Ohio Product Liability Attorney and Medical Device Defect Lawyer Reviewing Plaintiffs IVC Filter Lawsuit
IVC (Interior Vena Cava) filters are designed to trap dangerous blood clots. However, the safety profile and efficacy is not well established. The IVC Filter is associated with a number of serious medical complications. Initially introduced into the market in April 2003, the Recovery IVC filter was redesigned following several adverse event reports of device fractures. The new design, Bard G2 IVC, was then introduced to the market place in October 2005. In 2010, the FDA reported that over a five year period it had received over 900 adverse event reports related to defective IVC complications and injuries and released an advisory report.
IVC filters are small, cage-like devices that are intended to capture blood clots and prevent them from reaching the lungs, heart or brain. The device catches the clots in the bloodstream and allows them to break down over time.
The filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when other anticoagulant therapy is ineffective. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.
Due to safety concerns, in 2012, the American College of Chest Physicians recommended that IVC filters should only be used in high risk patients who have contraindications for anticoagulants. However, many patients who were at a lower risk and did not have a contraindication for anticoagulants have been implanted with the device.
Joe Lyon is an experienced Cincinnati product liability lawyer and Ohio medical device plaintiffs attorney reviewing IVC filter injury lawsuits and actively involved in product liability litigation nationwide.
Defective IVC Filter Recalls
The Lyon Firm is dedicated to improving patient safety and engaging large medical device firms in product defect cases and liability IVC Filter lawsuits. Consumer safety advocates and medical experts work together to protect patients and recover rightful compensation for injured plaintiffs nationwide.
Joseph Lyon is a Cincinnati recall lawyer and actively involved in medical device litigation nationwide. For a no-cost and confidential consultation on the legal aspects of the IVC filter lawsuit, call (800) 513-2403.
IVC Filter Complications
The IVC (Interior Vena Cava) filter is intended to prevent blood clots from developing or migrating, however over the last ten years the devices have been associated with a number of serious medical complications. The history of the devices is short though fraught with problems.
In April 2003, C.R. Bard introduced the Recovery IVC filter and was quickly redesigned following several reports of device fractures. The device failures can cause severe medical issues, and may even lead to death.
In 2010, the U.S. Food and Drug Administration published a safety alert that recommended physicians “consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
Due to safety concerns, in 2012, the American College of Chest Physicians recommended that IVC filters should only be used in high risk patients who have contraindications for anticoagulants. Despite these warnings, many lower-risk patients have been implanted with the device.
Unfortunately, IVC Filters have been linked to a number of serious complications. There is a risk of the filters breaking, which may cause metal fragments to move through the blood, potentially causing serious medical issues, including:
IVC Filter Injuries
IVC Filters have been associated with a number of serious injuries, including, but not limited to:
- Vessel Perforation
- Organ Perforation
- Filter Embolization
- Vena Cava Thrombosis
- Explant Surgery
- Hemorrhagic Pericardial Effusion
- Arterial Hemorrhage
- Cardiac Tamponade
- Pericardial Pamponade
- Punctured Vena Cava
- Wrongful Death
Defective IVC Filter Injury Lawsuits
The decision to remove an implanted medical device is a serious medical decision and the risks and benefits of such a procedure must be discussed with the treating physician. Lawyers are not qualified to render advice on the appropriate candidacy for surgery, and it is important to know that the Society of Interventional Radiology (SIR) guidelines for removing an IVC Filter:
• No further medical reason for a permanent IVC Filter
• Patient is at a low risk for pulmonary embolus
• No expectation of the patient being at a high risk in the near future
• Life expectancy of more than six months
• Ability to retrieve the IVC Filter
Defective Bard IVC Filters
C.R. Bard and Cook are the two manufacturers that control the vast majority of the IVC filter market. The products most often associated with the IVC filter failures include:
• Bard Recovery
• Bard G2
• Bard Eclipse
• Bard G2 Express
• Bard Merdian
• Bard Denali
• Cook Gunther Tulip
• Cook Celect
Medical Device Failure & Lawsuits
Plaintiff attorneys have argued in court that the manufacturer C.R. Bard intentionally hid results of its own research which discovered the filters were potentially dangerous. Some cases even allege the company forged an employee’s signature on an FDA application in order to get faster approval.
Records claim that C.R. Bard was concerned about reports of failures for its G2 series filters within four months after the FDA approved the sale of the G2. Instead of recalling the G2 filter, Bard decided to keep them on the market for the next five years, selling more than 160,000 units.
At least 12 deaths are linked to the G2 series filters, according to Bard and FDA records, leading to a possible IVC filter lawsuit.
Medical Device Defect Settlements
There are more personal injury and IVC Filter lawsuit filings every month in the U.S. The overall increase in IVC failure cases may be due to the increased sale of these devices. One estimate reports that the IVC filter market may be over $70 million in 2016.
Defective IVC Filter Lawsuit
The decision to remove an implanted medical device is a serious decision and the risks and benefits of such a procedure must be discussed with the treating physician. Lawyers are not qualified to render advice on the appropriate candidacy for surgery, and if you are considering this as an option it should be discussed directly with your treating physician. By way of patient education, it is important to know that the Society of Interventional Radiology published guidelines on removing and IVC Filter provide the following indications for removing an IVC Filter:
- No medical reason for a permanent IVC Filter
- Patient is at a low risk for pulmonary embolus
- No expectation of the patient being at a high risk in the near future
- Life expectancy of more than six months
- Ability to retrieve the IVC Filter
- Patient/ Guardian Consents to the procedure understanding the risks.
If a loved one has suffered an injury due to a defective IVC Filter, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, a medical device defect lawyer, and he will help you answer critical questions regarding a potential IVC filter lawsuit.