For over 30 years, I have earned a living holding corporations, insurance companies, negligent drivers, doctors, and hospitals accountable for their actions (or sometime inaction). Our Constitution and Amendments provide PEOPLE and corporations with rights that may be acted on in our courts of law. But this is preposterous: Drugmaker Sues FDA Over Right to Discuss Off-Label Uses.
Right in the Throes of Huge Fraud on Families
No doubt the giant pharmaceutical manufacturers, like GlaxoSmithKline, have sent out a baby drugmaker like Amarin Pharma, much like a buck sends out the doe first to make sure it’s safe. Recently GSK paid $3 billion to settle criminal and civil charges of unlawful behavior, including withholding safety information from the U.S. Food and Drug Administration (FDA) and illegally promoting the off-label use of Zofran and other popular drugs. And now Big Pharma believes they have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful. Big drug manufacturers don’t know how to tell the truth – they only know how to make money.
The FDA is Not Great, But It Provides Some Minimum Oversight
The prescription drug Zofran, manufactured by GSK, was initially approved by the FDA to help cancer patients experiencing nausea after treatments and/or surgery. Not for pregnant moms suffering morning sickness. Based on court documents, GSK knew as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies because the drug passes through the placenta. Despite this knowledge, GSK continued to market this medicine to pregnant women by having their drug reps tell doctors about the off-label use of Zofran for morning sickness without telling the doctors about the risks and studies.
Now Children are Being Born with Major Birth Defects
- Cleft Palate
- Heart Defects
- Hearing Loss
- Sensitivity to Light
- Facial Dysmorphia
- Inguinal Hernia
- Webbed Toes
In spite of these serious injuries affecting innocent children and families, Big Pharma wants the FDA to allow it to continue promoting off-label use of medications. It’s clear these massive, profit-driven corporations can’t be trusted any more than you can trust a fox to watch the henhouse.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.