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Public Health Watchdog Breaking News

Cook Medical IVC Filter Lawsuit Alleges Injuries, Complications

A new lawsuit has been filed against Cook Medical alleging injuries from its Günther Tulip inferior vena cava (IVC) filter, a device placed in a major blood vessel to catch blood clots. IVC filter product liability lawsuits have been filed against Cook Medical alleging that the devices are defective and caused injuries. Plaintiffs allege that Cook Medical failed to warn patients and the medical community about the risks. Similar lawsuits have been filed against C.R. Bard.

The product liability lawyers and personal injury attorneys at Parker Waichman LLP are closely monitoring events in the IVC filter litigation against C.R. Bard and Cook Medical. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

According to court records, the lawsuit was filed on behalf of an Arizona man in the U.S. District Court for the Indianapolis Division of the Southern District of Indiana. The complaint states that the plaintiff was implanted with the IVC filter on Jul. 31, 2015. The plaintiff suffered subsequent injuries and complications, allegedly due to the defective nature of the IVC filter. The lawsuit alleges that Cook Medical failed to disclose the risks associated with the device. The plaintiff is seeking damages on multiple counts, including failure to warn, design defect, negligence, and breach of express and implied warranties, among others.

The lawsuit joins other claims as part of a federal multidistrict litigation (MDL) in Indiana before U.S. District Court Judge Richard Young. Court records indicate that the MDL contains over 1,000 Cook Medical IVC filter lawsuits. Plaintiffs are suing over the Celect and Günther Tulip models.

MDLs are a type of mass tort in which similar lawsuits are transferred to one court before one judge. The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes MDLs to make complex litigation more efficient, as consolidation eliminates the need for duplicate pretrial proceedings.

Judge Young has outlined a schedule for bellwether trials in the Cook Medical IVC filter litigation. Bellwether cases are the first few cases in a mass tort selected for trial; these lawsuits are often chosen because they represent most of the litigation. The outcome of bellwether trials can have important implications, as they are used to gauge how other lawsuits would proceed. Bellwether cases can facilitate settlement discussions.

“[t]he purpose of selecting bellwether cases for trial is to enhance the settlement prospects of the hundreds of other pending cases involving the Celect and Günther Tulip filters. … To further this end, the court must choose cases that are the most representative of the types of cases at issue in this MDL,” the court wrote.

Plaintiffs suing over IVC filters allege that the devices are prone to break or fracture within the blood vessel, presenting a life-threatening risk of embolization if the pieces migrate to the heart or other areas. Two of the bellwether plaintiffs allege that the IVC filter fragments remain within the body. In one bellwether case, the plaintiff alleges that the IVC filter perforated his inferior vena cava. Another plaintiff alleges that two legs of the IVC filter broke off, and remain lodged somewhere in his body.

Another bellwether plaintiff also suffered IVC filter complications. Doctors were eventually able to remove the device, but only after two years of advanced retrieval techniques.

IVC Filter Lawsuit Background

IVC filters are small, cage-like devices placed in the inferior vena cava to catch blood clots before they can reach the heart and lungs, where they can cause a life-threatening condition called pulmonary embolism. The inferior vena cava is a major vein bringing blood from the lower parts of the body back to the heart and lungs. IVC filters are typically placed in patients who cannot take traditional oral anticoagulants.

Some IVC filters are permanent, while others can be retrieved.

The U.S. Food and Drug Administration (FDA) addressed IVC filter complications in a May 2014 Safety Communication, citing reports of device migration, filter fracture, embolization (where the entire filter or parts of the filter move into the heart or lungs), perforation of the IVC, and difficult retrieval. The agency said IVC filter injuries may be more common when the filters are left for long periods of time.

“These types of events may be related to how long the filter has been implanted,” the agency said. “The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides,”

Regulators said that other IVC filter adverse events may include lower limb deep vein thrombosis, where a blood clot forms in one of the deep veins of the leg, and occlusion.

IVC filters were approved through 510(k), a fast-track process that approves medical devices if they meet “substantial equivalence”. This means that the new product must be at least as safe as a previously approved device, known as a predicate. Unlike devices that are approved through the FDA’s stricter premarket approval (PMA) process, products approved through 510(k) do not need to undergo clinical testing for safety or efficacy.

Parker Waichman product liability attorneys note that many medical device injury lawsuits involve devices that were approved through 510(k), such as transvaginal mesh and metal-on-metal hip implants. This process has raised important safety questions, as it was used to approve devices that are now considered controversial.

C.R. Bard is also facing IVC filter litigation. The JPML has created an MDL in Arizona before the Honorable David G. Campbell. The Bard IVC filter MDL contains lawsuits involving the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian and Denali IVC filters.

IVC filter lawsuits mounted against C.R. Bard after NBC released two investigative reports questioning the safety of Bard IVC filters, specifically the Recovery and G2 series filters. The NBC report raised questions about whether C.R. Bard acted ethically and appropriately with regards to injury and death reports in patients with IVC filters.

Filing an IVC Filter Lawsuit

If you or someone you know has questions about filing an IVC filter lawsuit, contact the personal injury attorneys at Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).