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 ...
continue reading...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 ...
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 ...
The health risks posed by retrievable inferior vena cava (IVC) filters have long been the subject of much scrutiny. IVC filter lawsuits allege that companies like C. R. Bard and Cook Group released defectively designed IVC filters onto the market without adequately testing for dangerous side effects. In legal battles, IVC filter manufacturers have frequently stated that the devices’ health risks are outweighed by their potentially life-saving benefits. However, ...
According to The Indianapolis Star, IVC filter company Cook Group will have a new president come this July. Current president Kem Hawkins will step down next month after 14 years in the position. He will be replaced by the current president of Cook Medical, Pete Yonkman, who joined Cook the same year Hawkins became president.
As president of Cook Group, Yonkman will have to attend to a slew of ...
continue reading...A Florida federal judge recently denied a motion to dismiss filed by C. R. Bard, Inc., in an IVC filter lawsuit. The judge dismissed a failure-to-warn claim, but allowed the Bard IVC lawsuit to proceed on the grounds of defective design. According to the court order, the judge found that the plaintiff may be able to convince a jury ...
