Lawsuits filed against medical device giants C.R. Bard and Cook Medical have alleged that the IVC filters made by these companies were defectively designed and improperly manufactured. The lawsuits also allege that C.R. Bard and Cook Medical failed to warn patients and their doctors about the risk of problems with their IVC blood-clot filters. IVC filters manufacturers by C.R. Bard and Cook Medical have been linked to dozens of deaths and hundreds of cases of complications linked to problems with these devices.
IVC filters (also known as Inferior Vena Cava filters) are a medical device designed to prevent complications in patients at risk of pulmonary embolism, potentially fatal blood clots in the lungs, especially in patients who are unable to take anticoagulant medications. The filters are implanted in the inferior vena cava, a major blood vessel that carries blood from the lower body, where they help to prevent blood clots from traveling to the heart, lungs, or brain.
About 250,000 patients in the U.S. are implanted with an IVC filter every year. Currently, there are 11 companies that manufacture IVC filters, including C.R. Bard and Cook Medical.
Risk of Complications Associated With IVC Filters
IVC filters can fail by fracturing, tilting or shifting, or migrating within a patient’s body. When IVC filters fail, patients may experience symptoms such as chest pain, heart rhythm abnormalities, changes in blood pressure, lightheadedness, nausea, neck pain, trouble breathing, internal bleeding, or other symptoms.
A defective IVC filter can cause severe medical complications including:
- IVC vein perforation
- Heart damage
- Heart blockage
- Damage to the lungs or veins
- Disruption of the heart rate
- Lower limb deep vein thrombosis (DVT)
- Pulmonary embolism
Lawsuits filed against C.R. Bard and Cook Medical have reported a high rate of complications with the following brands of IVC filters:
- Bard G2 or G2 Express
- Bard Recovery
- Bard Esclipse
- Bard Meridian
- Bard Denali
- Cook Celect
- Cook Platinum Celect
- Cook Gunther Tulip
FDA Warns of Potential Problems with IVC Filters
After Bard’s Recovery IVC filter was placed on the market in 2003, reports emerged of broken filters leading to the injury or deaths of several patients implanted with the device. Bard commissioned a confidential study which found that the Recovery filter had a higher rate of patient deaths, filter migration, and breakage than all of its other competitors. Although the physician who was hired to conduct the study warned the company that “further investigation” was needed, Bard chose not to recall the Recovery IVC filter from the market.
In 2005, Bard introduced its G2 series IVC filters. Over the next several years, the FDA received hundreds of reports of complications with the new filter, similar to the problems reported with the Recovery filter. Internal company documents from C.R. Bard showed that the G2 series had a higher number of device fractures, migrations, and other problems than competitor filters. Bard continued to sell the G2 filter even though the company had another IVC filter with few reported problems.
Problems with IVC filters sold by Cook Medical were first uncovered in 2012, when a study published in the journal Cardiovascular Interventional Radiology found that 100% of patients who had received a Cook Celect or Cook Gunther Tulip IVC filter experienced perforation of the venal caval wall within 71 days of receiving the device. The study also found that 40% of the filters had become tilted or out of position, increasing the risk of additional complications such as migration.
Experts have also warned about an increased risk of complications with other IVC filters. In 2010, the FDA warned about the risk of complications with IVC filters—regardless of what brand was used—stating that it had received more than 900 reports of complications with these medical devices. Although the agency recommended that doctors should remove retrievable IVC filters to prevent complications, a study published by JAMA Internal Medicine found that doctors were able to remove IVC filters in less than 10% of cases. Many of the patients who were implanted with an IVC filter suffered a pulmonary embolism despite having the device in their body.
Lawsuits Filed Against C.R. Bard and Cook Medical Over IVC Filters
The first lawsuits against C.R. Bard filed on behalf of patients who suffered injuries as a result of complications from the company’s IVC filters were filed in Pennsylvania and California state courts in 2012. In February 2015, Bard reached a settlement agreement 10 days into a trial involving a patient who suffered a perforated heart after his Recovery IVC filter broke inside his body.
Dozens of additional lawsuits have been filed against Bard the company by patients who were injured by Bard’s Recovery or G2 series IVC filters. In August 2015, 50 of these lawsuits were consolidated in a multidistrict litigation (MDL) in the United States District Court in Arizona.
Numerous lawsuits have been filed against Cook Medical on behalf of patients who were injured due to complications with the company’s IVC filters. In 2014, lawsuits from across the country involving IVC filters that had been filed against Cook Medical were consolidated in a MDL in Indiana.
Because hundreds of thousands of patients are implanted with IVC filters manufactured by Bard, Cook, or other medical device companies each year, experts have predicted that more lawsuits will be filed by patients who are injured by complications from these products.
IVC Filter Complications? You May Qualify for a Lawsuit.
Patients who have been hurt as a result of complications with IVC filters manufactured by C.R. Bard, Cook Medical, or other medical device manufacturers may qualify to file a lawsuit. The first step in taking legal action is to speak with a law firm with the knowledge and experience in handling medical device and product liability lawsuits to handle your case all the way through the litigation process.
The lawyers at Heygood, Orr & Pearson has represented hundreds of individuals who have been injured by dangerous medical devices like surgical mesh. Our attorneys believe that when companies who manufacture medical devices fail to ensure that their products meet basic health and safety standards, they should be held accountable for the harm caused by their products in a court of law. Our firm is dedicated to the belief that all patients should have the right to experienced and qualified legal counsel to ensure that their interests are represented and that their rights are protected.
For a free legal consultation and to find out whether you may qualify to file a lawsuit over injuries caused by a defective IVC filter, contact the lawyers at Heygood, Orr & Pearson. You can reach us by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form and answering a few simple questions about your case to get started.