Bard IVC Filters Warned by the FDA


BREAKING: Bard Owes Injured Woman $1.6M In IVC Bellwether, Jury Finds

By Cara Salvatore
Law360, Phoenix (March 30, 2018, 1:22 PM EDT) — A Phoenix federal jury awarded $2 million in compensatory damages on Friday to a woman who said a clot-stopping vein filter manufactured by Bard broke apart in her body, finding that the device maker was responsible for 80 percent of the harm, but also saying Bard is liable for punitive damages.
The punitive damages phase of the first bellwether over the IVC device will immediately follow Friday’s verdict, which came after six-and-a-half hours of deliberations beginning Thursday. The jury said Bard was not liable for strict…

https://www.law360.com/articles/1028298/breaking-bard-owes-injured-woman-1-6m-in-ivc-bellwether-jury-finds


 

The U.S. Food and Drug Administration (FDA) has issued the company, Bard, a serious warning that could impact you.  Bard has failed to file customer complaints, and even a death, appropriately, and did not let the FDA know its Recovery Cone Removal System had dangerous defects.  In fact, the company did not even get proper and required FDA approval to utilize this device in its use to retrieve vena cava filters that are inferior (Denali IVC Filter).  The malfunctioning devices could be responsible for serious injury or death.  The use of the Denali IVC filters is to catch blood clots of the legs, prior to their entry to the heart or lungs.  In addition to the above, Bard is also possibly in trouble for cleaning processes for the Denali IVC filter that were not validated.  The more serious warning and steps towards suspending marketing by the FDA occurred after Bard did not properly response to the FDA first bringing awareness to these issues.   

If you or a loved one may have been injured as a result of the Bard Denali IVC Filter and/or Recovery Cone Removal System, be sure to contact your doctor.  Also feel free to contact Inserra & Kelley Law Offices to discuss whether you are potentially entitled to compensation for potential injuries.