The news wires have been busy lately with reports of yet more examples of drug companies marketing their drugs illegally. St. Louis-based Forest Laboratories agreed to a settlement this month, in which it will pay over $313 million in penalties for civil and criminal complaints that it illegally marketed its antidepressant Celexa (citalopram) for uses beyond those approved by the U.S. Food and Drug Administration. Two weeks earlier, Botox (onabotulinumtoxinA) maker Allergan agreed to a settlement in which it will pay $600 million for its illegal off-label marketing. Most dismaying to me as a dangerous medication attorney, both companies were charged with trying to sell their drugs for use by children even though the drugs were only approved for use by adults. Celexa has been linked to suicide and suicidal thoughts in some children and adolescents, so marketing the drug to them illegally seems especially dangerous and unethical.
Among the charges that Forest Pharmaceuticals, a subsidiary of Forest Laboratories, settled was a charge that the company was marketing Celexa to treat depression in adolescents and children, and that it was giving doctors misleading information about the drug’s effectiveness for those age groups. According to the U.S. Department of Justice, the company publicized positive results of a study of Celexa’s effect in adolescents, while keeping quiet about another study that found negative results. Forest also allegedly paid doctors to prescribe Celexa and another antidepressant, Lexapro, handing out “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services,” according to the Justice Department’s civil complaint. From 1998 to 2005, Forest representatives rewarded cooperative doctors with tickets to St. Louis Cardinals and Boston Red Sox games, Broadway shows, gift certificates to expensive restaurants and deep-sea fishing trips.
The company denies the civil allegations, but admitted that its employees lied to FDA inspectors in 2003, that it misbranded Celexa as appropriate for use in children, and that it illegally distributed an unapproved thyroid drug. Thus, Forest pleaded guilty to one felony and two misdemeanors. In the case of Levothroid (levothyroxine), the thyroid pill, Forest was charged with deliberately increasing its distribution of the drug in quantities that exceeded what the FDA allowed, even after receiving an FDA warning letter. Along with the fines and forfeitures of assets, Forest has agreed to a corporate integrity agreement making its drug marketing subject to monitoring by an independent expert for the next five years.
As a pharmaceutical liability attorney, I am glad that the Justice Department is cracking down on dangerous and illegal marketing that puts children at risk. Children’s bodies are not the same as adults’ bodies, and it’s not safe to assume that drugs that are fine for adults will work the same way for children. The dosages may not work the same way in children’s smaller bodies, and we don’t know how the drugs might affect a child’s developing body and mind. This is precisely why the FDA does not approve a drug once for all age groups. Suicidal thoughts are a well known problem with antidepressant use in kids and teenagers, and as noted previously, Celexa studies have linked the drug to such thoughts in kids and teens. That makes Forest’s choice to market Celexa off-label for this age group particularly irresponsible.
Drug companies know very well that the law requires them to follow established safety procedures and warn the public of any risks associated with taking the drugs they manufacture. When a drug company engages in illegal, deceptive marketing, it does the opposite. Failing to get FDA approval for an age group (or any other group) bypasses the regulatory structures that are intended to keep us safe. There’s only one reason that companies do this: profit. Illegal marketing gives them an unfair advantage over their competitors who do obey the rules and get FDA approval for their medications, and that unfair advantage helps them and hurts everyone else. That’s why consumers who are harmed by taking a prescription or over-the-counter medication are entitled to make the drug manufacturer pay for any costs associated with that harm. Those costs may include more than just medical bills: the victim may also sue for lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused.
Consumers should not have to just hope for the best when they take a prescription or over the counter medication; they should be able to rely on the drug’s safety and effectiveness. If the manufacturer hid important safety information from them, the manufacturer should pay for the harm caused. The defective medication lawyers at Carey, Danis & Lowe help people who have been hurt by over-the-counter and prescription drugs, including but not limited to drugs that were deceptively or illegally marketed. If you or someone you love have been seriously harmed by a medication, we can advise you about making the company that caused your injury pay for medical expenses, lost wages, permanent injuries and pain and suffering. If you have been hurt by a defective drug, please call Carey, Danis & Lowe for a consultation, toll-free, at 1-877-678-3400 or contact us through our website.