IVC Filter Manufacturer Continued to Sell Defective Product Despite Knowledge of its Deadly Flaws

IVC Filter Manufacturer Continued to Sell Defective Product Despite Knowledge of its Deadly FlawsLast September, we discussed how defective IVC filters were linked with as many as 27 deaths and thousands of problems that required surgery. The manufacturer knew that the IVC filter could cause potentially fatal problems soon after it was released for sale, but they kept it on the market for five more years. In December of 2015, NBC News obtained confidential records from medical device manufacturer, C.R. Bard that details the failures of their G2 series filters within months of the device’s clearance by the U.S. Food and Drug Administration. Despite the company’s knowledge of the potentially fatal flaws in the device, they kept it on the market and sold hundreds of thousands of units.

Complications from defective IVC filters in the body

An IVC (interior vena cava) filter is a small metal device that resembles the metal framework of an umbrella. The filters are implanted to trap blood clots and prevent them from entering the heart and lungs in patients who are unable to take blood thinner medications. IVC filters are either permanent or temporary. The temporary device was meant to be removed when the danger of blood clots had passed. The delicate structure of the temporary IVC filers is so fragile that pieces of the device tend to break off and float away from the implant causing serious complications that could lead to death.

In 2010, the FDA warned that the temporary or retrievable filters posed a serious risk of fracturing, migrating away from the implant site and perforating organs with the fragments. The FDA released an updated safety warning in 2014, which urged that the devices be removed between the 29th and 54th day after they had been implanted. For some patients who had the filters in their bodies for much more than 54 days suffered from complications from the device that caused harm and in some cases it caused the death of the patient.

IVC filter lawsuits

Plaintiffs began filing lawsuits against IVC filter manufacturers claiming negligence, failure to warn patients about the possible complications, design and manufacturing defects and negligent representation of the product. In February of 2015, in the midst of a products liability personal injury lawsuit in which plaintiff, Kevin Phillips, claimed that a C.R. Bard IVC filter broke apart inside of his body, and one of the metal parts of the device perforated his heart forcing him to undergo emergency open heart surgery to have the IVC filter and the broken pieces removed. There are now more than 22 pending MDL consolidated multidistrict lawsuits in the U.S. District Court District of Arizona, and there are three class actions against C.R. Bard in California, Florida and Pennsylvania courts. .