C.R. Bard withdrew its Recovery IVC filter in 2005. The Bard Recovery blood clot filter has been linked to a 40% risk of filter fracture after five years. NBC News revealed the Recovery may have a fatal flaw, and that it may have gained FDA clearance – though not approval – through outright forgery.
IVC Filters Flawed – NBC Nightly News
Related: IVC Filters not FDA approved
Even those who don’t suffer life-threatening complications must have frequent monitoring to check for emerging IVC filter problems. Doctors are often unable to safely remove it. In addition, there is no evidence IVC blood clot filters help.
Bard Recovery Filter Lawsuits
Some two dozen Bard Recovery filter lawsuits and Bard G2 filter lawsuits sit pending in U.S. District Courts across the nation. Additional cases over problems with the inferior vena cava (IVC) filters will likely be filed in the near future.
All complaints against Bard IVC filters share similar allegations. Plaintiffs say they experienced complications after being implanted with the small blood clot filters in the inferior vena cava. The filters are designed to “catch” blood clots to stop them traveling to the lungs and causing pulmonary embolism. The problem is the filters have been linked to hundreds of adverse event reports. They can puncture the vena cava, tilt out of position, or fracture so that small fragments migrate to the heart or lungs.
The U.S. JPML determined in an August 17 transfer order that similar questions of fact and law raised in the cases justify coordinated pretrial proceedings. Consequently, cases pending throughout the federal court system will now be transferred to U.S. District Judge David G. Gampbell.
Federal MDL set in Arizona
Bard IVC Filter Lawsuits have been centralized in a federal MDL court. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established a single court in Arizona to consolidate all the IVC filter lawsuits filed against C.R. Bard.
The MDL process is designed to avoid or minimize duplication of discovery into common issues raised in the Bard IVC filter lawsuits. It can also help avoid conflicting pretrial rulings on similar issues from different judges, and serve the convenience of the parties, witnesses and courts.
Similar MDL proceedings have been established for all Cook Medical IVC filter lawsuits. More than 100 complaints, centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana, are on file over Cook Celect or Gunther Tulip filters.
Bard opposed MDL
Although Bard opposed the establishment of centralized proceedings for cases involving Bard products, arguing that the litigation in several of the cases is already very advanced, and that IVC filter settlements have already been reached in many cases, the U.S. JPML disagreed.
“Several of the pending cases have completed discovery and some are near trial. Given the ongoing overlapping discovery disputes, we find that centralization still would promote efficiencies,” the panel said. “While it may be that some cases are too advanced to substantially benefit from inclusion in centralized proceedings, the parties have not specifically identified any that should be excluded. The Panel has held that the transferee court is in the best position to identify claims that should be excluded from an MDL.”
Bard IVC Filter Lawsuits | Complaints
All complaints in the Bard and Cook IVC Filter litigation address similar claims. They argue that the manufacturers designed and sold retrievable devices that were unreasonably dangerous and defective.
The FDA issued a warning in August 2010 about the risk of IVC filter problems. The agency said it had received hundreds of adverse event reports where filters broke free and moved to other areas of the body or caused further injuries.
Less than 10% Safely Removed
A study published March 2013 in the medical journal JAMA Internal Medicine raised questions about IVC filters’ effectiveness. Less than 10% of filters evaluated in the study were successfully removed from patients. Eight percent (8%) of IVC filter recipients suffered a pulmonary embolism despite the device promoted to prevent that very problem..
The FDA in May 2014 urged doctors to remove IVC filters within one to two months after the risk of a pulmonary embolism had passed. This instruction suggested many doctors were not properly warned about the import of retrieving the devices.