Cook Celect IVC Filter Lawsuit Alleges Device Fractured Into Patient’s Vein

Lawsuit accuses Cook of failing to conduct adequate clinical trials by abusing the FDA’s controversial 510(k) fast-track approval process.

More than 11 years after receiving a Cook Celect IVC filter that was supposed to be retrievable, Sally Blommel was forced to undergo surgery to remove broken fragments from her renal vein.

Blommel filed a complaint (PDF) in the U.S. District Court for the Southern District of Ohio on February 24, seeking to hold Cook Incorporated and its subsidiaries liable for what she and thousands of other patients who suffered similar injuries say was a defective and dangerous design.

IVC filters are small, spider-like devices inserted into the vein to intercept blood clots that break free in the body and head for the heart and lungs. They are frequently implanted in patients at risk of pulmonary embolism who are unable to take, or are unaffected by, anticoagulants.

Over the past several years, several IVC filter designs have been linked to complications where the struts have punctured the vena cava or migrated out of position. In addition, the filters have been reported to fracture, sending small pieces into the lungs and heart and causing the very pulmonary embolism they were implanted to prevent.

As a result, tens of thousands of people have filed Cook IVC filter lawsuits and Bard IVC filter lawsuits in federal courts nationwide. Each of the claims raise similar allegations that the devices were defectively designed, and that the manufacturers either failed to adequately test them, or did not appropriately warn the medical community or patients of the potential risks.

Blommel indicates she was first implanted with a Cook Celect IVC filter in September 2013. She was told that it should be permanent but could be removed if necessary.

The implant was advertised as a safe and effective treatment for the prevention of pulmonary embolism, and there was nothing visibly wrong with the device when Blommel’s surgeon implanted it, the lawsuit states.

“On October 11, 2024, Plaintiff underwent a computerized tomography scan of her abdomen, which showed the filter fractured with a fragment extending into the right renal vein. It further showed multiple strut perforations with one strut into the vertebral body.”

– Sally Blommel v. Cook Inc. et al

According to her claim, Blommel underwent a “complex percutaneous retrieval procedure “ in January 2025. She indicates the doctor had to use forceps to retrieve the filter’s body, and a goose neck snare to retrieve the broken filter fragment.

The complaint states that Cook failed to conduct adequate clinical trials before the Celect IVC filter design was approved by the U.S. Food and Drug Administration (FDA) through its controversial 510(k) fast-track approval process. Medical devices cleared through the 510(k) process are required only to show they are “substantially equivalent” to a product already on the market. Critics argue that some manufacturers stretch that standard, using it to win clearance for devices with new features or significant design changes that were never independently tested for safety.

Blommel presents claims of negligence, failure to warn, design defect, breach of warranty, negligent misrepresentation, and seeks both compensatory and punitive damages.

IVC Filter Lawsuits

The complaint will likely be transferred to the U.S. District Court for the Southern District of Indiana, where it will be consolidated with nearly 7,000 similar IVC filter lawsuits, which are being overseen by U.S. District Judge Richard L. Young through coordinated discovery and pretrial proceedings.

To gauge how juries may respond to evidence common across the litigation, Judge Young has been preparing groups of representative cases for early trial. At the same time, the court has facilitated discussions between Cook Medical and plaintiffs’ attorneys aimed at resolving claims short of individual trials.

In recent months, Cook Medical has expanded those negotiations in an effort to reach broader settlements and avoid thousands of separate proceedings nationwide.

If no settlement agreements are reached after the negotiations or the bellwether trials, Judge Young will likely begin remanding large numbers of individuals claims back to U.S. District Courts nationwide for individual trial dates.

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