Every year, thousands of patients are implanted with a retrieval inferior vena cava filters (IVC) but they are not warned by doctors about the risk of injury from these temporary devices.
And as time passes, patients tend to forget that they had this device implanted and the first inkling that they had the device, is when they suffer serious injury from a complication.
Starting tonight, on NBC Nightly News, there is a 2 part news segment about the dangers of the IVC devices and in particular the Bard IVC Recovery Filter device, its failure rate and the propensity to cause personal injury damage to patients. Shockingly many doctors who implant these devices are unaware of the risk and the dangers associated with these devices.
According to some experts, there is a very high failure rate with these devices, which only increases with the duration of the filter in the body, eventually all of the devices will fail. So 100% failure of the device becomes not a question of “if” but “when.”
What is an IVC Filter?
The filter devices are used when there is a blood clot in the leg known as a deep vein thrombosis and there is a contraindication to using blood thinners, which is the standard therapy for leg blood clots.
These devices are supposed to trap blood clots from traveling from the leg to the lungs and causing a pulmonary embolism, which can be fatal.
These devices unfortunately, have been linked to hundreds of adverse event reports where they puncture the vena cava, tilt out of position or migrate or break apart and cause metallic fragments to travel to the heart or lungs, a condition known as embolization.
Now as many lawsuits are being filed, the lawsuits have similar allegations that plaintiffs experienced significant and serious side effects including death, after having the blood clot filter medical devices implanted into the inferior vena cava.
2 Major Manufacturers of IVC Filters
There are 2 major manufacturers of IVC filters, Cook Medical and C.R. Bard. The complaints in the Bard and Cook IVC Filter litigation have similar allegations, the injured patients claim that the manufacturers designed and sold retrievable defective devices that were unreasonably dangerous.
FDA Warnings and Its Lack of Action
The FDA in August 2010, announced a warning about the risk of IVC filter injuries, noting that they had received hundreds of adverse event reports where filter devices broke apart and traveled to other areas of the body or caused perforation and migration.
Unfortunately the FDA, when armed with the supreme power granted to the agency by Congress, has failed to launch a thorough investigation and recall these potential dangerous devices. Another glaring example of how the nation’s foremost pharmaceutical and medical device regulatory agency has failed to ensure the safety and health of its citizens. The FDA, refused to grant an on air interview to the NBC journalists.
Why doesn’t the FDA take Action?
The root of the problem with the FDA lies in its revolving door of paid industry experts, doctors, and employees previously employed by the FDA, who move with apparent ease between the agency and the giant medical device and pharmaceutical companies.
It is this obvious conflict between FDA employees and the device manufacturers that created the pervasive nature of corruption at the highest levels of government, which usurps the power of the agency, rendering it a toothless, paper tiger. The FDA is not accountable to any watchdog or supervisory agency, there is simply no accountability at the highest levels of government and a “business as usual” attitude throughout the agency.
To paraphrase a famous British politician, ” Power tends to corrupt and absolute power corrupts absolutely”. The multi-billion dollar huge medical device and pharmaceutical conglomerates, pour an incredible amounts of money in the TV advertising, the print ads and providing re-election funds to politicians that controls the mind of doctors, hospital, patients and control the purse strings for the agency’s funding.If the agency is zealous in doing its job, the purse strings gets yanked.
Just tune into the commercial tv adverts, the drug and medical device companies are pushing and touting the latest in technology and drugs, which on closer inspection are no better that the existing older technology or medical drug.
Adverse Medical Studies
In March 2013, JAMA Internal Medicine journal questioned the effectiveness of IVC filters, noting that less than 10% of the study patients had successful removal of the devices and 8% of IVC filter patients developed pulmonary embolism despite the device.
In May 2014, the FDA cautioned doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, noting that many doctors were not adequately warned about the importance of retrieving the devices.
Bard IVC Filter Claims Heading to Arizona
Recently, the U.S. Judicial Panel on Multidistrict Litigation (JPML), ordered all filed Bard Inferior Vena Cava filter injury, perforation and migration lawsuits, are to be consolidated and centralized before one federal judge in Phoenix, Arizona for coordinated pretrial proceedings.
Existing cases pending throughout the federal court system will be transferred to U.S. District Judge David G. Campbell, who will oversee the multidistrict litigation (MDL) proceedings. Bard Peripheral Vascular is the manufacturer of these Bard IVC filters and is headquartered in Phoenix, Arizona.
This consolidation and centralization of Bard IVC filter cases only applies to cases filed in the federal court system. There are less than 50 filed Bard Recovery filter and Bard G2 filter lawsuits currently pending in U.S. District Courts nationwide.
Cook Gunther and Tulip Filter Injury cases MDL in Indiana
MDL has been established for all Cook Medical IVC filter lawsuits, involving problems with the Cook Celect or Gunther Tulip filters. There are more than 100 complaints over those products centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.