ZOFRAN


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Cincinnati Zofran Lawyer

investigating zofran birth injury & birth defect cases

Pregnant women who take the anti-nausea drug Zofran (ondansetron) may be unknowingly exposing their babies to an increased risk for severe birth defects. Side effects linked to use include cleft palate, kidney failure and congenital heart defects.

Zofran is a potent anti-nausea drug designed to treat the most severe forms of nausea and vomiting. The drug is approved to treat patients undergoing cancer treatment, and people who fall ill after receiving surgical anesthesia.

But before the drug was marketed and distributed by GlaxoSmithKline, its use was never studied in pregnant women. Even so, Zofran has become the most common drug treatment for morning sickness in many parts of the developed world.

Parents have been filing civil lawsuits against GlaxoSmithKline, claiming that their drug Zofran caused birth defects in their children. The first lawsuit was filed in February, 2015, and there are many cases pending review.

If you have a child with a birth defect, speak to your doctor, and contact an experienced pharmaceutical injury attorney. The Lyon Firm has the skills and resources necessary to file a successful birth defect lawsuits against large pharmaceutical companies like GlaxoSmithKline. Rightful compensation can provide the financial resources for a difficult and costly medical future for your child.

During the past decade Zofran and Zuplenz have been increasingly used in the United States for nausea and vomiting of pregnancy. The drugs act by blocking the actions of chemicals in the body causing nausea.  The patent for Zofran expired in 2006 but Zuplenz was then approved in 2010. The main difference between Zofran and Zuplenz is that Zuplenz tablets will dissolve without water.

The drug indication is limited to patients following cancer treatments and surgery. However, the drugs have been routinely prescribed and used “off label” for stomach problems in children and morning sickness in expecting mothers.

It has been estimated that 80 percent of pregnant women consume a version of Zofran or Zuplenz.  In 2012, Glaxo Smith Kline plead guilty to fraud and illegal promotion of several drugs including Zofran and paid a $3 Billion fine as part of the Zofran Lawsuit settlement.

Joe Lyon is an experienced Cincinnati Catastrophic Injury lawyer and Ohio product liability attorney. He has represented hundreds of individuals harmed by pharmaceutical products nationwide. 

For questions related to the Zofran lawsuit call for a no-cost consultation.

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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.

Zofran Birth Defects

Earlier studies on Zofran showed there was no safety issue with the drug. However, fetal safety data was based on less than 200 births.  Newer research has called those conclusions into doubt with many questions related to the methodology applied to the data to reach such conclusions.

In 2013, the prominent New England Journal of Medicine published a study of 2,000 women from a Danish Birth Registry. The study showed that Zofran did not harm the fetus, but the study contained a major flaw in that most of the women took the medication past 10 weeks.  Malformations are not though to be produced beyond 10 weeks gestation, so the paper was severely limited in its application.

Following the NEJM study, the International Society of Pharmacoepidmiology published a paper entitled Ondanestron Use in Early Pregnancy and Risk of Congential Malformations evaluated women in the first trimester.  The researchers found that after exposure to ondanestron, children were more likely to suffer a birth defect. Specifically, the strongest association was related heart defects involving cardiac tissue that failed to develop.  Notably:

  • Atrial septal defects were 2.1 times more likely
  • Ventricular septal defects were 2.3 times more likely
  • Atrioventricular septal defects were 4.8 times more likely

Zofran Studies

In December 2014 , a group of Swedish publish health officials published a paper entitled ” Use of Ondanestron During Pregnancy & Congenital Malformations in The Infant” evaluating a total of 1,349 births.  The authors also concluded that there was a statistically significant increased risk of cardiovascular defects associated with Zofran.

A control study by Sloan Epidemiology unit and Centers for Disease Control found a 2 fold increase for cleft palate for Zofran taken in the first trimester [odds ratio = 2.37 (95% CI, 1.28-4.76).

  • In 2012, researchers at Harvard University took a look at common morning sickness treatments and their potential links to fetal harm. The study published in the journal Birth Defects Research found that women who took Zofran were more than twice as likely to birth children with a cleft palate. Cleft palate occurs when the roof of the mouth fails to seal during early fetal development, resulting in a gap on the roof of the mouth that sometimes extends into the throat or nose. It usually requires surgery in the child’s first two years of life. Conclusions were based on data from over 9,000 pregnant women who participated in the National Birth Defects Prevention study. By some estimates, the risk of delivering a child with cleft palate increases by over 200 percent when Zofran is taken by a mother.
  • Studies conducted in Denmark and Sweden have also discovered evidence that Zofran, when taken during the first trimester, may pose a risk to an unborn child’s heart. In two studies, European researchers found that Zofran may double the risk for cardiac septal defects, a condition where the walls of a baby’s heart fail to properly form.
  • Danish researchers from Copenhagen University analyzed national health records to investigate Zofran’s potential effects. Analyzing prescription and birth records, the team discovered an association between Zofran and congenital heart defects.
  • In 2013, a Danish study of more than 900,000 pregnancies found a two-fold increased risk of heart defects in babies whose mothers used the drug while pregnant.
  • study published in BioMed Research International notes Zofran is associated with a 20 percent increased risk of kidney defects and other congenital heart abnormalities.
  • A June, 2014 study conducted in Canada found at least 20 women who took Zofran during pregnancy and had children with birth defects, including 2 infant deaths and multiple cases of heart and kidney malformations.

Zofran Injuries

  • Heart Defects, including septal defects (holes in the heart)
  • Atrial septal defects
  • Ventricular septal defects
  • Atrioventricular septal defects
  • Cleft Lip
  • Cleft Palate
  • Club Foot
  • Craniosynotosis (skull deformities)
  • Kidney Malformations

Zofran Lawsuits

  • Glaxo breached its duty to adequately test Zofran before selling the product for use during pregnancy
  • Glaxo failed to warn physicians and patients about the risk of birth defects when taken during pregnancy
  • Glaxo promoted Zofran as safe for use during pregnancy when the FDA had not approved the drug for such use
  • Glaxo failed to properly communicate the results of animal studies that showed signs of abnormal bone growth and toxicity
  • Glaxo failed to properly analyze the available data and safety information on the drug before selling the Zofran for use during pregnancy

FDA Zofran Warnings

In September of 2011, the FDA issued a warning about possible QT prolongation and torsade de pointes among people receiving Zofran and called for closer monitoring of patients who may suffer QT syndromes, electrolyte imbalances, or congestive heart failure.

In 2012, the U.S. Food and Drug Administration (FDA) informed consumers and healthcare professionals that a clinical study suggested that a single intravenous dose of Zofran (ondansetron) could affect the electrical activity of the heart and pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.

As a result of the study, GlaxoSmithKline announced changes to the drug label. The updated label noted that the drug can continue to be used to alleviate chemotherapy-induced nausea and vomiting but at lower intravenous doses.

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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

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