Zofran

  • zofran

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. US FDA approved Zofran in January 1991.

While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.

In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.

Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved the drug was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.

Before getting a prescription of Zofran drug, the patient must inform the doctor about being diagnosed with phenylketonuria (PKU) or not. Zofran is a disintegrating tablet that may contain phenylalanine. Patients should be aware of the side effects of Zofran which include blurred vision, trouble in breathing, anxiety, slow heart rate, and having urination problems. If the patient comes across any of this problem, you should stop the use of Zofran immediately. 

The intake of Zofran should be avoided if the patient is using apomorphine (Apokyn) or allergic to ondansetron. To ensure the safety of the usage of Zofran drug, before getting prescribed, informed the doctor if you have been diagnosed with liver disease or not. Also, if patients have a blockage in their digestive tract or suffer from a slow heartbeat, they should inform the medical prescriber about these health concerns, which will let them decide whether to go ahead with this drug or not.

Zofran can be taken with or without food with a full glass of water. The first dose is usually taken just before the beginning of surgery or chemotherapy. Also, few important things need to be noted while having this drug, the tablet should always be kept in a blister pack where they should not be pushed through the foil. Dry hands should be used to take out the tablet and do not swallow the tablet in one single go, allow it to dissolve in your mouth without chewing. 

Serious Alleged Injuries may include:

  • Musculoskeletal anomalies
  • Mouth deformity
  • Heart defects
  • Jaundice
  • Kidney malformations
  • Cleft lip, Cleft palate, Club foot, webbed toes
  • Fetal growth restriction
  • Fetal Death

FDA Safety Warnings:

  • In September 2011, the FDA announced it made changes to Zofran’s label and required the manufacturer of Zofran to conduct “a thorough QT study to assess the potential for the drug to prolong the QT interval.”
  • In 2012, the 32 mg intravenous dose of Zofran was pulled from the market due to concerns that it could trigger QT interval prolongation, a heart rhythm disorder that could lead to an abnormal and potentially fatal heart rhythm called Torsades de Pointes.

Legal Updates:

Defendant:

GlaxoSmithKline 

Defendant Law Firm:

Shook Hardy & Bacon LLP.

Allegations

The lawsuits claim allegation from women throughout the country that the prescriber was not properly intimated about the pregnancy risk that comes along with this anti-nausea drug. Families of these women claim that due to intake of Zofran during pregnancy, children were born with birth defects like cleft plates, ventricular septal defects, and other lifelong health issues. 

Plaintiff Steering Committee

(As per MDL Order No. 8, December 17, 2015, ref: https://www.mad.uscourts.gov/worcester/pdf/2657%20orders%201-8.pdf)

Edward Blizzard - Esquire: Blizzard & Nabers

Kate Jaycox, Esquire - Robins Kaplan, LLP

Russell Budd, Esquire - Baron and Budd P.C.

Walter Kelley, Esquire - Kelley Bernheim Dolinsky, LLC

Amy Eskin, Esquire - Levin Simes

James Klick, Esquire - Herman, Herman & Katz

Wendy Fleishman, Esquire - Lieff, Cabraser, Heimann & Bernstein,LLP

Arthur Murray, Esquire - Murray Law Firm

Jeffrey Gibson, Esquire - Cohen & Malad, LLP

Steven Rotman, Esquire - HAUSFELD

Melissa Hague, Esquire - Anapol Weiss

Christopher Schnieders, Esquire - Wagstaff & Cartmell

Stephen Hunt Jr., Esquire - Cory Watson, P.C.

Anthony Tarricone, Esquire - Kreindler & Kreindler LLP

In 2012, GSK pled guilty to criminal charges filed by the U.S. Justice Department over the company’s illegal promotion of Zofran and other medications. Around the same time, GSK also entered civil settlements with the U.S. government that included over $1 billion in payments for its illegal marketing of numerous drugs, including Zofran.

In October 2015, lawsuits filed against GlaxoSmithKline (GSK) alleging that the anti-nausea medication Zofran caused birth defects were consolidated into a multidistrict litigation (MDL) in the District of Massachusetts before Judge Dennis F. Saylor, IV, forming MDL 2657 (In Re: Zofran (Ondansetron) Products Liability Litigation). Nearly 300 lawsuits are a part of the Zofran MDL.

Feb 2021: Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts, overseeing the Zofran product liability litigation, announced that he is considering October as the start date for the first bellwether trial in the multidistrict litigation (MDL). The first bellwether trial was initially scheduled to begin in May 2020 but was put on hold in March due to the coronavirus pandemic.

Judge Saylor, during a monthly status conference, said that he proposed starting the trial after the Columbus Day holiday as he was feeling compelled to get a date back on the books. He also noted that the vaccination program in the state is also picking up and existing plans to have everyone in the court system vaccinated could help ease current jury trial restrictions.

The company and the plaintiffs involved in the litigation agreed for opening arguments to tentatively begin on October 18, 2021, and told the judge that the trial should last for two to four weeks.

June 2019: Based on an opinion re: Fosamax, an osteoporosis drug, released by the U.S. Supreme Court in May 2019, Judge Saylor asked the parties involved in Zofran litigation to submit a memorandum on how the court should proceed. 

Following which GlaxoSmithKline asked U.S. District Judge Dennis Saylor overseeing Zofran birth defect lawsuits filed in the federal court to renew the request for summary judgment. The memorandum stated, ''Plaintiffs acknowledge that the FDA repeatedly rejected their proposed labeling change but claim that the FDA lacked four categories of information. This Court held that the materiality of those four categories was a question for the jury at trial. The Supreme Court has now made clear that this Court, not the jury, must resolve the materiality of such information.”

The plaintiffs submitted a separate memorandum requesting the Court to reject GlaxoSmithKline’s reasoning and proceed with the scheduled jury trials as planned for the following year.

August 2018 - The MDL proceeded with general discovery. The deadline was set to select potential bellwether trial cases before the end of 2018.

May 2018: U.S. District Judge Dennis Saylor overseeing hundreds of Zofran birth defect lawsuits ruled that GlaxoSmithKline can not be held liable in three cases where generic versions of the anti-nausea drug were ingested by three pregnant women that resulted in the dismissal of claims brought by the families. The generic versions were manufactured by other pharmaceutical companies, instead of the brand-name version of the drug GlaxoSmithKline developed and sold.

The plaintiffs involved in the lawsuits held GlaxoSmithKline liable for their injuries caused by the generic versions alleging GSK wisely promoted the off-label use of the anti-nausea drug for morning sickness that the FDA never approved Zofran to be used as an anti-nausea drug for pregnant women as safe and effective, and resulted in the prescription of generic equivalents.

Judge Saylor wrote in the decision: “[P]laintiffs seek to proceed on what is essentially a theory of intentional or negligent misrepresentation or negligent undertaking. The theory is based on the allegation that GSK ‘created a market' for the drug’s use to treat pregnancy-related nausea that led to the use of generic alternatives, and therefore should be liable for all injuries created by those products. None of the highest courts of the three states in question have issued rulings directly on point, and therefore this Court must endeavor to predict how those courts might rule.”

Evidence:

  • Usage of Zofran in pregnant females from Pharmacy Records.
  • Duration of Zofran in pregnant females from Pharmacy Records.
  • Diagnosis of birth related defects in child from Medical Records.
  • Treatment required for birth related defects in child.

Medical Record Review and claim validation of Zofran case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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