Articles Tagged with IVC Filters

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Plaintiff Sherri Booker Wins Jury Verdict Against C.R. Bard
Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

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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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