IVC Filter Lawsuits
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 product liability lawyer and medical device plaintiffs attorney reviewing IVC filter injury lawsuits and actively involved in product liability litigation nationwide.
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 product 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, contact the Lyon Firm.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
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The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
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:
• Pulmonary Embolism
• Hemorrhaging or Internal Bleeding
IVC Filters have been associated with a number of serious injuries, including, but not limited to:
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
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 Meridian
• Bard Denali
• Cook Gunther Tulip
• Cook Celect
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 possible IVC filter lawsuits.
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.
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:
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
Ohio Definition of Defective
Under Ohio law, a medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions a version of one or more of these cause of actions.
(1) Manufacturing/ Construction Defect of the medical device:
(2) Defective design and/or formulation of the medical device:
(3) Failure to warn or inadequate warning or instruction associated with the medical device:
(4) Misrepresentation on the Safety or Efficacy of the Medical Device:
(5) Fraud Related to the Safety or Efficacy of the Medical Device
(6) Negligent Distribution or Testing of the Medical Device
Defective design medical device cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk-benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh )
For these claims, the FDA Review process is critical on whether a pre-emption defense exists. For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward. Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective.
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a medical device: (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation. These factors are considered in most other jurisdictions.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with a medical device: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c) These factors are considered in most other jurisdictions.
Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).
A manufacturing defect claim arises where the medical device is released from the factory in a manner that deviates from the intended design or specifications.
Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures–these defects require an examination by a qualified metallurgist who can examine the medical device).
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care. Ohio Revised Code 2307.74.
All medical device products come with warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective.
The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted. Patient informed consent is critical because many devices are designed to be permanent.
Litigation arises where there is evidence the medical device manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
In determining whether a medical device is defective due to inadequate warning or instruction, evidence must be presented to prove:
Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).
Design and manufacturing defects result in medical device product recalls each year in the United States, initiated by federal safety agencies.
The foregoing listed government agencies may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product. Only litigation can utilized to compensate patients injured by a defective medical device.
Our Firm will help you find the answers. The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Results: Mr. Lyon has obtained numerous seven and six figure results in medical device cases. He has litigated cases successfully against some of the largest companies in the world including: Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer.
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.