New Research: IVC Filters Don’t Save Lives in Trauma Patients

Bard Denali IVC Filter
Bard Denali IVC Filter

New research in JAMA Surgery concludes that IVC filters don’t save lives in trauma patients, who are at increased risk of bleeding and thrombosis, and the devices should not be placed in trauma patients in an effort to decrease all-cause mortality.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis. The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the study concludes.

See Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality by Shayna Sarosiek, MD, Denis Rybin, PhD, Janice Weinberg, ScD, Peter A. Burke, MD, George Kasotakis, MD, and J. Mark Sloan, MD.

Should not be placed in trauma patients

“The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the researchers said. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

“Overall, these data indicate that IVC filters should not be placed in trauma patients in an effort to decrease all-cause mortality.”

Litigation against the makers of IVC filters is one of the largest mass torts today. “All these products are defective,” Mass Tort Consultant John Ray said, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

  • There are 886 cases in Bard IVC Filter Litigation in MDL 2641 before Judge David G. Campbell in US District Court in Arizona.
  • There are 993 cases in Cook Medical IVC Filter Litigation in MDL 2570 before Chief Judge Richard L. Young in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark.
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

Venous thromboembolism is a significant cause of death in the United States. Approximately 900,000 patients per year have a clinically significant deep vein thrombosis or pulmonary embolism. Since the invention of the permanent percutaneous IVC filter in 1973 and the retrievable IVC filter in the 1990s, its use has become a standard part of treatment for select patients with acute lower-extremity venous thrombosis who cannot receive anticoagulation.

 

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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Family Sues Boston Scientific over Defective IVC Filter that Killed Truck Driver

Boston Scientific makes the dangerous Greenfield Vena Cava Filters.
Boston Scientific makes the dangerous Greenfield Vena Cava Filters.

Federal litigation is building against Boston Scientific Corp. over defects in its IVC filter, a device implanted to control pulmonary embolisms (PE), a sudden blockage in a lung artery.

The family of a woman truck driver from Ohio filed a wrongful death suit after the company’s IVC filter perforated her inferior vena cava vein, killing her.

Even though plaintiffs are filing more cases against Boston Scientific over its Greenfield Vena Cava Filter, today there is no multidistrict litigation docket (MDL) for the litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be filed in an effort to form an MDL,” said John Ray, a leading consultant who has advised attorneys who practice in Mass Torts for more than a decade.

Greenfield Vena Cava Filter
Greenfield Vena Cava Filter

Boston Scientific, headquartered in Marlborough, Massachusetts, designed, manufactured, marketed and sold the Greenfield IVC Filter. It is a basket-like structure with 6 struts, each with a curved hook, and is designed to catch blood clots.

FDA warning and recall

The FDA recalled the Greenfield IVC Filter in May 2007 after reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters, causing a risk of cardiac and pulmonary embolization.

It also issued a warning on August 9, 2010 against leaving IVC filters in for extended periods of time, because they have a tendency to cause life-threatening problems.

The FDA reported that since 2005, there were 921 adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved detachments of device components and embolizations, 70 involved perforation of the IVC, and 56 involved IVC filter breaks.

Dangerous medical device

The co-administrators of estate of Cindi K. Ratliff filed a lawsuit in US District Court for the Southern District of Ohio, Eastern Division, alleging product liability, breach of warranty, negligence and wrongful death, Case: 2:15-cv-00076-GLF-NMK.

In 2004 Ratliff, of East Fultonham, Ohio, was diagnosed with deep vein thrombosis (DVT), which occurs when a blood clot (thrombus) forms in one or more of the deep veins in your body, usually in your legs. That year a surgeon implanted a Boston Scientifi IVC filter in her right inferior vena cava.

On May 3, 2013, she was working as a long‐haul truck driver and traveled to Oregon. While stopped at a rest area located on I‐5 in the vicinity of Coburg, Oregon, she suffered a medical emergency.  Shortly afterwards she was pronounced dead by medics who had been called to the scene. An autopsy that day determined the immediate cause of death was “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”

The lawsuit charges:

  • Boston Scientific knew or should have known that its Greenfield Vena Cava Filter when used as expected and intended, carrie the risk of breaking free from its implantation site, migrating, perforating the vena cava, and causing serious injury and death to patients.
  • Boston Scientific failed to properly design and manufacture Greenfield Vena Cava Filter.
  • Boston Scientific failed to give adequate warnings about the hazards associated with the filter.
  • Boston Scientific violated Ohio’s Product Liability Act.

The next of kin seek damages for loss of support, loss of services, loss of society of the decedent including loss of companionship, loss of prospective inheritance, and extreme mental anguish as a result of her death.

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