IVC Filter Lawsuits
In July 2015, the U.S. JPML established multidistrict litigation for federal IVC filter lawsuits pending against Cook Medical. MDL No. 2570 is presiding in the Southern District of Indiana, where similar cases alleging defects with Cook IVC filters have been consolidated before the Honorable Richard L. Young and Magistrate Judge Tim A. Baker. Cook’s IVC filter is a small medical device implanted in the inferior vena cava which is used to prevent blood clots from traveling to the lungs.
Plaintiffs contend that the Cook vena cava filters are prone to migrate, fracture and perforate internal organs, leaving recipients with catastrophic and sometimes fatal injuries. They are suing with claims of defective design, failure to warn and misrepresentation in marketing.
FDA safety communication highlights IVC filter risks
Manufacturer C.R. Bard is also defending allegations in a number of lawsuits alleging life-threatening complications from its retrievable IVC filters. Complications and potential injuries associated with IVC filters were highlighted in a 2010 FDA safety communication which included cautionary language to doctors regarding filter fracture, migration and organ perforation.
The agency’s Adverse Events Reporting System (AERS) has received more than 900 reports detailing IVC filter problems.
Adverse events reported to the FDA include:
- 56 reports of filter fracture
- 70 reports of IVC filter perforation
- 146 reports of embolization
- 328 reports of filter migration
According to federal health regulators, risk of IVC filter complications typically correlates to how long the device has been implanted.
“For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides,” states the 2010 safety communication.
By 2014, the FDA began recommending that doctors remove filters between 29 and 54 days of implantation due to long-term risks.
C.R. Bard faces IVC filter lawsuits
Dozens of product liability cases involving the G2 IVC Filter, G2 Express and Recovery IVC Filter are currently pending against C.R. Bard. The first case against the device manufacturer was filed back in 2004, and litigation continues to escalate with charges that the defendant knew its products were prone to fracturing, but neglected to warn physicians and their patients.
Plaintiffs contend that as early as 2003, Bard’s own research showed that its Recovery IVC filters posed a disproportionate risk of splintering after implantation. These fractured shards could then migrate to the lungs and heart, or other adjacent organs. However, Bard didn’t pull the Recovery IVC off the market until 2005, when its modified G2 IVC filter was ready. Unfortunately, both devices have been associated with perforated tissues, vessels and organs, pulmonary embolus, hemorrhage and persistent pain.
On at least two occasions, Bard has attempted to have cases alleging harm from their IVC filters dismissed. In 2013, a California Superior Court judge denied Bard’s motion for summary judgement. The manufacturer was attempting to stop a lawsuit from going to trial, but Judge Edward Sturgeon found sufficient evidence that the defendant had acted with negligence, and that the case should proceed.
In early 2015, the second Bard IVC lawsuit to go before a jury was quietly settled for a confidential sum after 11 days of trial. The plaintiff suffered debilitating injuries after the Recovery filter migrated out of position and punctured a hole in his heart.
Evidence presented by the plaintiff’s attorneys during the IVC filter trial included:
- In December of 2004, Bard’s own company analysis showed that the Recovery system was prone to fracture, migrate, and puncture the vena cava at rates well above the industry standard for other IVC filter systems.
- In March of 2004, two of Bard’s private medical consultants alerted the company of the substandard design of the Recover filter, which needed and overhaul to ensure stability.
- In July of 2004, Bard’s own studies showed that the Recovery IVC filter had a fracture rate 28.3 times higher than all other filters combined.
Dangers of fractured IVC filters
IVC filters are designed to protect patients from deadly pulmonary emboli, but post-market reports, medical studies and intensifying litigation suggest that the devices are potentially fatal in themselves. Research has shown that the fractured pieces of an IVC filter can pose greater dangers than that of a stroke. A study published by the The New England Society for Vascular Surgery found that 31 percent of IVC filters fractured, with most of the fragments finding their way to the victim’s heart.
Patients whose IVC filters fracture inside the body are at risk of life-altering injuries, such as:
- Perforation of the heart or lungs
- Cardiac tamponade
- Perforated aorta
- Chronic chest pain
- Respiratory compromise
- Hemorrhagic Pericardial Effusion
- Punctured vena cava
Compensation available to Cook IVC plaintiffs
Defective medical devices have the potential to completely undermine a patient’s health, future productivity and financial stability. Product liability lawsuits alleging design or manufacturing defects and failure to warn may seek monetary damages to account for lost income, hospital and medical bills, emotional anguish, diminished earning capacity, loss of spousal consortium and other, less tangible losses.
An IVC lawsuit may also demand additional punitive damages against a defendant, in an effort to deter similar conduct that has been deemed wanton or reckless in the context of consumer safety. However, all civil actions alleging personal injury are subject to time limits known as statutes of limitation, which is why it’s important to seek competent advice from a skilled attorney right away.
- Medscape, Inferior Vena Cava Vascular Filter Placement http://emedicine.medscape.com/article/1377859-overview
- Cleveland Clinic, Inferior Vena Cava (IVC) Filter Retrieval http://my.clevelandclinic.org/services/heart/services/vascular_surgery/ivc-filter-retrieval
- JAMA Internal Medicine, Indications, Complications, and Management of Inferior Vena Cava Filters: The Experience in 952 Patients http://archinte.jamanetwork.com/article.aspx?articleid=1669107&resultClick=3
- FDA, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
- Justia dockets, EBERT v. C.R. BARD, INC. et al https://docs.justia.com/cases/federal/district-courts/pennsylvania/paedce/5:2012cv01253/459619/79
- US JPML, IN RE: COOK MEDICAL, INC., IVC FILTERS MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION http://www.insd.uscourts.gov/sites/insd/files/MDL%202570%20Transfer%20Order.pdf