Oct. 15, 2018 – Indianapolis, Indiana – – The law firm of Baum Hedlund Aristei & Goldman filed an inferior vena cava (IVC) lawsuit today against Cook Medical Inc., one of the largest IVC filter manufacturers in the world.
Filed on behalf of Colorado resident, Deborah R. Briones-Ubaldo, the IVC filter lawsuit alleges that Cook Medical Inc.’s Gunther Tulip Vena Cava Filter is defective and dangerous, and that Cook hid known health risks associated with the device from patients and the medical community.
Baum Hedlund Aristei & Goldman attorneys Nicole K.H. Maldonado and Michael Baum filed the lawsuit in U.S. District Court for the Southern District of Indiana, Indianapolis Division (Civil Case No. 1:18-cv-3189).
Mrs. Briones-Ubaldo was implanted with the Cook Gunther Tulip Vena Cava Filter in 2008. According to the complaint, the device became dislodged, pinching a main artery. The first attempt at removing the IVC filter was unsuccessful, and Mrs. Briones-Ubaldo has not been able to find another surgeon willing to take the risk of a second attempt to remove the device.
The lawsuit names Cook Inc. of Bloomington, Indiana; Cook Medical, LLC of Bloomington, Indiana; and William Cook Europe APS of Denmark. The Defendants face nine counts:
- Strict Products Liability – Failure to Warn
- Strict Products Liability – Design Defect
- Negligence Per Se
- Breach of Express Warranty
- Breach of Implied Warranty
- Violations of Applicable State Law (Indiana and Colorado) Prohibiting Consumer Fraud and Unfair and Deceptive Trade Practices
- Loss of Consortium
- Punitive Damages
Mrs. Briones-Ubaldo’s lawsuit is part of a multidistrict litigation (MDL No. 2570, Master Complaint Case No. 1:14-ml-2570-RLY-TAB) against Cook Medical based on allegations related to four of the company’s IVC filters: the Gunther Tulip Vena Cava Filter, the Gunther Tulip Mreye, the Cook Celect Vena Cava Filter, and the Cook Celect Platinum. In addition to Mrs. Briones-Ubaldo, Baum Hedlund Aristei & Goldman represents several plaintiffs in IVC filter lawsuits consolidated in the Indiana MDL.
IVC filters are spiderlike medical devices implanted into the inferior vena cava, the body’s largest blood vessel, for the purpose of catching blood clots before they can travel to the heart and lungs. Patients receive an IVC filter when they are at risk for pulmonary embolism (PE) and cannot take standard blood-thinning medications.
FDA Warned of Filter Fracture and Migration in Multiple IVC Filter Safety Alerts
The U.S. Food & Drug Administration (FDA) issued two safety alerts in 2010 and 2014 that addressed IVC filter complications. The first alert was issued in August of 2010 after FDA received hundreds of IVC filter adverse event reports, including IVC filters fracturing and migrating to other places in the body. In other adverse events, broken IVC filter fragments perforated organs and blood vessels, resulting in severe injuries.
A second alert, issued in May of 2014, advised doctors that retrieving IVC filters was vital to avoid serious injury. FDA issued the second alert after a 2013 paper published in JAMA Internal Medicine found that only 8.5 percent of retrievable IVC filters were successfully removed.
A review of all Cook Celect IVC filters and Cook Gunther Tulip Filters retrieved between July 2006 and February 2008 found that 130 filter retrievals were attempted but in 33 cases, the standard retrieval technique failed.
Another study involving Cook Celect IVC Filters and the Gunther Tulip Vena Cava Filters implanted in patients between July 2007 and May 2009 found all of the filters imaged after 71 days caused some degree of filter perforation of the vena cava wall. According to the same study, 40 percent of the implanted IVC filters tilted, and all tilted filters perforated the vena cava. The study authors concluded, “Although infrequently reported in the literature, clinical sequelae from IVC filter components breaching the vena cava can be significant.”
Cook Medical Knew or Should Have Known That its IVC Filters Were Defective and Dangerous
According to the lawsuit, Cook Medical knew or should have known that its IVC filters were more likely than not to tilt and perforate the vena cava wall. Cook failed to warn physicians, patients, and/or plaintiffs that its IVC filters had scientifically known dangers, including breakage, tilt, inability of removal, and migration.
Cook allegedly stated in advertising that its IVC filters were constructed using Conichrome, which was intended to reduce the risk of fracture. But according to the allegations, the Cook IVC filters’ failure is attributable, in part, to the fact that these devices have a design defect that causes them to be unable to withstand the normal anatomical and physiological loading cycles exerted in vivo (inside a living organism).
Cook continued to market its IVC filters as safe and effective despite inadequate clinical trials to support long or short-term safety and/or efficacy, the lawsuit states. Cook IVC filters were designed, manufactured, distributed, sold and/or supplied by the Defendants, and were marketed while defective due to the inadequate warnings, instructions, labeling, and/or inadequate testing.
“These devices may have been intended to save lives by preventing blood clot complications, but studies have shown, and the FDA has recognized, that IVC filters can be dangerous,” says attorney Nicole Maldonado. “Cook has long known about the risks associated with these devices but to this day has not warned patients or the medical community.”
About Baum Hedlund Aristei & Goldman
Baum Hedlund Aristei & Goldman has successfully handled thousands of personal injury and wrongful death cases on behalf of clients, securing over $1.9 billion in verdicts and settlements. The firm has experience litigating against some of the largest pharmaceutical and medical device companies in the world, including Alere Inc., Alpha Therapeutic, Armour Pharmaceutical Co., Baxter Healthcare Corporation, Bayer, Eli Lilly, Forest Labs, GSK, Medtronic, Pfizer, Schering-Plough, Stryker Biotech, Takeda Pharmaceuticals and Wyeth Pharmaceuticals, among others.