Product News and Recalls

Bard IVC Filter Lawsuits Centralized in Arizona MDL

bard ivc filter lawsuits to be consolidated into multidistrict litigationThe U.S. Judicial Panel on Multidistrict Litigation decided on earlier this month to centralize 22 Bard inferior vena cava (IVC) filter lawsuits before the U.S. District Court for the District of Arizona. Lopez McHugh co-founder Ramon Rossi Lopez appeared last month when the Panel heard arguments in favor of centralization. Plaintiffs in Bard IVC filter lawsuits are expected to benefit from the Panel’s decision, which should lead to more efficient use of both the parties and the courts’ resources.

Though first used in the late 1960’s, retrievable IVC filters have only recently become popular. Today, IVC filters are a thriving business, with over 100,000 devices implanted annually. Major manufacturers include C. R. Bard and Cook Medical, who market their IVC filters as potentially life-saving devices. The retrievable filters have layers of spoke-like struts designed to anchor the implant within the vena cava and intercept passing blood clots before they reach the heart or lungs. In doing so, IVC filters lower the patient’s risk of stroke and other dangerous cardiovascular events—or so the manufacturers say.

In truth, IVC filters have received relatively little research, with only one randomized controlled trial conducted to date. The study, published in July 2005, reported that IVC filters reduce the chance of pulmonary embolism but increased the rate of of deep-vein thrombosis. It further found that IVC filters had no observable effect on the survival rate of patients. Lately, more and more people in the health industry have begun questioning whether IVC filters offer any health benefits at all beyond what a patient would get with anticoagulation therapy alone. A recent study published in the Journal of the American Medical Association concluded that IVC filters confer “no benefit in terms of pulmonary embolism recurrence or mortality” when used alongside an anticoagulant.

Medical inefficacy is not the only concern about IVC filters. In 2010, the U.S. Food and Drug Administration (FDA) revealed that since 2005, 921 adverse event reports had been submitted, “of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture.” Subsequent studies have observed a similar link between some IVC filters and vena caval perforation and device migration, both of which can have life-threatening consequences.

Bard IVC filters have proved particularly problematic over the years. Injured patients claim that Bard knew of the unreasonable health risks its Recovery and G2 filters posed, yet continued to market the potentially dangerous devices. Bard IVC filter lawsuits allege that Bard’s IVC filters are defectively designed and prone to migration or fracture while in the body, sending pieces or entire devices towards vital organs with disastrous consequences.

In its August 17 transfer order, the Judicial Panel on Multidistrict Litigation noted that upon examination of the 22 filed lawsuits, it found “common factual questions arising from allegations that defects in the design of Bard’s retrievable inferior vena cava filters . . . make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.” The Panel considered these similarities to weigh in favor of centralizing the lawsuits, and noted that “centralization will eliminate duplicative discovery, avoid inconsistent pretrial rulings, . . . and conserve the resources of the parties, their counsel and the judiciary.” The Panel also noted that Bard argued little would come of formally coordinating discovery, because plaintiffs have not sought additional discovery since 2013. The plaintiffs responded, however, that they will seek to reopen discovery in the wake of a recent FDA letter concerning IVC filter–related safety violations at Bard’s Arizona and New York facilities.

A few Bard IVC filter lawsuits have gone to trial ahead of consolidation. In January of this year, Lopez McHugh attorneys successfully represented a client in the second Bard IVC filter lawsuit in the nation to proceed to trial. The case resolved after more than a week of trial.

Although only 22 Bard IVC filter lawsuits were initially included in the MDL, many more are expected to follow, including 16 additional federal lawsuits already pending in 13 district courts.