Inferior vena cava filters (IVCs) can be implanted into patients’ veins by surgeons if the patients cannot take blood thinners, known as anticoagulants. Anticoagulants can prevent blood clots from traveling to the lungs. IVCs can catch the clot while it is in the blood stream. After a while, the blood clots dissipate. The U.S. Food & Drug Administration (FDA) collected hundreds of adverse reports about IVCs. Many complications were reported for the retrievable filters, including punctured organs, blood vessels and filter migration to other areas of the body.
FDA Statements About IVCs
The FDA issued a warning in 2010 that IVCs should be removed as quickly as possible once the patient’s risk for blood clots diminished, due to the potential hazards of organ perforation, filter fracture and device migration. In 2014, the FDA issued a safety communication update, specifying that most IVCs need to be withdrawn between the 29th and 54th day after they have been implanted. Unfortunately, this update was too late for some patients. Lawsuits were being filed across America with claims that the retrievable filters caused harm and even death in some cases.
IVC Filters and Manufacturers Named in Litigation
Two companies, C.R. Bard, and Cook Medical are the main manufacturers involved in the IVC filter litigation. At the core of the lawsuits, there are five main filters:
- The Cook Celect filter
- The Cook Gunther Tulip filter
- The Bard G2 Express filter
- The Bard G2 filter
- The Bard Recovery filter
The IVC Claims in the Lawsuit
Amongst the lawsuits filed, there are many claims made by the manufacturers. The claims include the following:
- failure to warn patients of risks
- breach of implied warranty
- design defects in IVC filters
- negligent misrepresentation on the part, the companies, and their subsidiaries
- manufacturing defects in the IVC filter
Status of IVC Filter Litigation
In 2012, Bard received the first round of lawsuits, which were filed in Pennsylvania and California state courts. The U.S. Judicial Panel on Multidistrict Litigation (MDL) later consolidated the lawsuits filed against Cook from 11 districts in October 2014. The combined lawsuits then became MDL in the Southern District of Indiana. There are now more than 100 lawsuits against Cook.
Kevin Phillips settled with Bard in February 2015, only ten days after his trial started. The lawsuit claimed that the IVC manufactured by Bard broke inside Phillips’ body, which allowed one of the small metal legs to travel to his heart. His heart was then torn. Phillips needed open heart surgery and then had a long recovery. Later that same year, in August, The U.S. Judicial Panel on MDL consolidated the Bard lawsuits to the U.S. District Court District of Arizona. There are over 50 lawsuits pending in the MDL, and even others still pending in federal and state courts.
There are three class-action lawsuits against Bard filed by those who had the Bard IVC filters. The lawsuits are in Pennsylvania, California, and Florida courts. The plaintiffs with G2, G2 Express or Bard Recovery filters are in need of medical monitoring due to Bard’s misrepresentation and negligence. Those filings claim that anyone who had one of those Bard filters implanted comprises a class which should be compensated for expenses incurred from medical monitoring. The formation of this class has not yet been approved by the courts.
Adverse Events Associated With Retrievable Filters
The IVC filters were created to prevent a life threatening issue, blood clots in the lungs. Ironically, however, the IVC filters were found to have life-threatening side effects. The FDA received more than 900 reports in 2010 of negative events that correlated with retrievable filters. Some of the most widely reported adverse events included:
- 56 filter fractures
- 70 filter perforations
- 146 embolisms
- 328 device migrations
Study From Journal of the American Medical Association Shows IVC Risks
The Journal of the American Medical Association (JAMA) conducted a study in 2013 that studied how 952 patients managed an IVC. Of those 952 patients, approximately 680 got retrievable filters. From that group, doctors were only able to remove 58 of them successfully. There were 13 removal attempts that were unsuccessful, with 11 of those occurring in patients who had the filters over 85 days. The study took an in-depth look at the 13 unsuccessful removal attempts and found the following reasons for why the filter could not be removed:
- Eight patients had a device that was embedded
- Three patients had a filter that protruded through a blood vessel
- Two patients had a device that shifted to an irregular position
- One patient had a blood clot inside the filter
Lehman Report Revealed Risks Known Internally
Not even a year after the Recovery filter was launched, Bard began to get complaints about the device malfunctioning. The complaints indicated that the device’s legs were apt to break off and travel to other areas of the body. At that time, Bard hired independent consultant Dr. John Lehmann to conduct a study comparing the-the rate of fracture and migration of the new filters to the 2004 models. Bard was aware of the problem with the IVC filter but failed to inform the FDA and the public. Lehmann concluded his study in 2004 finding that the Recovery filter had higher complication rates than its competitors. Lehman also determined, however, that further investigation was needed. Attorneys at Bard distributed copies of the report to employees on a need-to-know basis and let employees know that the report was to be kept a secret.
Lehmann Report Revealed to Public
Once the lawsuits were filed and got to court, the report by Lehmann became public. Bard argued, however, that the report should stay confidential “under the work-product doctrine.” This law would protect internal documents for a company if those documents were created in anticipation of potential litigation. Many court rulings vary on the question of whether the Lehmann Report is protected under the work-product doctrine.
Bard’s Questionable Signature on Their FDA Application
In 2015, NBC News conducted an investigation which reported that Bard might have been aware of the Recovery filter’s risks even before the Lehmann report or the early adverse event reports. Initially denied by the FDA in 2002, Bard then hired Kay Fuller, a regulatory specialist, to gain clearance. Fuller, however, was concerned about the device’s safety from the clinical trials. She did not support the request from Bard for clearance to market the filter. Oddly enough, though, her name and signature are on the device’s application that eventually gained clearance from the FDA. When interviewed by NBC, Fuller stated to NBC that she did not sign that form and that she had no knowledge of her signature being included on that application.