IVC Filter Verdict in Bellwether Case: Bard Will Pay $2 Million in Punitive Damages and $1.6 Million in Compensatory Damages
A jury in Phoenix, Arizona awarded $3.6 million in damages on Friday to a woman who alleged a C.R. Bard IVC filter fractured in her body, resulting in injuries so severe that she was forced to endure open-heart surgery.
The case of Booker v. Bard (case no: 2:16-cv-00474), is the first bellwether over allegations involving IVC filters. IVC filters are medical devices implanted in the inferior vena cava (IVC) that are designed to catch blood clots. The inferior vena cava is the body’s largest vein that carries blood from the lower body to the heart. It is located behind the abdomen and runs along the spine.
Thousands of individuals from across the country have filed IVC filter lawsuits against C.R. Bard (known simply as Bard) and several other manufacturers after sustaining injuries allegedly caused by the devices breaking apart in the body.
At present, there are more than 3,600 claims against Bard over IVC filters consolidated in a multidistrict litigation (MDL) before U.S. District Judge David Campbell for the District of Arizona. The IVC filter lawsuits claim New Jersey-based C.R. Bard failed to warn patients and the medical community about the risk of filter fracturing and other complications.
Similar claims have been filed against IVC filter manufacturers Cook Medical, Cordis and others.
Bard G2 IVC Filter Fracture
The Booker case involves the Bard G2 IVC filter. Like other IVC filters, the G2 resembles a spider with thin, spindly legs. Bard submitted the G2 for approval by the U.S. Food and Drug Administration (FDA) under a 510(k), in which a device manufacturer certifies that the device is similar to another device that has already been approved.
In this case, the earlier device that had received FDA approval was the Bard Recovery IVC filter, which was the subject of scrutiny following an in-depth investigative report by NBC News. According to the investigation, the Bard Recovery IVC filter had been associated with 27 deaths and 300 other adverse effects at the time of the report (September 2015).
NBC News reported that Bard responded to these adverse event reports associated with the Recovery filter by hiring a public relations firm and conducting a confidential study, which concluded that the risk of filter fracture, filter movement and death were all significantly higher for the Recovery filter than its competitors. Even after Bard was alerted to the serious risks associated with its filter, the company sold 34,000 Recovery filters before replacing it with the G2 model in 2005
After the G2 was approved via the 510(k) process, Bard was aware of reported problems with the device but continued to sell it and a related model, the G2 Express. By 2010, Bard had sold over 160,000 G2 filters.
IVC Filter Verdict Holds Bard Responsible for Failure to Warn
Plaintiff Sherri Booker was 37 years old when she received a Bard G2 IVC filter in her inferior vena cava. In her lawsuit, Booker claimed a piece of the Bard G2 IVC filter broke off inside of her body, resulting in injuries so severe that she was forced to undergo open-heart surgery.
After deliberating for over six hours starting on Thursday, the nine-member jury held that Bard negligently fail to warn about the risk of filter fracture and is responsible for 80 percent of the harm to Ms. Booker. The jury attributed 20 percent of the harm to a radiologist who failed to detect the visibly detached fragment of the Bard G2 IVC filter in Ms. Booker after a 2009 x-ray. Booker was visibly shaken after the verdict was read, dabbing her eyes with a tissue.
The jury also found that the surgeon who performed a 2014 procedure to retrieve broken filter piece was not a cause of Ms. Booker’s injuries, as attorneys for Bard attempted to argue. As with numerous retrieval surgeries involving fractured IVC filters, Ms. Booker’s surgery was only partially successful.
Lastly, the jury held Bard liable for punitive damages to the tune of $2 million.
Ms. Booker’s trial will be followed within the next few weeks by another case, Jones v. Bard, which will focus on the IVC filter manufacturer’s fourth generation product, the Eclipse. Booker, Jones and a handful of other IVC bellwether cases are meant to help determine the strength and dollar value of the patients’ claims.