Do you have an IVC filter?

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.

IVC filter lawsuit information

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Last update: February 16, 2017.

Situation in 2017

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:

IVC Filter Lawsuit Background and Current Status

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.

  • The legal battle against manufacturers officially commenced in 2012 when plaintiffs filed the initial IVC filter lawsuit against Bard in Pennsylvania. Additional suits then followed in California.
  • Two years later the U.S. Judicial Panel on Multidistrict Litigation, or MDL, consolidated suits against Cook Medical to create MDL 2570 in the Southern District of Indiana. The so-called Bellwhether trials are scheduled for 2017
  • In 2015 a further MDL was created when dozens of individual lawsuits against Bard were consolidated into MDL 2641 in the US Court District of Arizona.
  • The Cordis TrapEase filter has been linked to a high fracture rate and has generated numerous lawsuits itself. The company has also issued a recall of some 33,000 OptEase IVC filters out of concern they may be installed backwards due to unclear instructions.
  • Rex Medical currently faces a lawsuit over its Option Retrievable filter. The complaint alleges the device is prone to failure and that Rex Medical conducted insufficient clinical tests before determining the device was safe for use in humans.
  • Greenfield filter lawsuit: Boston Scientific is also facing lawsuits amid allegations that it had known for years about the potential dangers and, like Bard, did nothing about it.
  • Bard IVC filter lawsuit settlements: In 2015 on the 10th day of trial, Bard decided to settle an individual case brought by one Kevin Philips who had alleged that a metal leg on the device he received had broken off after being installed and perforated his heart. This is one of the few cases against Bard so far to result in a settlement.
  • As of this writing there are a number of other lawsuits pending in both state and federal courts alleging everything from failure to warn of potential dangers, defective designs, defective manufacturing techniques, negligence and more on the part of both the manufacturers and their subsidiaries. Update January 25, 2017: Earlier this month a lawsuit was filed by a man named Jeremy K., who was implanted with the Cook Celect® Vena Cava Filter in 2012 at a medical center in Illinois.

Pending Class Action Lawsuits

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.

I’ve had an IVC Filter Installed. What Risks do I Face?

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:

  • Filter fracture
  • Migration of the device or fragments thereof
  • IVC perforation of the heart and lungs
  • Pulmonary embolism
  • Intense, prolonged pain
  • The development of blood clots
  • Heart failure
  • Death

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.

If My Filter is Causing Problems Can I Seek Compensation?

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.

Why is Bard the Focus of So Many IVC-related Lawsuits?

Class action lawsuit against Bard

The company was the first to face an IVC filter lawsuit over complications. During early court proceedings it came to light that they may have known they were selling a defective product (the Bard Recovery filter) and yet they continued nonetheless (more on that below). They are also accused of replacing that defective product with other, equally inferior products in the form of the Bard G2 and G2 Express filters.

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.

What Did Bard Know and When Did They Know it?

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.

Bard Invokes the Work-Product Doctrine

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.

What has Become of The Lehmann Report?

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.

Did Bard Forge a Signature on Their FDA Application?

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.

IVC Filter Lawsuits Outlook 2016/2017

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.

 

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