IVC Filters – A Litigation Guide

A significant number of recent product-liability suits involve the implantation of dangerous medical devices that result in a patient’s injury, for which they are entitled to seek relief. The medical field is constantly evolving as it continues to utilize new technologies and introduce new techniques to administer treatments. One such procedure that has often resulted in litigation is the implantation of IVC (inferior vena cava) filters in patients at risk for pulmonary embolisms. We researched the various complications resulting from use of these devices that could result in a products-liability suit to provide an overview of the types of experts used in such instances. Use this litigation guide to get an idea of what experts you may need in an IVC filter case.

Background

IVC filters are small medical devices inserted into the main blood vessel in the abdomen, through minimally invasive surgery. It returns blood from the lower half of the body to the heart. The spider-like device is designed to catch the blood clots that develop deep in the lower veins. Thereby preventing them from reaching the lungs, resulting in a condition known as a “pulmonary embolism” (PE). It is estimated that over 50,000 people die year each from PEs. These occur when a blood clot dislodges from a deep vein in the lower extremities, travels through the body, and causes a blockage on its way to the lung.

The most common disease associated with PEs is a condition called “deep vein thrombosis” or DVT. Anti-coagulants, or blood thinners, are the preferred treatment for this disorder. However, for many people these types of medications cannot be used due to an adverse medical history. Of the patients who do receive IVC filters, most are given retrievable IVC filters intended for short term implantation. These filters are designed to be removed once a PE is no longer a threat.

Over the years, thousands of patients in the United States have increasingly been implanted with this device. The following fatal complications have made IVC’s the star of much litigation. Studies have shown that the filters are prone to fracture. They can then migrate through the body and cause bleeding, severe pain, and even death. Nationwide, patients are bringing personal injury and product liability suits against manufacturers of models like the Cook IVC filter, the Bard Recovery IVC filter, and the Bard G2 IVC filter. Twenty-two cases involving the Bard IVC Filter are being heard in Federal Court. Additionally, there are at least 16 additional cases pending in United States District Courts.

Complications

One of the largest issues at the center of litigation involving IVC filters concerns the different complications associated with the product that can result in severe injury to the patient. Especially due to the product’s design. An IVC filter is extremely small, measuring about 25-mm in length. Given its tiny size and placement in the body, the device can pose a large threat to a patient. The minuscule size and fragile construction of the device make migration of broken components through the body fairly common. For example, one of the prongs of the filter can shift out of place and puncture the wall of the vein. Thus causing internal bleeding, pain, and a slew of other issues.

Indications

What can sometimes be a litigious issue involving IVC filters concerns what medical professionals call the “indication”. In other words, the specific medical condition or circumstances that led to the determination that an IVC filter was needed. When a treating physician makes a medical prognosis determining that an IVC filter was necessary, that physician makes a judgment call, based on certain factors or “indications.”. Based on these indications, one of which includes the “contraindication” against anti-coagulants, doctors make an affirmative recommendation for the use of an IVC filter. In the litigation context, improper assessment of an indication or lack of care in thoroughly screening the patient for any pre-existing conditions could be the reason for an “indication” IVC filter suit.

Types of Experts

Hematologists

Hematologists are doctors who specialize in the diagnosis, treatment, and management of patients with blood conditions. With respect to IVC filter litigation, these are the lead specialists with expertise in the medical conditions precipitating the need for the filter. They are most familiar with how the product interacts with the passage of blood through the veins and arteries. IVC filters are designed to catch blood clots starting in the legs before they reach the lungs. However, they have actually been shown to increase the risk of blood clots forming in a patient’s veins.

Hematologists are able to assist the jury in understanding why and how these devices are used to prevent embolisms. They can include how they are inadvertently worsening the problem. Moreover, since hematologists are familiar with any pre-existing conditions in the patient- for example if a patient’s blood is prone to hypercoagulation- then a hematologist will be able to assess how much the device was at fault regarding a patient’s injuries. These experts know blood down to a molecular level. Thus they are one of the most important experts in any case involving IVC filters.

One of the most difficult aspects of this kind of expert’s unique testimony is the highly technical language involved. Especially because much of the terminology concerns medical biology- human blood, its composition, how it travels through the body and of course, what effect an IVC filter has on all these aspects. Since the primary job of an expert is to educate the jury, make sure your expert’s testimony is as simplified as possible. Sometimes medical terms tend to be compounded (just like “hypercoagulation”) and attorneys tend to become all too familiar with them.

Interventional Radiologists

After hematologists, interventional radiologists are experts who are also directly involved with the device and implantation procedure itself. Interventional radiologists are medical doctors who specialize in minimally invasive surgery, utilizing image-guided procedures to diagnose and treat nearly every organ system. When implanting IVC filters, interventional radiologists use minimally invasive methods, guided by a large-screen computer that dictates where the device should be placed. They can therefore be called upon to explain how and when an IVC should be removed, what the procedure entails, and effective techniques for complex filter removals.

It is crucial that their testimony is clearly communicated in a trial setting. Make sure that the individual mechanical components of the device are thoroughly covered. Factors that are sometimes overlooked include important background information, such as the material used in the manufacturing of the device and sometimes, as Dr. Schiff points out, the difficulties with using computer guided programs to insert such devices.

Vascular Surgeons

Alternatively, vascular surgeons can also place IVC filters in patients (though this is less common). A critical difference is that vascular surgeons will manually insert the device without as much reliance on the computer guided techniques, unlike interventional radiologists. Vascular surgeons are specialized in diseases plaguing the arteries, veins and vascular system overall. So this type of expert knows what circumstances lead to aneurysms and embolisms as a result of ruptures or clots in blood passageways. They can determine if the arteries need interventional treatment to prevent further strokes.

In a case about IVC filters, in addition to testimony about the implantation procedure, this kind of expert can offer in depth insight as to the anatomy of the vascular system. In a situation where the device may have negatively impacted a passageway, such as puncturing the wall of a vein or artery, the testimony of a vascular surgeon could prove vital.

Pulmonologists

This type of expert specializes in assessing diseases of the lungs and respiratory tract. The whole purpose of an IVC filter is to prevent blood clots in the lungs called pulmonary embolisms (PE). These can cause permanent damage to the lung and other organs, low oxygen levels in the blood, and death. Since many of the symptoms of PE include include shortness of breath, chest pains, and coughing up blood, this kind of expert is helpful for identifying the risks and consequences associated with PE and their connection with IVC filters. Furthermore, a pulmonologist can explain why an IVC filter may be recommended for the purpose of preventing a pulmonary embolism to the jury, as well as the dangers posed by the device’s increased risk of blood clots.

Epidemiologists

A growing number of attorneys have started retaining epidemiologists as part of their expert witness team in IVC filter cases. Epidemiologists investigate patterns and causes of disease and injury and seek to reduce negative health occurrences through clinical research. This type of professional can speak to the prevalence of defects in the treated population that will help the jury better understand the circumstances surrounding the case.

What makes epidemiologists unique in these circumstances is that they study diseases afflicting the population on a macro level, accounting for a variety of factors including differences among patients. An epidemiologist’s knowledge base is specifically oriented towards conditions among groups. So it is important to make sure the jury understands the nature of the expert’s research and why such an expert’s opinion is being offered. In IVC filter litigation, an epidemiologist can explain to the jury what portion of the population suffers from DVT or other conditions that increase the risk of PE in patients, and the proportion of those patients with IVC filters who have been negatively affected.

FDA Experts

Since this product is a medical device regulated by the United States Food and Drug Administration, it is crucial to understand the regulations governing sale, distribution and use of IVC filters. In instances where medical devices cause injury to a large number of individuals, it is essential that the jury has insight into the regulatory scheme and norms surrounding approval of devices for medical use. Since injury reports are submitted to the FDA, these experts will also be able to give testimony about reported instances of injuries involving IVF filters. More importantly, they can discuss any disciplinary history involving IVC filter manufacturers. For example, in 2010 the FDA issued letters to doctors warning them about the risks associated with retrievable Cook and Bard IVC filters. In 2015 it issued a warning letter to Bard for illegally marketing a device used in the removal of its Recovery IVC filter.

An FDA expert’s role in this litigation is distinct from any of the other experts we have mentioned thus far. Unlike the medical professionals, an FDA expert’s job is to educate the jury about a more legalistic aspect of the issue. Namely, the regulatory framework and guidelines in place for the use and implantation of IVC filter devices. In this type of expert’s testimony, certain elements such as a timeline of implemented regulations could be very helpful in illustrating the foreseeability of injuries associated with planting IVC filters in patients.

Marketing Experts

Cases involving IVC filters can also include testimony by marketing experts. As technology advances, an increasing number of medical devices and computer guided mechanics are being used for minimally invasive surgeries. Devices like IVC filters and the da Vinci robotic surgical system being a few examples. Since the sale of these devices is directed towards medical centers, which purchase devices en mass for use in treating patients and promise substantial financial rewards, they have been heavily and aggressively marketed by their manufacturers. A marketing expert in this kind of a case can speak to the norms surrounding the marketing and sales procedures associated with these devices. So the jury gets an idea of how wide of a reach these devices have and how medical professionals are solicited to use these devices.

Life-Care Planners

Life care planners assess the cost of any ongoing care that may be required for a patient; i.e. the projected future cost of living with an injury. This means accounting for the cost of every wheelchair, caretaker, hospital visit and treatment for as long as the injury affects the patient’s day-to-day life. In short, a life-care planner’s testimony is used for a calculation of damages associated with the injury caused by an IVC filter device. Since this kind of expert determines future medical expenses, they can help demonstrate to the jury a breakdown of the plaintiff’s future expenses; justifying damages with hard math. This includes measures such as the “average cost” of a certain medical treatment and the costs of installing any medical monitoring or assistance devices in the home, in cases where at-home care is required.

A Special Note on Damages

A special note on damages deserves brief attention here. With the exception of a life-care planner, none of the above-mentioned experts speak to the issue of compensatory damages directly. Rather, each expert (with the exception of an FDA expert) speaks only to the medical damages caused to patients as a direct result of the IVC filter device. Based on these evaluations, attorneys then address the issue of compensatory or monetary damages.

Tips For All

Though each of the experts above has a unique specialization, and each of their testimonies has a specific role in the context of IVC filter litigation, there are core elements that tie them together. All the experts are still speaking on one issue. That is, the injuries resulting from the use of IVC filters as part of a litigation against the manufacturers of such devices. As most of the experts are medical professionals, one tip that applies to all is ensure that their testimonies are clearly communicated.

One of the most fundamental tenets in evidence is that the trier of fact understands two things: 1) what is the substance of the evidence being offered and; 2) why is it being offered? When each of these experts offers clear, simplified and engaging testimony to the jury, the overall picture becomes a little easier to understand. In class-action suits the amount of evidence and witnesses can be overwhelming, without even addressing the complicated and technical nature of substantive medical and legal issues involved, so make sure your expert’s testimonies work well together and support the overall theme of the case.

As always, trial graphics are an incredibly useful tool in litigation and almost indispensable in injury cases where multiple medical experts must testify about different aspects of the same injury. In an IVC filter case, there are a large number of moving parts, all of high evidentiary value. The key is to make the pieces fit in a logical and cohesive way so that jurors can understand the bigger picture.

Using trial graphics for each of the expert’s testimonies can give jurors a visual aid and inside look as to the mechanics behind IVC filters as well an animated breakdown of the procedure, injury and complications resulting from the device. An interesting idea would be to use 3D printing to create a replica of the IVC filter at issue. Jurors can see firsthand how small the device is and how its manufacturing makes it prone to break and fracture inside the body. For a closer look on how trial graphics are used to enhance expert witness testimony, look here.

IVC filters have become the center of much litigation where medical products-liability cases are concerned. Manufacturers of these devices such as Cook and Bard are party to multiple litigations throughout the country involving popular models of removable IVC filters. Since there are a number of different aspects to the use of the device, from its computer-guided implantation, to the health conditions that precipitated the need for such a filter to the costs of living with the resulting injury from use, it is incredibly important to understand what role each expert plays in this kind of a case.