Ethicon, a subsidiary of Johnson and Johnson, is currently the target in numerous lawsuits nationwide because thousands of patients have been allegedly injured by hernia reparation devices, including the Proceed Ventral Patch.
Ethicon states on its Web site that the Proceed Patch model enables patients “to heal strongly, naturally, and comfortably.” But that claim has been discounted by thousands of hernia patients who have undergone surgery and had an Ethicon mesh device implanted. Infection, bowel obstruction, and other complications have been reported after the Ethicon patch disintegrated inside the bodies of patients.
Attorneys claim Ethicon knew that the polypropylene used to make the Proceed hernia mesh was not fit for human implantation. In fact, Ethicon added a coating to the Proceed in an attempt to mitigate injuries caused by the polypropylene. However, over time the coating disintegrates and only bare polypropylene remains.
The company claims a hernia recurrence rate of less than 10 percent, though patient reports suggest a much higher rate. The Proceed device has been recalled in the past after post-surgery complications, though the Ventral Patch continues to be implanted and cause serious health issues to patients.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio recall attorney representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
Thousands of Proceed hernia mesh units have been recalled in the last decade. All recalls initiated by the U.S. Food and Drug Administration (FDA) were due to the device coating delaminating, or peeling off of the polypropylene base material.
The FDA noted, “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.”
In their recall statements, Ethicon admitted that there was a higher risk of adhesions and fistulas when the Proceed delaminates. They said the defective devices “could increase the risk of adhesions and bowel fistulization.”
These are serious complications that may lead to permanent injury or even death. However, the Proceed hernia mesh is still on the market and continues to be implanted in patients nationwide.
The first Proceed Patch recall was initiated in 2006, and over 18,000 units were affected, many of them already implanted in hernia patients. Further FDA recalls were announced in 2010, and another in 2014. Incredibly, the patch remains on the market and is sold as a safe mesh product.
Mesh and patch devices are commonly used to strengthen weakened or damaged tissue in hernia repair procedures. Hernias are a relatively common problem that may require surgery to alleviate persistent pain, discomfort and other symptoms.
However, patients who selected Ethicon’s Proceed Ventral Patch may risk potential infections, hernia recurrence and secondary surgeries. Patients and doctors have reported severe complications including the following:
The Ethicon Proceed Ventral Patch is facing scrutiny over its effectiveness and poor safety record, though it is only one of Ethicon’s hernia products that have been potentially unsafe. The other models of hernia devices include the following:
Attorneys claim Ethicon’s hernia-related products, first approved in April, 2010, were not properly tested before they were marketed and distributed as a safe hernia solution. The Proceed Ventral Patch was approved by FDA 510(k) clearance, meaning it did not require FDA review or clinical trials to properly deem it safe or unsafe.
A number of settlements have been reached over Ethicon mesh litigation. If you have had surgery to treat a hernia using a mesh and you experience any signs or symptoms of recurrence or complications, talk to medical and legal experts. The Lyon Firm has experience litigating cases against Ethicon and other mesh device manufacturers including Gore, Aspide, Covidien, Atrium and C.R. Bard.
Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.
Product liability lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.
In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.
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.
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.
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.
Benefits: The 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).
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:
In determining whether a product 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”).
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.
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 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.
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 Product Liability 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. Product Liability 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
Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer
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.
(Pikeville, Kentucky): Confidential settlement for Plaintiff who suffered spinal cord injury resulting in paraplegia due to defectively designed seat belt. Four passengers with three-point (lap/shoulder) belts walked away from the accident, and the only passenger wearing a two-point belt (lap only) suffered a debilitating spinal cord injury. The settlement assisted with home improvements to assist in daily living. GM entered federal bankruptcy during the process and no longer manufactures two-point lap belts for vehicles.
(Hillsboro, Ohio): Confidential Settlement for the family of elderly man who was catastrophically burned while operating a propane wall heater. The burns resulted in his unfortunate death. The heater, manufactured and sourced from China, was alleged to allow the flame to reach outside the grid area in violation of ANSI standards. The Defendant resolved the case following discovery and mediation. The recovered funds were paid to the victim’s surviving spouse and children. The company no longer manufactures this type of heater.