By Amanda Antell  |  May 2, 2019

Category: Legal News

Blood cells in a clotA man from Florida recently filed legal action against Cook Medical Inc. alleging their Gunther Tulip Vena Cava Filter was defectively made and is unreasonably dangerous to patients.

This vena cava filter complications lawsuit is joining growing multidistrict litigation, which consists of other claims alleging similar injuries related to defectively made medical devices that could be breaking apart inside patients.

Plaintiff Walter M. says he had the Gunther Tulip Vena Cava Filter implanted for typical treatment purposes on April 9, 2007, and reportedly had no reason to believe he was at risk for any serious device complications.

Like other IVC filters, the Gunther Tulip Vena Cava Filter is often recommended for patients who cannot be prescribed anticoagulant medications and is supposed to mitigate the risk of blood clots.

IVC filters are small metal cage-like devices that are directly implanted into the inferior vena cava, which is the largest vein in the human body.

These devices work by trapping and preventing blood clots forming in the legs or pelvis from traveling to the heart or lungs, which ultimately prevents potentially fatal blood clot attacks.

While the Gunther Tulip Vena Cava Filter was supposed to improve Walter’s circulatory health, he says it has put him at risk for serious vena cava filter complications. Walter reportedly opted to file legal action against Cook, after discovering that other patients had allegedly faced similar problems.

Overview of IVC Filter Complications

The FDA first warned against vena cava filter complications in 2010, when it released a warning stating it had received 921 injury reports since 2005 reporting complications like:

  • 328 reports of IVC filter migration
  • 146 reports of IVC filter component detachment
  • 70 reports of IVC filter perforation of the inferior vena cava
  • 56 reports of IVC filter fracture

Each of the events described above describes complications commonly described in injury reports, with malposition and IVC filter migration being some of the most prevalent.

Malposition is when the IVC filter is not implanted properly, which often leads to perforating the inferior vena cava and migrating away from the implant site. This can severely complicate removing the device, especially in cases where the IVC filter has fractured inside the patient.

Due to the sensitive nature of the device’s placement in the vein, it is important for doctors to confirm the device’s position before deciding if removing the IVC filter is safe.

It is important to note that the FDA has stressed the importance of removing the IVC filter after the blood clot risk is resolved, with a 2014 warning stating the removal procedure should generally be done within 29 to 54 days.

Even though these vena cava filter complications can be devastating to patients, Cook Medical allegedly failed to warn the public. At all times relevant, Walter and his physicians had relied on the marketing materials and product information provided by Cook.

Walter’s IVC filter lawsuit is joining MDL No. 2570, where it will be streamlined through the litigation process and will avoid potential problems like conflicting rulings from different judges.

This IVC Filter Lawsuit is Case No. 1:19-cv-01368-TWP-DLP, in the U.S. District Court of Southern Indiana, Indianapolis Division.

If you were implanted with an IVC filter, you may be entitled to compensation–even if you did not suffer complications. Patients who did suffer complications may be able to seek significantly more compensation.

In general, IVC filter lawsuits are filed individually by each plaintiff and are not class actions.

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