Articles Posted in IVC Filter

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IVC Filter Bellwether CasesA “bellwether” is someone or something that leads others or shows what will happen in the future or is an indicator of trends. In the legal world a bellwether case is very important because it leads the way in how a large number of lawsuits may be litigated or settled.

Too Many Cases, Not Enough Resources

If there are many plaintiffs suing the same defendant for the same reason with similar facts there are different ways all these cases could be handled. They could,

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IVC Filter StudyPeople who get medical implants don’t do so out of boredom. They get the surgery because they have a serious medical problem or they want to prevent one. Many of these implants have benefits for patients while some, in addition to doing some good, also can do great harm. The Cook IVC filter may be a medical implant that not only may do you no good but can also do great harm, according to a recent study published in the medical journal Annals of Surgery.

What is a Cook IVC filter?

The Cook IVC filter is a wire device that looks like a cone shaped net. It is manufactured by Cook Group, Inc. The IVC filters are surgically inserted into a major vein, the inferior vena cava (IVC), of a patient who is at risk for a pulmonary embolism (or PE, a blood clot that passes into a lung, which can be fatal). The filter is supposed to trap or break up blood clots coming from the lower or middle part of the body. On first look it appears to be a great idea. But many medical emergencies have resulted from implantation of these IVC filters.

Hundreds of lawsuits have been filed by those injured by Cook IVC filters and by the families of people who died because of them. The filters are often in patients too long; they can break up (with pieces going into the heart or lungs) or the entire filter can be pushed up near or into the heart, causing death or injuries.

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IVC FilterApproximately 250,000 people have an IVC filter implanted each year. Each time it captures a blood clot and prevents it from moving into the heart or lungs, it is a great thing. Unfortunately, IVC filters often cause other health problems, sometimes as serious as the conditions they were designed to prevent. I wrote about the problems the IVC filter is causing many patients here.

Two corporations manufacture most of the IVC filters on the market: C.R. Bard, Inc. and Cook Medical, Inc. Lawsuits have been filed over Bard’s Recovery, G2, and G2 Express IVC filters. Lawsuits have also been filed over Cook’s Gunther Tulip and Celect IVC filters. Hundreds of people have been injured by these IVC filters. Try not to be one of them.

If you have an IVC filter implanted in your body, you must stay on high alert. I suggest taking the following actions if you have an IVC filter implant:

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Cook IVC Filter LitigationIn every lawsuit the court issues key rulings which will impact the outcome of the case. By “court” I mean the presiding judge. Some court decisions end the lawsuit (e.g., a judge granting a defendant’s summary judgment motion). Some decisions kick a leg of the stool out from under one party (granting a motion to exclude one side’s key expert witness). As I have written about in this blog, a judge has great power and influence over every court case. One decision has the power to make or break the lawsuit.

Recently, in the Cook IVC filter multidistrict litigation, a federal judge has refused to bar discovery involving an allegation that Cook failed to report to the FDA bad results with the Cook IVC filters.

What Is Discovery?

After a lawsuit is filed, the defendants have the chance to “answer” the complaint (“yes, we admit that happened” or “no, we deny the truth of that statement”). After these “pleadings” are filed, the parties engage in formal discovery. In civil litigation, discovery is the exchange of documents and information between the parties. It is required by the Rules of Civil Procedure. It goes like this: one side will write out questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. From there, the parties can build their cases for trial.

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When medical devices work as intended they are wonderful things. They can extend lives and improve the quality of life for patients and ease the stress on patients’ families. When they don’t work as intended medical devices can do more harm than good, possibly killing the patient. One example is the Cook IVC filter.

What is an IVC Filter?

The inferior vena cava (or IVC) is a large vein carrying blood from the lower and middle body into the heart where the blood is pumped into the lungs in order to have oxygen added to it. An IVC filter is a device that’s surgically implanted into the IVC just below the kidneys in cases where there is fear a blood clot from the legs (deep vein thrombosis) may travel from the body into the heart or lungs (pulmonary embolism). If that happens the results can be a serious, if not fatal, injury for the patient.

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Most people have heard of the claim “loss of consortium.” It comes from the root word consort meaning to associate, to spend time, to hang out with. The definition of the legal claim goes like this: loss of consortium is a claim for (money) damages by the spouse or close family member of a person who has been injured or killed as a result of the negligence or wrongful act of another person. It is a derivative claim, which means it derives or flows from the primary injury to the spouse or family member. Essentially, it creates a separate plaintiff (usually a spouse) and “piggybacks” off the injury to the injured person. A loss of consortium claim cannot exist without the recognized injury to the spouse or family member.

The Lost Sex Claim

People sometimes think of loss of consortium as the “loss of sex” claim. And in fact, one important injury under loss of consortium is that the primary injury prevented a loving married couple from enjoying intimacy and sexual intercourse in the same manner they enjoyed before the accident. Let’s face it, when intimacy is lost or diminished based on the negligence of others, people should be compensated. It’s one big reason we have the derivative claim.

Sailing CoupleBut loss of consortium extends beyond married sexual relations. Suppose a married couple were passionate about sailing and took sailing trips most weekends, but the failure of an artificial hip placed a married woman in a wheelchair and made it impossible for her to climb onto the sailboat. In most states a loss of consortium claim could be made that the loss of this treasured activity deeply damaged the quality of life of the husband. Similar claims can be made for couples who actively garden together, play tennis, travel, or even cook.

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Bard IVC Filter MDL Arizona I would chalk up this court decision as a victory for any injured person dealing with the C.R. Bard IVC filter. I would also chalk up the decision as yet another example of the complexities of handling statutes of limitations in defective product cases.

As always, let’s take a step back. I have written about C.R. Bard’s potentially dangerous IVC filters, which you can read about here and here. In 2015 a multidistrict litigation (MDL) site was selected for lawsuits arising from injuries relating to Bard’s G2 Series and Recovery IVC filters. The primary complaints have been that the Bard IVC filters moved out of position and/or broke apart. Lawsuits mounted, and the MDL was formed.

Lurking in virtually every personal injury case is a statute of limitations defense. I wrote about statutes of limitations here. To recap, a statute of limitations is a law which limits the time when an injured person may bring a lawsuit for money damages. You miss the deadline, you lose your right to bring a lawsuit forever.

But as I have discussed before, determining when the clock starts running on your injury case is far from easy.

Bard Lawyers Sought Rigid Framework For Statute of Limitations Analysis

In the Bard IVC filter MDL, C.R. Bard lawyers filed a motion seeking a bright-line test to identify the running of the statutes of limitation. The defense lawyers asked Judge David Campbell to adopt a strict procedure for this analysis similar to the procedure used in the Mirena IUD MDL. (Yes, there is an MDL for women injured by Mirena IUDs made by Bayer Pharmaceuticals.) The Mirena procedure was determined in the case titled Truitt v. Bayer.

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IVC Filter Which Has Migrated to the Heart

In this post we look at the history of C.R. Bard’s problematic IVC filters, which sadly have caused many injuries and several deaths. In May 2015 a multidistrict litigation site (MDL) was selected for claims across the country arising from injuries relating to C.R. Bard’s “G2 Series” and “Recovery” IVC filters. But before we get to the Bard MDL, however, we have to ask, “well, how did we get here?”

Bard Recovery IVC Filter

In 2002 C.R. Bard received approval from the FDA to market the Recovery IVC filter. The Recovery received approval for marketing under the dreaded 510(k) approval process, which I have written about often. Soon after the release of the Recovery filter, reports of injuries and deaths began to occur. The primary issues were that the Recovery filter moved (doctors call it “migration”) and broke apart much more often than other IVC filters on the market. After many of these alarming results, C.R. Bard arranged for a study to be performed on the Recovery filter, and this study, published in December 2004, concluded that the Recovery filter created a significantly higher risk of injury and death in patients compared to other IVC filters available to physicians and patients. The report qualified its findings by noting that given the “flaws in the data” (whatever that is) it cannot say conclusively that the Recovery filter presents an “excess risk”; the report nevertheless concluded that further investigation is “urgently warranted.”

Despite this dire warning, C.R. Bard continued to sell the Recovery filter. It finally discontinued the Recovery in 2005.  But this action was too late: as many as 20,000 people still have the Recovery IVC filter implanted in their bodies to this day.

Bard G2 and G2 Express IVC Filters

In 2005 C. R. Bard introduced the G2 IVC filter. That same year C.R. Bard circulated an internal memo in December 2005 expressing concerns with the safety and functionality of the G2 filter. The Bard Memorandum noted that the G2, much like the Recovery filter, had problems with perforation, tilting, and moving. Despite this information, C.R. Bard kept selling the G2 filter. In 2008, as part of the G2 Series, Bard introduced the G2 Express, which has also been found to move, tilt, migrate, and break apart.

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Inferior Vena Cava Filter

I have to say, this one looks a little terrifying. Check out the photo to the right. This is an IVC filter. As with most things, when you first learn what the object is and what it is intended to be used for, you should think “Brilliant! What took so long to invent this thing?” The problem is, the IVC filter can move, turn, or break apart inside a blood vessel, causing all kinds of problems, including death of the patient. So let’s take a look at the product and the lawsuits that have resulted from the medical device.

What Is IVC?

IVC is the acronym for “inferior vena cava,” which is the primary vein running from your lower body to your heart and which carries deoxygenated blood. (And just for completeness, the superior vena cava is the large vein carrying deoxygenated blood from the upper body to the heart.) The vena cava veins move this deoxygenated blood into the right atrium of the heart, where it can be oxygenated and sent back out into the body. Obviously the IVC is a vitally important vein inside the body, and when problems occur they can become serious and even life-threatening.

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