After sustaining extensive injuries over several years after an inferior vena cava (IVC) filter broke apart in her body, a Phoenix woman on Friday was awarded $3.6 Million in damages in the first bellwether trial over the device. Manufacturer C.R. Bard was found responsible for $2 Million worth of the harm.
IVC filters, spider-like devices placed in the largest vein in the body (the inferior vena cava), are designed to trap blood clots. But they are well-known to migrate elsewhere in the body and cause serious complications. This plaintiff’s case, allegedly involving injuries such as fracture and perforation, is 1 of hundreds of similar cases in multidistrict litigation against Bard.
First Bellwether IVC Filter Lawsuit Leads to Victory
The plaintiff, 37-years-old at the time of the procedure, received a Bard “G2” filter implant when at risk of pulmonary embolism (blood clotting in the lungs). According to her lawsuit, an X-ray later showed that the IVC filter had broken apart. But the device was left there until the plaintiff’s injuries were so severe she needed open-heart surgery.
The 9-member jury attributed 20 percent of the fault to the radiologist who failed to flag the X-ray in 2009. Bard argued the other 80 percent of the fault lay with the surgeon who attempted to retrieve the broken filter pieces 5 years later. However, the jury found this blame firmly attributable to Bard.
While Bard was not found liable for negligent design, strict product liability design defect, or strict product liability failure to warn, the jury found the device maker negligently failed to warn about design defects. Jurors awarded $2 Million in compensatory damages and $2 Million in punitive damages to the plaintiff after brief deliberations.
10 Years of Devious Sales, Thousands of Complaints
Some IVC filters are designed for permanent use. Others, like Bard’s, can be removed when the patient is no longer at risk of pulmonary embolism. However, back in 2010, the U.S. Food and Drug Administration (FDA) raised concerns that retrievable devices are not always removed when needed.
The controversy around Bard began when the FDA approved its “Recovery” IVC filter in 2002. The device was submitted for approval under a 501(k), which allows a manufacturer to bypass rigorous clinical testing by proving its product similar to 1 already approved. Bard’s application was rejected twice. And for its third attempt, the company apparently forged an independent regulator’s approval.
Bard’s associate general counsel for litigation, Greg Dadika, said the company was “obviously disappointed” in the verdict. “We, of course, believe these are important lifesaving medical devices whose benefits far outweigh the risks.”
But the dangers of Bard’s IVC filters vastly outweigh supposed benefits for far too many patients. Even after evidence uncovered an alarming 12 percent failure rate associated with its device, sales continued for 10 more years – during which time, 900 patients reported devastating injuries and 39 died. Bard devices are associated with 27 deaths in the U.S. alone.
The multidistrict litigation includes more than 3,600 pending claims over several Bard-manufactured IVC filters, also including the “Eclipse.” The next goes to trial within a few weeks.