R. Bard’s attempt to secure a new trial was denied last week by the Seventh Circuit, which pointed out the company’s inaction regarding certain testimonies during the trial, only to challenge them afterward.

Johnson had the Meridian filter implanted in 2013 as a preventive measure against varicose veins. However, shortly after, a CT scan showed the filter had shifted close to her heart. While most of it was successfully removed, a shard remained, potentially leading to future complications. The jury found Bard at fault for not adequately informing doctors about the risks associated with the filter, but cleared them of negligence and design defect charges. The appellate panel maintained the jury’s decision, underscoring the importance of real-time objections and decisions made during trials.

New Appellate Ruling in Cook MDL Class Action

On December 16, 2022, the Seventh Circuit ruled in favor of two Cook IVC filter plaintiffs, reversing the MDL judge who had dismissed their claim citing the statute of limitations.  The court found that Cook could not demand Indiana’s deadline to sue applied because it previously let use of statutes of limitation in the plaintiffs’ home states in the MDL.

Verdicts That Mean Something to You

The big news in these IVC filter cases came in April 2018 when the plaintiff scored their first big win.  An Arizona jury awarded a Georgia woman $3.6 million, including $2 million in punitive damages.

Cook Celect to a verdict in May 2018. A Texas jury awarded a firefighter $1.2 million.  The key to that verdict was a failure to warn. The jury believed should have properly the company had a duty to warn the man’s surgeon of the risks associated with its IVC filter.

In November 2019, a Pennsylvania jury awarded $34 million to a Georgia woman who was injured by a Rex Medical Option IVC filter.

There were three more plaintiffs’ verdicts in 2021.  These were not Cook or Cordis but every settlement amount of jury payout has an impact on settlement negotiations in the other IVC filter lawsuits.

Cook Medical Verdicts

Cook has been hit with large verdicts twice now.  The first was for $3 million in Brand v. Cook Medical. in February 2019.  Last year, the judge ordered a new trial because of evidence the judge now says should not have been admitted.  But the precedential value of the verdict when calculating future Cook Medical IVC filter settlements remains.

There was also a $1.2 million verdict in favor of a firefighter in Pavlock v. Cook Medical in May 2018.  The victim sued because his Celect inferior vena cava filter needed to be removed.

COVID has slowed things down to be sure.  But Cook is going to have to defend the Celect filter again and again.  At some point, it is reasonable to expect them to realize that juries won’t support them which will hopefully lead to a Cook Celect IVC filter class action settlement.

History of IVC Filters

IVC filters were developed for patients who have trouble with anticoagulation therapy because of concomitant bleeding or a high risk of bleeding.   IVC filters have been developed to address these issues. These devices are placed in the IVC. They are designed to allow uninterrupted blood flow while catching pieces of blood clots and preventing them from migrating to the pulmonary arteries. These devices essentially resemble the ribs of an umbrella without the cloth stretched between them.

The first IVC filter was the Mobin-Udin filter, developed in 1967.  It was replaced by the Greenfield filter in 1973. These first-generation filters required surgical access to the femoral vein for placement, and the threshold for their implantation was high.

Over time, IVC filters were able to be placed percutaneously through a large-bore IV placed in the femoral vein.  Then the retrievable filters were invented to be placed and left in place permanently or retrieved for months. These filters were attractive for patients needing temporary IVC filter therapy.  The same cast of characters we have today jumped into the retrievable IVC filters fray:  Cook Medical (Gunther-Tulip), Bard Medical (Bard Recovery Filter), and Cordis (Optease).

IVC Filter Problems

The Bard IVC MDL class action began in August 2015 with 22 IVC filter lawsuits.  By the time the MDL closed on May 31, 2019, 8,000 cases had been filed.  We have over 8,000 in the Cook IVC Filter class action lawsuit in 2023. How did we get here?

Venous thromboembolism, or the formation of blood clots in the veins, occurs in more than 200,000 Americans per year. Bard’s IVC filters are medical devices placed in the patient’s vena cava designed to catch blood clots for patients at risk for pulmonary embolism. The filters are designed to trap clots before they travel to the lungs. You don’t implant these filters unless the patient is at risk and attempts to mitigate risk using medications have not been effective. Only then do doctors turn to these Bard IVC filters.

But the Bard filters create their own problems. On August 9, 2010, the FDA released information warning of complications with the Bard IVC Filters. That same day, an article that appeared in the Archives of Internal Medicine concludes that the Bard Recovery® Filter has a 25% rate of fracture and the G2® Filter has a 12% rate of fracture.

The IVC filter failures included death, filter migration, caval perforation, filter embolization, pulmonary embolism (PE), caval thrombosis, and filter fracture.  In 2018, some data indicate that the G2 IVC filter was failing at a significantly increased rate relative to Bard’s predicate permanent device. This finding was particularly true for migration and perforation.  This has led to a lot of lawsuits claiming injury and death. The IVC filter lawsuits allege that these filters can migrate and fracture, causing injury and death. They can also perforate the inferior vena cava. When this happens, removal is sometimes near impossible.

Cook Medical and Cordis

Plaintiffs’ lawsuits allege Cook Medical and Cordis IVC filters are more dangerous than other IVC filters because of their fundamental flaws. These suits claim these filters have a greater risk of perforation, penetration, tilting, fracture, and migration. The victims bringing these lawsuits would concede that these risks are present in all IVC filters.  But the key is whether Cook and Cordis were worse.

The major issues issues in the litigation include claims that Cook Medical failed to adequately warn patients and healthcare providers about the risks associated with their IVC filters and that the devices were defectively designed. Plaintiffs are seeking compensation for medical expenses, lost wages, pain and suffering, and other damages resulting from the complications caused by the filters.

Defective design is important. But, ultimately this is a failure to warn claim.  The plaintiffs believe that Cook and Cordis had a legal and moral obligation to warn both patients and physicians about these risks and the fact that the filters had problems.

MDL-2570

The litigation was consolidated into multidistrict litigation (MDL) to streamline the pretrial process for the numerous cases filed across the United States. This MDL, known as MDL 2570, is overseen by Judge Richard L. Young in the Southern District of Indiana. The consolidation allows for more efficient handling of common legal and factual issues related to the Cook IVC filters.

Medical Literature on IVC Filters

  • Johnson, M. S., Spies, J. B., Scott, K. T., Zuckerman, D. A., Casciani, T., & Gillespie, D. L. (2023). Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. Journal of Vascular and Interventional Radiology, 34(4), 517-528.e6. https://doi.org/10.1016/j.jvir.2022.12.009:  The PRESERVE study, published in the Journal of Vascular and Interventional Radiology, evaluated the safety and effectiveness of inferior vena cava filters (VCFs) over a 12-month period. Conducted at 54 sites in the United States with 1,429 participants, the prospective, nonrandomized study found that VCFs were generally safe and effective for preventing pulmonary embolisms (PEs). Clinically significant VCF-related adverse events were rare, with only 0.5% of patients experiencing complications such as perforation, embolization, or thrombotic occlusion. The primary safety and effectiveness endpoints were achieved, demonstrating a high rate of procedural success and a low incidence of new symptomatic PEs. The study emphasized the importance of frequent reevaluation for potential VCF removal, which contributed to a high retrieval success rate and minimized adverse events.
  • Jia Z, et. al: Caval Penetration by Inferior Vena Cava Filters: A Systematic Literature Review of Clinical Significance and Management. Circulation. 2015. Sep 8; 132 (10): 944-52: A systematic literature review on inferior vena cava (IVC) filters found that caval penetration, where the filter extends into the caval wall, is common but often goes unnoticed. Out of 9002 patients in the reviewed studies, 19% experienced penetration, with 19% of these cases involving organs or structures. About 8% of patients with penetration showed symptoms, primarily pain. Major complications, which occurred in 5% of cases, often required surgical or endovascular interventions, including filter removal. The review concluded that caval penetration is a significant but underrecognized issue associated with IVC filters, frequently necessitating medical intervention.
  • FDA, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication (May 6, 2014).
  • Joels CS, et. al: Complications of inferior vena cava filters. Am Surg 2003;69:654-9.

 

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