Liz Dudley is an IVC Nationwide Personal Injury Attorney and Former Nurse
If you or someone you know has been injured by an IVC filter, contact us immediately at 316-746-3969 for a free case evaluation — You may be entitled to compensation if the device is or has failed —-time may be running out!
What is an IVC Filter?
A filter implanted into the large vein going into the lungs [inferior vena cava or IVC] to stop blood clots from going into the lungs, heart, brain & throughout the body. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. These IVC filters were designed to catch blood clots and prevent them from migrating to the lungs, thereby preventing pulmonary emboli, stroke and other serious life threatening events. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective.
Defective IVC Filter by Manufacturer
- BARD: Bard Recovery filter, Bard G2 filter, Bard B2 Express filter.
- COOK: Gunther Tulip, Celect;
- B.BRAUN: CORDIS, Boston Scientific
Risks of Defective IVC Filters
The defective filters at issue here are small, cage-like devices that look somewhat like a spider, set snugly against the walls of the inferior vena cava & are supposed to capture blood clots & prevent them from reaching the lungs. Any of the metal “spider legs” can fracture, migrate and be wisked away by the blood stream into the lungs, heart and other organs. These fragments can also perforate into the vessels [veins, arteries] and organs. Studies show the likelihood of device fracture increases the longer the device remains in the body.
A number of studies are showing that these filters break or fracture and that shards are breaking off and migrating to other areas or perforating vessels & organs. The studies show that these fragments can be as deadly as a stroke or the conditions the device was meant to prevent.
- One study by the New England Society for Vascular Surgery noted a 31% fracture rate in IVC filters; most of the fragments found their way into the right ventricles of patients hearts.
- Another study by Dr Nicholson of York Hospital, showed that 25% of the group had fragments that broke off and migrated to another organ such as the lungs, heart and hepatic vein.
INJURIES & RISKS TO PATIENTS FROM THE IVC FILTERS DOCUMENTED IN THE FDA DATABASES AND VARIOUS PUBLISHED MEDICAL STUDIES
- IVC Filter fracture
- IVC Filter migration
- IVC Filter embolization [movement of the entire filter or fracture fragments to the heart or lungs]
- IVC Filter perforation into vessels, organs
- Pulmonary Embolism
- Respiratory problems
- Malpositioning & Tilting of the IVC Filter
- Stroke or Cerebral Vascular Accident or TIA [transient ischemic attacks]
- Death
- Difficulty removing the device
THE FDA’s APPROVAL OF THIS DEVICE WAS SUSPECT DUE TO BARD ALLEGEDLY FORGING THE SIGNATURE OF ONE OF THEIR LEAD CLINICAL SPECIALISTS WHO QUESTIONED THE SAFETY OF THE DEVICE
NBC news recently did an expose of the Bard IVC filter entitled “Did Blood Clot Filter Used on Thousands of Americans Have a Fatal Flaw” and
“Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?”
NBC news found that in 2002 Bard recruited Kay Fuller, a veteran regulatory specialist to help get their IVC filter cleared to sell because the FDA had previously turned down their prior application. Fuller told NBC news that she had participated in a small clinical trial and it raised red flags and that Bard did NOT give her important safety performance test results. When she voiced her concerns Bard did not want to hear it & she refused to sign the IVC APPROVAL APPLICATION TO THE FDA until the device’s safety issues were resolved. However, Bard submitted its application with what appears to be her signature, but she told NBC that it was not her signature & that she did not sign the Application for FDA Approval for Bards IVC filter. Dr. Fuller resigned from Bard & told the FDA of her safety concerns about the device.
WHAT DID THE MANUFACTURERS KNOW ABOUT THE RISKS OF THEIR DEVICE DUE TO ITS DESIGN? THESE DEVICES WERE NEVER INTENDED TO BE PERMANENT BUT THE COMPANY MARKETED THEM AS SUCH.
Since 2002 and maybe earlier, Bard knew of the potential defective issues and injuries this device was causing but continued to sell the device after it was approved [allegedly after using a Drs forged signature]. After receiving FDA clearence, Bard sold about 34,000 filters to unsuspecting patients and their doctors. Over a 10 year period there were 27 deaths & several hundred non-fatal injuries reported.
As reports of death & fatal injuries were growing, Bard decided NOT to recall the Recover filter, but to hire a public relations firm to develop a crisis management plan to ward of “unfavorable press” that could damage stock prices and ruin reputations. [see crisis management plan 2004, Hill & Knowlton to Bard obtained by NBC news at FN2].
Bard also commissioned an outside doctor to conduct a confidential study which was obtained by NBC news. The results showed the IVC filter had higher rates of relative risk for death, filter fracture and movement than all its competitors. The doctor concluded that “Further investigation…is urgently warranted.”
NBC noted that Bard sold the Recovery until 2005 — then replaced it with a modified version with a new name. As of 2006, Bard’s own confidential records estimated there were more than 20,000 people still walking around with these.
These IVC filters were intended to be retrievable; and used on a temporary basis in order to protect patients from pulmonary emboli and blood clots traveling to the lungs. These IVC filters were to be removed when the danger had passed and the patient was stabilized.
Bard allegedly petitioned the FDA for the device to be approved as a permanent implant. Based on the above information, the FDA recently recommended that the devices be removed as soon as the risk of pulmonary embolism subsides.
If you believe you have a filter implanted, health officials say you should check with your doctor to determine what brand of filter you have and whether it should be removed. We recommend that you have a radiograph taken to determine if the device has fractured and evaluate the devices integrity. Some patients are asymptomatic but yet have a found the device has fractured & is ready to migrate.
FDA ACTIONS & RECALLS
2010: FDA recommends IVC filters be removed as soon as protection from pulmonary embolism is no longer needed. FDA reiterated that these devices are for short term protection only
2013: The FDA has recalled Cordis Optease Retrievable Inferior Vena Cava Filter 3.29.2013
2014: The FDA recommends that once the risk of pulmonary embolism has passed, the risk/benefit profile favors removal of the IVC filter between 29 & 54 days after implantation based on medical literature analysis.
2015: The FDA warned Bard that it has been illegally marketing the devices used to retrieve its IVC filters, known as the Recover Cone Removal System since 2003 as Bard has never sought clearance from the FDA to use these devices in humans. The FDA threatened seizure, injunction & Civil Money Penalties [See FDA warning letter 7.13.2015]
Why Choose the Dudley Law Firm
Ms Dudley is an attorney and former nurse with decades of experience in mass tort litigation and experienced in litigating & representing clients in defective device cases nationwide. Attorney Dudley has a different business model than most firms doing mass tort cases — she interviews & talks to every client; is the primary attorney on every client’s case and litigates each case; and assists her client’s in finding the best experts and healthcare providers to treat the clients injuries. Many Doctors are not aware of the defects in these devices nor the injuries the defects are causing. In addition, if the Doctor has no experience in treating these injuries, they may not have the expertise to treat some of the unique injuries these devices cause; whereas other Drs that Ms Dudley knows may have more expertise in this area & get better results for the patients.
Additionally, Ms Dudley is sought out by the national plaintiff’s attorneys involved in various device defect cases to work on science, expert issues involved in the litigation, including reviewing the manufacturers FDA submissions and finding experts to review documents & testify about design defect, liability, general causation issues, and damages.
ANOTHER DIFFERENCE: Ms. Dudley is involved in the prosecution & litigation of the case from beginning to end – she does not just collect clients & then pass them off to someone else to handle them. BEWARE OF ATTORNEYS WHO ARE JUST COLLECTING CASES & ARE NOT ACTIVELY INVOLVED IN LITIGATING THE CASES!!!
The other difference is COMMITMENT. Ms. Dudley takes cases were large drug or medical device corporations take advantage of consumers and their physicians causing severe injuries. These cases take years to resolve and the financial resources to prosecute them. We are committed to representing clients and effectuating a change in the corporation’s business practices that caused the harm in hopes that others are not injured also.
Ms Dudley litigates the case through trial or settlement and has recovered millions of dollars in settlements for her clients in these cases. Ms. Dudley has a nationwide practice and is located in the midwest for easy access to any area of the country.
If you or someone you know has been injured by an IVC filter, contact us immediately at 316-746-3969 for a free case evaluation — You may be entitled to compensation if the device is or has failed —-time may be running out!
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