IVC FILTER LAWSUITS


Ohio Medical Device Lawyer investigates defective IVC Filters and hospital negligence cases for injured plaintiffs nationwide
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Cincinnati IVC Filter Attorney

investigating ivc filter defects & patient injury cases

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 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, 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:

•    Pulmonary Embolism
•    Stroke
•    Hemorrhaging or Internal Bleeding
•    Death


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 possible IVC filter lawsuits.


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:

  1. No medical reason for a permanent Filter
  2. Patient is at a low risk for pulmonary embolus
  3. No expectation of the patient being at a high risk in the near future
  4. Life expectancy of more than six months
  5. Ability to retrieve the filter
  6. Patient/ Guardian Consents to the procedure understanding the risks.
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Questions about Defective Medical Device Litigation

What is a Defective Medical Device Lawsuit?

When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.

How is a Product Defined as Defective?
Ohio Definition of Defective

A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).

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.

(2) Defective design and/or formulation:

Defective design product liability 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.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.

Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the 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.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.

How do you prove design defects?

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (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.

BenefitsThe following factors are considered under Ohio law when determining the benefits associated with product design: (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)

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).

EXAMPLES:

What is a manufacturing defect?
  • A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.

    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.

    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.


    Manufacturing Defect Examples:

What is a failure to warn lawsuit?

In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:

  • The manufacturer knew, or in the exercise of reasonable care, should have known about a risk
  • A reasonable manufacturer would have provided a warning of the risk
  • The manufacturer failed to provide the warning
  • The person was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.

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”).

Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.


 

What are consumer product safety regulations?

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

  • The Food and Drug Administration (FDA)
  • The National Highway Traffic Safety Administration (NHTSA;)
  • The Consumer Product Safety Commission (CPSC)

The listed government agencies, however, 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.

Why should I hire The Lyon Firm?

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 personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world

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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. 

IN RE: DEPUY ASR

METAL ON METAL HIP IMPLANTS

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.

IN RE: BIOMET MSA MAGNUM

METAL ON METAL HIP IMPLANTS

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.

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