Generic Drug Manufacturers Escape Accountability, with Deadly Results

Emily Mitchell, of Chattanooga, Tennessee, had no reason to believe her newborn baby had any health problems. The sonograms had been normal. But her son, Lucian, was born with severe heart defects. He died one week later. 

Mitchell had taken fluoxetine, to ward off panic attacks, since before she became pregnant. She continued to take the medication during her pregnancy, with her doctor’s approval. What she did not know is that studies had indicated that pregnant women taking the drug had an increased risk of giving birth to children with heart problems. The drug’s safety labeling minimized these risks.

When Mitchell sought to hold the drugmaker accountable, she found that she could not have her day in court – simply because she had taken a generic version of the drug.

Generic drugs make up more than 80% of all prescriptions filled in the United States. But generic drug manufacturers are not allowed to independently update their labels to warn of newly discovered side-effects. And five years ago last month, the Supreme Court ruled that generic drugmakers can’t be held accountable for failing to warn consumers of the risks of their drugs.

In 2013, the U.S. Food and Drug Administration proposed to address the issue by allowing generic drugmakers to promptly update their safety labels, and be held accountable if they do not give adequate warnings. Thousands of consumers supported the plan. But it has been delayed repeatedly.

Writing in The Hill this month, Mitchell called on the FDA to take action:

This fix shouldn’t wait any longer. We put our trust in the companies who make medicines. And when those companies downplay the risks of their products, they are endangering the public, whether they are a brand-name manufacturer or a generics company.

When no one is accountable, no one is safe. For the millions of Americans who take generic drugs, this problem needs to be fixed.