FDA Safety Warnings and Investigations

As the defect issues with IVC filters have become more well known, and lawyers have begun to bring cases forward, the FDA has issued safety warnings and conducted investigations into the IVC manufacturers. The FDA warnings are evidence of the problems that are ongoing. For example, the FDA warning to Bard is a clear indication that, according to FDA, Bard is mischaracterizing the adverse events that they have reported with its filters.

This is always important evidence in any product liability case when the federal government and the agency in the government who is designated for patient safety has identified problems with the manufacturers or with the devices.

The Role of the FDA in Investigating IVC Filters

The FDA issued a safety communication back in 2010 and they reiterated that safety communication in May of 2014 where they reported known problems of received adverse event reports. In their words, the reports included, “Device migration, filter fracture, embolization, which is movement of the entire filter or fracture fragments to the heart or lungs, perforation of the IVC, and difficulty removing the device.” The FDA recommended at that time that physicians and clinicians who are caring for patients who have these filters consider removing the filters as soon as the protection from the pulmonary embolism is no longer needed, so once the risk has passed, they should consider retrieval and encourage doctors to follow up with patients with IVC filters to consider the risks and benefits of the filters remaining in place.

The FDA requires clinical data and adverse event reports. It has collected those reports and in 2015 the FDA sent communication to Bard, which is one of the two big IVC manufacturers, saying that the recovery cone filter retrieval system, which Bard still uses today, was manufactured, “Without marketing clearance or approval in violation of the Food, Drug, and Cosmetic Act.”

This is the retrieval device that doctors use to retrieve the filter when the time comes to do so. That was marketed without FDA clearance or approval. And in the same letter, the FDA cited Bard for failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints and for mischaracterizing the types of complaints they received when reporting them to the FDA.

The Effects of Filter Fracture

Filter fracture, as the name suggests, is when the filter breaks up. That can take many forms. It could be the hook at the top of the filter breaking off. Most often, it is a strut or leg of the filter, as they may have four or five, six or eight legs on them and one of those may break off and embolize. That can cause tremendous problems for people because it is free floating in the blood stream and it is in the IVC, which is sending blood from the lower part of the body where the IVC is implanted. This little shard can embed in the heart or lung, which can cause major problems, even including death.

Device Migration

Device migration is similar except instead of the device breaking up, the whole device is moving. It can move in what’s called cephalad migration, which is upward, or caudal migration, which is downward. Because these things have hooks, they have to anchor themselves in the IVC. It is important to understand that they need to engineer a product so that it will stay in place without penetrating or perforating the IVC.

When it embeds, if there is migration, there can be tears in the vein, there can be embolization of the entire device where the whole device travels up the IVC into a person’s heart, which has caused death and can cause all sorts of other complications.

Organ Perforation

The IVC is a large vein in the lower body. The filter hooks or legs are anchored into that vein, when they perforate the vein, they push all the way through to the outside of the vein, as far as two or three centimeters outside of the vein. That vein is adjacent to lots of important structures in the body. It can perforate or pierce the spine, and it can pierce the aorta. It can pierce the duodenum, which can cause sepsis.

Once these filters have perforated the IVC, it is essentially a small needle sticking out of the vein. If someone moves a specific way, they have an impact, they fall, they are doing yoga, because they have no idea this has happened in their body, they are at risk for that needle, that strut of the filter, piercing any number of organs or vessels, which can cause all sorts of internal hemorrhaging and other problems.

Role of a Lawyer in Holding IVC Filter Manufacturers Liable

A lawyer can hold the manufacturer liable because there is a problem regardless of whether the FDA says there is a problem. A manufacturer has a duty to properly design and engineer their product, to warn of all the problems that it knows are associated with it, and to properly report problems that are associated with it. Anywhere along the line, whether it is through negligence or through product defect, regardless of whether the FDA has acted, the law says that manufacturers have a duty and if they breach that duty, then people who are harmed as a result of that have legal redress and that happens through the courts by lawyers.