A plaintiff, Colleen F., has filed a products liability lawsuit against Cook Medical, alleging Cook Celect IVC filter complications.

The plaintiff is currently a resident of Massachusetts but was at the time a resident of New York when she was implanted with the IVC filter. She claims she suffered harm as a result of complications that went beyond what she was led to expect.

She files the following counts against the defendant including, but not limited to: Strict Products Liability, Negligence, Breach of Express Warranty, Breach of Implied Warranty, and Violations of Applicable Massachusetts Law Prohibiting Consumer Fraud and Unfair and Deceptive Trade Practices.

She files the lawsuit in Indiana federal court. As part of the Cook IVC filter multidistrict litigation, her complaint alleging Cook Celect IVC filter complications is filed through a short form complaint and does not specifically include the alleged complications suffered because of the implantation.

The inferior vena cava is a main vein which returns deoxygenated blood back to the heart for the replenishment of oxygen. The inferior vena cava (IVC) filters were designed to be implanted within the major vein and stop blood clots from migrating to the upper body. However, while benefits have been reported with the medical device, other reports of adverse medical events have also been announced.

Serious adverse effects and consequences of the IVC filter may include loose fragments of the device that can become lodged into a patient’s lung or heart; the migration of the device itself from its proper position; and failing to protect a patient against the formation of blood clots, which is what it is trying to prevent in the first place.

Colleen’s complaint is filed as part of a large multidistrict litigation, also known as an MDL. The MDL includes all allegations that are centered around a common complaint. The complaint includes the plaintiffs’ claims that the alleged IVC filter complications developed because of an alleged defective medical device.

The Cook Celect IVC Filter Complications Facts

The Cook Celect Vena Cava Filter was developed, promoted, and marketed by Cook Inc., and other affiliated companies. The Cook IVC filter was marketed to be a safe, effective, and allegedly secure method in preventing blood clots from causing injuries like deep vein thrombosis or pulmonary embolism.

According to reports, moreover, the Cook IVC filter was fast–tracked through a process known as the 510(k) program, brought forth by the U.S. Food and Drug Administration. The 510(k) program allows companies to sidestep a lengthy clinical trial period to test the safety and efficacy of the device so long as they can prove that similar or identical devices are already being sold on the market.

Plaitniffs in the Cook Celect IVC filter complications litigation believe that had the defendants performed clinical trials of the medical device to discern its safety and efficacy, they would have discovered the adverse side effects that occur because of its implantation.

Colleen’s Cook Celect IVC Filter Complications Lawsuit is Case No. 1:17-cv-02570-RLY-TAB, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division. The Cook IVC Filter MDL is In re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation, MDL No. 2570, in the U.S. District Court for the Southern District of Indiana.