Executive Summary

Cook Medical is a subsidiary division of the Cook Group Incorporated, a privately-held company headquartered in Bloomington, Indiana.  The Cook Group is involved in the manufacture of medical devices, building materials, and plastic packaging/containers.  In recent years, Cook Medical has been the focus of lawsuits over defects involving its line of Inferior Vena Cava (IVC) filter products, its transvaginal meshes, and a voluntary recall of its CrossCath support catheters in 2019.  The Cook Group has more than 12,000 employees and revenue of over $2 billion.  In 2008, Forbes magazine ranked the Cook Group as #324 on its list of “America’s Largest Private Companies”.

History

Cook Medical began as Cook Incorporated in 1963 when founder Bill Cook and his wife began manufacturing catheters in their spare bedroom with lengths of plastic tubing and a blow torch.  The company would grow from there and specialize in the manufacture and sale of catheters, needles, and wire guides for minimally invasive procedures in patients that are considered too high risk for surgery.  In the 1970s, the company rapidly expanded to Europe and Asia and shipped enough products to allow doctors to perform 2,000 cardiovascular catheterizations a day.  In the 1990s, Cook Medical introduced the world’s first intravascular coronary stent and began work on treatments for chronic disease management.

Lawsuits

IVC Filter Products

IVC Filters are miniature devices implanted in veins that supply blood running from the leg to the heart.  They are designed to catch and filter blood clots before they reach the heart or lungs causing sudden illness or death.  Along with Bard and Johnson & Johnson, Cook Medical was one of the three largest manufacturers of IVC Filters worldwide.  In recent years, it has emerged that some IVC filters, and in particular, some manufactured by Cook, are implicated inpatient complications as well as some deaths due to dislodgement in the vein or perforation of the vein itself.

Known primarily for three types of IVC filter products:

• Celect Platinum Vena Cava Filter
• Gunther Tulip Vena Cava Filter
• Bird’s Nest Vena Cava Filter

Today, there are thousands of pending IVC lawsuits naming Cook Medical as a defendant which have been consolidated into Multi-District Litigation (MDL) in federal court for the Southern District of Indiana. In February 2019, a bellwether jury trial found Cook Medical liable for a patient’s suffering following the fracture of her Cook IVC filter and ordered the company to pay $3 million in damages. Cook appealed that verdict and in January 2020, a judge vacated the jury verdict and granted the parties a new trial.

Recalls

CloverSnare 4-Loop Vascular Retrieval Snare (2014)

Cook voluntarily recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices because of a potential for the loop to separate from the shaft.  This separation causes the tip of the device to travel through the patient’s vascular system elevating the potential for embolism unless the patient undergoes a follow-up surgical procedure for removal.

Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays (2016)

Cook voluntarily recalled 17,827 of its Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to the potential for catheter tip fracture or separation.  The risk to the patient following separation or fracture involved potential vascular blockage and the necessity for a follow-up procedure to remove the fragment.

Beacon Tip Technology (2016)

Cook voluntarily recalled all of its catheters utilizing Beacon Tip technology due to complaints of tip splitting and fracture.

Roadrunner UniGlide Hydrophilic Wire Guides (2016)

DSM Biomedical B.V. in the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner UniGlide Hydrophilic Wire Guide product recalled 8,750 units due to concerns about possible glass particle contamination during the manufacturing process.

CrossCath Support Catheters (2019) 

CrossCath Support Catheters are designed to support a wire guide during access to blood vessels, allow for the exchange of wire guides, and provide a pathway for the delivery of saline solutions or diagnostic contrast agents.  Cook Medical agreed to a voluntary Class I (the most severe) recall after identifying an error during manufacturing which may cause marker bands to be too loose and possibly dislodge in patients.

Sources Cited:

1) “How Cook Medical Got Its Start” https://www.cookmedical.com/about/history/

2) “Cook Pharmica Sold To Catalent For $950M, Cook Group Buys GE Plant” https://indianapublicmedia.org/news/cook-pharmica-sold-catalent-950-million-127683.php

3) “Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling” https://www.fda.gov/medical-devices/medical-device-recalls/cook-medical-recalls-crosscathr-support-catheters-due-manufacturing-error-which-may-cause-marker#:~:text=Medical%20Device%20Recalls-,Cook%20Medical%20Recalls%20CrossCath%C2%AE%20Support%20Catheters%20Due%20to%20a,to%20Dislodge%20or%20Cause%20Buckling&text=The%20FDA%20has%20identified%20this,cause%20serious%20injuries%20or%20death

4) “Federal court vacates judgment in IVC filter litigation case, Cook Medical continues fight for physician access to life-saving filter technology” https://www.cookmedical.com/newsroom/federal-court-vacates-judgment-ivc-filter-litigation-case/

5) “Court Grants New Trial In Cook Medical Lawsuit” https://indianapublicmedia.org/news/court-grants-new-trial-in-cook-medical-lawsuit.php

6) “Bill Cook, Medical Device Maker” https://www.nytimes.com/2011/04/26/business/26cook.html

7) “Bloomington’s Med-Tech Industry Is A Lifesaver” https://www.fastcompany.com/1836156/bloomingtons-med-tech-industry-lifesaver

8) “CloverSnare™ 4-Loop Vascular Retrieval Snare Recall” https://www.cookmedical.com/newsroom/cloversnare-4-loop-vascular-retrieval-snare-recall-2/

9) “Cook Medical issues fourth recall in 18 months” https://www.ibj.com/blogs/the-dose/57229-cook-medical-battling-quality-issues-issues-another-recall

10) “Cook deluged by product lawsuits” https://www.ibj.com/articles/53869-cook-deluged-by-product-lawsuits

11) “Cook Medical issues global recall of select lots of Central Venous Catheters and Pressure Monitoring Sets and Trays” https://www.cookmedical.com/newsroom/cook-medical-issues-global-recall-of-select-lots-of-central-venous-catheters-and-pressure-monitoring-sets-and-trays/

12) “Cook Medical issues global voluntary recall of catheters with Beacon Tip technology” https://www.cookmedical.com/newsroom/cook-medical-issues-global-voluntary-recall-of-catheters-with-beacon-tip-technology/#:~:text=May%202nd%2C%202016-,Cook%20Medical%20issues%20global%20voluntary%20recall%20of%20catheters%20with%20Beacon,with%20Beacon%C2%AE%20Tip%20technology.&text=The%20catheters%20were%20recalled%20on,tip%20splitting%20and%2For%20fracture

13) “Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue” https://www.cookmedical.com/newsroom/cook-medical-issues-global-recall-of-roadrunner-uniglide-hydrophilic-wire-guides-due-to-raw-materials-issue/