What defenses are the drug manufacturer and/or my doctor likely to use?

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What defenses are the drug manufacturer and/or my doctor likely to use?

The basic defense that GlaxoSmithKline will probably rely on is that the use of Paxil did not cause birth defects, increase the chances of the user’s suicide attempt or commission, or create withdrawal symptoms. You can expect that they will try to use medical records in suicide cases to show that the patient had suicidal or homicidal tendencies before starting on Paxil. They will then argue that the use of Paxil did not increase these tendencies, but that it was a failure of the overall treatment plan that led to the incident. In the case of severe withdrawal symptoms, GlaxoSmithKline may, depending on when Paxil was first prescribed for you, argue that your doctor improperly prescribed Paxil after being warned about severe withdrawal symptoms.

If the doctor is also a party to the suit, you can expect that his or her arguments will try to shift all blame to the manufacturer of the drug, stating that GlaxoSmithKline advertised the drug in a misleading way that did not properly advise health professionals of the risks associated with its use. How strong this argument is will depend on the specific facts of your case. Your attorney will be able to advise you.

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What are the major legal issues involved in a case when someone has been injured by Paxil?

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What are the major legal issues involved in a case when someone has been injured by Paxil?

Your case, whether a wrongful death or a personal injury case, will most likely be brought under the theory of product liability – in other words, the manufacturer of the drug put the drug on the market and kept the drug on the market even though it was unreasonably dangerous. GlaxoSmithKline was aware of the serious side effects associated with withdrawal from Paxil; however, they chose to downplay those side effects until the FDA forced them to increase the label warnings in 2001. Furthermore, Paxil was never approved for use in children; nonetheless, GlaxoSmithKline promoted using Paxil for treating depression in children to the doctors who were prescribing it. It now appears that not only does Paxil not have any noticeable effect on depression in children; it increases any suicidal tendencies that the child may have. Whether GlaxoSmithKline realized that the drug acted this way on children or was careless in suggesting that Paxil could be successfully used in children, the fact remains that the company promoted the drug’s use by children knowing full well that this use had not received FDA approval.

Another issue that you and your attorney will deal with is who can be sued. It appears that GlaxoSmithKline was well aware of the difficulty of withdrawing from Paxil while continuing to market the drug as non-habit forming. Furthermore, GlaxoSmithKline knew that the drug had not been approved for use in children and that there appeared to be an increase in suicidal and homicidal tendencies in both children and adults. These problems were not adequately covered by warnings for many years, and GlaxoSmithKline actually marketed the drug in defiance of these issues. Therefore, the primary party to your lawsuit will probably be GlaxoSmithKline, the manufacturer of Paxil.

Another possible party to a lawsuit may be the doctor who prescribed the Paxil. Even if Paxil was being promoted as an antidepressant to be used by children, the FDA had not approved this use, a fact of which doctors should have been aware. If your doctor prescribed your use of Paxil after 2001 and did not adequately warn you about the problems with withdrawal symptoms, you may also have a claim against him or her. In 2001, the FDA required the manufacturer of Paxil to increase the label warnings about withdrawal symptoms, thereby putting your doctor on notice that there might be problems if you needed to stop using the drug.

Other possible plaintiffs may include the pharmaceutical sales representatives who worked with your clinic or the pharmacist who filled the prescription. To sustain a claim against the sales rep, you would need to show that the sales rep either shielded doctors from information about Paxil or provided some type of incentive that was sufficient to persuade doctors to prescribe Paxil in cases where they should not have done so (such as prescribing it for children). This information would probably be available from your doctor or clinic, but it is highly unlikely they would share this information with you. A case may be brought against the pharmacist if he or she did not properly warn you of the side effects of taking or withdrawing from the drug; however, the pharmacist’s defense is going to be that it was the duty of the doctor to determine whether it was appropriate to prescribe the drug in the first place. Therefore, these are not the strongest parties to go after in a lawsuit.

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Paxil Information and Warnings

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Paxil Information and Warnings

Paxil is a selective serotonin reuptake inhibitor (SSRI) approved for treatment of depression and several related disorders in adults. Paxil is not approved by the FDA (Food and Drug Administration) for treatment of children, because studies presented to the FDA have not shown that Paxil is effective for treating children under 18.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Paxil has been implicated in several serious and often life-threatening side effects including suicide, birth defects, and terrible withdrawal symptoms in patients and infants whose mothers took Paxil during pregnancy. A March 2006 study linked Paxil and other SSRIs to a new form of birth defect. The study, published in the New England Journal of Medicine, found that infants born to mothers who took SSRIs, including Paxil, in the last half of their pregnancies were 6 times more likely to develop persistent pulmonary hypertension (PPHN). Infants with PPHN don’t get enough oxygen and require intensive care to survive. Around 10 to 20 percent die soon after birth and some survivors suffer from deafness and neurological problems.
A 2005 FDA warning also implicated Paxil in congenital malformations. (See Drug Warnings: Paxil Side Effects and Risks) Two studies in 2005 indicated that Paxil was more likely to cause side effects than other drugs in the SSRI category. A September 2005 study presented to the FDA showed that there was a higher risk of major congenital malformations in infants whose mothers took Paxil during the first trimester of pregnancy than with other SSRIs.
Paxil, along with all the other SSRIs has been linked with suicide and suicidal thoughts in children, adolescents, and adults. An August 2005 study from Norway found that Paxil presented a higher risk of suicide in adults than other drugs.
Paxil and other SSRI drugs are often prescribed under the American Psychiatric Association treatment guidelines, which say, “most moderately and severely depressed patients will require medication.” A 2005 study led by Pennsylvania psychologist Robert DeRubeis and Steven Hollon from Vanderbilt, has challenged this assumption. Their study found that cognitive therapy was as effective and lasted longer than treatment with SSRI drugs in depressed patients. Most of the patients in the study took SSRIs received Paxil. DeRubeis and Hollon recommend that the American Psychiatric Association revise its treatment guidelines.
A study published in the New England Journal of Medicine in 2008 showed that there were several negative studies showing that antidepressants are not significantly successful in treating depression, but that these studies were either usually not published in the U.S. or were published with misleading results. Because this information has been withheld from doctors and the public, they have been unable to make informed choices about whether antidepressants like Paxil are worth the many risks.
If you’re taking Paxil, you may want to consult with your health care provider about alternative therapies. If you’re pregnant or considering becoming pregnant, consult with your health care provider immediately about possible birth defects. If you or a family member has been injured from using Paxil, you may be entitled to damages. See Paxil Attorney and Lawyer – How to Hire for more information on finding a qualified Paxil attorney to evaluate your case.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
To find out more about the FDA warning, see Paxil Side Effects and Risks
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Drug Warnings: Paxil Side Effects and Risks

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Drug Warnings: Paxil Side Effects and Risks

Paxil (generic paroxetine hydrochloride) is an antidepressant manufactured by the pharmaceutical giant GlaxoSmithKline. Paxil is approved by the FDA (Food and Drug Administration) to treat depression, anxiety, panic, obsessive-compulsive activity, and post traumatic stress in adults. It’s not approved for the treatment of children under 18, because studies have failed to prove Paxil is an effective treatment for children. Paxil is known as a SSRI (selective serotonin reuptake inhibitor) drug.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Paxil has been the focus of debates about safety and the target of several official warnings.
The FDA issued a December 2005 warning about the risks of birth defects in infants born to women who took Paxil during the first trimester of pregnancy. Paxil increased “the risk of congenital malformations, particularly cardiovascular malformations.” Paxil has been more likely to cause birth defects than other SSRIs.
In March 2006, Health Canada issued a strongly worded warning to all pregnant women to take great care in using SSRIs during pregnancy because of the risk of danger to their babies that could be life threatening. Pregnant women were advised to discuss the dangers with their health care providers.
Studies have linked Paxil in particular to cardiovascular malformations, and one study has linked all SSRIs, including Paxil, with three other malformations, two of the head and one of the abdominal wall.
A 2006 study linked SSRIs with a sometimes fatal lung condition in infants whose mothers had taken the drugs.
In March 2006, an FDA research team reviewed studies on children and suicide and concluded that SSRI use increases risks for suicidal thoughts and behavior in patients under 18. An earlier FDA Public Health Advisory warning was given in October 2003, to inform the public about possible increases in suicide and violence in children and teenagers using Paxil. A few months earlier, in June, the British drug regulatory agency had ruled that Paxil should not be prescribed for children. The FDA has not banned the use of SSRIs for children under 18, in spite of a lack of evidence that the treatment with drugs like Paxil is effective for patients in that age group. The FDA has chosen to rely on increased warnings.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease

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Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease

Antidepressant drugs have received a lot of scrutiny in recent years because of the large number of life-threatening and serious side effects they produce. Studies have shown that the antidepressant Paxil, manufactured by the pharmaceutical giant GlaxoSmithKline, is more likely to produce deadly side effects than other SSRI (selective serotonin reuptake inhibitor) drugs. See Paxil Information and Warnings for more information about Paxil’s safety.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Paxil produces a variety of side effects, all of them serious and several deadly.
Paxil is the only SSRI that carries an FDA warning for birth defects, and Paxil has been particularly linked to heart birth defects. Like other SSRI antidepressants, Paxil has also been linked to abdominal wall and brain birth defects in infants. The most recent side effect discovery concerns yet another form of birth defect. Infants born to mothers taking SSRIs in the last half of pregnancy are 6 times more likely to have persistent pulmonary hypertension (PPHN). Infants with this disorder are unable to get enough oxygen and require intensive care. Usually 10 to 20 percent die soon after birth and some survivors suffer from deafness and neurological problems.
Paxil and other SSRI drugs cause problems to babies whose mothers took the drugs during pregnancy, even if they are born without defects. These newborns often suffer withdrawal symptoms including:
Seizures
Tremors
Jitters
Gastrointestinal problems
Loss of appetite
Sleep disturbance
Additional studies have linked SSRIs with premature births and stillbirths. The long-term effects of fetal exposure to SSRI drugs like Paxil have not been tested and won’t be known for several years.
Paxil has also been linked to increased risk for:
Suicidal thoughts
Suicide attempts
Violent behavior
Aggression
Agitation
Worsening emotional states
Anxiety
Sexual dysfunction
Dizziness
Drowsiness
Gastrointestinal complications
An estimated 50 to 75 percent of patients who stop taking Paxil suffer withdrawal symptoms, which might include (and increase) suicidal thoughts and attempts. Other withdrawal symptoms include:
Electric “zaps” in the brain
Dizziness and vertigo
Nightmares
Sleep disturbance
Crying spells
Tremors
Agitation and irritability
Confusion
Difficulty concentrating and remembering
Changes in gait and coordination
Lethargy and fatigue
Weakness
Nausea and vomiting
High fever
Flu-like symptoms
Diarrhea
Another Paxil side effect has surprised researchers, because at this time it cannot be explained. SSRIs have also been found in a Duke University study to increase the risk of death in patients with coronary artery disease by 55 percent.
Recent studies have revealed another surprise. SSRI use has been linked to loss of bone density and bone in elderly men and women.
If you or a family member have suffered injury for Paxil side effects, you might be able to receive damages. See Paxil Attorney and Lawyer – How to Hire to find an attorney to evaluate your case and your assess your legal options.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney.
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
To find out more about the FDA warning, see Paxil Side Effects and Risks
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Paxil Overview: Paxil Side Effects and Claims

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Paxil Overview: Paxil Side Effects and Claims

Paxil, manufactured by GlaxoSmithKline, is one of several selective serotonin reuptake inhibitors (SSRIs) on the market. Paxil was first approved by the FDA (Federal Drug Administration) in 1993, and an estimated 70 million Paxil prescriptions have been filled worldwide, bringing GlaxoSmithKline around $3 billion in annual profit. Paxil is prescribed for depression, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder, and social anxiety disorder. The Paxil claim is that increased levels of serotonin in the spaces between brain cells and that these increased levels allow more efficient transmission of electrical signals to the brain and increases a patient’s feelings of well being.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Several studies have found that SSRI drugs have serious side effects, but that Paxil has a greater risk of side effects than other SSRIs. Paxil has been the subject of FDA warnings on suicide in children and adolescents and for the danger of birth defects. A recent study has implicated Paxil in a new form of birth defect. See Paxil Information and Warnings for study results and Drug Warnings: Paxil Side Effects and Risks for information about official warnings on the safety of Paxil.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding Paxil attorney:
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
To find out more about the FDA warning, see Paxil Side Effects and Risks
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Court Rules Paxil Manufacturer Can’t Hide Behind Preemption

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Court Rules Paxil Manufacturer Can’t Hide Behind Preemption

A Pennsylvania court recently ruled that GlaxoSmithKline (GSK), the manufacturer of the popular antidepressant drug Paxil, cannot claim that those injured by the drug are preempted from suing the company.
No preemption
The Philadelphia, PA court denied GSK’s request to dismiss a case brought by the parents of Harold Garrison, a 16 year-old who committed suicide after taking Paxil (generically known as paroxetine hydrochloride) for approximately nine months. According to the judge in the case, “The evidence suggests a triable issue of fact as to whether GSK indeed possessed information, not available to the FDA [U.S. Food and Drug Administration], upon which it could have unilaterally added a warning to its labeling, consistent with FDA regulations.”
The FDA’s position
The FDA has been investigating whether antidepressant drugs such as Paxil increase the risk of suicide in children. The FDA issued a warning in September 2004 for Paxil stating that the drug can cause suicidal behavior in minors. That warning followed a study from Great Britain which reported that over 1,000 children taking Paxil had an increased rate of suicidal behavior.
The FDA issued another warning for Paxil in May 2006 after a different study showed that young adults ages 18 – 30 also showed an increased rate of suicidal behavior. The court’s ruling to let the lawsuit go forward was partially based upon the fact that the FDA had not yet taken a position on antidepressants prescribed for children at the time of Garrison’s suicide in 2002. However, the issue of preemption and drug manufacturers will be decided by the U.S. Supreme Court in the next few months.
Why didn’t GSK warn consumers?
That’s what the parents of Garrison want to know. In fact, many others in the U.S., Canada and the Great Britain also want to know. While GSK states that it wasn’t required to warn consumers about suicidal behavior in children because the FDA hadn’t required it to, the court disagreed and stated that the FDA’s rules allow drug manufacturers to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.”
According to news reports, GSK faces several lawsuits in each country alleging that Paxil causes suicidal and homicidal behavior and is an addictive drug. They claim that GSK knew of the increased risks of suicide in minors, but kept that information to itself to boost sales.
If you or a loved one has been injured due to Paxil use, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.

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Indiana Judge Rules Preemption Not a Factor in Paxil Case

Preemption Not Factor In Paxil Case Drug Toxic Chemicals

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Indiana Judge Rules Preemption Not a Factor in Paxil Case

A federal judge in Indiana has reversed his prior ruling that the family members of a Paxil patient who committed suicide were preempted from suing SmithKline Beecham, the manufacturer of the drug.
The underlying case
The underlying case involves a 55 year old Indiana Catholic priest who committed suicide by shooting himself in the head after he began taking the anti-depressant drug Paxil for 22 days in 2000. The sister of the priest brought a lawsuit against SmithKline Beecham, now GlaxoSmithKline, alleging that her brother’s Paxil use caused him to commit suicide.
U.S. District Court Judge David Hamilton originally dismissed the case based on preemption – which states that a plaintiff cannot bring a claim against a drug manufacturer when the U.S. Food and Drug Administration (FDA) was ultimately responsible for approving the drug’s use in the marketplace. However, Hamilton reversed his own decision and allowed the case to move forward. In his opinion, he explained that he originally “failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.”
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
What the case means
This case comes on the heels of a similar case to be decided by the U.S. Supreme Court this fall. In that case, Wyeth v. Levine, a Vermont woman lost her arm after taking Wyeth Pharmaceutical’s drug, Phenergan. She sued Wyeth in a case that ended up in the Vermont Supreme Court, which ultimately upheld a $6 million judgment in her favor. She alleged that the pharmaceutical giant had not established an adequate warning – even though it complied with the FDA’s requirements.
The ruling in the Indiana case lends further credence to the theory that pharmaceutical companies should be held liable for their products regardless of the FDA’s involvement. However, others – such as Bush Administration – disagree and believe that the FDA, and not pharmaceutical companies, should be responsible for drug safety. Unfortunately, patients cannot sue the FDA when it errs.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Paxil Investigation Increases in Scope

Paxil Investigation Increases In Scope Drug Toxic Chemicals

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Paxil Investigation Increases in Scope

The investigation into GlaxoSmithKline’s (GSK) anti depressant drug Paxil, and its link to adolescent suicide, is increasing in scope. The U.S. Attorney’s office in Boston is now involved as additional information is sought about how GSK portrayed the drug.
Investigation
Senator Charles Grassley (R-IA) had asked the U.S. Food and Drug Administration (FDA) to investigate what GSK knew about the risk of adolescent suicide and Paxil, or paroxetine hydrochloride, which is an SSRI (selective serotonin reuptake inhibitor) prescribed for the treatment of depression, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder and social anxiety disorder.
The investigation has now increased in scope to include the U.S. Attorney’s office in Boston, Massachusetts according to a story published in the Wall Street Journal last week. It is being alleged that GSK may have downplayed Paxil’s risk of suicide in adolescents to doctors and to the FDA. Although Paxil was not approved for use by anyone under the age of 18, experts say that many doctors have prescribed the drug to adolescents for a variety of off-label uses and the FDA has since required GSK to provide a warning of those risks on the drug’s label.
Lawsuits over Paxil span the globe
U.S. patients are not the only ones who have brought lawsuits over Paxil. In fact, it was a British study on the links between adolescent suicide and Paxil (marketed there under the name Seroxat) that prompted the U.S. investigation. Although GSK was not charged with any wrongdoing in the British investigation, many believe that was simply due to differences in how data is collected in the United Kingdom. Patients there have brought another lawsuit against GSK alleging that the drug is defective in that it creates an addiction – even though the label specifically claims that it is not. Patients have not been able to get off of the drug without going through serious withdrawal.
It is estimated that nearly 100 million prescriptions of Paxil, which received FDA approval in 1992, are filled each year. If you believe your child was harmed by Paxil, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.

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Hiring A Paxil Attorney and Lawyer – How to Hire

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Hiring A Paxil Attorney and Lawyer – How to Hire

If you or a family member has suffered injury from one or more of the many Paxil side effects, you may be entitled to receive compensation for those injuries. You will want to have your Paxil lawsuit evaluated as soon as possible, because your state’s law limits the time you have to file this litigation. It is important to get your case to an experienced Paxil attorney before the deadline. Your qualified Paxil lawyer can help you file your case on time and make procedural decisions, such as who to name as defendants and the best and most favorable court to file your Paxil lawsuit.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Pharmaceutical litigation is very complicated and specialized and not the kind of litigation that you would want to handle on your own or where you would want to be represented by an inexperienced attorney. You are up against the power and resources of expert and very competent attorneys who regularly represent large pharmaceutical companies. Where the stakes are high, the most prudent course is to consult with an attorney, even to negotiate your case.
Finding a good specialist is not always easy. You might try getting recommendations from friends or attorney you know. If that doesn’t work, a good place to start looking is AttorneyPages.com, where you’ll find listings for drug liability specialists in your area, or post your case to the free Case Evaluation Form. After posting your case, an experienced law firm that handles Paxil and similar cases will contact you for a free case evaluation, without any obligation.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
To find out more about the FDA warning, see Paxil Side Effects and Risks
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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