Advances in medical technology in recent decades have improved and saved the lives of millions of Americans. But sometimes, due to design flaws or defects in the manufacturing process things can go wrong and cause injury or even death. When that happens, seek justice and proper compensation for you or your loved ones.
One common example of a defectively designed medical device is an IVC filter, which can fracture and cause chest complications or even death. Cochran, Kroll & Associates, P.C. offers a free consultation for anyone who thinks they may have an IVC filter case.
IVC – Inferior vena cava (IVC) filters – are very small filters that a surgeon inserts into your body’s largest vein. They are designed to prevent any blood clots from reaching your heart and lungs. If a blood clot reaches your lungs, it can cause fatal pulmonary embolisms.
Until quite recently, IVC filters were implanted permanently, but newer filters called retrievable filters, can either be left in or removed once the risk of clotting has passed. This should be done by the doctor who installed it, usually within six months of placement, but should still be removed up to two years later.
The benefit of using a retrievable IVC filter is that leaving in for less time reduces that chance for fracture and migration over the course of the patient’s life. IVC filters should only be removed once the risk of blood clots has passed, and its quality should be able to function for that time without calling complications. The IVC filters under question were specifically developed and sold to be used in this way, a temporary and removable filter to support the patient’s recovery.
When a medical product that is supposed to save your life becomes a medical concern, it is important the responsible parties rectify such issues by providing adequate medical support and financial compensation to assure the patient’s health and wellbeing. Product recalls were issued for a number of IVC filters regarding a design flaw that could lead to breakage or migration, and many of them could not be removed as originally planned.
There are three types of recalls that the FDA (Food and Drug Administration) issues, Class I, II, and III. Class I FDA recalls occur when the FDA finds that a product is dangerous or defective and could lead to severe health problems or death. Class II FDA recalls occur when the defective product poses a threat of a significant nature or risk of a health problem. Class III FDA recalls are an FDA violation in manufacturing or labeling laws but are not necessarily likely to cause medical problems.
Regarding IVC filters, the FDA has issued seven recalls in all three classes for filters from four companies. Three Class I recalls were issued for the Cordis OPTEASE filter, the Cordis OPTEASE filter introduction kit, and the Greenfield filter system. Three Class II recalls were made regarding the Bard Denali, the Greenfield, and the Cordis OPTEASE filters. There is one Class III recall of the Gunther Tulip filter.
IVC filters are inserted into around 250,000 Americans every year. This continues despite a lack of long-term trials to prove their efficacy and effectiveness. The main reason for their continued use is that many people cannot use anticoagulant drugs and the IVC filter is the best option to prevent any clots from moving through the body.
But over the last 15 years, there have been negative reports in the United States about these blood clot filters. Issues regarding fracturing and migration have been reported and can be extremely dangerous. From 2005 to 2010, the FDA received more than 900 reports. The three most common complaints received were:
While newer models of the filters are designed to be removed if the patient’s condition improves, there have also been problems in this area, with 2% of filters unable to be removed for various reasons.
These filters are still used, however, and for many patients cause no issues and function normally. For many others, the design defect of the IVC filter can lead to a number of complications, especially if left in for more than two years. These complications can include deep venous thrombosis, lumbar artery pseudoaneurysm, as well as issues arising from the device breaking, splintering, or moving. The possibility of breakage, migrations, or the inability for removal is the cause of these retrievable IVC filter recalls.
The United States Judicial Panel on Multidistrict Litigation consolidated several cases regarding IVC filters throughout the country under one to determine the FDA recall status. As of mid-2019, more than 14,000 lawsuits had been filed against two IVC filter manufacturers. Bard has had 8,423 lawsuits filed against the court for a district of Arizona while Cook Medical had 5,627 filed in federal court in Indiana, with victims receiving up to $3.6 million in compensation for IVC filter settlements.
There have been no global offers from either manufacturer, though a number of standalone claims have been settled. There have been a number of Bellwether Trials (test cases to examine potential settlements) and this process is still ongoing. Although there have been no class action lawsuits or mass torts in the U.S., there are at least two class-action suits against Cook Medical in Canada.
As professional lawyers specializing in medical malpractice, we have a lot of experience working alongside doctors, hospitals, and medical companies to ensure that patients and clients are protected and reimbursed for any medical fees or costs they are entitled to. When a medical error is made, we do all we can to make sure you are compensated properly. In addition, senior partner, Eileen Kroll specializes in medical malpractice cases, with a background as a registered nurse. Her background in medicine as well as her enterprise in law makes her an excellent attorney to handle medical malpractice cases. She has worked on claims regarding emergency medicine, general surgery, and medical negligence. She has also worked with Mass Tort cases and other cases regarding recalled products.
As a nurse-attorney, Eileen is extremely familiar with the medical system and devotes herself tirelessly to get the best results for her clients. Her understanding of the legal and medical fields gives her unique insight as to the best ways to represent her clients and negotiate the best settlement. Eileen and her team have personally handled hundreds of personal injury cases, and have defended and won class-action suits.
If you have had any of the problems associated with the recall of this IVC device, or you think your doctor has not properly handled the implanting, upkeep, or removal of you IVC device, contact Eileen Kroll and her team at Cochran, Kroll & Associates, P.C. to better understand what your options are. We stand by you to make sure you are properly compensated, and we use our unique insight into both the legal fields to get you what you are entitled to.
Cochran, Kroll & Associates, P.C. offers advice and representation in filing claims for any problems arising from IVC filters. We carefully review your legal and medical cases to see where and how you may be eligible for compensation. Your health and wellness are important to us, and as lawyers experienced with IVC recall cases, we can properly advise you on making the best moves to ensure you get the medical and financial support you deserve.
If you have had required open-heart surgery as a result of a defective filter then we can help review your case and see if there is a way you can be compensated due to the defective IVC filter. These risks may have been associated with the implanting of the device, but may not have been made known to the patient.
Another reason you may be entitled to compensation is if your doctor recommended you get a retrievable IVC filter installed with the intention that it be removed once the risk of clotting has passed, and it is now irremovable.
If you or a relative have had a retrievable IVC filter installed and it has been more than two years, you may benefit from medical support and compensation due to this recall. Additionally, if you were not properly informed of the liability and potential risk involved, you may be entitled to compensation.
If you have a medical device implanted, you should have been made aware of all the risks involved. As one of the leading law firms in Michigan specializing in the area of product liability, medical malpractice, and tort cases, contact our team as Cochran, Kroll & Associates, P.C. to better understand your risk and your options.
If you or a loved one has had an issue with an IVC filter, contact our team at Cochran, Kroll & Associates, P.C. to get a free consultation on your best course of action. Even if you have already filed a lawsuit and are still seeking legal advice, our expertise and knowledgeable team can successfully guide you through the process.
An IVC filter is a medical device intended to prevent blood clots from reaching the heart and is implanted to support the patient’s recovery. If something goes wrong with your implant, such as it fracturing, migrating, or being unable to remove, you may be eligible for compensation under the FDA’s recall of this device. Call Cochran, Kroll & Associates P.C. at 866-MICH-LAW to know your options.
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