What Must be Alleged in a Zofran Lawsuit in Federal Court?

In 2017, GlaxoSmithKline (GSK) asked a federal judge to dismiss all lawsuit fraud claims filed by hundreds of families who say that the anti-nausea medication Zofran caused their child's congenital disabilities. The judge presides over consolidated MDL (multidistrict litigation) cases involving hundreds of Zofran lawsuits based on fought allegations stating that GSK was negligent in providing accurate Zofran warnings on their labeling. So far, the judge is siding with plaintiffs' demand to be heard at trial.

Rosenfeld Injury Lawyers LLC represents victims who are harmed by taking bad medications and other types of professional negligence. Our law firm has successfully prosecuted Zofran lawsuits to hold the pharmaceutical giant financially accountable. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your injuries were a result of someone else's negligence. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.

What is Zofran?

Zofran (ondansetron) is a 5-ht3 antagonist medication that was approved by the FDA (Food and Drug Administration) in 1991 for the treatment of nausea. The drug works by blocking serotonin, a natural substance in the body that induces vomiting. The medication is the leading anti-vomiting and anti-nausea prescription drug approved by the FDA for cancer patients who are undergoing radiation treatment, chemotherapy, or surgery. Children are also prescribed Zofran to alleviate vomiting caused by acute gastroenteritis.

Zofran and Pregnancy Complications

Doctors prescribe Zofran to treat morning sickness in expecting mothers, even though the FDA has yet to approve the medication for this use. Statistics show that one in four pregnant women take Zofran or its generic equivalent ondansetron. As a result, mothers who gave birth to babies with congenital disabilities after taking the medication are filing Zofran lawsuits against the pharmaceutical manufacturer citing negligence.

The Food and Drug Administration and medical boards allow doctors to prescribe medications for “off-label” use if there is a general belief that the drug can produce a positive effect on the patient's condition. However, pharmaceutical manufacturers including GlaxoSmithKline are legally restricted from marketing and promoting any drug they sell for off-label use.

When the pharmaceutical company's original patent expired in 2006, Sandoz, a subsidiary of Novartis, bought the rights to market Zofran even though they were aware of the horrific congenital disabilities the medication caused.

Birth Defect Lawsuits

GlaxoSmithKline is facing years in court resolving their medication marketing campaigns that are known to harm unborn children. Even though the company will likely payout of millions of dollars to settle hundreds or thousands of lawsuits, the drug maker continues to market the medication to pregnant women suffering from morning sickness.

Some of these cases are built on the company's deliberate action to circumvent the necessary approval from the FDA to promote the drug for use by pregnant women. In 2012, GSK settled a massive lawsuit filed by the US Government to pay out $3 billion in damages for fraudulently promoting numerous drugs including Zofran to expecting mothers. Now that the drug is being marketed and sold by Novartis, the new pharmaceutical manufacturer will likely be involved in future cases involving congenital disabilities.

FDA Briefing Document

In March 2018, the FDA released a Risk Communication Advisory Report to help expecting mothers make informed decisions about using the medication. The committee was concerned about the risk-perceptions expecting mothers had when taking anti-nausea medication to treat morning sickness.

The committee noted that “pregnant women and their healthcare providers rely on information and the prescription product labeling to guide the safe and effective use of these products.… However, the data available to inform about the risks of use during pregnancy are often limited and difficult to interpret. The lack of interpretable human data combined with the potential risk misconceptions can impact appropriate risk-benefit decisions about the use of a drug during pregnancy.”

Building a Zofran Lawsuit Case

Attorneys working on behalf of plaintiffs in a Zofran lawsuit case will build a claim for compensation by making specific allegations based on evidence and testimony by expert witnesses. The lawyer will specify certain factors and evidence that the jury might consider, which include:

• What and when the drug maker knew about the dangerous side effects of Zofran (ondansetron) when the medication was prescribed to expecting mothers.


• The pharmaceutical company's marketing campaigns that promoted Zofran (ondansetron) use for pregnant women who are suffering severe morning sickness.


• The lack of posting the correct information concerning congenital disability side effects on the medications Black box warning label.


• The company's failure to warn the public of the known associated risks of taking Zofran.


• Proving that the company withheld pertinent research information detailing the dangers of taking Zofran.


• Why the company chose to market and sell Zofran knowing that the medication could be dangerous.


• The extent of the Zofran congenital disability including the treatment and care required to correct the problem if possible.


• The physical and mental health challenges the child faces due to their congenital disability caused by the mother taking Zofran during pregnancy.


• The child's pain and mental anguish throughout its lifetime.


• The effect of long-term injuries the child will endure and how the congenital disability will change their enjoyment of life or future health.

Building a case on the allegations above and others can support a claim for compensation to hold the drug maker legally responsible for the child's congenital malformations including a cleft lip, cleft palate, musculoskeletal problems, jaundice, spinal abnormalities, or heart defect.

To successfully resolve the case, the attorney will need to show that the drug maker manufactured, marketed, promoted or sold an unsafe product, and continues to do so.

Filing a Zofran Lawsuit in Federal Court

If you choose to file in state court, your specific jurisdiction might have variable requirements to file. However, many Zofran lawsuits are being filed in federal court, and this requires a few key things by law:

• Citizenship: The plaintiff must be from a different state than all defendants, and the amount in controversy must exceed $75,000 as stated in 28 U.S.C. § 1332: "The district courts shall have original jurisdiction of all civil actions where the matter in controversy exceeds the sum or value of $75,000, exclusive of interest and costs, and is between citizens of different States."


• Venue: The plaintiff must pick a federal jurisdiction that has some connection to the parties or circumstances of the case as stated in 28 U.S.C. § 1391: "A civil action may be brought in (1) a judicial district in which any defendant resides, if all defendants are residents of the State in which the district is located; (2) a judicial district in which a substantial part of the events or omissions giving rise to the claim occurred, or a substantial part of property that is the subject of the action is situated; or (3) if there is no district in which an action may otherwise be brought as provided in this section, any judicial district in which any defendant is subject to the court's personal jurisdiction with respect to such action."

Will There be a Zofran Class Action Suit?

Likely not. Currently, the cases are being heard in multidistrict litigation (MDL) court that work differently than a class action suit. The MDL judge will schedule a few bellwether cases to serve as a starting point for jurors to hear the evidence that is common to the hundreds or thousands of plaintiff's filing separate cases. When the jury returns its verdict, both the defendant and the plaintiffs in all remaining cases will know what to expect in compensation in the cases that are negotiated or heard at trial in the future.

Every plaintiff that files their claim for compensation in multidistrict litigation court has an individual case that is not part of a class action lawsuit. Other plaintiffs are choosing the file their claim in state court to face the pharmaceutical manufacturer in their local county.

How Much is my Zofran Case Worth?

Most Zofran lawsuits are still pending in court and have yet to go to trial or settle. Because of that, there has not yet been an established amount of financial compensation. Determining the value of your case without reviewing the evidence and medical records is nearly impossible based on your unique circumstances.

An attorney who specializes in Zofran injury cases can evaluate your claim and provide legal options on how to proceed. Nearly all Zofran lawsuits are settled out of court at a negotiation meeting between the plaintiff's attorneys and that defendant's lawyers. A trial is significantly different than a settlement where the plaintiff agrees to accept a compensation amount. Defendants typically agree to a settlement to avoid going to trial where facts, statistics, and evidence will be presented in open court to the public. Avoiding a trial might also be important to you because a settlement provides various options that include:

• All your personal information involved in your case will usually be kept private.


• The amount of expenses of negotiating instead of presenting evidence at trial is greatly reduced.


• The chance of not receiving any compensation at the jury's verdict is uncertain can be avoided.


• The amount of time it takes to negotiate a settlement out of court is significantly shorter compared to the months it takes to build the case to present to a jury at trial.


• Trials are significantly more stressful than settling the case out of court and could produce an uncertainty of the outcome.

Likely, as the plaintiff in the case, you can decide whether to settle your Zofran (ondansetron) lawsuit or not. Your attorney will likely provide good legal advice on what serves your best interest especially if the settlement amount offered by the defendant is not sufficient.

An experienced attorney will never pressure you into settling your case. However, the lawyer might provide legal guidance so you completely understand how the settlement would work and what you can expect from the trial if you proceed to go to court.

Hire an Attorney to Begin Your Case

The Zofran injury attorneys at Rosenfeld Injury Lawyers LLC understand the injuries your child has suffered were not anyone's fault other than the irresponsible pharmaceutical manufacturer. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.

Our legal team encourages you to contact our attorneys today to schedule an initial, no-obligation case consultation to discuss the merits of your monetary recovery claim at no charge to you. We accept all personal injury cases, wrongful death lawsuits, and defective medication injury claims through contingency fee arrangements. This legal agreement postpones the payment of our services until after we have successfully completed your case by winning your lawsuit at trial or through a negotiated settlement.

Our law firm gets results quickly because we fight aggressively on your behalf. We proudly offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.

Sources:

• https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM597309.pdf
• https://www.fda.gov/Drugs/DrugSafety/ucm271924.htm
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf
• https://www.fda.gov/Drugs/DrugSafety/ucm310190.htm?source=govdelivery

For additional information see the following pages:

• Why were pregnant women prescribed Zofran?
• What types of birth defects in children have been associated with Zofran usage?
• Has the FDA issued any warnings concerning the use of Zofran during pregnancy?
• Has there been a recall of Zofran from the market?
• Have there been any lawsuits filed against the manufacturer of Zofran related to birth defects in children?
• If I took Zofran during my pregnancy and my child was born with birth defects, can I file a legal claim or lawsuit to recover compensation for their injuries?
• Are there any time constraints for pursuing a lawsuit related to Zofran-birth-defects?
• What damages are available for myself and my child in a Zofran birth defect lawsuit?
• If a took a generic version of Zofran, can I still pursue a legal claim for damages related to my child's birth defects?
• Are there any class action lawsuits against GlaxoSmithKline, the manufacturer of Zofran, for children who have birth defects following Zofran usage during pregnancy?