BOSTON — Litigants before U.S. District Judge F. Dennis Saylor IV in Massachusetts urged him to allow their lawsuits against GlaxoSmithKline to continue, arguing that no discovery had taken place and that there was solid evidence linking Zofran and serious birth defects.
GSK insists that the drug is safe and that a statement from the Food and Drug Administration supports this position. But court documents state that researchers in Japan found a link between Zofran and birth defects in animals well before GSK began promoting the drug as an alternative to treat morning sickness.
The attorneys for the victims also point out that the statements made by the FDA are disputed and therefore do not legally qualify as admissions.
The pending lawsuits, the first of which are scheduled for October trial dates, are not the first time that the drug or its manufacturer have been under scrutiny.
In 2012, GSK paid $3 billion to resolve claims from the United States Department of Justice that it recklessly promoted experimental use of Zofran and other drugs in an attempt to increase sales.
Despite the fact that it has received over 200 complaints, GSK has refused to update Zofran’s warning label.
Zofran and Birth Defects
Zofran is an incredibly powerful anti-nausea drug that was government-approved to treat nausea and vomiting in surgery and chemotherapy patients.
After some initial success in this area, GSK began aggressively promoting it as an option to treat morning sickness in pregnant women, even though the FDA had not approved of this use.
There is a growing body of research that supports the victims’ claims against GSK. In 2013, researchers in Australia concluded that Zofran was unsafe to consume during pregnancy. Some of the possible birth defects include:
- Cleft palates,
- Heart defects, and
- Disfigured livers.
Damages in a dangerous drug case can be substantial, both due to the severe emotional and economic losses and the company’s misconduct in failing to warn the public about a drug’s known dangerous side-effects.
Our Zofran Attorneys Can Help
Our dangerous drug lawyers help if you or someone you care about was harmed while taking this medication.
Lawsuits have been filed against the manufacturer by both patients and their families seeking compensation for injuries caused by the dangerous drug. You may be entitled to a cash settlement.
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