C.R. Bard Granted Leave to Present 510(k) Clearance Evidence at First IVC Filter Lawsuit Trial

Published on February 8, 2018 by Sandy Liebhard

The Arizona federal judge overseeing thousands of IVC filter lawsuits filed against C.R. Bard, Inc. will allow the medical device manufacturer to present evidence pertaining to its blood clot filters’ 510(k) clearance at the litigation’s first bellwether trial.

Plaintiffs were seeking to preclude that evidence, but their motion was denied on January 29th. However, U.S. District Court Judge David Campbell of the District of Arizona did indicate that the defendants would not be permitted to use the evidence as proof that the devices were approved by the U.S. Food & Drug Administration (FDA).

First Bard IVC Filter Trial to Begin in March

C.R. Bard is named a defendant in at least 3,400 product liability claims involving its retrievable inferior vena cava (IVC) filters, including the Recovery and G2 models.  The devices are intended to be placed in the inferior vena cava in patients at risk for pulmonary embolism but for whom standard anticoagulant medications are inappropriate.

Plaintiffs pursuing these cases claim that Bard’s IVC filters are defective and place recipients at risk for serious and life-threatening complications, including:

  • IVC filter fracture
  • IVC filter migration
  • Heart or chest pain
  • Pulmonary embolism
  • Organ perforation
  • Blood vessel perforation
  • Erosion into the inferior vena cava
  • Bleeding or fluid buildup around the heart
  • Embolization of filter fragments
  • Death

The case selected for the first bellwether trial is Sherr-Una Booker v. C R Bard Incorporated and Bard Peripheral Vascular Incorporated (2:16-cv-00474). The litigation is currently moving forward with jury selection, having already mailed case-specific questionnaires to 200 prospective jurors.

A final pretrial conference will be convened on March 2nd. Voir dire to seat 9 jurors is scheduled for March 18th. Opening statements will begin that afternoon.

FDA 510(k) Clearance Program

C.R. Bard obtained regulatory clearance for its IVC filters via the FDA’s 510(k) clearance program. Unlike the agency’s strict premarket approval protocols, a 510(k) clearance does not require a device to undergo human clinical trials if a manufacturer can demonstrate that it is “substantially equivalent” to a product that was previously approved by the FDA.

Critics of the 510(k) system claim that many of the devices cleared in this manner -such as transvaginal mesh and metal-on-metal hips – have caused significant harm to thousands of patients.

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