IVC Filter Lawsuit
Many Inferior Vena Cava Filters (IVC) lawsuits have been filed against Cook Medical and C. R. Bard after their dangerous device injured several patients. Thanks to the 510(k) approval process, the medical device released to the market by the two pharmaceutical companies had a deadly high risk of breakage and malfunction. Although their use was to trap blood clots and reduce the risk of pulmonary embolism as an alternative to blood thinners, many defective IVC filters grievously injured thousands of patients after a metal fragment perforated one of their organs.
What is an IVC Filter?
An inferior vena cava filter (IVC filter) is a small medical device shaped like a cage that traps blood clots in order to prevent them from reaching the lungs and heart. A thrombus that reaches these organs may cause serious complications such as excruciating pain, difficulty breathing, stroke and even death. They are implanted in patients who are at risk for pulmonary embolism (PE), suffer from deep vein thrombosis (DVT), severe trauma or prolonged immobilization. IVC filters are placed within the inferior vena cava, one of the largest blood vessels that returns blood from the lower body to the heart and lungs. These medical devices are usually employed as an alternative in all patients who cannot be treated with traditional anticoagulant therapy with blood thinners such as antiplatelet drugs, heparins, warfarin or the Novel Oral Anticoagulants (NOAC). Although usually the vascular filter is retrieved several months after it is placed, some of them are implanted permanently.
Why should I file an IVC filter lawsuit?
IVC filters manufactured by C. R. Bard such as the Bard Recovery and Bard G2 filter are dangerously prone to breakage, fragmentation, and migration. Data from a study published in 2010 in the journal Archives of Internal Medicine showed that one Bard filter in four fractured and traveled to a nearby organ (usually the heart) causing a life-threatening embolism. Metal fragments can have potentially lethal consequences such as organ puncturing and perforation, internal haemorrhages, and serious bleedings. A second research published in 2012 in the Journal of Vascular and Interventional Radiology provided evidence showing that that up to 40% of the devices fractured within 5.5 years since they were implanted. In several instances, the “metal cage” migrated after being improperly placed, forcing the patient to undergo multiple surgeries in order to retrieve it. Another study showed similar failure percentages for the Günther Tulip and Celect retrievable filters manufactured by Cook Medical. A study published in 2013 in the Journal of the American Medical Association (JAMA), however, found that up to 18.3% of retrieval attempts were unsuccessful, increasing the device dangerousness.
C.R. Bard, however, tried to conceal the truth about their filters’ unreliability. Desperately trying to prove their device’s safety, in 2004 the pharmaceutical company hired Dr. John Lehmann, a medical a consultant. The independent physician reviewed all the evidence and found that the device was exceptionally dangerous when compared to similar products. Instead of recalling their product from the market, the New Jersey-based company decided to ignore the doctor’s warning and bury the report. An investigation by NBC News later found that the documents submitted by Bard to the Food and Drug Administration (FDA) to obtain market approval for the IVC filters, did not mention the risks associated with the devices. In a blatant attempt to deceive the regulatory agency with a “flatly untrue” report, the company forged Lehmann’s signature cheating thousands of patients.
Plaintiffs across the country are now seeking the help of a competent lawyer to file a litigation and bring Bard to justice. The company must be held liable for all the damage and harm caused by their poorly designed device since they kept hiding the truth regardless of the consequences on patients’ health. Finding the best lawyer to present your case in court is the only way to seek just compensation and ask a tribunal to grant you a monetary damage award to could help pay your past, present, and future medical expenses. If you or your beloved one suffered from any injury after being implanted with an Inferior Vena Cava filter, you should file a lawsuit as soon as possible. Our attorneys are always available to assist you with free legal advice.
IVC filters side effects
- Breakage and migration
- Device fragmentation
- Internal bleeding
- Blood clots
- Organ puncturing and perforation
- Cardiac arrhythmias
- Excruciating pain
- Unsuccessful retrieval
- Additional surgery
Are IVC filters safe and effective devices?
In 2013, a study published in the Journal of the American Medical Association (JAMA) questioned the safety and effectiveness of the already controversial IVC filters. Researchers examined a total of 952 subjects who were implanted with the vascular filters and found that 74 of them (7.8 percent) still suffered from pulmonary emboli and other thrombotic events. The study also found that almost one retrieval attempt out of five was unsuccessful, forcing surgeons to reoperate the patient to remove the implant. Although IVC filters are indicated only in patients who can’t tolerate treatment with anticoagulants, one-quarter of the subjects still received blood thinners after they were discharged from the hospital. Researchers concluded that since the use of the device was associated with an unsettlingly high rate of thromboembolic accidents, its effectiveness was “suboptimal.” To date, only one trial allegedly demonstrated that these medical devices could reduce the risk of pulmonary embolism, but all the patients controlled during this study were on anticoagulant drugs too.
In less than five years, the FDA received 921 adverse reaction reports filed by patients who suffered the consequences of device migration (328 cases), perforation of the inferior vena cava (70 cases), embolizations after detachment of device components (146 cases), and filter fracture (56 cases). In 2010 the agency released a safety alert announcement about the risk associated with the use of IVC Filters and determined that they should be used only for short-term placement or until the risk of PE subsided. After finding that many retrievable blood clot filters were kept inside patients’ bodies for years, in 2014 the FDA updated the recommendation explaining that the devices should be removed between the 29th and 54th day after implantation. In July 2015, the FDA issued a warning letter to Bard to recall a device used to remove the Recovery IVC filter which was marketed illegally as well as for several quality system regulation violations for the Simon Nitinol, Eclipse, and Denali Filters.
Cook IVC Filter Multidistrict Litigation (MDL)
To avoid conflict rulings from different courts and expedite discovery by reducing cumulative or duplicative activities, it’s common during product liability litigations to centralize a large number of disputes as part of a Multidistrict Litigation (MDL). In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) transferred more than 100 IVC Filter lawsuits against Cook Medical from 11 districts to the Southern District of Indiana under the supervision of Honourable Judge Richard L. Young. The pharmaceutical company, however, opposed the centralization, arguing that the circumstances surrounding the litigation against the Celect and Gunther Tulip Vena Cava Filter models may be different. The JPML rejected these arguments, and many attorneys are now reviewing and filing new claims every day.
Bard IVC filter Multidistrict Litigation (MDL)
Many plaintiffs claim that the G2 and Recovery filters injured them and are seeking monetary compensation by filing a suit. The first disputes against Bard were submitted to the Pennsylvania and California state courts back in 2012. On August 17, 2015, more than 50 IVC filter lawsuits have been consolidated in the Multidistrict Litigation No. 2641 in the U.S. District Court of Arizona presided by the U.S. federal Judge David G. Campbell. Many more litigations are still pending in state and federal courts.
Kevin Philips vs. Bard
In 2005 plaintiff Kevin Phillips from Nevada was implanted with a Bard Recovery filter. Five years later, one the filter’s legs broke as soon as it trapped a thrombus as it was designed to do. The metal fragment moved dangerously close to the man’s heart, requiring an emergency open-heart surgery and a lengthy recovery. In 2012 Phillips filed a litigation in the US District Court of Nevada, which reached trial in 2015. Just ten days into court proceedings, the pharmaceutical company settled the case for an undisclosed sum of money.
IVC filter Class-action lawsuits
To date, three IVC filter class-action lawsuits have been filed against Bard in California, Pennsylvania, and Florida courts. The company is accused of negligence, concealment, and misrepresentation of data concerning the safety of the G2 and G2 Express filters. Plaintiffs ask for compensation for the medical expenses they have to face continuously. Constant medical monitoring is, in fact, required even in those instances where the device did not fracture or migrate. The three class-action suits were filed in 2012 by plaintiffs Janet Roberts, Eula Huff, Sandra Lorenz, and Samantha Bouldry in Palm Beach County; by Shantel Brown and Goldie Brown in the Court of Common Pleas for Philadelphia; and by David DeLeon and Richard Gonzalez in Los Angeles. All the claims are still pending since no court has yet approved the formation of a class.