A federal jury in Phoenix awarded $2 million in compensatory damages to a woman who sued a medical device manufacturer and doctors over serious injuries she suffered from an IVC filter that splintered in her body and punctured her spine and heart.
The trial was the first bellwether in the products liability multidistrict litigation (MDL) alleging medical device manufacturer, C.R. Bard, failed to warn about the dangers associated with its blood clot capturing inferior vena cava (IVC) filters (Sherr-Una Booker v. C.R. Bard Inc. and Bard Peripheral Vascular Inc., 16-CV-474). The IVC is the large vein that carries deoxygenated blood from the lower body to the heart. The devices are tiny open-ended cages that are implanted in the IVC designed to trap blood clots before they reach the heart or lungs, preventing pulmonary embolisms. Bard IVC filter products include G2, G2 Express, G2X, Eclipse, Meridian, and Denali.
The jury found that Bard — one of the largest manufacturers of IVC filters — was responsible for 80% of the compensatory award at $1.6 million. They also found that a radiologist who failed to identify a visible metal shard from the implanted IVC filter on an X-ray in 2009 was responsible for the remaining $400,000 in damages. Jurors additionally ordered Bard to pay $2 million in punitive damages.
The trial involved the case of Sherr-Una Booker, who was 37 when she was implanted with Bard’s G2 filter on June 21, 2007 before she had surgery to remove a cancerous cervical mass. In 2009, a radiologist performed an X-ray from which it was determined that Booker’s filter fractured inside her IVC, migrated and tilted, and one or more of its parts perforated her IVC and lodged into her spine and heart. This required open-heart surgery in 2014, when Booker underwent revision surgery to retrieve the bits of filter. One of the pieces of the filter remains in her IVC. The jury did not find the surgeon responsible as the cause of Booker’s injuries, as Bard had argued.
The Bard IVC Filter MDL
In August 2015, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal cases against C.R. Bard Inc. and Bard Peripheral Vascular be centralized in the District of Arizona (IN RE: Bard IVC Filters Products Liability Litigation, MDL No. 2641). Even though no related action was pending in the District of Arizona, the panel chose the district because Bard is headquartered there. The panel assigned the MDL to U.S. District Court Judge David G. Campbell.
The complaints against Bard allege that the manufacturer concealed potentially dangerous side effects and defects of its filters, including filter migration, fracture (when a piece of the filter breaks off and travels through the bloodstream), organ perforation, embolization, inferior vena cava punctures, and other serious complications, and that they failed to warn patients about these risks. There is alleged to be a higher risk of fracture, complication, and death associated with Bard’s IVC filter in comparison to its competitors.
As of March 15, 2018, 3,639 lawsuits are pending in the MDL. The court has selected five bellwether cases to represent cases consolidated in the MDL.
In November 2017, Judge Campbell denied the company’s attempt to have all the cases against it dismissed. The company argued the lawsuits were preempted under federal law because the FDA had approved the company’s IVC filters. Judge David Campbell, in his ruling, found Bard’s argument was “without merit.” His ruling pointed out that Bard’s IVC filters had been approved through the FDA’s 510(k) process (see our blogs, Hip Replacement Failures and the FDA’s 510(k) Expedited Device Clearance Process and FDA: Pharma Fast Track Protocol & Product Recalls), whereby manufacturers can bring “substantially equivalent” medical devices to market that carry a similarity to products already on the market and performing within expectations without going through the agency’s more rigorous Premarket Approval (PMA) process.
Another 3,826 cases involving IVC filters made by Cook Medical Inc. are pending in an Indiana federal court. The first bellwether case in that MDL ended in Bard’s favor in November 2017. Cook Medical Inc. brands include Celect and Gunther Tulip.
IVC filters are metal, cage-like devices that protect patients from pulmonary embolisms. They are inserted into the patient’s inferior vena cava, a large vein in the abdomen through which blood travels from the lower body to the heart. When blood clots in the lower body travel to the lungs, they can cause a dangerous blockage or pulmonary embolism. IVC filters reduce the risk by trapping blood clots and preventing them from reaching the heart and lungs. IVC filters are used on patients that cannot be successfully treated by other means, such as with blood thinners. The U.S. Food and Drug Administration (FDA) approved the device in 1979, and over 30,000 IVC filters have been implanted into patients since.
After the FDA received numerous adverse event reports, it released a safety communication in 2010 advising of the risks associated with IVC filters, which included filter migration, embolization, filter perforation, and filter fracture, leading to serious injuries including deep vein thrombosis (DVT)and organ perforation. In 2014, the FDA strengthened its warning, advising doctors to remove the filters within 29-54 days after implantation, as long as the patient’s risk of pulmonary embolism had subsided.
Associated problems with IVC filters include:
- Migration: The IVC filter becomes loose from the location where it was implanted, and moves toward the heart and lungs. Migration can render the filter ineffective at stopping blood clots. Migration into the heart and lungs can cause immediate death.
- Fracture: The legs or arms of the IVC filter can break spontaneously and also break during attempted removal procedures. The fractured pieces of metal can then travel throughout the body, where they can puncture organs or become lodged in the heart or lungs. It is extremely difficult to remove pieces of an IVC filter after it has fractured. Many patients must have subsequent revision surgeries to remove the broken filter pieces.
- Puncture: The fishhook anchors and fractured filter pieces may puncture the IVC and cause internal bleeding. Some patients with these problems think they are simply not feeling well, and can die within hours or days if the problem is not diagnosed. Some filters may pierce the IVC into the spinal canal and cause paralysis or other neurologic injury.
If you or a family member have suffered injury from an implanted medical device such as an IVC filter, you and/or your family member may be entitled to money damages.
We take your calls and meet with your family personally to answer all your questions. We will press your insurance company for the coverage you are entitled to and help you recover the compensation you deserve. Personal injury cases require a wealth of experience, and a network of proven experts, including doctors and medical experts, accident recreation experts, insurance investigators, private investigators, and the resources necessary to fight large insurance companies.
For more information, please contact The Ahearne Law Firm, PLLC for an initial consultation and case evaluation. Call nationwide at (845) 763-4100.