$3.6M Verdict Affirmed In Bard IVC Filter Case

$3.6M Verdict Affirmed In Bard IVC Filter Case

Introduction

The Ninth Circuit Court of Appeals upheld a $3.6 million jury award over C.R. Bard's IVC filter, after finding that state-law duty to warn was not preempted by federal edicts.

The case was filed over the G2 model inferior vena cava filter that was placed near the plaintiff's heart in 2007. The suit claimed that pieces of the filter eventually broke off, and the metal shards moved towards the heart, leading to open-heart revision surgery. The plaintiff was awarded $3.6 million by a federal jury in Phoenix in March 2018.

The company challenged the initial 2018 verdict in the appeals court, arguing that the claim was preempted by federal law of Georgia, where the case originated, which doesn't allow failure to warn claims and also maintained that there were no grounds for the punitive damages claim.

Last Thursday, a panel of three federal judges rejected multiple arguments by the manufacturer to overturn the verdict, which includes $1.6 million in compensatory damages and $2 million in punitive damages. The case was the first to go for a trial in federal multidistrict litigation (MDL) over Bard IVC filters. The number of cases is slowly winding down, as the manufacturer has reached settlements with thousands of patients.

The judges mentioned in their opinion that Bard's arguments failed because the plaintiff’s claim rested on an asserted state-law duty to warn of the risks posed by the particular design of the device, and the FDA had not imposed any requirements related to the design or labeling of the device.

An Inferior vena cava filter (IVC filter), earlier popularly known as Greenfield filter, is a medical device implanted in the inferior vena cava just below the kidneys to capture blood clots, preventing them from reaching the heart and lungs, thereby, safeguarding against life-threatening pulmonary emboli (PE). IVC filters were cleared for use through the 510(k) process since 1976. However, in 2010 the FDA issued a device safety communication after reviewing more than 900 adverse events related to the devices over a period of five-years C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) and Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS (collectively, Cook) are the main manufacturers of retrievable IVC filters. Other manufacturers include Argon Medical Devices, Cordis Corporation, Rex Medical, Johnson & Johnson, ALN, B. Braun Medical, and Rafael Medical.

In all, C.R. Bard faced 8,000 IVC filter product liability lawsuits, which were consolidated under MDL No. 2641 and presided by U.S. District Judge David G. Campbell in the District Court of Arizona. Last August, Judge Campbell returned hundreds of cases to different federal district courts nationwide for individual trials, as the vast majority of claims were settled or closed.