Due to a failure to warn doctors and patients of the complications of IVC filter usage, Houston firefighter Jeffrey Pavlock was awarded $1.2 million in a jury verdict against Cook Medical after experiencing blood vessel and organ perforations from his IVC filter. As of May of 2018, there have been more than 8,000 lawsuits filed against two IVC filter manufacturers, Cook Medical and Bard. Many IVC filter attorneys believe there are more than hundreds of potential cases. The devices are useful for people who are unable to take blood thinners, but their complications can be dangerous.
An inferior vena cava (IVC) filter is a small device surgically inserted into the inferior vena cava, the largest vein in the body. These devices, resembling a cage with spindly legs, are designed to trap blood clots from traveling to the lungs and causing a pulmonary embolism. A pulmonary embolism is a potentially fatal blockage of an artery that carries blood from the heart to the lungs. The idea is that the clots will dissolve naturally once trapped in the filter. Some filters are permanent, but otherwise the U.S. Food and Drug Administration (FDA) recommends removing the filter between the 29th and 54th day after the filter is implanted, unless the threat of pulmonary embolism hasn’t subsided. The FDA concluded this specific time span based on a mathematical model they developed using available medical data. When the agency discovered this, they did issue a safety notice in 2010 and again in 2014 outlining the risks of leaving the devices in for too long.
Missing IVC Filter
The IVC filter used in Pavlock was planned to be removed seven weeks after it was implanted. Unfortunately, during the surgery, they could not find the device because it had moved and lodged in a blood vessel. Even the second surgery to remove the device was unsuccessful. Now Pavlock will require ongoing health monitoring. There are other obstacles that can complicate the removal surgery, such as large clots and scars in the vein that prevent removal, as well as longer surgery times due to difficulty removing the device.
Aside from complications in retrieving the filter, there are also complications with the implanting procedure, such as punctured blood vessels, incorrect placement of the filter, defective filter deployment, and access site bruising and/or bleeding. Complications also occur after the device is implanted, including the device moving within the vena cava, blood clots in the legs, perforated organs, and device infection. If the filter does migrate in the vena cava or to other organs the device can become ineffective or even cause a pulmonary embolism.
Due to these serious problems, many patients are blaming the manufacturers, like Cook Medical, for their IVC filter injuries, and in some cases, death. According to an NBC news investigation, IVC filter injuries were associated with thirty-nine deaths, and thousands of others have suffered from complications. The FDA believes many of the injuries occurred because the filter remained in the body after the risk of pulmonary embolism subsided. For current IVC filters on the market, the agency required additional information to be collected. They have two options for research: either participate in the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study or conduct investigations under the FDA’s 522 Postmarket Surveillance Studies program. The PRESERVE study is an independent national clinical study investigating IVC filters’ effectiveness in preventing pulmonary embolisms. The research will hopefully allow manufacturers and health care professionals to understand the uses and risks of the devices. The main goal is to ensure the filters are safe.
Two IVC Filter MDLs in Process
Gathering extra data may be helpful for preventing injury in future patients. However, there are still many people who have already suffered from complications. Between 2005 and 2015, six recalls have been made, with the big issue being packaging and labeling issues. As a result of the widespread complications, there are two major multidistrict litigations (MDLs) currently underway involving Cook Medical and Bard. An MDL combines many similar cases so they move through the legal process more efficiently. Most patients in the MDLs believe they weren’t completely informed of the risks, such as Elizabeth Jane Hill. She claims her Cook Celect IVC filter traveled into her intestine, causing severe gastrointestinal symptoms. Her attorney argued that Cook knew or should have known the devices were defective, and they failed to warn patients and doctors. There is also a claim that the filters were unable to withstand normal physiological pressures due to poor design, so the filters were ineffective. Bard fought back, claiming the lawsuits should be dropped because the FDA approved the devices, therefore Bard can’t be sued over them.
Bellwether Trial Results Mixed
Cook Medical won the first bellwether trial in which they were being blamed for a Florida woman’s injuries. A bellwether trial is where a smaller group of lawsuits are tried first out of a much larger collection of lawsuits, such as an MDL. These trials are a way to determine how similar future cases will go and give the attorneys of both parties the opportunity to sharpen their arguments. These cases are not considered class actions because a class action suit in the U.S. requires that each person suffered from the same injury. However, in IVC filter cases, injuries vary, with some being more severe than others.
After Cook won the first bellwether trial, vice president of Cook’s vascular division said they were pleased with the outcome. The second trial against Cook was dismissed because the judge concluded the plaintiff waited too long to file suit. In the first bellwether trial against Bard, $3.6 million was awarded to the plaintiff who claimed a Bard IVC filter broke and injured her. Bard won the second trial. The jury believed the warnings Bard made to doctors were sufficient. So far, neither company offered a global settlement.
Even earlier than the Bard bellwether trials began, Bard had payouts for three other cases. In March 2013, Lisa Davis sued Bard, claiming their G2 IVC filter broke and migrated to her heart, causing her ongoing heart problems. Another suit was filed by Kelly and Chris Vlasvich, claiming problems with the Bard G2 filter. However, after getting close to reaching a settlement in 2014, the Vlasvichs dropped the suit. The third case was over the Bard Recovery. Kevin Phillips filed a suit because his filter broke and lodged itself into his heart; Bard agreed to a confidential settlement.
There are additional treatment options for patients at risk of blood clots, such as traditional blood thinners like warfarin. Changes in lifestyle can also help prevent blood clots. Avoiding smoking, high-sodium diets, and stress are all ways to decrease risk.