The son of an Oklahoma woman is suing Bard alleging that his mother died because of a defective IVC filter.
The plaintiff says that his family member was implanted with a vena cava filter, also known as an IVC filter manufactured by Bard in August of 2015; however, shortly after it was implanted, the vena cava filter fractured, injuring the surrounding tissues, vessels, and organs.
Additionally, pieces of the filter migrated to his mother’s heart, requiring open heart surgery. Unfortunately, the plaintiff’s mother passed away in October of the same year.
Vena cava filters are meant to prevent recurrent pulmonary embolism, however, the removable filters made by Bard and other companies have been shown to fail, causing the very serious medical problem they were meant to stop.
“Studies have also revealed these devices suffer common failure modes such as migration, perforation, thrombosis, and fracture, all of which can cause serious injury or death,” alleges the plaintiff. “For example, recent studies have revealed fracture rates over 50%.”
The plaintiff claims Bard and other temporary vena cava filter makers bypassed regular approval from the Food and Drug Administration by convincing the agency that their product was “substantially equivalent” to a pre-existing device. Vena cava filters have been used since the 1960s, points out the plaintiff, but these were permanent devices.
Even under the shortened FDA approval process, medical device manufacturers remain “under an obligation to investigate and report any adverse events associated with the drug…and must periodically submit any new information that may affect the FDA’s previous conclusions about the safety, effectiveness, or labeling,” alleges the plaintiff.
“The design for the IVC FILTER suffers flaws making them defective and unreasonably dangerous. The IVC FILTER is designed in such a way that, when exposed to expected and reasonably foreseeable in-vivo conditions, the device will fracture, migrate, tilt, perforate internal organs and vasculature, and lead to the formation of thromboembolism and pulmonary embolism,” states the vena cava filter lawsuit.
Further, says the plaintiff, the Bard vena cava filter “actually leads to the formation of blood clots and pulmonary embolism – the exact condition the devices are meant to protect against.”
Bard and other manufacturers falsely marketed vena cava filters as safe, alleges the plaintiff, and failed to conduct post-market research that would have warned them and the medical community that these devices present a danger to patients.
The lawsuit claims that Bard and other manufacturers received numerous “adverse event reports” indicating the vena cava filter was causing severe injuries to patients.. These injuries include:
- Death
- Hemorrhage
- Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
- Cardiac arrhythmia and other symptoms similar to myocardial infarction
- Severe and persistent pain
- Perforations of tissue, vessels and organs
- Chronic deep vein thrombosis
- Pulmonary embolism
- Compartment syndrome
However, says the lawsuit, Bard failed to warn patients and doctors about the vena cava filter’s severe side effects.
Additionally, a safe alternative to Bard vena cava filters exists, alleges the lawsuit – other vena cava filters and drugs, like warfarin.
The plaintiff wants to hold Bard and other companies that manufactured the vena cava filter responsible for the additional medical bills his mother incurred as well as for the loss of his mother, her lost earnings, parental guidance, love and affection.
If you’ve suffered complications due to a vena cava filter defect, contact the attorneys at McDonald Worley today. The experienced team of IVC filter lawyers at McDonald Worley offer a FREE case review.