Newsletter - April 2015

The drug Zofran (Ondansetron) was manufactured to help cancer patients to treat nausea that usually follows chemotherapy treatments. The FDA's approval of Zofran was limited to only this use. However, manufacturer GlaxoSmithKline took the liberty of marketing the drug to pregnant women to treat morning sickness. Unfortunately, not only did the FDA not approve the drug for this use, but studies soon found that use of the drug to treat morning sickness was linked to birth defects.

After pleading guilty to federal charges of fraud and illegal promotion, and settling the matter for $3 billion, the manufacturer now faces various others pending lawsuits as a result of the injuries stemming from Zofran's unapproved use.

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

While Zofran has never been tested or approved for use by pregnant women, it is often given a label for morning sickness and hyperemesis gravidarum, a serious form of morning sickness that causes severe nausea and weight loss.

In the last few years, however, disturbing results have emerged from several studies linking Zofran with congenital birth defects. Mothers and families of children born with serious mental and physical disabilities now continue to sue pharmacists, claiming that they have been misled and lied about the dangers and safety of the drug.

Zofran is labeled as a Risk Risk of Pregnancy B, which means there is no evidence of risk in humans. Many mothers have taken this assurance that the drug is safe, but many studies show evidence to the contrary. Because Glaxo did not prove that the drug was safe, the FDA never approved the sale of the drug to pregnant women. No matter, Glaxo continued to advertise anti-emetic for morning sickness.

Prior to receiving the prescription Zofran, the patient should inform the physician of his diagnosis of phenylketonuria (PKU). Zofran is a divisive tablet that can contain phenylalanine. Patients should be aware of the side effects of Zofran including blurred vision, respiratory distress, anxiety, low heart rate, and urinary incontinence. If the patient experiences any of these problems, you should stop using Zofran immediately.

Zofran injections should be avoided if the patient is taking apomorphine (Apokyn) or is allergic to ondansetron. To ensure the safety of the use of the drug Zofran, prior to prescribing, inform your doctor if you are diagnosed with liver disease or not. Also, if patients are restricted from their digestive tract or have a slow heart attack, they should inform their healthcare provider about this health concern, which will lead them to decide whether to continue the treatment.

Zofran can also be taken with food in and out with a full glass of water. The first dose is usually taken just before the start of surgery or chemotherapy. Also, there are a few important things that need to be noted while you have this drug, the tablet should always be kept in a package where it should not be wrapped in foil. Dry hands should be used to remove the tablet and do not swallow the tablet once, letting it spill into your mouth without chewing.

Zofran (ondansetron) has been recommended as the most prescribed treatment for morning sickness medication. However, the U.S. Families of children who developed birth defects after mothers took Zofran during pregnancy have sued GlaxoSmithKline for allegedly selling the drug to pregnant women without FDA approval and failing to warn of the dangers.

Heart failure, cleft lip and palate are some of the birth defects mothers say are caused by their use of the anti-nausea Zofran during pregnancy. As a result, GlaxoSmithKline (GSK), the company that originally marketed the drug, was named in more than 600 cases in the organization's court.

Prosecution charges against GSK allege that the company illegally and fraudulently promoted Zofran as a treatment for morning sickness, a U.S.-sanctioned use. Food and Drug Administration. They also suspected that the company had misrepresented the results of animal studies, claiming that the studies showed the drug was safe - while actually showing abnormal bone growth and toxic symptoms - and mistakenly claimed that Zofran was safe for pregnant women.

Nausea and vomiting in pregnancy usually occur in the first trimester and are very common. You may be interested in how you can stop a bad feeling, especially if you feel like you have tried all the tricks in the book. Enter Zofran.

Zofran is a trademark of ondansetron. It is a drug that inhibits the action of serotonin, a naturally occurring factor that can lead to nausea and vomiting.

Originally it was used to treat nausea associated with chemotherapy or surgery. It is still in use and approved by the Food and Drug Administration (FDA) for this purpose. But now, Zofran is also a common drug for reducing nausea and vomiting during pregnancy.

Morning sickness can be caused by chorionic gonadotropin (hCG), a hormone released by the placenta. When severe nausea and vomiting lead to weight loss and weight loss, your doctor may diagnose hyperemesis gravidarum and prescribe additional medications.

A common, cooked consensus made in the past is that Zofran is the safest in all trimesters. Now, though, some people are suggesting otherwise.

One recent meta-analysis A reliable source for eight studies suggested that exposure to ondansetron in the first trimester could cause a very small increase in the risk of heart failure and orofacial paralysis such as cleft palate in children.

On the other hand, citing a 2018 study, CDCTrusted Source found that taking ondansetron in early pregnancy does not appear to be linked to the chance of having a child with a health problem at all.

A trusted Food and Drug Administration (FDA) source agrees with the CDC. It shows that the available data do not create a reliable correlation between ondansetron and an increased risk of heart failure and orofacial paralysis.

According to the FDA, other factors could have contributed to the reported health issues. For example, people with severe nausea are more likely to experience changes in the body and a lack of healthy food, which can put their children at higher risk for these problems.

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: “|LS|P|RS|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.