Lawsuits against Cook Medical and C.R. Bard were filed this month on behalf of women in Texas and Virginia who were injured as a result of complications from inferior vena cava filters (or IVC filters) manufactured by these companies. Hundreds of lawsuits have been filed against Cook Medical, C.R. Bard, and other IVC filter manufacturers on behalf of patients who suffered complications from these medical devices.
IVC filters are used to prevent pulmonary embolisms or other serious health conditions in patients at risk of blood clots who cannot be treated with blood thinners. The devices are implanted in the inferior vena cava – a blood vessel that carries blood from the lower body to the heart. IVC filters can be implanted temporarily to prevent blood clots for a shorter period of time, or permanently.
Health experts have warned about the risk of serious and potentially fatal complications associated with IVC filters. In September 2016, health officials in Canada warned that patients treated with IVC filters to prevent blood clots may be at an increased risk of perforated veins, thrombosis, broken filters, migration of the device within the body, cardiac perforation, or death.
IVC Filter Lawsuit Against Cook Medical Filed in Texas
A lawsuit filed in Texas against Cook Medical alleges that the company’s Cook Celect Vena Cava Filter caused complications in a Fort Worth woman after she was implanted with the device to prevent blood clots. The lawsuit alleges that Cook marketed a defective product because it failed to properly conduct safety studies of the Cook Celect filter before placing it on the market.
The Cook Celect device was approved by the FDA without safety testing because it was “substantially equivalent” to another Cook IVC filter, the Günther Tulip. Under the FDA’s 510(k) approval process, medical devices that are deemed equivalent to products already on the market are not forced to undergo testing to ensure that they are safe to be used on patients.
However, subsequent studies revealed that patients who received the Günther Tulip may be at risk of perforation from the filters or other complications. Patients who were implanted with the Cook Celect may also face risks of serious complications from the device. According to one study, 43% of patients who received the Cook Celect filter had at least one strut of the device perforate their inferior vena cava within two months. About 9% of the patients had serious tilting of the filter.
C.R. Bard Faces Lawsuit Over IVC Filter Complications in Virginia
In a separate lawsuit, a woman in Virginia alleged that she suffered complications from a Meridian Vena Cava Filter manufactured by C.R. Bard after being implanted with the device in a hospital. Bard is facing more than 1,000 lawsuits in the U.S. over the Meridian or other IVC filters sold by the company.
Like the Cook Celect, the Meridian Vena Cava Filter was approved under the FDA’s Meridian Vena Cava Filter. The Meridian filter was approved by the FDA in 2011 without clinical trial testing because it was judged to be substantially similar to several IVC filters sold by Bard.
One of the IVC filters that was used in the approval process for the Meridian filter was Bard’s Recovery IVC filter. The Recovery filter was approved by the FDA in 2003, but was recalled in 2005 because of a high rate of complications. A study found that 40% of the Recovery filters would fracture within five and a half years, putting patients implanted with these devices at risk of serious complications. Following the Meridian recall, Bard introduced the G2 filter in 2005. A 2014 study of the G2 filter found that an estimated 38% of these devices would fracture within five years.
Injured by IVC Filter Complications? You May Qualify to File a Lawsuit.
If you or a loved one have suffered complications from an IVC filter sold by C.R. Bard, Cook Medical, or other medical device manufacturers, you may be eligible to file a lawsuit. The first step in taking legal action against an IVC filter manufacturer on behalf of yourself or a loved one it to speak with an experienced attorney who can advise you regarding your legal options and guide you through the process of filing a claim in court.
The lawyers at Heygood, Orr & Pearson have represented numerous clients who have been injured by defective medical devices, dangerous drugs, or other medical products. Heygood, Orr & Pearson has the financial resources and legal expertise to ensure that your legal rights are protected in a court of law.
At Heygood, Orr & Pearson, we believe that when medical device manufacturers fail to properly ensure that their products meet minimum health and safety requirements, they should be held accountable for the injuries caused by their products in a court of law. Our firm believes that all patients deserve access to qualified legal counsel to represent their interests and ensure the best possible result in their case.
For a free legal consultation and to find out more about whether you may be eligible to file an IVC filter lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few questions about your case to get started.