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Medication Labeling and the FDA

Posted on January 8, 2016

The U.S. Food and Drug Administration (FDA), which is charged with protecting the public in terms of what medications are deemed safe, has contributed to a medication labeling crisis. In 2000, the FDA mandated that drug manufacturers shouldn’t include references to “rare” diseases and side effects of their medications in the product labeling. The mandate even advised against including frightening “life threatening disease” language in product labeling.

This puts drug manufacturers in a bind because while adhering to the FDA’s labeling guidelines, they are putting themselves at legal risk for not warning the public of all potential side effects.

Though drug companies have used FDA approval as a legal shield in the past, it may no longer work. Let’s look at two cases:

  • In a 2002 case where a 15 year old girl committed suicide while taking the antidepressant Zoloft, the girl’s parents sued the drug’s manufacturer, Pfizer. The case was dismissed because the FDA didn’t consider increased suicide risk an adverse side effect of the drug.
  • In a more recent case, 2009’s Wyeth vs. Levine, the United States Supreme Court ruled that FDA approval does not shield a medication manufacturer from liability.

If you or a loved one has suffered an injury due to an adverse side effect from a prescribed medication, it is important that you consult a pharmaceutical litigation attorney.

Farah & Farah handles pharmaceutical litigation claims nationwide. We’;re ready to fight drug companies and their negligent actions. Call (800) 533-3555 for a free consultation.