IVC filters were designed to prevent blood clots from reaching vital organs.
Some patients who received IVC filters claim that, among other things, the filters broke apart and migrated to other parts of the body where they caused sometimes life-threatening complications.
Many individuals that have used an IVC filter filed claims in 2016 and before against the manufacturers of IVC filters, alleging poor design, various forms of negligence and prior knowledge of risks that were kept quiet. New lawsuits are scheduled for 2017 as well.
IVC (Inferior Vena Cava) filters were designed to stave off pulmonary embolism by catching migrating blood clots before they reach the lungs or even the heart.
A segment by NBC News gives insight on the issues:
While Bard (formerly C.R. Bard) face perhaps the largest number of lawsuits, other makers including Rex Medical LP, Boston Scientific, Cordis (Johnson & Johnson) and Cook Medical all face litigation over their own devices.
As mentioned above both the US Court Districts of Southern Indiana and Arizona have consolidated numerous individual lawsuits into Multidistrict Litigations or MDLs. Many an IVC filter lawyer believes this to be the preferred route in such matters as class actions sometimes force plaintiffs to accept lower settlements while simultaneously paying higher attorney fees.
A number of class-action suits against Bard have commenced nonetheless. The thrust of these lawsuits currently working their way through courts in Florida, California and Pennsylvania is that, because of known issues with Bard IVC Recovery filters, G2 filters and G2 Express filters everyone who has received one must undergo constant, and often costly, medical monitoring.
The class in this case then is everyone who ever had one of the Bard devices in question implanted and these individuals seek compensation to cover expenses incurred during the aforementioned monitoring activities.
As early as 2010 the FDA had received hundreds of reports alleging IVC filter complications and issued a MedWatch warning that stated, among other things, ìKnown long-term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis [DVT], filter fracture, filter migration, filter embolization, and IVC perforation.”
Several other studies including one by the National Institutes of Health showed an elevated failure rate, problems with removal of the ivc filter (which are after all intended to be temporary) and a slew of other potential issues as well including:
In addition, an eight year review of patients at Boston Medical Center that ended in 2011 concluded that, of 679 retrievable filters, less than 9% had been successfully removed and that removal of the IVC filter was unsuccessful 18.3% of the time.
The review found patients suffered dozens of venous thrombotic events including many that occurred with the IVC filters in place. It also concluded that many filters had been placed after the highest bleeding risk had passed and anticoagulant therapy may have been a more appropriate choice.
Yes. If you are experiencing IVC filter complications you are eligible to seek compensation from the manufacturer for a variety of potential reasons (pain and suffering, medical costs associated with dealing with the defective filter, lost wages and more). If it can be proven the manufacturer knowingly sold a defective device you may also be eligible to file a lawsuit seeking punitive damages.
The number of lawsuits against the manufacturers grows by the day and are expected to grow even further in 2017 and 2018.
You may want to file an individual suit or join an existing MDL against Bard, Cook or another company. Or you may want to join a class-action suit seeking compensation for monitoring expenses.
The variety of Bard filter types involved, the number sold and the apparent lack of interest on the company’s part in being forthcoming about potential risks are all possible reasons why Bard is facing more lawsuits than other companies. It must also be said though that future developments could cause focus to shift to any of the other manufacturers who are currently the subject of litigation.
As early as 2004 Bard received complaints that their IVC filters were breaking apart and migrating within the bodies of recipients. In response the company commissioned what has become known as The Lehmann Report. This report, conducted by independent consultant Dr John Lehmann, concluded the Bard IVC Recovery filter generated a higher rate of IVC filter complications than its competitors.
The Lehmann report was never intended for public consumption – indeed it was distributed by company lawyers on a need-to-know basis with instructions it be kept secret – but was eventually disclosed unwittingly during an early trial.
Once The Lehmann Report came to light litigants sought to use it as proof the company had prior knowledge of the risks associated with their IVC Recovery filter and suppressed it while continuing to sell thousands of the devices.
In response the company sought to have the report excluded from use in existing or future lawsuits under what is known as the ‘work-product doctrine’. This law is intended to protect a company from documents it produces in anticipation of future lawsuits.
Part of Bard’s legal maneuverings to suppress The Lehmann Report includes a request for a protective order under the work-product doctrine. This order would force plaintiff’s attorneys to destroy all copies of the report in their possession and refrain from using its contents during the conduct of IVC related lawsuits.
As of this writing Bard’s request for an order to destroy all copies has achieved mixed results. A California state court denied Bard’s request while the US District Court of Nevada upheld it. Other proceedings have produced similarly mixed results.
Prior even to The Lehmann Report there are indications Bard was aware of their IVC Recovery filters potential risks. In 2002 the company’s application for FDA approval for the device was denied. In response Bard hired Kay Fuller, a regulatory specialist, to help improve their chances of receiving approval when they resubmitted their application.
Fuller though became concerned about the overall safety of the device herself and wound up refusing to support the company’s subsequent efforts to get FDA clearance. In a disturbing twist however the company’s re-submitted application form bears her signature although she told an investigative team from NBC news that she never signed the form.
Since 2005 the FDA has received more than 1,000 reports of IVC filter complications involving various manufacturers. Since they’ve been the subject of the most lawsuits, Bard has understandably been out front in trying to have these suits dismissed.
In 2014 for example, Bard was denied a motion for summary judgment on two different occasions with the judge in the case ruling the lawsuits could proceed because there was evidence Bard may have engaged in negligent practices.
The judge also ruled that plaintiffs were entitled to seek punitive damages in their IVC filter lawsuit. Keep an eye on the site to see how things develop in 2017 onwards.