A federal jury has ordered medical device manufacturer C.R. Bard to pay $3.6 million to a Georgia woman who was injured by a faulty Inferior Vena Cava (IVC) filter.
The IVC filter lawsuit is the first of several thousand against the New Jersey-based company over its blood clot preventing implants, and only the second ever for IVC filters after a case against rival Cook Medical reached trial last November.
The trial started on March 15 and took place in Phoenix, where a federal panel has convened a special multidistrict litigation court to handle more than 3,600 lawsuits and counting against Bard over injuries from its IVC filters.
Plaintiff’s IVC Defect Led to Open-Heart Surgery
Ms. Sherr-Una Booker originally received her IVC filter in June of 2007 to prevent blood clots in preparation for a surgery to remove a cervical tumor. And, while such devices are only intended to be temporary, she was never told of the need to have it removed.
According to her lawsuit, Ms. Booker was first hospitalized for IVC problems in 2014 after her filter broke, became dislodged and moved out of place. It eventually tore through her inferior vena cava vein and required open-heart surgery to repair the damage and remove the broken shard.
However, a piece of the IVC filter still remains lodged near her heart with the risk that it may cause additional damage, a fear she faces every day.
She filed an IVC filter lawsuit against C.R. Bard alleging the company failed to properly warn patients or doctors of the impending dangers of extended use.
After a trial that lasted more than 2 weeks, a jury found that Bard is 80% liable for Ms. Booker’s injuries and ordered the company to pay her $1.6 million in compensatory damages, plus an additional $2 million in punitive damages.
What Are IVC Filters?
Inferior vena cava filters are small, umbrella shaped metal devices that are designed to prevent dangerous blood clots known as pulmonary embolisms. They are used most often in patients who can’t receive or wouldn’t benefit from blood thinning medications.
These often include patients who have a history of internal bleeding, or who are only facing a short-term risk of blood clots due to surgery.
IVC filters are surgically implanted into the inferior vena cava, a large vein that carries deoxygenated blood from the middle and lower parts of the body back to the heart
FDA and Doctors Warn of IVC Dangers
IVC filters have been around since the 1970s, and are used in around 250,000 patients each year. However, recent reports suggest they may have greater risks than expected, especially when used past their recommended lifespan, which is often the case.
A recent study in the Journal of the American Medical Association recommended that IVC filters be removed as soon as the threat of blood clots has passed, or when the patient can tolerate oral blood thinning medications.
However, a 2016 report from several radiologists cautioned that many IVC filters were left in patients for up to ten years or more. Doctors warned that, as time passes, the risk increases that the metal legs holding the filter in place may fail, raising the chances of damage to the heart, lungs or veins.
In 2010 and again in 2015, the U.S. Food and Drug Administration warned that they were receiving more reports than expected of IVC filter failure. They also warned IVC maker Bard that they were misstating the potential safety of the devices.
In fact, studies have shown that up to 43% of IVC filters may malfunction when used longer than for short-term treatment.
The biggest risk is for failure of the metal spider-like arms that hold the filters in place. If these break or become worn, they may perforate the vein wall or worse yet allow the filter to be pulled into the heart or lungs.
More than 7,600 IVC Lawsuits Filed in Federal Courts
Judges have ruled that patients injured by IVC filter movement, breakage or perforation may file lawsuits against the manufacturers of these devices for failing to adequately warn of the dangers.
The majority of these cases have been filed against the two largest IVC filter makers, Cook Medical and C.R. Bard, with each having their own dedicated multidistrict court.
In 2014, the JPML moved all federal IVC injury lawsuits filed against Cook Medical to a special court known as MDL 2570 in the Federal District of Indiana. At this time, 3,914 cases have been filed against Cook in this court for patient injury or death.
In 2015, a transfer order consolidated all IVC lawsuits against C.R. Bard to a similar court in the Federal District of Arizona under MDL 2641. At the present, 3,741 cases have been filed in this court, including the claim filed by Ms. Booker.
For now, lawyers are continuing to file claims on behalf of those injured or killed by an IVC filter failure. And, while more trials are scheduled that could reach similar results as Ms. Booker’s, there is a greater likelihood that the makers of these devices may try to reach a settlement with all victims rather than face thousands more trials.
Due to this and the unique statute of limitations in each case, lawyers are urging anyone affected by IVC filter failure to learn their legal options before it’s too late.
To learn more about the dangers of IVC filters, the current lawsuits, or to speak directly with a lawyer about your case at no cost, contact DrugNews today.
Salvatore, C. Bard Owes Injured Woman $3.6M In IVC Bellwether, Jury Finds. Law360. (March 30, 2018). Retrieved from www.law360.com
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.