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Background to the Suit

The story behind Forest Pharmaceuticals' court decision starts back almost 20 years ago, in the early 1990s. At that time, the company was distributing Levothroid, a drug for hypothyroidism, but they hadn't yet attained FDA approval.

The FDA tried to go easy. First, in 1997, they agreed that the drugs were medically necessary, and they allowed the company to take the time they would need to conduct the proper studies and obtain official approval.

Four years later in 2001, the FDA announced that various manufacturers of levothyroxine sodium-based drugs – the same base ingredient to Levothroid – could continue to distribute unapproved drugs until August of that year, as long as they met certain requirements. One of the requirements was that any manufacturer which hadn't yet obtained approval (such as Forest Pharmaceuticals) would have to gradually phase-down unapproved drugs until it did obtain approval. Forest deliberately continued the distribution in quantities that well-exceeded the FDA's requirements.

When Forest was officially warned by the FDA in 2003, instead of slowing distribution, the company actually sped up distribution. St. Louis distribution center employees were forced to work overtime in order to ship out as much Levothroid as they could.

The saga on Levothroid continued even after that, but the company's deliberate defiance of the FDA was only one part of the case that led to the $164 million fine.

Anti-depressants for Children and Adolescents

As is now well-known, certain anti-depressant drugs can have very adverse effects in children and adolescents, sometimes even increasing suicide rates. Nevertheless, even though the FDA only approved Forest's anti-depressant Celexa for adults, Forest promoted the drug as the anti-depressant for children and adolescents.

The drug label itself never said anything about children and adolescents, but indicated use for adults. Meanwhile, Forest Pharmaceuticals sales representatives specifically targeted pediatricians. The company also hired outside speakers to talk to pediatricians about the benefits of Celexa for youth.

Was the $164 Million Fine Enough?

Considering the danger Forest Pharmaceuticals posed to its patients through the actions outlined above, one can't help but ask: was a fine of $164 million enough to change the behavior of Forest Pharmaceuticals executives?