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The U.S. Food and Drug Administration (FDA) approved IVC filters in 1979, and its uses have grown significantly over the years. These filters are designed to prevent pulmonary embolisms, which are blood clots in the lungs that can cause permanent damage or death.
Like other medical devices, IVC filters come with certain risks that can negatively impact a patient’s health. Some of these complications include inferior vena cava occlusion, problems removing the devices, embolization, filter fracture, deep vein thrombosis, and device migration. Some of these result from the device being defective.
Physicians will often place IVC filters in patients who are at risk for a pulmonary embolism. Patients who cannot use blood thinners can fall into this category. IVC filters may be used in individuals who are recovering from surgeries or accidents, such as:
The IVC filter looks somewhat like a metal cage, and its metal wires function to catch and trap blot clots before the clots can travel to the lungs and heart. A physician inserts the permanent or temporary IVC into a patient’s inferior vena cava. This is the largest vein in the human body and is next to the spine at the back of the abdomen. It transports deoxygenated blood from the body’s lower half up to the heart.
Vascular surgeons can implant IVC filters during outpatient procedures. A catheter is used to place the filter, and if the filter is temporary, it may be removed at a later time. The surgery can take from one to two hours or longer, and the patient may even be able to return home the same day. In some cases, a few days of hospitalization may be required.
There are risks involved with IVC filter implantation, such as blood clots, vein blockage, and bleeding at the site of insertion. Patients should be made aware of these risks before agreeing to the procedure. Post-IVC surgery patients may be prescribed antibiotics to prevent infection, as well as pain medication. It is important to monitor the site where the catheter was inserted; patients should look for pain, redness, swelling, and other signs of infection. Patients should not lift heavy objects, drive, or return to manual labor work until being cleared by their physicians. IVC filter revision, retrieval, and removal surgeries can also cause complications.
Patients with IVC filters should be vigilant about their health and take immediate action of any concerning symptoms present after their procedures. Feelings of nausea, confusion, neck pain, and lightheadedness may not seem serious, but these symptoms could be indicative of mild or serious complications. Other signs to look out for include low blood pressure, chest pain, shortness of breath, and heart rhythm abnormalities. In these situations, contacting the physician immediately, or even calling 911 in some cases, is highly recommended.
Defective IVC filters can lead to a host of different complications, some of which can be fatal. One significant complication is cardiac tamponade, or fluid buildup, that results from filter fragments traveling to the heart. The IVC filter can also fracture, and the pieces can perforate organs or veins.
These devices can also migrate and compromise organs and veins, causing damage, such as pulmonary embolisms and bleeding. If the filter becomes blocked, it can lead to deep vein thrombosis, which are blood clots that often form in legs, and pulmonary embolism. There is also the added risk of MRI complications, which occur if the filter’s materials interfere with the testing.
Defective IVC filters can cause serious injuries. Individuals can end up being unable to work and having to go on disability. There could also be several revision surgeries, followed by pain and long-term medical care. Facing piles of medical bills can make things even more difficult for patients and their families.
Some injured patients may be able to sue manufacturers. It is important to keep in mind that the statute of limitations for initiating an IVC filter lawsuit varies by state, and averages about two years after the patient discovers the injury. This timeframe will also depend on the type of claim and the state where the lawsuit is brought.
Although cases differ, these lawsuits can fall into certain categories. First, a lawsuit could arise from manufacturing and design defects. The other three main categories include negligence by the manufacturer or marketing company, and a failure to alert consumers about known health risks.
Poor construction can lead to several problems. The components of the filter could have their own defects to begin with, or human error could be the culprit. Proving this can be complicated, especially since it might be difficult to gather evidence. To help their cause, plaintiffs might benefit from testimonies from workers who assembled these devices and experts who are familiar with their components and manufacturing methods.
Defective designs can also be dangerous, causing injuries to show up after the IVC is implanted. These could be present immediately or take up to a few months. Sometimes, manufacturers are aware of the defects; other times, devices are not used as intended. Defective design liability is referred to as strict liability. In defective design scenarios, patients are not required to prove negligence, but they must prove that a manufacturer could have designed and produced a filter with less risk. In order to do so, expert testimony and the filter’s original design schematics should be procured.
IVC filter manufacturers owe their patients a duty of care, and this includes procuring all needed FDA approvals, creating safe, properly functioning devices, advising patients about possible hazards and side effects, and giving medical providers accurate instructions. Not completing these is a breach of duty of care.
To prove negligence, the patient has to address and prove that the defendant owed them this duty of care and breached this duty. It must also be shown that this breach directly caused the patient’s injuries, and these injuries caused them to suffer monetary damages. To build such a case, plaintiffs will need to present past paychecks to show lost earnings, medical bills, and whatever else they can gather as proof of pain and suffering incurred by the injuries.
Medical device manufacturers are also responsible for instructing physicians and consumers about their IVC filters proper usage, possible health risks, and complications. This is done through training, printed information, and through other means of instruction. The devices must also have warning labels on packaging that should be easy to find, have specific details, and be easy to understand. Some warning labels can be either missing or have the wrong information.
In 2010, the FDA issued their first IVC filters safety communication, which familiarized medical professionals with safety risks. One risk is the danger of leaving in an IVC filter for too long. At the time, the FDA recommended that physicians should remove a filter soon after the risk of a pulmonary embolism was no longer present. Four years later, the agency sent another IVC filter safety communication, stating that the filters should be removed from patients from 29 to 54 days after being planted. Otherwise, the risks of leaving them in outweighed any benefits. If a patient has a defective IVC filter, it is encouraged to seek legal counsel immediately.
Defective medical devices can ruin lives, but our experienced Pennsylvania defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler are on your side. For a free consultation about a defective IVC filter, complete our online form or call us at 215-569-4000. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.