- Section 1 What is an IVC Filter?
- Section 2 IVC Filter Side Effects
- Section 3 Symptoms of IVC Filter Complications
- Section 4 IVC Filter Manufacturers Facing Litigation
- Section 5 C.R. Bard
- Section 6 C.R. Bard IVC Filters
- Section 7 Cook Medical
- Section 8 Cook Medical IVC Filters
- Section 9 Status of the IVC Filter Lawsuits
- Section 10 FDA News & Warnings
- Section 11 Medical Device Litigation Attorneys
What is an IVC Filter?
IVC filters are small devices with several prongs, designed to prevent a blood clot from traveling into the lungs. Some IVC filters are intended to be retrievable. Once the eminent threat of death has passed and the patient’s health has improved, then the device should be removed. Generally, removal of the IVC filter should occur between the 29th and 54th day after initial implant.
An IVC filter may be inserted after a patient has developed DVT due to surgery, obesity, advanced age, or prolonged immobility such as bed-rest or long plane rides. Injury to the veins, or increased production of the hormone estrogen can also cause deep vein thrombosis. Although the precise number is unknown,
the CDC estimates that as many as 900,000 people may be affected by DVT at some time in their lives.
IVC Filter Side Effects
In 2010, the FDA listed the following side effects from IVC filters:
- Filter perforation of the heart or surrounding tissue
- Device migration (movement out of set place)
- Fracture and break off of the filter’s prongs
- Failure to capture an embolism (blood clot) capture
In many cases of IVC, the device may not be removed within the recommended timeframe. In other instances, surgeons may attempt to retrieve the device, but are unsuccessful. A review by the Journal of the American Medical Association found that out of 680 patients, only 8.5% had their IVC filters removed successfully as recommended. The study also found that 13 removal attempts failed due to device migration, perforation of a blood vessel, or device embedment in a venal wall. There were also 74 venous thrombotic events (blood clots) after IVC filters were placed, including 25 pulmonary emboli (blood clots in the lung).
Symptoms of IVC Filter Complications
The longer a retrievable IVC filter device stays implanted in a patient, the greater the chances of adverse effects. Warning signs the IVC filter is failing include:
- Abdominal pain
- Chest pain
- Back pain
- Shortness of breath
Should you experience any of the above symptoms, seek medical help immediately.
IVC Filter Manufacturers Facing Litigation
Two major medical device manufacturers, C.R. Bard and Cook Medical, are defending their products in multidistrict litigation (MDL) for IVC filter injury. Five IVC device types are the focus of these lawsuits:
- Bard Recovery Filter
- Bard G2 filter
- Bard G2 Express filter
- Cook Gunther Tulip filter
- Cook Celect filter
After reported complications with defectiveness of different IVC filter devices, the FDA issued a safety update in 2014 stating most devices should be removed between the 29th and 54th day of being implanted.
This alert came two years after the first lawsuits had already been filed.
C.R. Bard is a multinational manufacturer of medical devices for surgical specialties. A NBC News investigation has linked more than 300 injures and 27 deaths to the Bard Recovery filter.
C.R. Bard IVC Filters
A little less than a year after the Recovery filter was put on the market, the company started receiving complaints of device malfunction. In particular, the “legs” or prongs of the device were breaking loose and eventually puncturing tissue in another part of the body. In 2004, Bard hired consultant D. John Lehmann to review the device.
The findings resulted in the Lehmann report, which concluded the Recovery filter was more likely to cause injury or death through migration than other IVC filters on the market at the time. Bard also failed to disclose these adverse effects to the FDA. This report would have remained a secret, had it not been accidentally disclosed to the plaintiff’s lawyer during the trial Ebert v. C.R. Bard, Inc. in 2012.
Cook Medical is one of the world’s largest private medical device manufacturers, and is one of three divisions that form the 42-company conglomerate, Cook Group, Inc. Forbes magazine has listed the Cook Group as one of the largest private companies in the U.S.
Cook Medical IVC Filters
Several of the company’s devices are involved in MDL proceedings, including transvaginal mesh and the Celect and Gunther Tulip IVC filters. As far back as 2009, the Celect filters were found to puncture the walls of the vena cava (large veins carrying blood into the heart).
Status of the IVC Filter Lawsuits
There are class-action lawsuits against Bard in Florida, Pennsylvania and California that have yet to be approved by courts. Also, in October 2014, over 100 lawsuits against Cook from 11 districts around the country were consolidated into an MDL in the Southern District of Indiana.
How these suits may potentially resolve as a settlement to the victims came in early 2015. In February of that year, Bard chose to settle a case with Kevin Phillips, a mere 10 days after trial began. As part of the allegations against the manufacturer, Phillips claims that he was forced to have open heart surgery after one of the Recovery filter’s legs broke off, traveled through his bloodstream and punctured his heart.
Numerous lawsuits remain pending in courts both at the state and federal levels.
FDA News & Warnings
In 2010, the FDA issued its first Safety Alert for retrievable IVC filters after receiving over 900 reports of device fracture, perforation and migration. Broken pieces of IVC filters become a type of embolism, exposing patients to the very risk of sudden death that the filters were intended to prevent.
Soon thereafter, a study published in the Journal of Vascular Surgery found that retrieving the device reduced the risks of adverse events This lead to an FDA alert update in 2014 alert, recommending that physicians provide ongoing care and follow-up removal procedures once immediate danger from pulmonary embolism has passed.
Medical Device Litigation Attorneys
When manufacturers of medical devices push products on the market that are harmful to consumers, they should be held responsible. The attorneys at Pittman, Dutton and Hellums has the legal expertise and experience necessary to stand up to corporations when their products cause more harm than good.
If you or a loved one suffered injury due to C.R. Bard or Cook IVC filters, please call our attorneys to discuss your legal options. We offer free consultations and there is no obligation.
Across the country upwards of 100,000 Americans are diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE). DVT are blood clots that develop in deep veins and can travel into the lungs. PE is a blockage in one of the pulmonary arteries in the lungs. These medical conditions are dangerous and relatively common in the U.S. population. In fact, the risk for developing PE is so prevalent that the US National Library of Medicine declared the disorder a public health concern in 2010.
According to the Centers for Disease Control, more than 30% of pulmonary embolism patients die within three months of diagnosis. Typically doctors prescribe anti-coagulants, or blood thinners, to treat the condition. However, not all patients respond well to blood thinners. When this happens, a doctor may insert a device called an Inferior Vena Cava (IVC) Filter.
Although IVC filters can be a lifeline for patients with blood clots, some of these devices have their own fatal dangers. In 2014, the U.S. Food and Drug Administration (FDA) issued a safety warning for certain retrievable IVC filters, citing that product may cause serious and life-threatening health conditions.
If you or a loved one has suffered the adverse medical effects of IVC filters, it is time to consider legal action. An experienced attorney can get you the compensation you need to heal from life-threatening injuries, or help you recover from the loss of a family member. Contact the law firm of Pitman, Dutton & Hellums today for a free case evaluation and learn your legal options.
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