Zofran Lawsuit Settlements
The pharmaceutical company GlaxoSmithKline introduced their anti-nausea medication Zofran (ondansetron) into the US market after it was approved by the FDA in 1991 as treatment for chemotherapy and radiation patients, or for those struggling with nausea or vomiting after surgery.
Zofran was never approved by the FDA as a morning sickness treatment. Women who were prescribed the drug “off label” for this purpose may not have been aware that no studies had definitively proven Zofran exposure in utero was safe for a developing fetus. What exactly the risks to the fetus are, and even the question of whether Zofran is capabale of crossing the placental barrier, are yet to have been fully determined.
Despite conflicting scientific findings, Zofran lawsuits filed against GlaxoSmithKline allege a link between the drug and an increased risk of birth defects, including congenital heart defects. Lawsuits also recapitulate allegations made by the U.S. Department of Justice against GSK, which were resolved, without admission of liability on the part of the drug maker, as part of a billion-dollar civil settlement in 2012.
According to the DOJ, “GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. [GSK] also … paid kickbacks to health care professionals to induce them to promote and prescribe these drugs.”
GlaxoSmithKline denies engaging in illegal marketing tactics or kickbacks, and claims that Zofran is safe. Plaintiffs seeking Zofran settlements or jury awards alternatively claim that the drug maker has known about the potential risk of fetal malformations since the 1980s, and willfully withheld this information from the public and medical community so as not to adversely interfere with sales profits.
Who may be eligible for a Zofran settlement?
No settlements have been negotiated with regard to Zofran side effects, and GlaxoSmithKline denies any liability for injuries to children whose mothers took Zofran as described during pregnancy. Anyone who believes they may have a case may be asking the question, who is eligible to file suit?
The following factors may disqualify you from pursuing a Zofran lawsuit:
- If no actual harm occurred. Many women who took Zofran while pregnant gave birth to healthy babies. The mere possibility that taking a medication could carry the risk of birth defects in a developing child does not represent grounds for a Zofran lawsuit if no harm actually occurred.
- If other factors may have caused the birth defect(s). It is important to be able to make the link between Zofran usage and the birth defect(s) in question. If, for example, a mother-to-be engaged in high risk behavior or was genetically predisposed to give birth to a child with certain congenital birth defects, the cause and effect relationship between Zofran and actual injury to a child would be considerably weakened in the eyes of the judge and jury. Attorneys need to be able to confidently present Zofran as the causal agent for the birth defects in question.
- If a woman knew the risks. If there is evidence that a woman was aware of possible risks before she took Zofran (such as signed documentation from the woman in question substantiating the awareness of such risks), she may not have a case in court.
What steps should those pursuing a Zofran lawsuit take?
Those who believe that their child’s birth defects or other medical issues may be related to their use of Zofran during pregnancy should take the following steps:
- Save all relevant medical documents.
- Consult a lawyer about the viability of a potential case.
- Engage a lawyer who has a proven reputation for taking on large pharmaceutical companies and winning substantial settlements for his or her client.
A Zofran attorney with the right background in this area of litigation will have an in-depth understanding of GlaxoSmithKline’s history in connection to the research, development, and marketing of the drug. A qualified product liability lawyer will marshal any scientific research that may support your case, and seek out established medical experts to testify on your behalf.
What can plaintiffs expect regarding Zofran settlements?
The size of a potential settlement in a drug injury case could vary based on a number of factors. Settlements can be negotiated to cover medical expenses (past and future), cost of rehabilitation, loss of earnings or earning potential, or pain and suffering (both for parent and child).
In addition, settlements related to defective or dangerous drugs may also involve punitive damages for unethical or illegal actions taken by the pharmaceutical company in question.
Settlements vs. jury awards
Zofran litigation is in its earliest stages at this point, with lawsuits only now being filed on behalf of plaintiffs who allege that their children have suffered as a result of undisclosed drug risks. If lawsuits progress to trial, a jury will decide the outcome and, if they find in favor of the plaintiffs, will award them suitable damages.
Alternatively, plaintiffs and defendants may negotiate an out-of-court settlement before a case comes to trial. It may be more cost effective for both sides to agree on a settlement than to endure the costs associated with a protracted legal battle. Additionally, a pharmaceutical company can, in this way, avoid the prolonged media scrutiny that would come with a public trial. Non-disclosure agreements are often negotiated as part of settlements in drug injury cases.
Consolidation of drug injury lawsuits
Generally any plaintiff who files a drug injury lawsuit, will begin proceedings as an individual party who hopes to receive a settlement or jury award on the basis of his or her individual injuries or losses. If many plaintiffs file lawsuits alleging similar complaints against the company, the court may arrange for consolidated litigation known as mass tort or multidistrict litigation (MDL), depending on whether it is structured on a state or federal level. In a mass tort or MDL, all pre-trial proceedings will be centralized for the sake of a more efficient process. Hypothetically, pre-trial Zofran settlements could be more likely if cases are consolidated.
As the litigation proceeds, a small number of cases will typically be chosen as preliminary (or “bellwether”) trials to set a precedent for the others. One function of these trials is to serve as an indication of the possible outcome of other cases. For instance, if juries in the first three trials overwhelmingly decide in favor of the plaintiff, the defendant may decide that it is in its best interests to negotiate a settlement with all remaining parties. The individual share of this mass settlement will typically be standardized or allotted based on predetermined criteria, such as the severity of personal injuries in question.
- TheStar.com, Birth defects blamed on unapproved morning sickness treatment, http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
- Today’s Parent, Morning sickness drug linked to birth defects: Report http://www.todaysparent.com/blogs/on-our-minds/morning-sickness-drug-linked-to-birth-defects-report/
- WebMD, Zofran http://www.webmd.com/drugs/2/drug-30/zofran-oral/details
- Drugs.com, Zofran side effects http://www.drugs.com/sfx/zofran-side-effects.html
- Us Department of Justice, GSK to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report