NBC News spent two years investigating Bard G2® and Bard Recovery® inferior vena cava (IVC filters), spider-like devices implanted in the inferior vena cava (the largest vein in the body) to trap blood clots and prevent them from traveling to the heart and lungs. C.R. Bard sold Recovery filters from 2002 to 2005 and then, after reports of 27 deaths associated with Recovery filters, sold G2 filters from 2005 to 2010.
According to NBC News:
Confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration. But instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them.
To date, C.R. Bard has not issued a recall of any of these products.
There have, however, been lawsuits. In August of 2015, a court order centralized some of the suits against C.R. Bard involving IVC filters for the following reason:
All actions involve common factual questions arising from allegations of defects in the design of Bard’s retrievable inferior vena cava filters (“IVC filters”) make them more likely to fracture, migrate, tilt or perforate the inferior vena cava, causing injury.
This centralization of cases throughout the United States (in the U.S. District Court for the District of Arizona) is not a class action, where there is one lawsuit for many. It is multi-district litigation (MDL), where there are many lawsuits but all of the pretrial work is done by one group of attorneys for the benefit of all of the people who have filed.
The Bard MDL Master Complaint for Damages for Individual Claims alleges the following (among other things):
- “Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery® filter fractured, migrated, or perforated the vena cava, caused thrombus and clotting, and caused serious injury, including death.”
- “Premarket and post-market clinical trials revealed that the Recovery® failed and caused serious risk of harm. In addition, peer-reviewed literature reflected that such filters actually increased the risk of patients developing thromboembolitic events.”
- “Approximately a month after the full-scale launch of the Recovery® filter, on February 9, 2004, Bard received notice of the first death associated with this filter. The next day, a MAUDE analysis was performed which revealed that there had been at least two other migration0related adverse events reported to Bard in 2003.”
- “By April of 2001, at least three deaths had been reported to Bard. Yet again, instead of recalling its deadly device.”
- “Bard made the decision to continue to market and sell the Recover filter until its next generation product, the G2® IVC filter, was cleared by the FDA.”
- “Almost immediately upon the release of the G2® filter, Bard received notice of the same series of advers events of migration, fracture, tilt, and perforation causing the same type of harm as the Recovery filter. This time, however, a new and different adverse event emerged: the G2® filter could caudally (moving against the blood flow) migrate in the direction of the groin.”
The Master Complaint also alleges the following about adverse events reported to the FDA:
“A review of the FDA MAUDE database from the years 2004 through 2008 shows that Bard IVC Filters are responsible for the following percentages of all IVC filter AERs [Adverse Event Reports]:
- 50% of all adverse events:
- 64% of all occurrences of migration of the IVC Filters;
- 69% of all occurrences of vena cava wall perforation; and
- 70% of all occurrences of filter fracture.”
“These failures were often associated with severe patient injuries such as:
- Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart);
- Cardiac arrhythmia and other symptoms similar to myocardial infarction;
- Severe and persistent pain; and
- Perforations of tissue, vessels and organs.”