Sept. 20, 2018 – Indianapolis, Indiana – – The law firm of Baum, Hedlund, Aristei & Goldman filed a personal injury lawsuit today against Cook Medical, one of the largest manufacturers of inferior vena cava (IVC) filters.
The IVC filter lawsuit claims that Cook Medical Inc.’s Celect Vena Cava Filter is defective and dangerous, and that the manufacturer concealed from patients and the medical community known health risks associated with the device.
Baum, Hedlund, Aristei & Goldman attorneys Nicole K.H. Maldonado and Michael Baum filed the lawsuit on behalf of California resident Michele D’Amico in U.S. District Court for the Southern District of Indiana, Indianapolis Division (Civil Case No. 1:18-CV-2922). Mrs. D’Amico was implanted with the Cook Celect Vena Cava Filter in 2009 and sustained injuries she alleges were caused by the defective device.
The Defendants include Cook Inc. of Bloomington, Indiana; Cook Medical, LLC of Bloomington, Indiana; and William Cook Europe APS of Denmark. The complaint lists nine counts against the Defendants:
- 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 California) Prohibiting Consumer Fraud and Unfair and Deceptive Trade Practices
- Loss of Consortium
- Punitive Damages
Mrs. D’Amico’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 the company’s Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter, Gunther Tulip Mreye, and the Cook Celect Platinum.
IVC filters are implanted into the inferior vena cava, the body’s largest blood vessel, for the purpose of intercepting blood clots before they travel to the heart and lungs. The devices are implanted in patients who are at risk for pulmonary embolism (PE) that cannot take standard blood-thinning medications.
FDA Issued Multiple IVC Filter Safety Alerts
The U.S. Food & Drug Administration (FDA) has issued two safety alerts since 2010 regarding IVC filter complications. The first came in August of 2010 after IVC filters were linked to hundreds of adverse events, including IVC filters fracturing and migrating to other parts of the body. In other cases, broken filter fragments perforated organs and blood vessels, causing severe injuries.
A second alert was issued nearly four years later (May of 2014) advising doctors about the importance of retrieving IVC filters. In 2013, a paper published in JAMA Internal Medicine found that only 8.5 percent of retrievable IVC filters were successfully removed.
In a retrospective review of all Cook Gunther Tulip Filters and Cook Celect IVC filters that were retrieved between July 2006 and February 2008, 130 filter retrievals were attempted but in 33 cases, the standard retrieval technique failed, according to the Master Complaint.
Another study involving the Gunther Tulip Vena Cava Filter and the Cook Celect Filter implanted in patients between July 2007 and May of 2009 found that all of the IVC filters imaged after 71 days of implant caused some degree of filter perforation of the vena cava wall. The study also found that 40 percent of the implanted IVC filters tilted, and all tilted filters demonstrated inferior vena cava perforation. The authors of the study concluded, “Although infrequently reported in the literature, clinical sequelae from IVC filter components breaching the vena cava can be significant.”
Plaintiff Alleges Cook Knew or Should Have Known That its IVC Filters Were Dangerous
According to the Master Complaint, Cook knew or should have known that its IVC filters were more likely than not to tilt and perforate the vena cava. Nevertheless, the IVC filter manufacturer failed to warn physicians, or patients that its IVC filters were subject to scientifically known dangers, including breakage, tilt, inability of removal, and migration, the lawsuit alleges.
Cook allegedly advertised that its IVC filters were constructed using Conichrome, which purportedly “reduces the risk of fracture.” But according to the allegations, the failure of Cook IVC filters is attributable, in part, to the fact that the devices suffer from a design defect that causes it to be unable to withstand the normal anatomical and physiological loading cycles exerted in vivo (inside living organisms).
The lawsuit further alleges that 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. Cook IVC filters were designed, manufactured, distributed, sold, and marketed while defective due to inadequate warnings, instructions, labeling, and/or inadequate testing, per the allegations.
“Cook could have and should have implored doctors to retrieve these dangerous and defective devices as soon as they hit the market,” says Mrs. D’Amico’s attorney, Nicole K.H. Maldonado. “Instead, the company decided to tell doctors that retrieval was optional, and as a result, many people were seriously injured, or in some cases killed. Profit should never be more important than safety.”
About Baum Hedlund
The national law firm of Baum, Hedlund, Aristei & Goldman represents many plaintiffs in the IVC filter litigation against Cook Medical Inc. and C.R. Bard Inc. Juries in IVC filter bellwether cases against both manufacturers have turned in multi-million-dollar verdicts this year.
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 on their behalf in all areas of practice the firm handles. Baum Hedlund 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.