As of the beginning of September 2017, there were over 1500 lawsuits either pending or in progress citing injuries allegedly caused by inferior vena cava (IVC) filters. Most of these have been filed against Bard Medical, which is the largest manufacturer of these dangerous devices. However, they are only one of several companies that have produced devices that have caused serious harm to.
For the benefit of those who believe they may have been injured by an IVC filter, here is a list of current defendants and their devices. Note: unless otherwise noted, the products listed below are still on the market and in use by surgeons and hospitals.
Based in New Jersey, C.R. Bard has been a named defendant in lawsuits over surgical mesh devices and prosthetic hips as well as IVC filters. Since 1990, Bard has produced a total of six distinct IVC filter models, five of which are still on the market as of this writing.
In every single case, these devices gained FDA approval through the 510(k) Pre-Market Notification process, which has allowed the manufacturer to bypass clinical study and testing requirements by demonstrating that the new product is “substantially similar” to an older model.
Bard went so far as to forge an employee’s signature on an FDA application in order to gain approval for a device. The majority of IVC filter lawsuits have named Bard as a defendant. Although the company has settled a number of cases, it is still facing class-action lawsuits in California, Florida and Pennsylvania.
Bard IVC filters include:
- Simon Nitinol VC Filter
- Recovery Filter System (taken off the market in 2005 and replaced by the G2 Series)
- G2 Vena Cava Filter
- G2 Express Vena Cava Filter (virtually identical to the previous model)
- Eclipse Vena Cava Filter
- Meridian Vena Cava Filter
- Denali Vena Cava Filter
- Braun Interventional Systems
Based in Pennsylvania, Braun came out with its first IVC filter in 1989. That model was replaced because of a high incidence of “incomplete deployment”; however, its successor has had similar issues. The first IVC filter lawsuit filed against this company was in June of 2017.
- VenaTech LGM Vena Cava Filter System (discontinued in 2001)
- VenaTech LP Vena Cava Filter System
- VenaTech Convertible Vena Cava Filter System
Based in Bloomington, Indiana, Cook Medical touts itself as a manufacturer of “medical devices for minimally invasive procedures.” The company came out with its first IVC filter in 1989, which was designed for permanent implantation. As in the case of Bard, all of Cook’s devices were approved through the 510(k) Clearance process.
- Gianturco-Roehm Bird’s Nest Bena Cava Filter
- Günther Tulip Vena Cava Filter (designed for long and short-term implantation)
- Celect Vena Cava Filter
While Bard and Cook have received the most attention from injury plaintiffs, Cordis, a subsidiary of Johnson & Johnson, is currently targeted in approximately 10% of IVC filter lawsuits. Both of its IVC filter received FDA approval through the 510(k) Clearance process and are still available.
The earlier model, the TRAPEASE Permanent Vena Cava Filter was found to have an abnormally high rate of fracturing by Japanese researchers. The OPTEASE Retrievable Vena Cava Filter was subject to a Class 1 recall by the FDA in 2013 because of inaccurate labeling, resulting in surgeons implanting the device incorrectly.
Other IVC Filter Manufacturers
Boston Scientific came out with its Greenfield Vena Cava Filter in 1989. Designed for both long-term and short-term implantation, this device is still on the market. The company is a named defendant in a number of lawsuits.
Rex Medical, also based in Pennsylvania, manufactured the OptionELITE Retrievable Vena Cava Filter, which was approved by the FDA in 2013 via 510(k) Clearance. Since 2016, this filter has been manufactured and sold by Argon Medical Devices.
A recent adverse event report submitted to the FDA indicates that the device is subject to fracturing and migration. A lawsuit was recently filed against Rex and Argon by a Michigan woman whose IVC filter became embedded in a vein, requiring complicated and dangerous surgery.
French medical device manufacturer ALN Implanats Chirurgicaux has a single IVC filter model, known as the ALN Optional Vena Cava Filter with Hook. This device was cleared for the U.S. market in 2008 through the 510(k) process. As of this writing, only five adverse event reports on this device have been received by the FDA.