In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Cook Medical IVC filter lawsuits into one court, in the Southern District of Indiana. Since then, both sides have been involved in pre-trial proceedings to prepare a small number of cases for trial.
The judge presiding over the litigation recently scheduled a “science day” to take place on March 22, 2016. Both sides are expected to present information about the filters, including how they work, and the risks associated with them, to help increase understanding about issues that will likely come up again and again over the course of the litigation.
IVC Filter Science Day
Mass tort cases, like this one, often involve complex medical and scientific issues. Both sides will likely argue about things such as whether or not the device worked as expected, whether the device was properly designed, and whether or not its interaction in the human body was within the realm of reasonable standards.
Therefore, the court must be educated on the foundation of scientific issues likely to be encountered as the parties prepare for trial. What is an IVC filter anyway? How does it work? What is it for? The court and its staff are unlikely to know the answers to these questions unless they are medical specialists. A science day provides a forum in which doctors, scientists, and other experts can provide tutorials that assist the court in understanding the subject matter related to the case.
An IVC filer, or “inferior vena cava” filter, is a medical device that is used to help prevent blood clots from traveling to the lungs where they can cause a pulmonary embolism (PE, blood clot in the lung). This is a serious and potentially deadly condition, and patients with deep vein thrombosis (DVT) or other blood clotting medical conditions may be more at risk for it than others.
Though there are anti-coagulant medications that help reduce the risk of blood clots, some patients are unable to use them, or do not respond well to them. These patients are sometimes implanted with an IVC filter, which is a small, cage-like device put into the main vein that carries blood from the legs back to the heart and lungs. It is designed to trap and dissipate any potential blood clots.
Facts like these are explained during a science day, to help all parties understand more clearly the device at issue in the litigation.
Tutorials Help the Parties Better Understand the Issues
What can go wrong with an IVC filter? This is another question likely to be answered at the science day.
Studies have found, for instance, that some Cook Medical IVC filters are more prone to fracturing than other types of filters. That means that part of the device breaks off and either penetrates the vein, or migrates to other organs, like the heart or lungs, where it can cause other significant health problems.
How might the device break, and why? These are other issues that may be covered. Cook Medical created later models of their IVC filters, for example, that were reinforced to help reduce the risk of fracturing, but subsequent studies indicated that they still fractured at rates higher than expected.
What kind of side effects may occur if a filter moves from its original position, penetrates the vein, or breaks and becomes lodged somewhere else? Tutorials on these issues can help the court further understand how the device may act inside the human body, and under what circumstances things may go wrong.
Information may be delivered via in-person tutorials and recorded expert presentations. The court has final approval on any of the proposed tutorials. The idea is to help increase the knowledge of those present in a non-adversarial way.
Currently, more than 250 Cook IVC filter lawsuits are pending in Indiana.
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