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Did you or a loved one suffer any of the following complications after receiving the IVC Filter implant?

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Many individuals that have used an IVC filter filed claims against the manufacturers of IVC filters, alleging poor design, various forms of negligence and prior knowledge of risks that were kept quiet.

In short: What is a IVC filter and the IVC Filter lawsuit 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.

On May 31, 2019, Judge Campbell recommended all parties to agree to settlement agreements before remanding back cases to other courts for trial, and closed the MDL to new cases. Today, nearly 600 cases are still unresolved but many others are currently being settled by Bard such as Debra Tinlin’s one .

This was the first trial in a centralized case, and many others followed it. After losing the first trial for a sum of $3.6 million, in June 2018 Bard won the second. A jury in Arizona sided with the company and found that C.R. Bard warned doctors of the risks of IVC Filters adequately.

Back in 2018, we announced that the company Bard has been sentenced to pay out $3.6 million in a IVC Filter lawsuit that was filed against C.R. Bard in the District of Arizona (Case Number 2:17-cv-04755-DGC). The patient suffered complications after a G2 Filter was fractured inside her body.

As of January 2020, the total number of actions pending against C. R. Bard in the respective multidistric litigation (MDL) has reached a total of nearly 8,000 cases. The Cook IVC Filter MDL instead has surpassed 6,000 cases, although another approximately 1,000 have been settled or discarded already.

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.

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.

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.

In January 2017 an IVC Filter 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.

As of this writing there are a number of other IVC FILter lawsuits pending in both state and federal courts alleging everything from:

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.

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.

I’ve had a 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, “Known 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:

IVC filter fracture

Migration of the filter or fragments thereof

IVC filter perforation of the heart and lungs

Pulmonary embolism because the filter is defective

Intense, prolonged pain due to the filter

The development of blood clots

Heart failure because the filter didn’t work

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 anti blood clot device 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.

What are the side effects of IVC Filters?

The IVC filter has important uses in the medical profession. It is a small metal device that doctors will recommend to insert in a patient’s body when they believe there is a serious danger of blood clots reaching the patient’s lungs. But the side effects of these IVC filters are so serious that many patients decided to file lawsuits against several manufacturers. The FDA even released warnings about the IVC filters in 2010 and 2014.

Blood clots can form in older patients, those with poor health, or those who have been through some type of serious trauma, injury or surgery. In most cases, patients are treated with medication that helps them get over the risk of a blood clot forming. But other patients cannot be treated with that medication, or the treatment is not enough.

In those cases, the IVC filter is used. With many cases, the filter does its job and is eventually removed. The issue is that more than a quarter of patients over the years have noticed some type of complication resulting from the filter. That complication could happen when it is being inserted or removed, or while the filter is still in the body.

Side effects that can occur while the device is in the body include:

Chest and neck pain

Confusion, lightheadedness and vertigo

Nausea, shortness of breath and rapid heart rate

Pain in the abdomen or back

Pain in other parts of the body

These side effects are the result of the IVC filter not performing as needed. The filter can sometimes dislodge from the vein and end up near the heart or another organ. That is why patients can feel pain in different parts of the body, but the cause is still the IVC filter.

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 IVC manufacturer knowingly sold a defective filter you may also be eligible to file a IVC Filter lawsuit seeking punitive damages.

The number of lawsuits against the manufacturers grows by the day and are expected to grow even further in 2020.

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.

Cook Bellwether IVC Filter Lawsuits 2020

In August 2017, the judge overseeing the multidistrict lawsuits concerning Cook IVC filters set the dates for three bellwether lawsuit trials. These trials will set the standard for all other trials regarding the Cook filters.

Many of these lawsuits allege the Cook filters tend to break apart and patients have claimed they’ve been injured by them, including the puncturing of organs by the device’s components.

The three lawsuits allege the Cook Celect and the Gunther Tulip filters have caused several injuries. The first trial is set for a case of negligence against Cook for concealing “the known risks” and failure “to warn of known or scientifically knowledge dangers”.

This case, Hill v. Cook Medical, and the other two, Gage v. Cook Medical and Brand v. Cook Medical, have had settlement dates scheduled, but if the settlements fail, the bellwether cases will proceed next year.

Gage v. Cook Medical, the second bellwether case, for example, failed when Judge Young decided to dismiss it since the claim was not filed within the appropriate time frame. Several laws known as the Statute of Limitation are set in each state to determine the maximum time limit during which a claim can be submitted to a state or federal court. Gage’s case was the only one involving the infamous Günther Tulip filter. Even if the judge’s decision was only related to time issues, Cook Medical saw the trial as a fundamental victory that demonstrated the safety of the devices.

The next bellwether trial was scheduled for September 2018, with a claim from Tonya Brand who experienced severe complications from the manufacturer’s Celect filter. (Update: This case was lost by the plaintiff)

There are hundreds of outstanding lawsuits involving IVC filters made by Cook Medical, Bard and other manufacturers. Bookmark this page (ctrl + D) for regular updates in 2020 and onwards.

Bard Bellwether Filter Trials 2020

The first bellwether trial filed against Bard is set to in March 2018. The judge presiding over the multidistrict litigation said the bellwether cases should be narrowed down to about six cases by early next year.

Trials for other bellwether cases may also be possible by the end of next year as well. The Bard filters in question are the G2, Recovery, Denali, Eclipse and the Meridian, among others.

There have been allegations Bard knew about possible problems before they put their IVC filters on the market and that they forged the signature of a regulatory specialist on an application for the FDA to request clearance for their devices.

Why is Bard the Focus of So Many Lawsuits?

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 About Their IVC Filter Complications 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 medical 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.

Greenfield filter lawsuit

Lawsuits claim that, like many other device manufacturers, Boston Scientific also willfully released a

potentially dangerous device to the public. The safety of the Greenfield filter, in fact, was never

independently evaluated by the FDA before it hit the market, and was approved through the infamous

510(k) premarket notification process. Unsurprisingly enough, the filter was associated with undisclosed yet

significant risks. According to court documents, in more than one occasion, patients who received it had to

face serious injuries as the implant broke, migrated or fragmented.

For example, between August 05, 2005 and November 09, 2006, Boston Scientific issued a Class 2 Recall ofits Titanium Greenfield Vena Cava Filters. Apparently, several units of this product lacked a taper on the

braided sheath of the delivery system which could cause serious injury by tearing the veins they were

inserted into. The lack of taper could cause the sheat to catch on the edge of the blood vessel and lacerate

it.

Despite this serious threat, the manufacturer kept selling an allegedly defective product for years, harming

hundreds of patients in the process.

Cordis Optease litigation

After suffering serious injuries and harm, a large number of people took a step forward and filed a lawsuit

against Cordis Corporation, the manufacturer of the Cordis Optease IVC filter. At least 21 cases are

currently pending in California state court, and dozens more have been filed in courts across the country as

the litigation keeps growing.

In 2012, a group of Japanese researchers questioned the clinical trials that allegedly demonstrated the

safety of the Cordis Optease filter. According to their research, most of these studies did not adequately

assess the risk of fractures associated with this device because of inappropriate evaluation methods and

lack of long-term observation. In their findings, the Japanese scientists noted that the Cordis Optease IVC

filter showed a 50% fracture risk, and that the rate of the filter removal was as low as just 20%.

Back in 2013, almost 33,000 such devices were already recalled because the label wrongly instructed

surgeons to implant the filter backward. Since the device is linked with an alarming rate of fractures, one of

these barbs pointing in the wrong direction could easily migrate directly inside the patient’s heart.

Lawsuits Outlook 2020

Since 2005 the FDA has received more than 1,000 reports of IVC (Inferior Vena Cava) 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, in a product liability case, 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.

For 2018, a MDL lawsuit against Bard is scheduled in Arizona. The suit will bundle more than 4500 lawsuits that have been filed against the manufacturer in case number 2641.

Fall 2019 update

In May 2019, just a few weeks before it reached trial, a case against Bard was settled by the manufacturer. The case was filed by plaintiff Debra Tinlin, who was severely injured after a Bard Recovery IVC filter fractured inside her body. After the device was surgically removed, the doctors found that several small pieces had started moving towards her heart. Some of the fragments perforated her vena cava and lodged in the pulmonary arteries, where they could not be removed anymore. Judge Campbell has been informed that the parties reached a settlement, although no details have been disclosed about the agreement.

Keep an eye on the site to see how things develop in 2020. You could always fill out the form on the top of this page for a free case review.

