The United States District Court in the District of Arizona is scheduled for its first bellwether trial against C.R. Bard, the manufacturer of an IVC filter alleged to have caused serious injuries to thousands of patients. Over 3,000 lawsuits against Bard are pending in this district, which were consolidated for pretrial proceedings by the U.S. Judicial Panel on Multidistrict Litigation (IN Re: Bard IVC Filters Products Liability Litigation, 15-02641 (PHX) (DGC)). The Court selected five bellwether cases to represent cases consolidated in the MDL. The purpose of these trials, which encompass a smaller representative subset sample of the lawsuits, is to help provide insight to the parties as to the validity of their claims and defenses. The first case, Sherr-Una Booker v. C.R. Bard Inc. and Bard Peripheral Vascular Inc., 16-CV-474, is scheduled to begin trial on March 13, 2018. The outcome may help facilitate global settlement negotiations before the remainder of the cases are transferred back to their original respective districts for trial.
What is an IVC Filter? The Allegations Against Bard
Inferior Vena Cava filters are metal, cage-like devices that protect patients from pulmonary embolisms. They are inserted into the patient’s inferior vena cava, a large vein in the abdomen through which blood travels from the lower body to the heart. When blood clots in the lower body travel to the lungs, they can cause a dangerous blockage or pulmonary embolism. IVC filters reduce the risk by trapping blood clots and preventing them from reaching the heart and lungs. IVC filters are used on patients that cannot be successfully treated by other means, such as with blood thinners.
Over 30,000 IVC filter have been implanted into patients within the last thirty years. After the U.S. Food and Drug Administration received thousands of adverse event reports, it issued a warning in 2010 as to the risks associated with the filters, which include IVC filter migration, embolization, filter perforation, and filter fracture. In 2014, the FDA strengthened its warning, advising doctors to remove the filters within one to two months after the patient’s risk of a pulmonary embolism decreased.
Medical reports questioned the efficacy of IVC filters, with a May 2012 research paper in the American Journal of Medicine finding that “the vast majority of filters that are placed in patients with a pulmonary embolism may not reduce mortality.” An October 2015 paper published in the Annals of Surgery indicated that IVC filters provided no additional benefit in trauma patients and that the patients had, in fact, developed deep vein thrombosis at a higher rate than those who did not receive the filter. An April 2013 study published by JAMA Internal Medicine stated that IVC filters have never been validated by empirical studies.
In 2015, a media report claimed C.R. Bard, one of the largest manufacturers of IVC filters, continued to market and sell their filters despite claims of serious injury and death. The report linked at least 27 deaths and over 300 injuries to Bard’s Recovery Model IVC filters. The investigation found that IVC filters produced by Bard and Cook Medical (another leading manufacturer of IVC filters) had punctured the vena cava or migrated out of their placed positions, causing metallic fragments to travel to the heart or lungs and cause embolization. Despite these warnings, Bard continued to sell its devices without warning patients and doctors about the defects.
Notably, Bard’s former employee, a regulatory affairs expert, has accused her former employer of forging her signature on compliance documents. Kay Fuller, the (medical device regulator) hired to help Bard obtain FDA clearance for its IVC filter, was concerned about the device’s safety after reviewing reports which indicated patient complications during clinical trials. Fuller refused to sign Bard’s clearance application, and contends that the documents ultimately filed with the FDA bear a forged signature.
Lawsuits against Bard and other IVC filter manufacturers began to rapidly mount, with 3,400 cases pending in the consolidated MDL in which the Booker case is scheduled to go to trial. The complaints against Bard allege that the manufacturer concealed potentially dangerous side effects and defects of its filters, including filter migration, fracture (when a piece of the filter breaks off and travels through the blood stream), organ perforation, embolization, inferior vena cava punctures, and other serious complications, and that they failed to warn patients about these risks. There is alleged to be a higher risk of fracture, complication, and death associated with Bard’s IVC filter in comparison to its competitors.
Many of the plaintiffs share the same experiences. Dodi Froehlich, for example, received an IVC filter in 2004. Four months after the implantation, an X-ray showed a piece of the filter had perforated her heart. Although Froehlich was saved by emergency surgery, not all plaintiffs managed to survive. One patient, Gloria Adams, died after a blood clot pushed a fractured piece of the filter into her heart, causing it to puncture the organ.
Several plaintiffs have received settlements from Bard. In 2011, Lisa Davis sued Bard after her implanted IVC filter migrated to her heart, causing ongoing health issues. A settlement was subsequently reached in 2013. In 2015, a plaintiff from Nevada sued the company after his IVC filter fractured and perforated his heart, requiring surgery to remove pieces of the device. After only 10 days, the parties reached a settlement.
How Can the Experts Weigh In?
As with any medical device trial, expert witnesses will be a crucial component of establishing causation and damages. Plaintiffs intended to call four medical professionals to testify as expert witnesses. The experts, all colleagues at Northwestern University’s interventional radiology department, formed a consulting group for the purposes of testifying. Interestingly, one doctor, Scott Resnick, was disqualified from testifying by the Court on the basis that he previously served as a consultant and expert for Bard in connection to the IVC filter litigation. Despite the loss of one expert, the plaintiffs’ experts can still provide critical testimony as to the defects and dangerous side effects of the IVC filter.
Although Interventional radiologists are the physicians who typically implant the device, there are several other medical specialists that can provide insightful testimony as to the IVC filter’s side effects. Hematologists, who are trained in handling conditions within the blood stream, as well as vascular surgeons may opine. Pulmonologists can also testify to the effects the IVC filter may have had on the lungs.
Overall, the purpose of this trial, like other bellwether cases, is to gauge the strengths and the weaknesses of each party, which can have far-reaching implications for the thousands of other cases against Bard. If the plaintiffs are successful, and are awarded a substantial amount of damages, the defendants will be more likely to settle to remaining cases. Conversely, if the plaintiffs lose at trial, the defendants will have less incentive to settle. Even if settlement is not feasible, the bellwether trial can still help the parties assess their case strategies and how they should proceed at future trials.