Bard IVC Filter Device Still Sold Despite Serious Allegations

0
99
Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

At least 27 deaths were linked with the original Bard blood clot filter called the Recovery. Bard replaced the Recovery filter with a modified version, called the G2 Bard blood clot filter. However, not long after its approval, the company allegedly knew that it had comparable problems to the first version of the device.

C.R. Bard received failure reports concerning the allegedly improved G2 filter just four months after its release, according to NBC News. Bard had sold 160,000 of the redesigned filters and kept the G2 Bard blood clot filter on the market for an additional five years. Since then, it has been associated with over a dozen deaths and many adverse event reports.

A specialist in removing blood clot filters that have not worked, Dr. William Kuo, told NBC, “All of the data that we’ve seen in our own studies, as well as other clinician researchers,’ is that this device consistently fractures, consistently causes major complications.” The Stanford radiologist continued, “the number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

The national law firm Parker Waichman LLP has extensive experience in medical device lawsuits and is closely monitoring IVC filter litigation. Attorneys at the firm are available to answer any questions for those individuals seeking legal information.

Function of a Blood Clot Filter

The inferior vena cava (IVC) is the main vein in the body. The IVC filter, a small cage-like device, is implanted in certain patients, who for various reasons are unable to take blood thinners. The filter is meant to trap blood clots before they migrate to vital organs such as the heart or lungs and prevent a potentially life-threatening situation.

Blood clots from the lower body can be common after knee or hip replacement surgeries. If a blood clot travels to the lungs, it can cause extensive damage with dangerous complications such as difficulty breathing, chest pain, heart attack, and pulmonary embolism (PE). IVC filters are designed to catch these clots before serious damage can occur.

IVC Filter Complications

The Bard Recovery device was approved in 2002 and the manufacturer anticipated it would do well in the highly competitive IVC filter market. However, with filter fracture and device movement events, some adverse events so severe, including a higher risk of death for its patients, emerged.

Both the Recovery filter and the G2 filter lines proved to be failure-prone with many problems and complications linked to them. Several confidential memos show clearly that Bard was aware of the problems with migration, tilting and perforation, meaning the device may perforate the vein itself or other organs, reports NBC News.

Dr. Kuo maintains that both devices should have been withdrawn from the market. He claims to have removed over 1,000 filters in the last decade and of these thousand filters, he has removed more Bard-made filters than from any other manufacturer. “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been reached,” Dr. Kuo said.

IVC Removal Difficulties

When the IVC filter is removed, complications may include blood vessel perforation, large clots in the filter that may prevent removal, difficult removal that may require long surgery times, and scars in the vein that may hamper removal.

Taking into account the FDA’s claim that IVC filter complications increase the longer the filter is left in place, some reports imply that in the majority of cases, retrievable filters are not removed, and no doubt, not within the recommended retrieval time. In numerous cases, an attempt to remove an IVC filter has failed because the device became embedded in tissue, or migrated so close to vital organs, removal is considered too great a risk.

Lawsuits Regarding IVC Filters

A Florida woman had an IVC filter implanted in November 2010. In March 2011, doctors tried to remove the filter, but determined that it could not be removed. The plaintiff developed debilitating gastrointestinal symptoms, including bowel inflammation, diarrhea, vomiting, fatigue, and abdominal pain. A colonoscopy revealed that the IVC filter had perforated her vena cava and migrated into her intestines. The filter had migrated to the duodenum, the first part of the small intestine. She eventually had another surgery at a different hospital and the filter was successfully removed.

In April 2011, an Illinois man had an IVC filter inserted. The filter perforated his vena cava and caused him severe pain and shortness of breath. The filter remains in his body because doctors deemed it too dangerous to remove the filter.

An IVC manufacturer is facing a wrongful death lawsuit over its Option Inferior Vena Cava filter. The family of the Florida man alleges that the device, caused a pulmonary embolism and subsequent respiratory failure. The man died in October 2014. His family alleges that the IVC filter was defectively designed and accuses the manufacturer of failing to disclose the risks to patients and the medical community.

Legal Help for Inferior Vena Cava Filter Recipients

Parker Waichman LLP has had years of experience representing clients in allegedly defective medical device lawsuits, such as Bard IVC filters. The firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).