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CASE UPDATE: Multidistrict Litigation's Continue to Move Forward February 2019 - The Cook IVC MDL began another trial on January 14, 2019, which is expected to last several weeks. We will update on the results of this trial in the next newsletter. The Bard IVC MDL continues forward in preparation for the next trial. Plaintiffs' counsel is hopeful that we will be able to build on our success from 2018.
IVC filters are small, cage-like devices that are inserted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. 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. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.
Since the introduction of IVC filter in 2005, the FDA has received thousands of adverse reports involving these filters. Specifically, it was reported that the IVC filters fragment and embolize in the body.
The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes such as:
Unless there is a very good reason to keep the IVC filter in place, the FDA now recommends the removal of retrievable IVC filters.
According to a safety communication posted by the FDA in August of 2010, IVC filters are intended for short-term placement and have caused risks when left in long-term including lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization, and IVC perforation. The FDA’s original safety alert was then followed up by a decision analysis published in the Journal of Vascular Surgery: Vein and Lymphatic Disorders in October 2013.
Research studies confirm the problems with the retrievable IVC filters. A 2013 research study published in the Journal of American Medical Association (JAMA) looked at the filter’s failure. It reviewed medical records of a level 1 trauma center for the indications, complications, and management of the IVC filters.
Despite FDA warnings, physicians were not removing the filters. Researchers discovered only 58 out of 679 (less than 10%) retrievable IVC filters inserted were actually removed. Other results discovered a majority of the filters remained in patients longer than medically necessary with the following results:
As of 2012, it is estimated that 259,000 filters were deployed and the market value of vena cava filters continues to increase despite FDA warnings. Today, the IVC filter market is worth $190 million and is growing.
A 2016 study published in the American College of Cardiology cited evidence that found that IVC filters were being over-used by doctors. The study concluded that doctors were using IVC filters for a variety of medical purposes, despite the lack of information regarding appropriate use and surveillance of the filters. The study also found retrievable rates to be lower than expected.
The FDA first released a public safety communication in 2010, warning of possible adverse health events associated with long-term IVC filter use.
In 2014, the FDA released a second public safety communication, warning of further adverse health events associated with long-term IVC filter use, as well as problems with specific products. The safety communication explained that the FDA had concerns that retrievable IVC filters, purposed for temporary use, are not always removed within the appropriate time span. “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 recommends that retrievable IVC filters be removed between the 29th and 54th days after implementation for patients who risk pulmonary embolism.
In 2013, the FDA announced a recall of all Cordis retrievable IVC filter manufactured citing an issue with the device’s labeling and implant instructions. Around 33,000 devices were recalled, all of which were distributed between May 6, 2010, and April 2, 2013.
In 2015, C.R. Bard came under fire after an FDA investigation found that the manufacturer was producing a certain IVC filter device removal system without marketing clearance or approval. As a result, the FDA sent a warning letter to C.R. Bard notifying the company that they were in violation and subject to penalization.
TorHoerman Law is currently pursuing IVC filter lawsuit cases for the following injuries:
TorHoerman Law is currently pursuing IVC filter lawsuit cases for patients who used retrievable filters manufactured by the following companies:
If you believe that you have suffered one or more of the injuries mentioned above because of an IVC Filter manufactured by one the companies mentioned above, and you want to participate in the IVC filter lawsuit, contact the offices of TorHoerman Law today.
It is up to the manufacturer to satisfy safety concerns using a combination of testing and trials. However, many lawsuits have been filed claiming that the manufacturers of these filters have not satisfied safety concerns and, instead, continue to move forward with sales of these filters.
Thousands of lawsuits have already been filed and continue to move forward against C.R. Bard, Cook, Cordis and Argon IVC filter manufacturing companies.
TorHoerman Law is currently accepting IVC filter lawsuit cases on behalf of individuals who suffered injuries due to IVC filters manufactured by C.R. Bard, Cook, Cordis, or Argon.
A panel on multidistrict litigation decided that it would be appropriate to consolidate IVC filter lawsuit cases. Currently, IVC filter lawsuit multi-district litigations (MDLs) are being consolidated in courts in Indiana (Cook) and Arizona (C.R. Bard).
A number of individuals who received C.R. Bard IVC filters have filed three separate class-action lawsuits against the manufacturer in California, Pennsylvania, and Florida courts, claiming that because their devices have migrated (but not fractured) they should be compensated for medical monitoring. These lawsuits cite Bard’s negligence, misrepresentation, and data concealment.
Plaintiffs named in the MDLs, as well as other individual IVC filter lawsuit cases, alleging that defects in the design of some retrievable IVC filters increase the likelihood of certain adverse health events.
There are more than 6,000 IVC filter lawsuits pending in federal court. These pending lawsuits claim that the adverse health events associated with retrievable IVC filters are the result of the manufacturer’s negligence, defective design in the product, manufacturing defects, failure of the manufacturer to adequately warn consumers of risks, breach of implied warranty, and misrepresentation of the product by manufacturers and their subsidiaries.
If you believe that you may have suffered injuries as a result of an IVC filter, contact the offices of TorHoerman Law today for a free no-obligation IVC filter lawsuit case consultation. Our experienced team can help to determine whether you have a viable claim.
February 6, 2019 - In the third bellwether trial over Cook Medical's IVC filters, an Indianapolis federal jury awarded $3 million in damages to a Georgia woman who faces serious medical complications and possibly death as a result of a blood clot filter device. For the first time in the history of this multi-district litigation (MDL), the jury reached a finding that the IVC filters are, in fact, defective. "Jurors in this trial considered all of the evidence presented. They've sent a message that there's a problem with IVC filters and they've put manufacturers on notice that they will be held accountable," said Majed Nachawati, attorney for the Fears Nachawati law firm, a member of the prosecution. Tonya Brand, the plaintiff in the Indianapolis bellwether trial, alleged that her Cook IVC filter broke apart post-insertion. Brand received her Celect IVC filter – manufactured by Cook Medical – in 2009 with no complications. In 2011, she noticed a painful area on the inside of her right that, which developed into a protrusion. Once the protrusion popped, a one-and-a-half-inch metal wire appeared – later determined to be a strut from the IVC filter. Brand underwent multiple unsuccessful attempts to remove the fractured filter. Deteriorated pieces of the filter still remain internally lodged in Brand’s body, but it would be too dangerous to perform surgeries to remove these pieces. These remaining unremoved pieces put Brand at risk of a number of serious medical issues, including death. Prosecutors claimed that Cook was aware of their filters defective tendencies, but failed to warn physicians and patients. The defense argued that Cook Medical had no duty to warn plaintiffs of any medical risk because the device was supplied to consumers with adequate warning and instructions. Cook Medical representatives went on to argue that the device complied with all applicable FDA codes, going on to say that any injuries to Brand were the result of her own actions or the fault of other products, persons, or entities. This was the final of three bellwether trials held in the Southern Indiana District Court against Cook Medical IVC filter devices.
June 5, 2018 - The next Bard trial resulted in a verdict for the manufacturer.
May 25, 2018 - A Texas jury awarded $1.2 million to a firefighter who said a Cook Celect IVC Filter caused debilitating injuries. The jury found a failure to warn, but no design defect or gross negligence.
April 13, 2018 - A day after a jury awarded Mary McGinnis and her husband $33 million in compensatory damages, the same jury found that an additional $35 million in punitive damages was warranted because Bard "acted maliciously or in wanton and willful disregard of the rights" of the plaintiff.
March 30, 2018 - An Arizona jury unanimously ruled in favor of a plaintiff who claimed that she suffered injuries after receiving an IVC filter device which later fractured in her body. The plaintiff, Sherri Booker, was awarded $4 million in total damages, $3.6 million of which are to be paid by IVC filter manufacturer, C.R. Bard Inc. In her lawsuit, Booker alleged that the Bard G2 IVC filter she received fractured inside her inferior vena cava post-op, subsequently causing her to suffer a number of adverse health events, including undergoing open-heart surgery. During the initial stage of the trial, the jury found manufacturer C.R. Bard Inc. guilty of negligent failure to warn but said that the company was not liable for claims of strict product liability design defect, or negligent design. The jury awarded Booker $2 million in compensatory damages for her suffering. Following the compensatory phase of the trial, the jury awarded Booker an additional $2 million in punitive damages, designating Bard to cover 80% of the total costs of both compensatory and punitive damages. The court ordered the additional $400,000 to be covered by a radiologist who, in 2009 during an X-ray procedure, failed to flag a visibility separated component of Booker’s IVC filter. The court found that the radiologist’s failure to flag the separated component greatly contributed to the events that led Booker to undergo open-heart surgery to retrieve the component, along with other fragmented pieces, in 2014. Booker’s case is the first of more than 3,600 cases involved in the multi-district litigation (MDL) consolidated in the Arizona courts filed against Bard. A second bellwether trial is set to begin in the next few weeks. Unlike Booker's case, which challenged Bard's second-generation IVC filter, the next trial will challenge Bard's third-generation device. IVC filter lawsuits are still being accepted for a variety of injuries, against a number of distinct manufacturers.
August 11, 2017 - According to a new study published in the Journal of Thrombosis and Thrombolysis, inferior vena cava (IVC) filters may be overused by medical providers. The study also found that, based on managed care board guidelines, the retrievable IVC filter is not always removed after it is no longer needed, imposing greater risks to patients. The study analyzed data from Humana's managed care population from 2013 to 2014. Researchers collected data by pooling two separate groups and analyzing the health outcomes of both: patients who received IVC filters and patients who were eligible to receive IVC filters but did not. Of these groups, there were four subcategories: recipients of prophylactic IVC filters, recipients of therapeutic IVC filters, and two control groups. The study included 435 recipients of prophylactic filters and 4,376 recipients of therapeutic filters. The control group sizes were equivalent to each recipient group. The study found that patients in the control group were hospitalized much less frequently than recipients of both the prophylactic and therapeutic IVC filters. Scientific evidence from similar studies has almost unanimously pointed to the inefficiency and increased health risks related to IVC filter implementation and subsequent retrieval. Along with an increased risk of hospitalization, the study also found that anticoagulant treatment was more prevalent in IVC recipients than in non-recipients. IVC filters are not recommended for patients that can use anticoagulants. The findings suggest that IVC filter recipients are often eligible to receive anticoagulant treatment, eliminating the need for the alternative IVC treatment. There is no scientific evidence that supports the use of both anticoagulation and IVC filter treatment. A 2016 study published in the Journal of Vascular Surgery concluded that "In hospitalized patients with acute pulmonary embolism use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone does not reduce the risk of symptomatic recurrent pulmonary embolism (PE)." Some IVC filters are designed to be permanently placed into the vena cava. But most are meant to be temporary, removed after they are no longer needed. The longer that a temporary device remains in place, the greater the risk to the patient. Of the study participants who received therapeutic filters, only 6% of filters were removed. Of the participants who received prophylactic filters, only 16% of filters were removed. The remaining participants were put at a higher risk for DVT, filter migration, fracturing, embolization, and perforation.
"Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism." Journal of Vascular Surgery Venous and Lymphatic Disorders, www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM396384.pdf
Deso, Steven E., et al. Seminars in Interventional Radiology, Thieme Medical Publishers, June 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC4862854/
“Appropriate Use of Inferior Vena Cava Filters.” American College of Cardiology, www.acc.org/latest-in-cardiology/articles/2016/10/31/09/28/appropriate-use-of-inferior-vena-cava-filters
“Warning Letters - C.R. Bard, Inc. 7/13/15.” U S Food and Drug Administration Home Page, www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm455224.htm
“Class 1 Device Recall OptEase Vena Cava Filter.” Accessdata.fda.gov, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119066
Last Modified: August 13th, 2019 @ 12:09 pm
Retrievable IVC filter devices have been linked to a number of adverse health risks that the manufacturers failed to test for and warn consumers about. As a result, an IVC filter lawsuit has been filed on behalf of individuals who have suffered an injury as a result of their IVC filter. If you have suffered an injury due to your device and want to participate in the IVC filter lawsuit, contact TorHoerman Law today.
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