Friday, August 6, 2010

Lexapro Legal Problems Mount Against Forest Laboratories

Evelyn Pringle November 15, 2006

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

The drugs belong to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Sales of Lexapro, the filing notes, increased 16% in the 4th quarter to $464,100,000, compared to $399,381,000 in the same quarter a year ago.

However, the Report filed with the SEC on June 14, 2006, also says that Forest Labs is currently a named defendant in approximately 25 active SSRI related lawsuits, with most of the cases claiming that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.

On November 7, 2005, Forest moved to consolidate all of the cases pending in Federal courts into a multidistrict proceeding, and on February 6, 2006, its motion was granted and multidistrict litigation was established with the cases then pending transferred to Judge Rodney Sippel in the US District Court for the Eastern District of Missouri.

But the company's legal troubles by far are not limited to a few civil lawsuits. The US Attorney's Office for the District of Massachusetts is investigating whether Forest has committed not only civil violations but also criminal violations of the Federal Anti-Kickback laws with "off-label" promotional activities in the marketing of Lexapro and other products.

As part of the investigation, Forest first received a subpoena from the Office of Inspector General of the Federal Office of Personnel Management requesting documents relating to Celexa, but the company has since received another subpoena from the US Attorney's Office related to Lexapro and other products.

The subpoenas request documents relating to a broad range of the company's marketing and promotional activities dating back to January 1, 1997, all the way up to the present.

The truth is, right along with all the other SSRI makers, Forest has been marketing Lexapro for the off-label treatment of a wide variety of ailments in part, by promoting the notion that every uncomfortable feeling is caused by a "chemical imbalance." However, according to Dr David Healy, "none of the SSRI manufacturers can tell us what constitutes a proper chemical balance of serotonin in the brain."

"Thus," he says, "the truth is that Lexapro and its serotonergic cousins lie somewhere on the continuum between "magic bullets and snake oil."

Dr Healy is one of the world's leading authorities on SSRIs and the author of, "The Antidepressant Era," and "The Creation of Psychopharmacology."

To expand the market for SSRIs, the drug companies have transformed everyday sadness, stress, and worry into mental disorders that demand one cure: drugs. Strong emotions felt after the death of a loved one, or a divorce, or job loss are now irrational and symptoms of mental illness.

In fact, over the past 15 years Big Pharma has managed to cultivate the development of a whole new batch of mental illnesses, with names like generalized anxiety disorder, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder, by simply greasing the palms of the so-called psychiatric "experts" who determine the criteria for the inclusion of a disorder in the Diagnostic and Statistical Manual for Mental Disorders (DSM).

Other more recent additions to the DSM, intended to further widen the customer recruitment net to specifically target children, have names like reading disorder, mathematics disorder, disorder of written expression, and oppositional defiant disorder.

And with the inclusion in the DSM, comes the guaranteed payment for the drugs to treat the disorder from public and private health insurance programs. The first edition of the DSM had a little over 100 disorders; the latest edition lists close to 375.

The mass marketing of mental illness has led many people experiencing minimal symptoms of distress to believe they need drugs to exist. And because most doctors are not trained on the side effects of SSRIs, patients can exhibit a wide range of actions or behaviors that appear to be symptoms of another "disorder," and are then prescribed more drugs to counter the unrecognized adverse reactions to the first.

Even the medical education courses that doctors must take each year to maintain their professional license are most of the time sponsored by drug companies which means the courses are intended to increase the sale of specific drugs, and to educate doctors on their adverse effects would defeat the whole purpose of the seminar.

In fact, experts say the drug makers continue to ignore and discount all of the adverse effects associated with SSRIs. For instance, sexual dysfunction, such as lack of libido or interest, orgasmic dysfunction in women, and delayed ejaculation in men, are extremely common but seldom mentioned. Studies have shown that as high as 70% of patients on SSRIs experience sexual side effects.

According to WebMD, on July 2005, these side effects cause significant problems of their own. "For both men and women, this means being unable to initiate, participate fully in, or enjoy sex," the article states, "and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery."

But then not to worry, because a study in the January 1, 2003, Journal of the American Medical Association says that people experiencing SSRI related sexual dysfunction may be helped by simply taking another pill, Viagra.

And, although the FDA has not approved Viagra for women, some "experts" recommend that women experiencing SSRI related sexual problems should give it a shot anyways.

Whenever possible, patients are convinced that they need to take SSRIs for life. It would be interesting to see the results of a survey that asked patients if they would be willing to begin a life-long drug treatment if it meant waving good-by to a normal healthy sex life.

As a follow-up, a survey should also be conducted on the partners of SSRI patients to find out how long they will be willing to remain in what often becomes a sexless relationship.

The drug companies have also tried for years to discount the many studies showing an increased risk of suicide in patients taking SSRIs, when compared to patients taking a placebo, by claiming that suicide is a side effect of depression.

This claim is an insult to the intelligence of consumers. If that assertion were true, there would be more suicides by people taking placebos, not the other way around.

An FDA patient information sheet for Lexapro now says: "Persons taking Lexapro may be more likely to think about killing themselves or actually try to do so, especially when Lexapro is first started or the dose is changed."

"People close to persons taking Lexapro can help by paying attention to changes in user's moods or actions," the paper says. "Contact your health-care professional right away," it warns, "if someone using Lexapro talks about or shows signs of killing him or herself."

"If you are taking Lexapro yourself and you start thinking about killing yourself," it instructs patients, "tell your health-care professional about this side effect right away."

That simple warning, critics say, added to the doctor and patent information sheet for SSRIs when the problem was first discovered could have saved tens of thousand of lives.

One of the Lexapro-induced suicide lawsuits mentioned in Forest's Annual Report, was filed by Raymond Badyna, as the administer of his deceased son, Ray Badyna's estate.

The action was filed in the US District Court for the District of New Jersey on September 25, 2005, by attorneys, Derek Braslow and Harris Pobust, of the Pogust & Braslow, LLC law firm in Conshohocken, Pennsylvania.

On September 30, 2003, Ray was prescribed Lexapro by his primary care physician who noted that Ray was experiencing anxiety, depression and was having problems relaxing and sleeping at night.

Ray's doctor said that he prescribed Lexapro because he believed the drug was effective in treating depression and anxiety based on research that was distributed by Forest Labs.

However, the drug did not help and Ray's condition immediately began to deteriorate. Friends and co-workers spoke with Ray concerning his use of Lexapro and they recall that Ray said that he was not feeling himself and feeling very strange.

At his sister's birthday party on October 4, 2003, the family observed Ray as appearing extremely withdrawn, tired and isolated. His sister noticed that he was pacing back and forth throughout the house, looked uneasy, and that his hands were shaking.

His sister became convinced that something was seriously wrong with Ray and she was right. Unbeknownst to his family, Ray was suffering from suicidal ideation and had expressed thoughts about harming himself to others.

In a conversation with his friend, Ray complained that Lexapro was making him "feel weird" and said that he "had very strange thoughts running through his mind."

On October 7, 2003, while at work, Ray got what should have been great news when he was notified that his year to date performance had qualified him to receive the, "Countrywide Circle of Excellence Award," for the second consecutive year in a row.

Two days later, on October 9, 2003, Ray, age 32, committed suicide by overdosing and cutting his wrists. An autopsy showed the presence of Lexapro in his bloodstream.

Ray's death was senseless. He life was a model for the all-American success story. He was popular, outgoing and sociable and had a loving close relationship with his family.

Ray had a college education, and a good career in real estate and owned his own home, as well as four other investment properties, and even a boat.

Family members, friends and co-workers alike, all say Ray was outgoing, had a great sense of humor, enjoyed life and seemed to everything to live for, prior to being prescribed Lexapro. If Ray's family members had been told to watch for the warning signs that Ray was exhibiting, they would have intervened, and he would be alive today.

The family's lawsuit alleges that in "the last decade there has been a host of peer-reviewed scientific literature linking the SSRI drugs, of which Lexapro is one, to violence - both self-directed and directed towards others."

Among others, the complaint specifically cites a peer reviewed article published in 2000, on an epidemiological study, funded in part by Eli Lilly and SmithKlineBeecham, that reports that the incident of deliberate self-harm of people on SSRI medications is 5.5 times higher than that of people on the more traditional tricyclic antidepressants.

"Had Ray or his physician known of the increased risk of suicide and suicidal ideation from Lexapro," the family's lawsuit states, "Ray would have never taken the drug."

Next year's annual report will have new additions to the list of lawsuits against Forest. For instance, in July 2006, Mark Bibbee, filed a lawsuit after losing his only 2 sons to Lexapro-induced suicides. The family's attorney, Charles E Grisi, filed the action in Summit County Ohio Common Pleas Court.

David Bibbee was only 27 when he killed himself on February 23, 2003 at his fathers home, and Brian Bibbee was only 24, when he committed suicide 17 months later at his mother's home on July 24, 2004.

The lawsuit charges that Forest Labs knew of the increased risk of suicide, yet failed to conduct tests to see how often the problem occurred and failed to properly warn doctors, pharmacists and patients of the risk, or provide ways to reduce the risk.

The lawsuit points out that a link between SSRIs and suicide was first noted in 1990, even though the FDA did not issue a public health advisory until March 2004, more than a year after David's death and about four months prior to Brian's death.

"Strong warnings and instructions, coupled with reasonable effort to 'get the word out' could still have saved Brian Bibbee's life," the lawsuit states.

"Unfortunately," the complaint charges, "Forest took the path of least resistance and greatest profits by doing only the minimum amount that the FDA urged it to do."

"Therefore," the lawsuits states, "this warning was 'too little, too late' for David and Brian Bibbee."

These three cases of unexpected suicides by young people taking Lexapro are not isolated incidents. Jo Ann Kelly has been trying to raise awareness about the increased risk of suicide associated with SSRIs since her son, David died of a self inflicted gun shot wound after he was prescribed Lexapro for an anxiety disorder.

A few days before his death, Jo Ann noticed a dryness of skin and an increased agitation in David, and her son-in-law noticed a yellowish appearance in David's eyes.

Jo Ann became frantic and feared that her son might not be metabolizing the Lexapro correctly so she called to schedule a doctor's appointment but could not get in for 2 days.

The day of the appointment came too late; David had already shot himself.

Over the past several years, studies have shown that SSRIs are associated with serious birth defects in babies born to women who use the drugs during pregnancy. Within the last year, the FDA has added warnings to the labels on SSRIs about the risks of heart birth defects and a life-threatening lung disorder.

As a result of the new revelations about birth defects, lawsuits are now being filed against the SSRI makers on behalf of injured infants.

Medical professionals say the value of any drug must be determined by weighing its benefits against its risks. In the case of SSRIs, the benefits, if any, are a topic of great controversy. An analysis of studies submitted to the FDA between 1987 and 1999, on the six most popular SSRIs, found that approximately 80% of the positive responses to the drugs were the same in patients participating in the placebo groups.

Simply put, with all the known harms identified over the past 20 years associated with SSRIs, they do not even work.