Plaintiffs Aline and Samuel S., a married couple, filed a new Cook Celect IVC filter lawsuit in U.S. District Court, District of Ind., Indianapolis Division on July 13, 2017.

In this Cook Celect IVC filter lawsuit, the plaintiffs state that Aline S. was implanted with the device on Oct. 26, 2010 at Duke University Hospital in Durham, N.C. Aline later suffered complications related to her IVC filter that the couple believes exceeded what they were led to expect by the information provided by the defendant, Cook Medical.

Aline S. brings several counts against Cook Medical in this Cook Celect IVC filter lawsuit. Her spouse, Samuel S., joins the litigation with his complaint of loss of consortium.

Her complaints are: Strict Products Liability – Failure to Warn, Design Defect; Negligence and Negligence Per Se; Breach of Express and Implied Warranty; Punitive Damages. Aline and Samuel S. are represented by Christopher Spanos and Kerrianne Waters, attorneys registered with the State of Illinois.

This couple, residents of the State of North Carolina, joined multidistrict litigation (MDL) No. 2570 which is now proceeding in an Indiana federal court. This MDL is a collection of individual Cook IVC filter lawsuits raising similar claims against Cook Medical. Other similar devices made by Cook Medical are named in the MDL include Gunther Tulip IVC filter, Gunther Tulip Mreye, and Cook Celect Platinum.

Preventing Blood Clot Conditions with IVC Filters

Blood clots tend to form in the lower extremities and can travel from them to the heart via the inferior vena cavity, a major vein for returning de-oxygenated blood.

These blood clots can loge in the lungs or brain, causing a pulmonary embolism or even a stroke. An IVC filter is installed into the IVC and is anchored there to trap blood clots before they can cause such damage.

The Cook Celect IVC filter, according to the MDL, has four anchoring struts and eight independent secondary struts. These struts are made for anchoring the unit to the vein walls and for allowing the unit to self-center and improve filtration of clots.

It was made to be retrievable, but issues with the legs of the unit penetrating the vein and life-threatening difficulties removing the device led to the associated MDL.

There have been many alleged problems ensuing from the use of this group of IVC filters which were pushed through the Food and Drug Administration (FDA) via the 510(k) process for new medical devices.

Cook IVC Filters and the 510(k) Process

The FDA’s 510(k) approval process is essentially a short cut to the marketplace. While highly controversial, it allows pharmaceutical and medical device companies to get medications and devices cleared as opposed to approved, without the full testing required for medical devices that are completely new to the market.

The difference is that a clearance is much like letting one medical device ride on the coattails of another. The applying company must prove that the product is substantially similar to another product that is on the market.

The master complaint associated with this Cook Celect IVC filter lawsuit cites a Supreme Court opinion that notes the amount of time required to get 510(k) approval is an average of 20 hours. By contrast, pre-market approval of an all-new medical device takes an average of 1,200 hours to reach.

Yet, Cook Medical could advertise its family of IVC filters as safe and effective for the prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) under this short cut.

Aline and Samuel S. are asking for compensatory and punitive damages. They are also requesting all courts costs and fees be returned to them.

The Cook Celect IVC Filter Lawsuit is Case No.1:14-ml-2570-RLY-TAB, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.