A complaint by a South Carolina woman involving a Cook IVC filter joins a multidistrict litigation (MDL) against the medical device manufacturer. The plaintiff alleges that the Cook Celect Vena Cava (IVC) Filter she had implanted in July 2010 has caused her serious injury. She claims that Cook was aware of the problems associated with the devices and intentionally failed to warn patients and the medical community of the dangers and disadvantages of its IVC filters.
IVC filters are small, spider-like medical devices implanted into the vena cava, and have been used since the 1960s. By 2012, about 259,000 filters had been inserted as a temporary measure to impede blood clots before they have an opportunity to travel from the legs and pelvic region to the lungs or heart. The inferior vena cava is a major vein that returns blood to the heart from the lower part of the body. The IVC is used as an alternative for those patients for whom anticoagulants or blood thinners are not an option, according to the Mayo Clinic.
Cook IVC Filter Complications
The Cook Celect IVC filter has four struts to anchor the device and eight independent secondary struts to center the mechanism and trap potential blood clots. Plaintiffs in the Cook IVC MDL allege the company was aware the struts could break off as they were not affixed strongly enough to withstand normal anatomical and physiological movement within the body. Despite knowing this, the IVC filters were widely promoted as a safe and effective treatment for the prevention of pulmonary embolisms by way of placement in the vena cava.
The Cook filters were designed as a temporary measure and to be retrievable, but a study revealed that of 130 retrieval efforts made between July 2006 and February 2008, 33 failed. Either the struts had penetrated the vena cava wall, or tissue grew around the small hooks of the IVC filters.
The product liability lawyers and personal injury attorneys at Parker Waichman are closely monitoring events in IVC filter litigation. Associates at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.
Vena Caval Penetration
Between August 2007 and June 2008, a study of 73 patients implanted with the Celect filter found a “high incidence of caval filter leg penetration.” Caval penetration is a frequent, but clinically underrecognized complication of IVC filter placement, according to PubMed. Immediately after placement of a fluoroscopy-guided filter in 61 patients, four filters (6.5 percent) showed significant tilt. A subsequent abdominal CT (computed tomography) scan in 18 patients demonstrated filter related issues in seven (39 percent), which included penetration of filter legs in four and fracture/migration of filter components in one.
A story published in the March 30, 2011 journal Cardiovascular Interventional Radiology revealed that one hundred percent of Cook Celect and Guther Tulip IVC filters imaged after 71 days of implantation “caused some degree of filter perforation of the vena caval wall.” The filters that were studied had been implanted in 2009 between July and May. The same study showed that 40 percent of the filters had tilted, and that all the tilted filters had vena caval wall penetration.
Based on studies such as these, the Cook filter MDL says that Cook knew or should have known that their IVC filters were probably going to perforate the vena cava wall. An MDL is a type of mass tort that transfers lawsuits with common questions of fact to one court before one judge. This type of consolidation makes the legal process faster and more efficient because it eliminates duplicate discovery and streamlines proceedings. The Cook IVC Filter MDL case will take place in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.
FDA’s Controversial 510(k) Approval
Plaintiffs in the Cook litigation point out that IVC filters were approved through 510(k), meaning manufacturers did not have to submit clinical test data proving that devices were safe and effective prior to obtaining approval. This contrasts to the FDA’s normally strict premarket approval process which does mandate clinical testing. The 510(k) process is a fast-track route that only requires products to be “substantially equivalent” to a previously approved device, even if that device had safety issues of its own.
Substantial equivalence means that a product is at least as safe as its predicate. However, safety advocates have argued that 510(k) is not appropriate for certain medical products. The route was never intended for high-risk devices. Due to a regulatory loophole, however, some high-risk devices have been cleared through 510(k).
Have You been Injured by a Cook IVC Filter?
If you or someone you know has sustained injury associated with a Cook IVC filter, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/cook-ivc-filter-complications-lead-massive-mdl/