Inferior Vena Cava filters, or IVC filters, were created to eliminate much of the risk of life-threatening pulmonary embolism. For many patients, they’ve caused other serious problems.
Friday, January 24, 2020 – IVC filters have, no doubt, saved lives, but they have also severely injured and even caused death in patients. Thousands of people who are victims of faulty IVC filters have filed lawsuits hoping to receive compensation for their medical bills and other expenses, and to hold the companies who make defective filters accountable for knowing about the problems for years without warning physicians, surgeons, and patients.
IVC Filter Problems
C.R. Bard, Inc., Cook Medical, and Cordis are responsible for manufacturing most of the retrievable IVC filters in question. These filters are intended for short-term use, and have resulted in serious problems.
The FDA first approved retrievable IVC filters in 2002. Most retrievable IVC filters were approved under the FDA’s fast-tracked process, meaning they did not require clinical trials or studies to determine safety.
For Cook, Bard, and Cordis, retrievable IVC filters became a significant source of profits. For example, Bard held only 12% of the market share when they were introduced in 2002. By 2012, its share had risen to 42%. Bard’s annual revenue more than doubled, from $1.27 billion to $2.96 billion. By 2014, C.R. Bard, Inc. was bringing in $3.3 billion in annual sales.
Testimony from multiple lawsuits has revealed that Bard became aware that patients were being harmed by their IVC filters in 2004. Plaintiffs claim they withheld that information from the FDA and from physicians, surgeons, and patients. The FDA did not receive enough information to realize Bard IVC filters posed significant risk to patients until six years later in 2010, when they issued the first of three warnings.
Plaintiffs in thousands of lawsuits against Cook, Bard, and Cordis believe that all three companies failed to properly test their IVC filters before subjecting patients to the risks, and that, once they were aware of problems with their devices, they failed to properly warn physicians and patients.
Do Patients Benefit from IVC Filters?
According to a 2012 study on in-hospital fatality rates, IVC filters did little to reduce mortality rates for patients who were stable.
A year later, a JAMA Internal Medicine editorial noted that the benefits of IVC filters had never been validated by empirical studies, and that device safety had similarly not been established.
Another study published by JAMA that same year found that IVC manufacturers and the hospitals using them had no universal, or institutional in some cases, standards for using or monitoring the devices. The study concluded with questions as to whether or not the devices should even be used.
In 2015, a study published in JAMA compared data from patients suffering from pulmonary embolism. Some were treated with only blood-thinning drugs, while others received both blood-thinning drugs and an IVC filter. Researchers found no significant benefits for the patients who also received IVC filters compared to those who didn’t receive them.
Questions still remain as to the effectiveness and benefits of IVC filters in patients with other treatment options available. In the meantime, patients have suffered severe injuries and even death as a result of faulty devices.
Bard FDA IVC Filter Warnings
2010 FDA Warning
In 2010, the FDA announced that it had “received reports of adverse events and product problems associated with IVC filters.” Those problems included:
- Filter breakage
- Device migration
- Difficult removal
- Embolisms
- Perforation of veins or organs
The FDA reported that patients had suffered serious complications, including:
- Death
- Recurrent deep vein thrombosis
- Recurrent pulmonary embolism
- Vena cava thrombosis
- Thrombotic complications
2014 FDA Warning
The FDA issued a second warning in 2014, this time concerning the length of time a Bard IVC filter could be implanted before problems were likely to occur. Their research indicated that the filters should only remain implanted for 29 to 54 days to avoid problems that could result in serious injury or death.
This warning was issued because retrievable IVC filters were being left in patients for too long, including indefinitely, when the initial risk for pulmonary embolism was no longer present.
2015 FDA Warnings
A stern warning was issued to Bard by the FDA in a July 13, 2015 warning letter. Among several violations of federal law, the FDA said Bard had failed to properly document and report consumer complaints after they reported several incidents as “product malfunctions,” when they should have been reported as serious injuries, and after a patient death caused by an IVC filter problem was also reported as a “malfunction.”
The letter also admonished Bard for failing to properly document complaints due to difficult removal of retrievable IVC filters, and of manufacturing and selling IVC retrieval devices that had not been approved by the FDA.
IVC Filter Lawsuits
Victims of faulty IVC filters have suffered immeasurably. When the devices fail, they can become difficult or impossible to remove. In some cases, components have broken off, or the filters have slipped out of place and moved throughout the body. They have pierced organs and blood vessels, and in some cases, have even resulted in death.
IVC filter lawsuits maintain that, not only have there been severe complications for many who have been implanted with the devices, but that Bard, Cook, and Cordis did not properly warn physicians or patients that these complications were a possibility.
Not Only About the Money
Lawsuits have been filed to help victims recover medical expenses, lost wages, and compensation for pain and suffering. This is compensation that both judges and juries have recognized that victims deserve — and often need — due to the damage that has been caused.
More importantly, lawsuits are the only way companies can be held accountable for putting lives in danger for the sake of profits. Lawsuits shine a light on the misdeeds companies have committed, including failing to properly test products, failing to report problems, and failing to ensure the safety of the people who depend upon them.
Lawsuits send a strong message to other companies that would otherwise try to cut similar corners, and they can even result in needed changes in laws and regulations.
Attorneys Fighting for IVC Filter Victims
OnderLaw is representing individuals and family members of people who have been implanted with an IVC filter, regardless of whether or not complications have occurred. Our attorneys are deeply troubled by the safety risks associated with these devices, and at the fact that these companies sought to minimize those risks by misleading an unsuspecting public.
OnderLaw medical device attorneys believe these companies must be held accountable. We provide confidential, free consultations with no obligation. Our lawsuits are handled on a contingency basis, meaning we don’t get paid unless you receive compensation.
Contact OnderLaw
If you have been implanted with a Bard, Cook, or Cordis IVC filter, Contact us today, or click here to schedule a free consultation. We will fight for you.
