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IVC Filter & C.R. Bard Complications

The medical device manufacturing company, C.R. Bard was hit with another inferior vena cava (IVC) lawsuit from a woman who supposedly suffered from design deficiencies of the product that is plaguing the nation. The injured patient has claimed that the IVC filter failed because the product broke apart and caused serious injury and damages. South Carolina plaintiff Joanne D. had the Bard Eclipse IVC filter implanted on October 26, 2010 to resolve a blood clot formation in her body. Several years after the surgery, it was discovered that the IVC filter had failed by perforating the wall of Joanne’s inferior vena cava which led to the migration into a different area of her body; thereby causing her significant medical complications.

Joanne has since been required to undergo extensive medical treatment, which included an open vascular surgical removal of the IVC filter. Her IVC filter lawsuit explains the fact that she has to undergo future intensive medical care due to the after effects of the migrated device. Joanne alleges that she has suffered various damages from the IVC filter, including high medical bills, pain and suffering, disability, and permanent scarring [1].

IVC Filter Complications

IVC filters are small, cage-like devices that are designed to prevent blood clots that can move from the legs or pelvis to the heart or lungs. Blood clots in either region can cause dangerous complications such as strained breathing, chest pain, heart attack or pulmonary embolism. The blood clots trapped by the IVC filter remain in the device until the body dissolves them. Some IVC filters are designed for temporary placement, while others are meant to be permanently implanted in the vena cava.

The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that “retrievable” IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides [2].

Furthermore, a recent study published in the European Journal of Haematology in March 2015 reviewed the indications, complications and follow-up data of patients undergoing IVC filter placement. This review was retrospectively done by thrombosis specialists who consecutively admitted patients that underwent IVC filter insertion in a large university hospital with a level I trauma center. They reviewed assessments made about the appropriateness of indication for IVC filter placement as well as the referral for retrieval.

Overall, 405 filters were inserted between 2009 and 2013. All filters were meant to be retrievable. An IVC filter was placed as a primary prevention measure in 42% of patients. Fifty-two patients (12.8%) experienced at least one filter-related complication. The most common complication was deep vein thrombosis occurring in 6.9% of cases.  Almost a third of all complications occurred in filters originally placed for prophylactic indications. Only 13.6% of filters were successfully removed. Their low retrieval rates together with the relatively high risk of long-term complications, questions their extensive utilization [3].

C.R. Bard

A company such as Bard, with a century of history, is likely to have a few skeletons in their closet. Today, it faces charges for fraud and manufacturing dangerous products that put consumers at risk.

  • Early 1990s: Bard pleaded guilty to 391 criminal charges in the medical fraud case. The New Jersey based company pleaded guilty to selling defective heart catheters, concealing problems with devices from the Food and Drug Administrations and illegally experimenting on people [4]. The catheters manufactured by USCI, one of Bard’s units, is a device that has a wire and balloon-like tip that is threaded through a clogged coronary artery to allow blood to flow. Unfortunately, the tip broke off in some patients and required immediate bypass graft surgery. Some of the company officials were indicted over these issues and Bard recalled the catheters in 1989 and 1990. Bard had to pay $61 million in fines for violating the Federal Food Drug and Cosmetic Act, the False Claims Act and the Civil Monetary Penalties Law.
  • 2000s: Bard had to recall a large number of surgical patches known as the Composix Kugel Mesh Large Patches due to the fact that the coil rings in some patches broke under stress, puncturing bowels and causing abdominal pain. The company had to pay $1.5 million in one lawsuit that spurred nearly 2,000 of others to come forward.
  • 2012: Bard stopped selling its Avaulta Plus mesh products in July and in the same month, the jury found the company liable for $3.6 million in damages for a transvaginal mesh cases involving Avaulta Plus. Eventually, nearly 11,000 federal lawsuits were consolidated into a MDL in West Virginia. In the first wave of claims, Bard agreed to settle 500 lawsuits for $21 million. In the second wave of settlements, Bard settled 3,000 cases for $200 million.
  • 2013: Bard agreed to pay $48.2 million to resolve claims related to a cancer-treatment business dedicated to rapid radiation. Bard’s brachytherapy unit was investigated because of allegations of questionable sales and marketing practices over a period of years.
  • 2015: In August of this year courts consolidated lawsuits against Bard for IVC filters. Reports indicate that as early as 2002, Bard knew of IVC filter flaws within the product design. An expert regulator hired by Bard warned the company of problems but Bard ignored them. There was also a special investigation made by NBC that revealed the company may have forged the expert’s signature on the FDA application for approval.

Regardless of the bad history, the future of Bard is continuing to grow in worth. In 2012, it established its sixth division, Bard Biopsy Systems (BBS). Through its acquisition of SenoRx, which makes stereotactic and therapeutic products, Bard established itself as a frontrunner in ultrasound-guided breast biopsy. It continues to operate in 90 countries and in 2014, it reached a net sales of nearly $3.3 billion. With its worldwide domination and innovative new units, it’s safe to say that the company is here to stay [5].

Sibley Dolman Gipe Accident Injury Lawyers, PA

While filing a claim against a major device manufacturing company such as Bard can be daunting, the lawyers at Sibley Dolman Gipe Accident Injury Lawyers, PA know that no illegal action contrived by said companies should be swept under the rug. These major powerhouse medical suppliers need to be held accountable when they get greedy and think about profit over safety.

If you or a loved one is suffering from injuries sustained due to a faulty IVC filter or any other device manufactured by C.R. Bard or company in comparison, please contact the experienced defective product attorneys at Dolman Law. Call (727) 451-6900 for a free case evaluation and schedule a consultation today.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher road
Clearwater, FL 33765
(727) 451-6900

https://www.dolmanlaw.com/legal-services/defective-medication-attorneys/

References:

[1] https://topclassactions.com/lawsuit-settlements/lawsuit-news/58658-inferior-vena-cava-ivc-filter-side-effects-class-action-lawsuit-investigation/
[2] https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
[3] https://onlinelibrary.wiley.com/doi/10.1111/ejh.12542/abstract
[4] https://www.nytimes.com/1993/12/16/business/company-news-c-r-bard-pleads-guilty-to-criminal-charges.html
[5] https://www.drugwatch.com/manufacturer/bard/