A South Carolina woman has filed a Denali blood clot filter lawsuit, joining numerous other plaintiffs who claim the device caused them serious internal injuries.

Plaintiff Penny N. asserts that an Inferior Vena Cava (IVC) filter, manufactured and sold by defendant C.R. Bard, was defective in design. She and other plaintiffs allege that the company failed to warn patients and doctors about possible problems with the Denali blood clot filter, misrepresented the product, and is in breach of warranty under the law.

About the Denali Blood Clot Filter

C.R. Bard and other health care products companies have manufactured, designed and marketed a number of similar devices, known collectively as IVC filters. These are small, cage-like devices, most of which resemble a cellar spider or “daddy longlegs,” that are inserted into the primary artery leading from the lower body to the heart.

The purpose of the Denali blood clot filter is to trap blood clots, preventing them from traveling to the heart and lungs and causing an embolism. IVC filters are typically indicated for patients who may be at risk for embolism following joint or other surgery, but cannot tolerate anti-coagulant drugs. They were meant to be temporary and retrievable – but that has not always been possible.

The Dangers of IVC Filters

Devices such as the Denali blood clot filter have not only proven difficult to remove, they are also reportedly prone to migration and and fracturing. This means that IVC filters can come loose and move into different places in the body. They can also fall apart, allowing tiny metal shards to travel in the blood stream to other parts of the body. If these shards or the filter reach the heart muscle or other internal organs, the consequences can be severe and even fatal.

510(k) Premarket Notification Strikes Again

Like a number of controversial medical devices in recent years, the Denali blood clot filter was given FDA approval through a process known as 510(k) Premarket Notification. This regulation originally had good intentions; the purpose was to make new, potentially life-saving medical devices available more quickly to patients who could benefit.

Normally, such devices require extensive laboratory tests and clinical trials before they are submitted for approval. By demonstrating that a new product is “substantially equivalent” to an older product currently on the market, a medical device manufacturer or drug maker can bypass these requirements. Unfortunately, this has resulted in the release of many dangerous products to the healthcare market.

IVC Filter Litigation Moves Forward

Penny is only one of more than 6,300 plaintiffs who have claimed injuries due to defective IVC filters and have filed lawsuits against manufacturers. Because there are so many plaintiffs, these cases have been consolidated into multidistrict litigation. This differs from a class action. Plaintiffs in an MDL have similar causes of action and common facts pertinent to their cases, yet each lawsuit remains an individual action. It allows pre-trial procedures to be carried out before a single judge before the cases are returned to individual jurisdictions.

The Blood Clot Filter MDL is In re: Bard IVC Filters Products Liability Litigation, Case No. 2:18-cv-04386-DGC.