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IVC Filters Offer No Benefit to Trauma Patients

October 17, 2016/in Defective Devices /by damg

For years, Inferior Vena Cava filters (IVC filters) were used to help mitigate the risk of blood clots in patients who cannot take traditional blood thinners. An increasing number of lawsuits claim IVC filters are defective, cause serious side effects, and have incredibly high rates of fracture. A new study published in the Journal of The American Medical Association (JAMA) found IVC filters did not provide any benefits to trauma patients.

IVC Filter Usage

Patients who have experienced some type of trauma, like an accident or surgery, cannot take blood thinners to reduce their risk of blood clots because it could cause dangerous bleeding. Instead, surgeons often utilize IVC filters to catch blood clots before they travel into the heart or lungs and cause a life-threatening condition called pulmonary embolism (PE).

The newly published JAMA study advises doctors to rethink the use of IVC filters in trauma patients. The study looked at both patients who had received IVC filters and those who had not received IVC filters and found no difference in mortality rates regardless of whether a filter was used. Doctors also discovered only 8% of IVC filter patients had their device removed within 3.8 years of implantation. The FDA recommends filters removal between 29 and 54 days after implantation to decrease the risk of suffering complications.

The study recommends IVC filter use “should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”

The seven most dangerous IVC filters most commonly named in lawsuits include:

1. Cook Günther Tulip Filter – Approved by the FDA in 2003, the Günther Tulip was one of Cook Medical’s first IVC filters. However, a study in 2012 in Cardiovascular and Interventional Radiology found 86% of patients with Günther Tulip IVC filters experienced device perforation of the inferior vena cava wall.

2. Cook Celect Filter – Released onto the market in 2008, it did not take long for reports of Celect filter device failure to come in. The Celect proved to be no better than its predecessor, the Günther Tulip, at resisting failure.

3. Bard Recovery Filter – The Recovery filter was C.R. Bard’s first IVC filter to hit the market in the U.S. when it received approval in 2002. However, as early as 2004, the company received reports that the devices were causing serious complications. In 2005, Bard voluntarily removed the Recovery filter from the market.

4. Bard G2 Filter – While the Recovery filter was being recalled, Bard released the G2 filter onto the market. Although the G2 was supposed to have enhanced fracture resistance, the FDA continued to receive reports of device failure.

5. Bard G2 Express – Released shortly after the G2, the G2 Express proved to be just as dangerous. The G2 Express has a fracture rate of 12%, and only half of fractured devices can be successfully removed.

6. Cordis OptEase – Not only was the OptEase by Cordis dangerous for its failure rate, a labeling error printed an arrow pointing the wrong direction, causing devices to be implanted upside down. Only when the device is in the upright position can it be anchored in place by the struts. The printing error led to many patients having the device migrate through the body, causing severe complications.

7. Cordis TrapEase – Although the Cordis TrapEase filter contained better labeling and instructions, a 2011 study found the TrapEase had a higher risk of fracture compared to other IVC filters.

IVC Filter Litigation

Patients in the various IVC filter litigations believe manufacturers like C.R. Bard, Cook Medical, and Cordis Corporation failed to adequately warn them of the risks associated with the defective medical devices. Thousands of IVC filter lawsuits now seek justice from more than a dozen manufacturers. The first Cook Medical IVC filter lawsuits will go to trial in early 2017.

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IVC Filter Litigation Update

July 24, 2016/in Defective Devices /by damg

Lawsuits surrounding Inferior Vena Cava Filters (IVC Filters) has been surging lately as the first lawsuits are prepared to go to trial this September. Manufacturers like Boston Scientific, C.R. Bard, Cook Medical, and Cordis Corporation are all facing lawsuits both in the United States and in Canada.

What Is An IVC Filter?

IVC filters are medical devices implanted into the largest vein in the body, the inferior vena cava, to carry blood from the body to the right atrium of the heart. The purpose of an IVC filter is to prevent blood clots in the lower extremities from traveling into the heart or lungs. They are commonly used in patients at risk for Pulmonary Embolism (PE), patients who have experienced trauma, or patients who have recently undergone surgery.

In 2010, the Food and Drug Administration (FDA) released a safety communication warning doctors and patients that IVC filters could cause severe and life threatening side effects. Between 2005 and 2010, the FDA received 921 reports of device failure of IVC filters. Of these reports, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the inferior vena cava wall, and 56 involved filter fracture. The FDA also warned that the risk of experiencing one or more of these complications greatly increases with time in the body.

C.R. Bard, one of the largest IVC Filter manufacturers in the world, has contested liability every step of the way. Currently facing over 3,000 lawsuits, the company will face its first bellwether trial on March 14, 2018 in an Arizona court. U.S. District Court Judge David Campbell is overseeing what is anticipated to be a several weeks long jury trial.

The bellwether plaintiff alleges Bard failed to warn of the failure risk associated with its IVC Filters. Once implanted, IVC Filters can tilt, migrate, fracture, and perforate the vein, making removal difficult if not impossible. As one of the largest IVC Filter manufacturers, the outcome of Bard’s litigation could set a precedent for other IVC Filter litigations.

Expert Witness Testimony

Bard lost its bid last December to have all of the plaintiffs’ expert witnesses disqualified. Plaintiffs engaged the expertise of four doctors from Northwestern University’s Interventional Radiology department who had extensive experience with Bard’s IVC Filters. The judge overseeing the case ruled three of the four doctors could give testimony.

2018 and Beyond

While no other IVC Filter trials have been scheduled for 2018 so far, it is likely Bard will face more bellwether trials this year. Other IVC Filter manufacturers like Cook Medical, Cordis Corporation, and Boston Scientific, among others, will likely use Bard’s experience as a litmus test for their own litigations. Cook Medical came close to settling its cases last year, but both sides were unable to finalize an agreement. However, depending on the outcome of Bard’s bellwether trials, manufacturers might go back to the negotiation table.

IVC Filter Lawsuits

With thousands IVC filters implanted in patients each year, the litigation against IVC filter manufacturers has quickly grown. The first manufacturer to go to trial this year will be Cook Medical. Cook has tried to settle its cases since February, but the two sides were unable to come to an agreement and the first bellwether trials are scheduled for this September.

The outcome of Cook’s lawsuits could set a precedent for other IVC filter manufacturers like Bard, facing its own trials scheduled to begin in mid-2017. The bellwether selection process is underway and it is anticipated to conclude in January or February of next year.

https://www.blizzardlaw.com/wp-content/uploads/2018/11/iStock_000014137699_Large-copy-2.jpg 1920 2560 damg https://www.blizzardlaw.com/wp-content/uploads/2020/07/logo-blizzard-law-pllc-2-300x92.png damg2016-07-24 14:52:402019-11-07 17:01:47IVC Filter Litigation Update

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