The federal court overseeing thousands of IVC filter lawsuits filed against C.R. Bard, Inc. has denied the company’s Motion for Summary Judgment, which sought to dismiss plaintiffs’ state failure-to-warn claims.
C.R. Bard’s motion had asserted that the claims are preempted, as the company’s IVC filter producets were approved under federal regulatory requirements.
But in an Order dated November 22nd, U.S. District Court Judge David E. Campbell, District of Arizona, rejected the company’s reasoning, noting that the blood clot filters at the center of the litigation were all cleared via the U.S. Food & Drug Administration’s (FDA) 510(K) program. This fast-track approval protocol does not require that a device undergo human clinical trials as long as a manufacturer can show that it is “substantially equivalent” to an earlier device that had undergone the agency’s far more stringent Premarket Approval (PMA) process.
While Campbell’s decision acknowledged that the FDA did impose additional prerequisites on Bard’s IVC filters, he determined that the requirements did not meet the standards for preemption set by several recent U.S. Supreme Court decisions.
“Bard has failed to show that it is impossible to make any labeling changes that may be required by state law. Indeed, Bard acknowledges that the FDA previously has cleared labeling changes to Bard IVC filters and in one instance found that no 510(k) was needed,” he wrote. “Bard’s impossibility preemption defense is without merit.”
More than 3,000 cases are pending against Bard in the litigation now underway in Arizona, all of which were filed on behalf of patients who allegedly suffered serious complications following implantation of the company’s blood clot filters, including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures. Plaintiffs claim that C.R. Bard concealed the dangers associated with its retrievable IVC filter products and failed to warn doctors and patients about these risks.
Bard’s IVC filters are indicated for use in patients who are at risk for pulmonary embolism, but for whom standard blood-thinning medications are inappropriate. The tiny metal devices resemble a wire cage, and are inserted into the inferior vena cava to intercept blood clots before they can make their way to the heart and lungs. Once a patient is no longer at risk, the filters are supposed to be retrieved.
In 2010, the U.S. Food & Drug Administration disclosed that its adverse event database had received more than 900 reports of IVC filter complications linked to retrievable devices. Four years later, the agency issued a second advisory that urged doctors to remove temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.
In 2015, NBC News reported that C.R. Bard’s Recovery blood clot filter had been linked to more than 300 non-fatal injuries and 27 deaths before the company stopped selling the devices in 2005. Months later, the network reported that Bard’s G2 IVC filter – which replaced the Recovery filter – were associated with a higher rate of complications compared to other competitor filters. G2 filter malfunctions were also tied to at least a dozen deaths.