Inferior Vena Cava Filters Are Linked to Serious Complications in Patients
Inferior Vena Cava (IVC) filters have resulted in numerous injuries to patients since their introduction into hospitals in 2005, as well as fatalities. Lawsuits over the device have been filed in the courts since 2012 and are still coming in. The Ramji Law Group law firm is on your side to help those affected by these filters.
What Are Vena Cava Filters?
The inferior vena cava is the largest vein in the body. It carries de-oxygenated blood from the lower extremities to the right atrium of the heart and then to the lungs.
IVC filters are small, cage-like devices that are inserted into the inferior vena cava of a patient to capture blood clots and prevent them from reaching the lungs where they can cause serious complications and prove to be fatal. Surgeons frequently place IVC filters in patients at risk for pulmonary embolism (a blood clot in the lungs) when other treatments such as anticoagulant therapy cannot be used or has proved to be ineffective. IVC filters are designed to be permanent implants although some of the devices may have the option to be removed. The IVC filters associated with problems are manufactured by C.R. Bard and Cook Group, Inc.
What Are the Dangerous Side Effects of Inferior Vena Cava Filters?
In 2010, the U.S. Food and Drug Administration (FDA) issued a warning highlighting a number of adverse events associated with IVC filters. By the time it had issued its cautionary bulletin to doctors, more than 900 reports had been received of issues with the devices. Problems include:
- Device Migration – there have been incidents of the filters migrating to other parts of the body.
- Filter Fracture – The FDA warned the struts or legs of the devices are prone to break loose and travel to other parts of the patient’s body, potentially causing serious injury. A study published in 2012 found that all of the Cook filters studied perforated in the study participants’ venal wall within 71 days of being implanted.
- Embolization – The filters have been known to block one or more blood vessels or vascular channels.
Lower Limb Deep Vein Thrombosis – Blood clots in the legs may occur due to filters migrating. They can prove to be fatal because they can travel through the body and lodge in the lungs.The FDA is also concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides. The reports of adverse events associated with IVC filters in the FDA’s 2010 report include:
- 70 filter perforations
- 328 device migrations
- 56 filter fractures
Recommendations and Actions by the FDA
The FDA recommended in its 2010 advice that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
The FDA has encouraged all doctors who are involved in the treatment and follow-up of patients receiving IVC filters to carefully consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the “risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.”
In July 2015, the FDA issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. for eight violations of federal law relating to the safety of its Inferior Vena Cava (IVC) filter. These violations concern safety of the use the Recovery Filter, G2 Filter, G2X Filter, G2 Express Filter, Eclipse, Meridian Filter and Denali. Among the listed violations, The FDA said Bard illegally sold adulterated and misbranded IVC Filters and failed to report complications and adverse events. The letter further cited Bard with violations for withholding critical information about the product from the FDA and public. The letter has fueled further lawsuits against the manufacturer.
Lawsuits Against IVC Filter Manufacturers
The first lawsuits were filed against C.R. Bard in California and Pennsylvania state courts in 2012, alleging the filters caused injuries. In the fall of 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated lawsuits from 11 districts into Multidistrict Litigation in the Southern District of Indiana.
C.R. Bard settled a case with Kevin Philips 10 days after trial began in In February 2015. According to Philips’ lawsuit, the Bard Recovery IVC filter fractured inside his body and one of the small metal legs traveled to his heart, perforating it. The subsequent rip forced him to have open heart surgery and a lengthy recovery.
Many other cases are pending. Plaintiffs claim the manufacturers of IV filters fraudulently concealed the health hazards of the devices and failed to test them properly.
Our Houston personal injury lawyers at Ramji Law Group help patients who have been harmed by dangerous drugs and medical devices in Texas. Call us at 888-630-9898.