The U.S. Judicial Panel on Multidistrict Litigation is expected to decide soon on whether to centralize lawsuits filed against C. R. Bard over its allegedly defective inferior vena cava (IVC) filters. Plaintiffs in Bard IVC filter lawsuits filed for centralization back in May, requesting that at least 25 IVC filter lawsuits in 22 federal jurisdictions be brought before a single judge. On July 30, the Judicial Panel convened ...
Lopez McHugh Founding Partner Speaks at IVC Filter MDL Hearing
Posted August 17, 2015 in IVC Filter Failure | Product News and Recalls
PHILADELPHIA (August 2015) – Lead IVC filter attorney Ramon Rossi Lopez recently appeared before the U.S. Judicial Panel on Multidistrict Litigation in support of an effort to centralize all federal lawsuits filed against medical device manufacturer C.R. Bard, Inc. over allegedly defective IVC filters.
Lopez, founding partner of Lopez McHugh LLP, spoke during arguments on July 30 at a hearing ...
continue reading...IVC Maker Committed Quality System Violations
Posted August 3, 2015 in IVC Filter Failure | Product News and Recalls
A recent letter from the U.S. Food and Drug Administration (FDA) reveals that IVC maker C. R. Bard committed several quality system violations at its facilities in Queensbury, New York, and Tempe, Arizona. According to the FDA, Bard failed to “establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by [law].” The agency cites several instances in which Bard’s quality system did not ensure adequate evaluation of ...
Bard Failed to Submit IVC Filter Reports
Posted July 30, 2015 in IVC Filter Failure | Product News and Recalls
In a July 13 letter, the U.S. Food and Drug Administration (FDA) called out IVC filter maker C. R. Bard on medical device reporting violations. Inspection of the Bard Peripheral Vascular facility in Tempe, Arizona, in late 2014 revealed that Bard failed or refused to submit reports regarding the safety of its IVC Denali Filter Delivery System.
Bard is already in hot water for its allegedly defective inferior vena ...
continue reading...FDA Cracks Down on Unapproved Bard IVC Filter Recovery Devices
Posted July 29, 2015 in IVC Filter Failure | Product News and Recalls
In addition to warning IVC filter maker C. R. Bard about medical device reporting and quality system violations, the U.S. Food and Drug Administration (FDA) has also cracked down on two Bard IVC filter recovery devices that have not been cleared for market. In its July 13 letter, the FDA held Bard accountable for adulteration/misbranding violations at its Tempe, Arizona, facility. The charges concern Bard’s Recovery Cone Removal ...
FDA Finds Bard Violated Federal Law In Manufacture and Marketing of IVC Filters and Threatens Seizure, Injunction, and Civil Money Penalties
Posted July 23, 2015 in IVC Filter Failure | Product News and Recalls
On July 13, 2015, The FDA warned Bard that it has been illegally marketing the devices used to retrieve its IVC filters, which are known as the Recovery Cone Removal System, since 2003. Bard’s marketing of these devices is illegal as Bard has never sought clearance from the FDA to use these devices in humans. Thus, Bard has essentially been subjecting patients to an illegal research trial without the safeguards and oversight ...
