Cook Medical, Inc. and C.R. Bard, Inc. continue to face mounting lawsuits over their retrievable IVC filters, with 3,769 cases filed against the companies in two federal MDLs.
Cook Medical is a defendant in at least 1,918 product liability claims involving its Gunther Tulip and Celect IVC filter blood clot filters. IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation is pending before US District Chief Judge Richard L. Young in MDL 2570 in the Southern District of Indiana.
In March 2017, Judge Young ordered both sides to appear at three hearings with a proposed settlement framework.
Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of 1,851 injury claims. IN RE: Bard IVC Filters Products Liability Litigation is pending before US District Judge David G. Campbell in MDL 2641 in the District of Arizona.
On March 21, 2017, Judge Campbell appointed the Plaintiffs’ Co-Lead/Liaison Counsel and State/Federal Liaison Counsel:
- Ramon R. Lopez, Lopez McHugh, LLP, Newport Beach, CA.
- Mark S. O’Connor, Gallagher & Kennedy, PA, Phoenix, AZ.
Failure to Warn
IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.
Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.
The FDA has issued two safety alerts about using retrievable IVC filters.
- The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
- The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.
“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”