INFERIOR VENA CAVA (IVC) DEFECTS
FDA ISSUES WARNING FOR VIOLATIONS OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT IN CONNECTION WITH IVC FILTERS
On July 13, 2015 the FDA recently issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively referred to as "Bard") for eight violations of federal law relating to the safety of its Inferior Vena Cava (IVC) filter product line. The FDA warning letter concern safety of the use the Recovery Filter, G2 Filter, G2X Filter, G2 Express Filter, Eclipse, Meridian Filter and Denali Filter were sold and implanted in individuals as retrievable filters who had a temporary need to prevent a blood clot from travelling to the heart or lung. Among the number of violations, Bard illegally sold adulterated and misbranded IVC Filters and failing to report complications and adverse events. The letter further cites Bard with violations for withholding critical information from the FDA and public.
IVC Filters are intended to screen for blood clots before clot enter the lungs. IVC Filters have been linked to serious and sometimes fatal complications including:
- Fracture of the IVC Filter
- IVC Filter Migration
- Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- Respiratory Distress
- Shortness of Breath
- Other Serious Injury and Death
The FDA recommends that physicians consider removing the IVC filters so that the long term risks of the IVC Filters are minimized.
Craig Crockett is pursuing legal claims against IVC manufacturers Cook Medical Inc. and C.R. Bard for violating the standard of care owed by a manufacturer to a patient. These claims include defective design and failure to warn claims among others.