In recent years, hundreds of thousands of patients in Chicago, Illinois and across the country at risk of blood clots have been treated with the Bard Recovery and G2 series inferior vena cava (IVC) filters.
As studies and investigations show, these patients may have been unknowingly exposed to serious, potentially fatal health risks due to a design defect in these medical devices that makes them fracture, tilt or perforate the vena cava.
If you believe that you or a loved one has been harmed by a Bard IVC filter, the defective medical device lawyers of Salvi, Schostok & Pritchard P.C., want to help. You may be entitled to compensation for the harm you have suffered. We can explain your legal options.
To get started with a free consultation, call or click here today.
What Are Bard Recovery IVC Filters?
Many patients, such as those who recently underwent surgery, are at risk of developing a blood clot in the legs called deep vein thrombosis (DVT). For many years, filters have been inserted in the inferior vena cava – the body’s largest vein – to catch these blood clots.
The filter is designed to prevent a blood clot from reaching the lungs. If clot does reach the lungs, it can cause a pulmonary embolism (PE).
In 2002, C.R. Bard, Inc. entered the market for these devices with a small, cage-like device called the Bard Recovery IVC filter. Three years later, Bard replaced the Recovery with its G2 series. These are “retrievable” filters. This means they should be removed from a patient’s body once the risk of blood clots has passed.
In addition to Bard, 11 other companies manufacture IVC filters, including Cook Medical.
What Dangers Are Associated with IVC Filters?
Although IVC filters have been widely used for many years, concerns have surrounded them – specifically retrievable versions.
In 2010, the U.S. Food and Drug Administration (FDA) issued a safety communication about IVC filters. The agency reported that it had received hundreds of adverse event reports involving the devices, including reports of:
- Device migration
- Filter fracture
- Filter embolization
- Perforation of the vena cava.
In 2010, researchers also published a study in the Archives of Internal Medicine. The study analyzed 80 patients who had been treated with IVC filters.
The study found that fragmentation and embolization of the device occurred in:
- 7 of 28 patients treated with Bard Recovery filters (25 percent)
- 6 of 52 patients treated with Bard G2 filters (12 percent).
As MedPage Today reports, the researchers said that more study would be necessary to determine whether these issues were limited to Bard IVC filters or “a flaw inherent in all brands.”
More recently, in May 2014, the FDA warned that complications could arise if retrievable IVC filters are left in patients for too long.
A study published by JAMA in April 2015 cast doubt on whether retrievable IVC filters are even necessary when patients at risk of blood clots can be treated with anticoagulant drugs.
Recent News About Bard IVC Filters
IVC filters manufactured by Bard have been at the center of questions surroundings the safety and effectiveness of these devices.
As it has been widely reported, the FDA sent Bard a warning letter in July 2015, alleging that the company was marketing its Recovery Cone Removal System without the agency’s approval.
Additionally, in 2015, NBC News reported on its long-term investigation of Bard IVC filters. As part of its investigation, NBC discovered “confidential company records” indicating Bard officials had long known about problems with the filters.
In fact, a company document contains data showing that the G2 series IVC filters “had more fractures, migrations and reported problems than any of its competitors,” NBC reports. Bard didn’t pull the device off the market until 2010.
As one doctor tells NBC, “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient.”
Harmed by a Bard IVC Filter? What Are Your Legal Options?
If you recently underwent a medical procedure that involved the implantation of an IVC filter, you should pay close attention to signs of pulmonary embolism. According to the Mayo Clinic, these signs include:
- Shortness of breath
- Chest pains
- Coughing blood
- Irregular or rapid heartbeat
- Dizziness or lightheadedness
It is important to see a doctor right away and receive proper treatment, which could include removal of the IVC filter.
If you or a loved one has suffered harm after being treated with an IVC filter, you should contact an attorney as well in order to protect your legal rights. A lawyer can review your medical records to determine whether you received a Bard IVC filter or one manufactured by another medical device company.
A lawsuit against the manufacturer of a defective medical device can seek compensation for your related medical expenses, lost income, pain and suffering and more.
Lawsuits currently are being filed in state and federal courts against the manufacturers of defective IVC filters, including claims against Bard and the entity responsible for the design, testing, marketing, labeling and post-market surveillance of Bard IVC filters, Bard Peripheral Vascular, Inc. (BPV).
Because BPV is based in Arizona, defective Bard IVC filter lawsuits that have been filed in federal courts have been consolidated in a multidistrict litigation case, or MDL, in the U.S. District Court for the District of Arizona. (MDL No. 2641).
In an MDL, each lawsuit remains separate and distinct. However, the lawsuits are brought into the same court for the purpose of avoiding inconsistent rulings and making pretrial litigation more cost-effective and streamlined.
Get Help Today from Our Chicago Bard Recovery IVC Filter Attorneys
At Salvi, Schostok & Pritchard P.C., we can review all of your legal options if you or a loved one has been harmed by Bard IVC filter, which may include pursuing a claim in state or federal court.
Our law firm has recovered $975 million in verdicts and settlements on behalf of our injury clients, including 210 cases with awards of $1 million or more. We are dedicated to protecting the rights of patients who have suffered harm from defective medical devices.
We serve clients throughout Illinois from our offices in Chicago and Waukegan.
To schedule a free consultation, contact us today by phone or reach us online.
Sources / More Information:
- Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, FDA
- Warning Letter, FDA
- Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Archives of Internal Medicine
- Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurrent Pulmonary Embolism, JAMA
- Why Did Firm Keep Selling Problem Blood-Clot Filters? NBC News
- Vena Cava Filter Fractures Not Uncommon, MedPage Today
- Pulmonary Embolism: Symptoms, MayoClinic.com