Lieff Cabraser Civil Justice Blog
California Parents File Zofran Lawsuit Against GlaxoSmithKline

Pro Publica: Why Drug Testing’s Omission of Pregnant Women May Have Led to Zofran Birth Defect Injuries

Pro Publica has published a lengthy article exploring how the medical establishment’s long-standing approach to “protecting” fetuses by restricting testing on pregnant women has resulted in a critical shortfall of knowledge. While the intention was mostly good — to protect women and babies from the kind of severe birth defects and other harm caused by thalidomide and other drugs in the 1960s and ‘70s (but also to protect pharmaceutical companies from legal liability for those injuries) — the result is less certain. By excluding women — and pregnant women in particular — from clinical trials, doctors have been forced into prescribing untried medications “off-label” to pregnant women, with results that can lead to serious negative health consequences for mothers, and birth defects for babies.

As the journal put it, “When it comes to drug safety, pregnancy is a largely research-free zone, women’s health experts say. The consequence? Treatment that often is based on informed guesswork rather than solid evidence, in which medications that have never been approved for use during pregnancy, and whose long-term dangers may not be known, become the standard of care.” As Pro Publica goes on to note, “Zofran is a case study in just how problematic this system has become. For years, Zofran was the most popular morning-sickness medication in the U.S. Now it’s being accused of causing birth defects.”

Zofran is far from unique — almost every drug prescribed during pregnancy in the U.S. is ‘off label,’ meaning it hasn’t gone through the clinical trials required by the Food and Drug Administration before approving a drug for a specific use in a specific population.

Pro Publica goes on to note that “[H]ampered by a lack of peer-reviewed evidence and hard data, ob/gyns find themselves in the dark about some basic best practices.”

“Although doctors may decide to prescribe a medication for unapproved uses, it’s illegal for drug companies to encourage them to do it. In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line.

“The allegations originated with ex-Glaxo marketing execs turned whistleblowers. The DOJ accused the company of engaging in all kinds of banned behavior to drive up sales — plying doctors with Caribbean vacations and hunting trips, misreporting clinical trial findings to a medical journal, withholding safety data from the FDA. In a civil settlement, DOJ said Glaxo had spread ‘unsubstantiated and/or false representations’ about Zofran’s use for morning sickness and ‘paid illegal remuneration’ to doctors to promote and prescribe the drug, in violation of federal anti-kickback laws. Glaxo didn’t admit any wrongdoing where Zofran was concerned, but it pleaded guilty to fraud in connection with other drugs and paid a $3 billion fine, the largest ever levied against a drug maker.”

The Pro Publica piece is well worth reading in its entirety.