OpEdNews - Article: Forest Labs Bogged Down With Celexa Legal Woes

According to Forest Laboratories Annual Report for the year ending March 31, 2006, the company's antidepressant franchise, consisting of Celexa and Lexapro, accounted for 68% of the company's sales.

But the flip-side of the coin is that Forest Labs is currently facing a wide variety of legal problems involving civil lawsuits and government investigations that could result in fines and damage awards that will off-set the profits from its top selling drugs for many years to come.

Celexa and Lexapro belong to the relatively new class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Celexa was developed by the Danish pharmaceutical firm, H. Lundbeck A/S and was introduced into the US market by Forest Laboratories and Parke-Davis in September 1998.

According to its Annual Report filed with the SEC on June 14, 2006, Forest Labs is a defendant in approximately 25 active product liability lawsuits, with most of the complaints alleging that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.

"The suits," the Report states, "seek substantial compensatory and punitive damages."

Possibly unbeknownst to Forest, the company is set to be hit with the first Celexa birth defects lawsuit in Kentucky alleging that the company has engaged in "repeated and persistent fraud" by misrepresenting, concealing and otherwise failing to disclose, information concerning the safety and effectiveness of Celexa in treating pregnant women.

A plaintiff in the case, Lacee Shore, was prescribed Celexa during her first trimester of pregnancy by Dr. David Smith, another defendant to be named in the lawsuit, and as a result, Ms. Shore's baby, Gavin Shore, was born with serious heart birth defects.

Gavin was born on May 2, 2006 and diagnosed with Shone's Complex, a form of congenital heart disease that consists of multiple anatomic defects that lead to the obstruction of blood flow from the left side of the heart to the body.

Doctors have performed surgeries in an effort to correct the heart defects but if he survives, Gavin will have to undergo another surgery at the age of 3, and another in his teenage years.

According to the Madison Foundation, although current advances in heart surgery have helped increase the survival rate of infants in recent years, the overall prognosis for infants with the Shown's Complex is still poor. "Infection, stroke, heart block (interruption of the electrical activity of the heart) and chronic heart failure are frequent complications of repeated surgeries," its web site explains.

According to Robert Kwok, the Houston, Texas attorney handling the lawsuit, "Little Gavin is a fly-weight contender in a heavy-weight fight against Shone's Anamoly."

"A 1990 study by the University of Michigan shows the outlook for patients like Gavin is very poor," he states.

"One quarter of patients die after their second operation," he says, "and second operations are very often necessary because of the complexity of the heart problem."

In regard to Celexa, the Shore lawsuit accuses the defendants of, "misrepresenting the severity, frequency and discomfort of side effects; and manipulating statistics to suggest widespread acceptability, while downplaying the known adverse and serious health effects, including but not limited to, risk of birth defects to the fetus, particularly major congenital malformations, and damage to the heart in infants born to a women taking Celexa the first trimester of pregnancy, and other related illnesses and conditions."

According to Mr Kwok, "Forest Laboratories is selling the idea of a depression epidemic to doctors and women, creating a market for its antidepressant drugs, and then reaping billions of dollars in prescriptions."

"But they sure don't put the same level of effort into the science of their drugs," he notes.

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