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The U.S. District Judge presiding over all federal IVC filter lawsuits filed against C.R. Bard has rejected a motion for summary judgment that sought to dismiss thousands of cases, determining that manufacturers who introduce medical devices through the FDA’s controversial 510(k) “fast-track” approval process can not claim they are insulated from liability under federal pre-emption.
There are currently about 6,000 product liability lawsuits pending in a federal multidistrict litigation (MDL) over the risk of problems with Bard IVC filters, which are small devices implanted in the vena cava to prevent blood clots from traveling to the lungs and causing a pulmonary embolism. However, cases brought nationwide allege that design defects make the devices prone to move out of position, puncture internal organs or fracture, causing small pieces to travel throughout the body.
Since August 2015, the Bard IVC filter litigation has been centralized before U.S. District Judge David G. Campbell in the District of Arizona for coordinated pretrial proceedings, to reduce duplicative discovery into common issues, avoid conflicting rulings from different Courts and serve the convenience of the parties, witnesses and the judicial system.
C.R. Bard recently filed a motion for summary judgment, indicating that the cases should be dismissed on the basis of federal pre-emption, arguing that state court failure to warn claims should be barred since the devices were approved under federal regulatory requirements. However, in an order (PDF) issued on November 22, Judge Campbell rejected the company’s motion, clearing the way for cases to move forward to trial.
According to the decision, Bard cannot claim preemption because it’s IVC filters were approved using the FDA’s 510(k) fast-track approval process, which allows medical device approval if it is “substantially equivalent” to an existing product, without the manufacturer having to go through extensive testing or clinical trials.
Judge Campbell indicates that preemption only comes into play if a medical device has gone through the much more extensive premarket approval (PMA) process, which then sets up a situation where state law requirements may conflict with federal laws for purposes of determining the adequacy of warnings or design defects.
Even though Judge Campbell acknowledges that Bard had additional specific requirements added by the FDA, he says those requirements do not rise to the bar that the Supreme Court has set in previous rulings for preemption, and do not make it impossible for Bard to meet state label warning requirements.
“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.”
As part of coordinated MDL proceedings, Judge Campbell has previously established a bellwether trial plan, which calls for a small group of cases to be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout many lawsuits.
While the outcomes of these early bellwether trials will not be binding on other cases, they will be closely watched by those involved in the litigation, as they may influence eventual IVC filter settlements in hundreds of cases.
In addition to cases against Bard, hundreds of similar Cook IVC filter lawsuits and Cordis IVC filter lawsuits are also pending against the manufacturers of these similar medical devices. A separate group of Cook bellwether cases are also being prepared for a series of bellwether trials, which are scheduled to begin in October 2017.