Send GlaxoSmithKline Executives to Prison for Zofran Birth Defects

Dangerous drugs

By David Carnes, Staff Writer

What should we do with a criminal organization that profits even while it injures women and children for decades? Send the leaders to prison. We jail the leaders of the Ku Klux Klan, Cosa Nostra and Al-Qaeda -- and we should do the same with the executives of GlaxoSmithKline.

The pharmaceutical company GlaxoSmithKline reached settlement of $3 billion with the Justice Department in 2012, the largest health care fraud settlement in history. Glaxo agreed to pay this amount to resolve criminal and civil complaints arising from its fraudulent marketing  of a number of pharmaceuticals including Zofran, which causes birth defects. 

The Glaxo case was part of a Justice Department crackdown on fraud within the pharmaceuticals industry. Previously, fines had been low enough to allow pharmaceutical companies to profit even after paying them, encouraging unscrupulous pharmaceutical industry executives to treat them as simply a "cost of doing business."

Although the drugs marketed by Glaxo were FDA-approved, it broke the law by aggressively marketing the drugs for "off-label" uses, meaning for uses not approved by the FDA. Doctors were paid off to prescribe the drugs more frequently than they otherwise would have.

Zofran birth defects

Zofran is a dangerous drug approved only for the relief of nausea in chemotherapy patients, but has never been approved for use by pregnant women. Despite this, Glaxo marketed Zofran for use to relieve morning sickness and hyperemesis gravidarum (nausea, vomiting and weight loss) caused by pregnancy. Because Glaxo marketed Zofran as safe for pregnant women despite failing to perform clinical trials to verify this claim, more than a million women a year use Zofran or one of its equivalents.

Unfortunately, Zofran passes to the unborn child through the placenta, resulting in an unreasonable risk of harm to the baby, a fact that Glaxo knew as early as 1992 despite its failure to perform clinical trials. Allegations have also surfaced that Glaxo may not be safe for pregnant women themselves. Since the 2012 settlement, multiple lawsuits have been filed against Glaxo alleging birth defects caused by Zofran. these birth defects include heart defects such as

  • atrial septal defects

  • ventricular septal defects  

  • heart murmurs

  • cleft lip

  • cleft palate

As of April 2015 at least five lawsuits are pending against Glaxo in U.S. courts, two of which were filed within the first three days of April alone.

Honor Whistleblowers, Imprison Glaxo Execs

Given the shockingly callous nature of Glaxo's offense as well as the potential magnitude of the damage done, a criminal case against Glaxo itself is simply not enough to protect the public interest. The specific Glaxo executives responsible for making the decisions that created this debacle should either pay the lifetime expenses of the children they harmed, or otherwise go to prison.

The Justice Department should continue imposing colossal fines on healthcare fraud to ensure that it is simply no longer profitable for a pharmaceutical company to play Russian Roulette with public health in pursuit of windfall profits.

Meanwhile whistleblowers such as former Glaxo executives Thomas Gerahty and Matthew Burke, who first brought the case to the attention of the Justice Department, should be publicly honored.

If you think you or your child might have been harmed by Zofran take the first step by searching our directory to find an attorney near you.


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