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 Zofran Lawsuits

How does the FDA process impact pharmaceutical litigation?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Litigation?

Current Examples of Pharmaceutical Litigation. 

Opiod Crisis: The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis.

Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. 

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

Will my case be consolidated with other similar cases?

Pharmaceutical Injury Cases are Typically Consolidated in an MDL. 

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

 

What is Multi District Litigation (MDL)?

Federal Courts Utilize the MDL Process to Consolidate Pharmaceutical Injury Cases. 

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

can you sue a drug company?

Absolutely. If a pharmaceutical company sells a product that is improperly tested or fails to warn of certain health risks, and an injury occurs, a lawsuit may be filed. 


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