Many surgical devices were created to save lives by making post-surgery recovery easier and safer for patients. One such device is the Inferior Vena Cava (IVC) filter, a tiny device that is implanted into a patient’s vein to catch blood clots and prevent them from wreaking havoc throughout a patient’s body. However, former recipients of retrievable IVC filters are claiming that the devices caused bleeding and injuries as the devices broke apart inside them.
Complications of the Bard Inferior Vena Cava (IVC) Filter
These filters were originally designed to be a temporary solution for blood clots for patients who were unable to take blood thinners after surgery. The filters are meant to catch clots in the blood stream, preventing them from traveling to the lungs and causing a pulmonary embolism. The filters are supposed to be removed from the patients’ bodies a few weeks after surgery when clotting risks have returned to normal.
In the weeks following surgery, many patients suffered injuries as the legs of the spider-like Bard IVC filters fractured and broke apart, migrating to other locations in the body. Pieces of the defective Bard IVC filters traveling freely throughout the patient’s bloodstream have caused a number of serious risks, including:
- Pulmonary embolus
- Respiratory compromise
- Punctured veins
- Perforation of tissue, vessels, and organs
- Constant severe pain in the heart, chest, or elsewhere
The FDA began receiving reports of the dangers of retrievable filters as early as 2010. In a report from that year, the FDA received nearly 1,000 reports of adverse events associated with IVC filters, including 328 filter migrations, 146 embolisms, 70 bodily perforations, and 56 cases of fracture or device breakup inside a patient’s body. The FDA updated its safety warning for IVC filters in 2014, stating most devices should ideally be removed as soon as the patient's risk for blood clots has subsided, or between the 29th and 54th day after implantation.
Bard Allegedly Knew About IVC Filter Risks to Patients
Various lawsuits have claimed that Bard, maker of the Bard Recovery filter, the Bard G2 filter, and the Bard G2 Express filter, was aware of the risks to patients and made no attempt to warn the public. In some cases, victims have alleged that the company knew of design and manufacturing defects and actively tried to conceal risks, including suppressing its own research.
One report that has recently come to light involves a company investigation of the Recovery filter. After receiving reports that the IVC filter’s legs could break loose and injure patients in 2004, Bard hired an independent consultant to prepare a report comparing fracture and migration rates of its filters to other models.
When the study determined that the Recovery filter was more likely to break and migrate than its competitors, Bard neglected to issue a safety warning or inform the FDA of the findings. Instead, the company distributed copies of the results to certain employees and demanded that it be kept secret.
Another allegation against the company is its potential forgery of the device’s application for FDA approval. When approval was denied for the Bard IVC filter in 2002, the company hired Kay Fuller, a regulatory specialist, to examine the device and help it get FDA clearance. Fuller eventually refused to support Bard’s application, citing safety concerns based on clinical trial results. Although Fuller’s name and signature appear on the approved application from the FDA, Fuller attests that she never signed the form nor gave her approval.
We Hold Manufacturers Accountable for Causing Patient Injuries
If you were harmed by a Bard IVC filter, we can help you get the justice you deserve for your suffering. The McGartland Law Firm has recovered millions of dollars in damages for patients who were injured through no fault of their own, and can provide you with the legal counsel and vigorous representation you deserve.
Our legal team can calculate your damages for losses such as hospital bills, lost wages, pain and suffering, future medical costs, and any permanent disabilities. If you or a loved one suffered harm from a Bard IVC filter, we will fight to recover what you need to move forward with your life. Best of all, we work on a contingency-fee basis, so you will owe us no legal fees unless we win your case. Call the number on this page today to speak with one of our representatives about your case.