A federal judge in Boston issued a protective order banning disclosure of documents, materials or other information produced in discovery in Zofran litigation, consolidated in federal court in Massachusetts.
Judge F. Dennis Saylor IV granted the request of Zofran manufacturer GlaxoSmithKline to hide the company’s patient medical records and pharmacy records; design, development, research, and testing regarding products; non-public clinical studies and related documents to the extent not otherwise published or previously released — and more.
Zofran is a powerful drug developed by GSK to treat only those patients who were afflicted with the most severe nausea imaginable – that suffered as a result of chemotherapy or radiation treatments in cancer patients.
The U.S. Food and Drug Administration (“FDA”) approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy.
Expectant mothers were human guinea pigs
Although the only FDA approval for this drug was for seriously ill patients, GSK marketed Zofran “off label” as a safe and effective treatment for pregnancy-related nausea and vomiting – otherwise known as “morning sickness.” GSK did this despite having knowledge that such representations were false, because GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero.
GSK never conducted a single clinical trial before marketing Zofran to pregnant women. The company simply chose not to study Zofran in pregnant women or seek FDA approval to market the drug for treatment during pregnancy. GSK avoided conducting these studies because they would have hampered its marketing of Zofran and decreased profits by linking the drug to serious birth defects. GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.
As a result of GSK’s fraudulent marketing campaign, Zofran was placed into the hands of unsuspecting pregnant women throughout the United States. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.
By contrast, GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations. GSK did not disclose this information to pregnant women or their physicians.
In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran. GSK had received at least 32 such reports by 2000, and has received more than 200 such reports to date. GSK never disclosed these reports to pregnant women or their physicians. In addition, scientists have conducted large-scale epidemiological studies that have demonstrated an elevated risk of developing birth defects such as those suffered in this case. GSK has not disclosed this to pregnant women or their physicians. Instead, GSK sales representatives specifically marketed and promoted Zofran as a morning sickness drug throughout the relevant time periods discussed herein.
In 2012, GSK reached a settlement in connection with charges lodged by the United States of America, through the Department of Justice, for its “off-label” promotion of its drugs for uses never approved by the FDA. At or around the same time, GSK also entered civil settlements with United States that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically.