VACCINE DEFECTS


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Vaccines are undoubtedly an important part of modern medicine. They have saved the lives of millions across the globe, protecting people from terrible diseases and illnesses like measles, typhoid, influenza, hepatitis, shingles, pertussis and others.

According to the Centers for Disease Control and Prevention (CDC), vaccines have reduced preventable infectious diseases to an all-time low.

With that said, some newer vaccines, produced by for-profit laboratories and drug companies, have caused serious injuries. If vaccines are mass produced without being properly tested or controlled, a company may release defective vaccines, which can result in various adverse health consequences.

The U.S. Food and Drug Administration (FDA) regulates vaccine products available on the market. If a series of complaints of injuries or safety concerns are verified by the agency, a vaccine may be recalled.

If you have been vaccinated with a defective or recalled vaccine, and have suffered a related injury, seek medical assistance, and contact an experienced attorney to help recover the costs of medical expenses, lost wages and pain and suffering.

Joe Lyon is a highly-rated Cincinnati, Ohio personal injury lawyer representing plaintiffs nationwide in a wide variety of product liability claims against pharmaceutical companies


Defective Vaccine Injury


Due to the most common method of vaccination, tissue and nerve damage injuries in the shoulder are the most common adverse effect reported. Needles can do damage if a vaccine is improperly administered too high on the upper arm.

A needle may pierce the deltoid muscle and continue into the shoulder joint. The tissue damage from the needle can be exacerbated by an immune reaction to the injected vaccine, and can lead to inflammation that damages tendons, ligaments, and bursas. Other defective vaccine injury may include:

  • Guillain-Barré Syndrome (GBS)—a neurological malady associated with some influenza vaccines
  • Anaphylaxis—a life-threatening allergic reaction from almost any vaccine
  • Intussusception—an intestinal blockage
  • Brachial neuritis (Personage Turner Syndrome)—an inflammation of the nerves supplying the hand and arm, which afflicts some tetanus vaccine recipients
  • Febrile seizures

Zostavax Vaccine Lawsuits


Over the last decade, several product liability and personal injury lawsuits have been filed against Merck, alleging the company produced and sold “unreasonably dangerous” vaccines, which directly caused serious injuries after vaccination.

One class action defective vaccine injury lawsuit claimed Merck knew their shingles vaccine Zostavax could cause shingles, but failed to list this as a side effect until almost 8 years after the vaccine was approved by the FDA in 2006.

Instead of preventing shingles, Zostavax caused several patients to contract a persistent strain of herpes zoster, resulting in painful outbreaks. The FDA and injured patients reported that Zostavax side effects could include:

  • Shingles
  • Chickenpox
  • Rash
  • Hives
  • Headache
  • Fever
  • Nausea
  • Joint pain
  • Muscle pain
  • Eye disorders—possible blindness
  • Hearing loss
  • Liver failure

Merck Vaccine Recalls


Merck has been involved in other defective vaccine-related recalls and lawsuits as well. In 2007, Merck recalled 1.2 million doses of Haemophilus influenzae type b (Hib) vaccines due to concerns about potential contamination with bacteria called B. cereus.

In 2013, Merck implemented a recall for the HPV vaccine Gardasil, due to the potential for a number of vials to contain glass particles as a result of breakage during the manufacturing process.


Rotavirus Vaccine Injury


Rotavirus is a foodborne infection and the most common cause of diarrhea in infants and children worldwide, according to the U.S. Centers for Disease Control and Prevention (CDC).

Before the development of a relatively recent vaccine, most children in the United States had at least one rotavirus infection by age 5. Even with vaccination, however, infection is still possible and dangerous, and sometimes the risk of infection increases with vaccination.

Rotavirus is a contagious virus that can cause gastroenteritis. Symptoms include severe watery diarrhea, often with vomiting, and may result in severe dehydration. Infants and young children may need to be hospitalized in some cases.

Most rotavirus infections can be treated at home with extra fluids to prevent dehydration but severe dehydration requires intravenous fluids in the hospital. Dehydration is always a serious condition and a major cause of childhood deaths in developing countries.

A rotavirus infection caused by a vaccination typically will present within two days of exposure to the virus. Initial symptoms are a fever and vomiting, followed by three to seven days of watery diarrhea. In adults, a rotavirus infection may cause only mild signs or none at all. Rotavirus may be suspected if a patient presents with the following:

  • Diarrhea for more than 24 hours
  • Frequent episodes of vomiting
  • Black or tarry stool
  • Stool containing blood or pus
  • A high fever
  • Lethargy
  • Symptoms of dehydration, including dry mouth, little or no urination
  • Inability to keep liquids down
  • Dizziness or lightheadedness

Defective Vaccine Injury Lawsuits


In recent years, several vaccine lots have been recalled because of a possible safety concern. When a vaccine recall occurs and a safety concern is noted by the FDA or the manufacturer, people who were vaccinated should talk to their doctor.

If a defective vaccine injury has occurred, it is prudent to contact an experienced attorney who can investigate the cause and assist in recovering compensation for injuries and damages that result.

The Lyon Firm is dedicated to protecting consumers in the face of dangerous and misrepresented medical products like various vaccines, including the zoster virus vaccines Zostavax and Shingrix. When drug companies fail to warn consumers of health risks associated with their products, they may be held liable for complications and injuries.

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A Voice for Those who have suffered 

Why are these cases important?

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.

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Questions about Product Liability & Case Types

What is a Product Liability Lawsuit?

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.

What are some examples of Product Liability?
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 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 casesThe cases have involved successfully litigating against some of  the largest companies in the world 

Your Right to Safety

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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

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. 

DEFECTIVE LAP BELT RESTRAINT

SPINAL CORD INJURY

(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.

DEFECTIVE PROPANE WALL HEATER

WRONGFUL DEATH 

(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.

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