Cook Medical is a business unit of the Cook Group Incorporated, a global privately-held conglomerate headquartered in Bloomington, Indiana. Established in 1963, the Cook Group is made up of five distinct business sub-units spanning: Hotels & Resorts; Property Management; Medical Services/Aviation and Component Manufacturing; Life Sciences; and Medical Devices. Today, the Cook Group employs more than 12,000 people around the world and last year reported revenue in excess of $2 billion. It is widely acknowledged to be one of America’s largest private companies.
The Cook Medical unit has attracted a great deal of attention on its own in recent years. Most recently the company made headlines for its Gunther Tip and Celect lines of Inferior Vena Cava (IVC) filter products which are the subject of multidistrict litigation currently underway before a federal court in Indiana. Claimants implanted with the Cook Medical IVC filters have alleged in court filings a number of serious injuries they believe were caused by manufacturing and design defects that Cook Medical allowed onto the market without adequate testing or refinement.
History and Background of Cook Medical
The story of Cook Medical began when company founder, Bill Cook, and his wife started making catheters in a spare bedroom of their apartment in Bloomington, Indiana, during the early 1960s. Aside from catheters, the duo also manufactured needles and wire guides. Despite its humble start, Cook Medical rapidly grew in sales and expanded internationally throughout the 1970s. By the 1990s, Cook Medical had diversified into intravascular coronary stents, programmable pumps, and infusion devices. Cook describes its approach to medical device manufacturing as “Minimally Invasive Medicine”.
Cook Medical’s IVC Filter Products
The Gunther Tulip
The Gunther Tulip is an IVC filter that has been marketed in the United States since 2003. It was designed as a retrievable filter, meaning it is only supposed to be implanted for short periods of time. If it is left in the vein for a long period of time (3-4 months), the Gunther Tulip increases in its risk of fracture or migration, which can lead to Pulmonary Embolism (PE) and possibly death.
Celect IVC
Similar in shape and design to the Gunther Tulip, the Celect line of IVC filter is a retrievable, umbrella-shaped filter made of a cobalt-chromium alloy. The Celect was approved through the 510(k) Clearance process (like the Gunther Tulip). And similar to other IVC filters, the Celect has the potential for fracture and migration the longer it is left inside of the human body.
Issues with Cook Medical Technologies and Product Lines
In re: Cook Medical, Inc. IVC Filters (MDL-2570)
Lawsuits revolving around the Gunther Tulip and Celect lines of IVC filters manufactured by Cook Medical began to make their way into courtrooms around the country in 2013 and 2014. These cases were then consolidated into multidistrict litigation in Indiana. The implantees in this MDL complained of alleged design and manufacturing defects such as tilt, migration, and fracturing. Specifically, some claimants referenced a study published in Cardiovascular Interventional Radiology in 2012 which assessed that the Gunther Tulip and Celect lines failed at a rate of 100% up to 71 days following implant and caused some degree of perforation of the wall of the vena cava. The same study reported that tilt was witnessed in 40% of the Gunther Tulip and Celect filter lines.
The outcomes of the various bellwether trials in this MDL have been a mixed-bag:
- In November 2017, a jury sided with Cook Medical and failed to find the company liable.
- A second bellwether case was dismissed in April 2018 due to statute of limitation issues.
- A Houston firefighter was awarded $1.2 million by a Texas jury in May 2018 (not actually a bellwether case and not part of the MDL).
- In December 2018, the presiding judge in the MDL granted summary judgment to Cook Medical in a Georgia case brought by Tonya Brand.
- Most recently, in February 2019, an Indiana jury awarded $3 million to a woman who suffered a range of injuries from one of its IVC filter lines.
Sources Cited (27):
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
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
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11. “Long-Term Clinical Outcomes of Complicated Retrievable Inferior Vena Cava Filter for Deep Venous Thrombosis Patients: Safety and Effectiveness” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6330022/
12. “Inferior Vena Cava Filter Placement and Removal” https://www.radiologyinfo.org/en/info.cfm?pg=venacavafilter
13. “Filter tilting and retrievability of the Celect and Denali inferior vena cava filters using propensity score-matching analysis” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134324/
14. “About Your Inferior Vena Cava (IVC) Filter Placement” https://www.mskcc.org/cancer-care/patient-education/ivc-filter-placement
15. “What is the evidence behind the IVC filter?” https://emcrit.org/pulmcrit/what-is-the-evidence-behind-the-ivc-filter/#:~:text=37%20patients%20with%20recurrent%20venous,rate%20of%20IVC%20filter%20thrombosis.&text=Therefore%2C%20they%20concluded%20that%20this,two%20problems%20with%20this%20argument.
16. “Vena Cava Filters” https://my.clevelandclinic.org/health/treatments/17609-vena-cava-filters
17. “Vena cava filters: Tiny cages that trap blood clots” https://www.health.harvard.edu/heart-health/vena-cava-filters-tiny-cages-that-trap-blood-clots
18. “Inferior Vena Cava Filters: Guidelines, Best Practice, and Expanding Indications” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4862857/#:~:text=There%20are%20two%20general%20types,and%20absolute%20contraindications%20to%20anticoagulation.
19. “Inferior Vena Cava Filter” https://www.ncbi.nlm.nih.gov/books/NBK549900/
20. “Permanent versus Retrievable Inferior Vena Cava Filters: Rethinking the “One-Filter-for-All” Approach to Mechanical Thromboembolic Prophylaxis” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4862850/
21. “FDA Issues Statement on Treatment and Follow-Up Regarding IVC Filter Complications” https://evtoday.com/news/fda-issues-statement-on-treatment-and-follow-up-regarding-ivc-filter-complications
22. “Predicting the Safety and Effectiveness of Inferior Vena Cava Filters” http://www.preservetrial.com/
23. “Vena cava filters” https://www.medicalexpo.com/medical-manufacturer/vena-cava-filter-44592.html
24. “Complications of Inferior Vena Caval Filters” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3036364/
25. “IVC Filter Migration: How Does It Happen?” https://medium.com/@Drug_Justice/ivc-filter-migration-how-does-it-happen-1e453d77a0af
26. “FDA Updates Safety Communication on IVC Filter Retrieval” https://evtoday.com/news/fda-updates-safety-communication-on-ivc-filter-retrieval
27. “Lara L. Adams et al. v. Cook Medical Incorporated, et al” https://www.courtlistener.com/docket/5117387/adams-v-cook-medical/
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
