ATRIUM MESH


Ohio product liability attorney investigating defective hernia mesh for injured plaintiffs nationwide
Nationwide Success

Atrium Hernia Mesh Lawsuits

investigating mesh device complications & injuries

A large number of patients throughout the United States have reported severe and debilitating problems following hernia implantation with Atrium C-Qur mesh or Proloop Mesh products. Common complications include chronic pain, infection, device rejection and hernia recurrence.

But rather than issuing a recall for the ProLoop or C-Qur devices, Atrium instead elected to quietly remove certain devices from the market and failed to warn consumers of their serious risk.

Atrium Medical embarked on what lawyers are calling a “stealth” recall of their C-Qur mesh products due to allegations that the device increased the risk of hernia mesh complications and Atrium mesh injuries.

Atrium knew or should have known about the potential risks of their products. However, information was withheld from patients and the medical community. Many surgeons and hospitals have recently stopped implanting the C-Qur hernia mesh due to high rates of infections, bowel obstructions, and allergic reactions.

Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio mesh recall attorney representing plaintiffs nationwide in a wide variety of defective medical device and Atrium mesh injuries linked to ProLoop or C-QUR defects.

Atrium Mesh Injuries

The Atrium C-Qur mesh failure rates are unreasonably high, potentially resulting in the need for revision surgery and leaving patients with permanent and debilitating health problems.

The C-Qur mesh is made from polypropylene, the polymer plastic that is known to shrink, cause a foreign body reaction, become infected and erode. These mesh injuries are often life-changing, due to the pain and loss of function related to the faulty products,

If the hernia mesh adheres to the bowel, it could lead to a twisted and perforated bowel, causing gastric ulcers or other intestinal problems, including infections like sepsis and gangrene. Some reports also suggest that patients may suffer from the following:

•    Infection
•    Device rejection
•    Organ Perforation
•    Adverse foreign Body Response—inflammation and allergic reactions
•    Seroma
•    Revision Surgeries
•    Bowel Obstruction
•    Adhesion

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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.

NO COST UNLESS WE WIN

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.

Atrium C-Qur Hernia Mesh

Despite signs of potential problems with the Atrium C-Qur mesh, the manufacturer continued to release products for use in hernia repair. All of the listed products are constructed out of an Atrium polypropylene mesh, with an outer coating of gel made from omega 3 fatty acids, called the O3FA layer. Surgeons utilize several types of C-Qur mesh for various abdominal procedures, including the following:

•    C-Qur
•    C-Qur Edge (officially recalled)
•    C-Qur V-Patch
•    C-Qur Tacshield
•    C-Qur FX
•    C-Qur CentriFX
•    C-Qur Mosaic
•    C-Qur Film

C-Qur Edge Recall

On October 11, 2012, the FDA issued a warning letter to Atrium Medical, noting that the company was failing to address serious complaints related to infections associated with their C-Qur hernia mesh product. The letter also revealed that Atrium Medical appeared to be ignoring sterility complaints.

In August, 2013, the FDA announced a recall of the C-Qur Edge mesh because the Omega 3 fatty acid coating on the mesh could adhere to the inner packaging liner due to exposure to high humidity. The recall affected over 1,500 C-Qur hernia mesh units.

Atrium warned physicians to inspect the C-Qur mesh device, but did not pull any of the C-Qur products off the shelf. Attorneys believe that the coating of the C-Qur mesh has peeled off in patients once implanted, and has resulted in significant injuries.

Atrium Mesh Lawsuits 

Many lawsuits have been filed against Atrium after patients allegedly suffer from a variety of ProLoop and C-Qur mesh injuries. One particular plaintiff underwent surgery for a hernia in which Atrium C-Qur mesh was used, and roughly two years post-operation, the patient noticed an onset of severe stomach pain.

The hernia also recurred, and the patient underwent surgery again to remove the Atrium C-Qur mesh. Surgeons found the C-Qur mesh crumpled in her abdomen, where it had caused scar tissue, making it impossible to replace the C-Qur with new mesh. The patient’s attorneys argue that the C-Qur fish oil coating resulted in her body rejecting the hernia mesh.

Other patients who are implanted with similar Atrium devices have alleged similar foreign body reactions. Physicians have reported to the FDA experiences of the coating peeling off during implantation or within a week after implantation.

Atrium’s C-Qur hernia mesh is among many devices on the market that have not been proven safe through extensive testing for Pre-Market Approval. As a result, an increasing number of claims against Atrium Medical have been filed in the courts.

The lawsuits contend that Atrium knew or should have known about both the risks of rejection, and other associated complications. Medical device companies like Gore, Covidien, Aspide, Atrium, Ethicon and Bard have agreed to pay million to settle lawsuits. The companies currently face thousands of pending lawsuits.

If you have had surgery to treat a hernia using a device and you experience any signs or symptoms of recurrence of the hernia, please consult with a medical and legal expert. The Lyon Firm has experience litigating cases against medical device manufacturers.

photo of attorney Joe Lyon reviewing atrium mesh lawsuits
A Voice for Those who have suffered 

Why are these cases important?

Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.

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Questions about Atrium Mesh 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

FAULTY MEDICAL DEVICES

Learn about Medical Device Approval Processes

Our Victories

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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