The Cook Group Inc. faces at least 100 lawsuits over its blood clot filters. Patients from around the country have filed lawsuits against Bloomington, Indiana-based Cook. Lawsuits allege the company’s blood-clot filters have broken apart, migrated and/or perforated the inferior vena cava, the blood vessel in which they are implanted. The inferior vena cava brings blood from the lower body back to the heart; the filter is designed to keep blood clots from reaching the lungs.
Begun in 2012, the Cook litigation has recently been consolidated in federal court in Indianapolis.
Cook IVC Filter Attorney
Houston attorney David Matthews, a member of the plaintiffs steering committee for the Cook litigation, said Cook may have a much larger problem than the company thinks it does.
One study showed that 100% of Cook filters implanted and left in place for 2½ months or longer caused damage to some patients’ organs and required medical procedures to remove the filters. Many other patients experience no symptoms after their blood-clot filter fails to remain in place.
Huge Public Health Risk
Mr. Matthews believes there may be tens of thousands walking around with a perforated vena cava, creating a potentially huge public health risk in the country.
Some 250,000 blood-clot filters are implanted each year to prevent pulmonary embolisms – an often fatal event that occurs when a blood clot moves into the lungs. The market for IVC Filters is expected to reach $435 million in 2015, according to a 2014 market analysis by research firm Axis Research Mind.
Cook is one of three leading corporations in the industry, along with New Jersey-based C.R. Bard Inc., and the Cordis subsidiary of New Jersey-based Johnson & Johnson.
Cook thinks problems with its blood-clot filters are extremely rare. Even when filters break or fail, Cook believes it is not at fault because the patients’ doctors chose Cook’s implant products.
In response to the lawsuits filed against the company, Cook attorneys issued a blanket denial of responsibility or (at least) legal liability and pointed fingers everywhere but at Cook, stating, “A cause of any physical harm sustained by Plaintiffs was misuse of any medical device or product for which Cook Defendants are responsible. (Plaintiffs’) damages or losses, if any, were caused or contributed to by the fault of other products, persons, firms, corporations or entities over whom Cook Defendants had and have no control.”
Costly Legal Trouble for Cook
For Cook and other medical-device makers, the cost of dealing with product-liability litigation is an increasing burden.
A 2012 analysis by McKinsey & Co. estimated “non-routine” quality issues – recalls, warning letters, warranties and lawsuits – cost medical-device companies one (1) percent to two (2) percent of annual revenue.
Cook enjoys $2 billion in annual sales, which would mean (if the analysis is correct) Cook spends more than $20 million each year on “non-routine quality issues.”
Medical Device Recalls Doubled
The frequency of those issues grows. FDA in a 2014 analysis noted medical-device recalls nearly doubled from 2003 to 2012.
A 2011 FDA report found the number of patients seriously injured because of a medical device had nearly quadrupled from 2001 to 2009, growing eight (8) percent faster than medical device sales every year.
Cook makes many variable products for small numbers of patients. Most medical-device companies have some 400 products in their catalogs. Cook has 15,000.
Founder Bill Cook’s mission was to produce products that help physicians solve patient problems, regardless of sales potential. The company secured its first sales in 1963 when Cook took a blow torch to a medical conference and used it to bend Teflon tubing into the odd shapes surgeons said they needed for difficult procedures.
The Cook group is a global power, employing more than 12,000 people.