Stltoday.com

by Jim Doyle

A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

Last month, the company’s subsidiary — Forest Pharmaceuticals, based in Earth City — agreed to plead guilty to criminal charges involving its marketing and manufacturing practices and also to pay more than $300 million in criminal and civil penalties. The U.S. attorney’s office in Boston is continuing to investigate the potential criminal liability of Forest officers and employees.

According to federal regulators, Forest waged an aggressive campaign from 1999 through at least 2005 to promote the use of Celexa and Lexapro in children and teenagers, although neither drug was approved for pediatric use.

Details of Forest Laboratories’ monetary settlements with aggrieved families have not been made public, but the lawsuits themselves present a glimpse of the alleged harm caused by the company, including hefty payments to pediatricians and other physicians to tout the benefits of the drugs.

In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence. And the victims’ families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs’ known dangers.

But the settlements are cloaked in secrecy, with each side vowing not to disclose the dollar amounts paid or other aspects of their agreements.

Frank Murdolo, the chief spokesman for Forest Laboratories, was unavailable for comment.

Harris Pogust, a Pennsylvania attorney who is the plaintiffs’ lead counsel in the multidistrict litigation, said, “I can’t really discuss anything that’s going on between the parties.”

The Celexa and Lexapro cases have been consolidated in federal court in St. Louis.

Several years ago, some of Pogust’s clients testified before Congress and the Food and Drug Administration about the dangers of marketing the drugs to children.

One of the cases settled Friday involves Andrew Tradd of Massachusetts, who was 13 when he tried to hang himself in April 2004. Seven days later, he died as a result of a brain injury suffered in that attempted suicide. He had been prescribed Celexa in 2002.

According to his family’s lawsuit, Forest was aware through numerous studies that some patients taking Celexa and similar drugs were much more at risk of suicidal behavior but chose not to warn physicians or strengthen the warning on the drug’s packaging.

Celexa’s sales skyrocketed from $92 million in 1999 to $1.6 billion in 2002. But the firm was under pressure to sell as much of Celexa as possible because the U.S. patent on the drug would expire in 2004.

H. Lundbeck, a Danish firm that developed Celexa, had placed a suicide warning on the drug in Europe for many years but not in the United States — until a “black box” warning was mandated for Celexa and similar drugs in 2004 by the FDA.

The Tradd lawsuit and another suit quote Howard Solomon, the chairman and chief executive of Forest Laboratories, as saying in a letter to shareholders, “We believe that the studies and experience with our products, Lexapro and Celexa, do not indicate any increased suicidality.”

But the Tradd family alleged that “contrary to these claims, for years Forest Laboratories Inc., was aware of clinical trials that showed that some persons who took Celexa suffered damaging side affects including agitation, aggressive and suicidal tendencies.”

Another settled case involves Rachel Weiss of Belchertown, Mass., who was 16 in November 2002 when she suffered a panic attack while at school. En route to the school nurse’s office, her suit alleges, Rachel threw herself down concrete and metal stairs, causing permanent injuries to her back and spine.

A high school sophomore, she had been taking Celexa for about nine days for depression and anxiety. After she began taking Celexa, the suit alleges, “her symptoms worsened dramatically.”

In 2002, a four-year clinical trial by the Danish Lundbeck firm revealed that Celexa did not help depressed adolescents more than a placebo. But the results were not made public until 2004, when they appeared on a single line of a chart contained in a Danish textbook, the suit alleges.

The U.S. attorney’s office in Boston has asserted that the results of the Lundbeck trial had been provided to Forest two years earlier, but the company chose to keep the negative results hidden from the public.

Another settled case involved Danielle Henrikson, who was 15 when she hanged herself in the garage of her parents’ Idaho home in July 2004. Within a few weeks after taking Celexa, their lawsuit alleges, her condition began to deteriorate.

“The company suppressed the negative results of some studies, which showed that Celexa could cause an increased risk of suicidal thinking and acts in those adolescents who were prescribed to it,” the suit alleges.

Forest Laboratories denied the allegation in court documents.

A case settled Friday was on behalf of Alex Kim of Gwinnett County, Ga., who hanged himself in June 2004 when he was 13 after his Lexapro dosage had been doubled. He had been taking the drug for about three months.

In their lawsuit, Alex’s parents asked for $10 million in general damages, plus $10 million in punitive damages from Forest for “failing to provide information regarding serious health risks, failing to publicize the risks, failing to timely alert the public, and failing to recall the product.”

Read the rest of the article here: http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html