Baum Hedlund client testifies about Paxil to the FDA

Baum, Hedlund, Aristei & Goldman's drug department litigates pharmaceutical drug product liability lawsuits.  They have represented thousands of victims of drug-induced injury and death for more than 20 years. Baum Hedlund has extensive experience in litigating personal injury, wrongful death and consumer class action cases against major drug companies and has been litigating a number of different types of cases against GlaxoSmithKline (GSK), the maker of Paxil, for many years.  Baum Hedlund has the longest track-record of handling SSRI antidepressant litigation.

Paxil Birth Defects - First Trial Updates!

Paxil and PPHN

Paxil and Other Birth Defects

Baum Hedlund’s Extensive Experience re: Paxil

Paxil Suicide and Suicide Attempt Cases

Paxil Consumer Class Action Lawsuits


Paxil Birth Defects

The firm represents dozens of families whose children were born with congenital heart defects after their mothers' ingestion of Paxil during pregnancy. Beginning in 2006, we filed a number of Paxil birth defect cases against GSK, which cases are pending in courts across the nation.

Kate Gillespie: Preparing for the Battle Over Paxil and Birth Defects | “These are truly tragic cases,” says Gillespie. “Many babies do not survive beyond birth, while others only live days or months. Those who survive may require a heart transplant at some point in the future... These moms and dads have to go through this over and over."

In 2003, GSK initiated a retrospective analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of their pregnancies and who had given birth to children with major congenital malformations. The analysis showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants. Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005, also found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.

Child born with severe heart defects sues Paxil - makerIn September 2005, GSK sent out a “Dear Doctor” letter informing physicians throughout the United States that the results of its analysis showed a higher rate of “congenital malformations associated with the use of Paxil as compared to other antidepressants” in infants born to women taking antidepressants during the first trimester of pregnancy. The most common malformations for mothers taking Paxil were cardiovascular, particularly ventricular septal defects (“VSD”).

The FDA has issued a number Public Health Advisories since December 2005 concerning the risk of congenital heart defects and has changed Paxil’s pregnancy category from C to D, which indicates that “[t]here is positive evidence of fetal risk.”

On November 29, 2006, the American College of Obstetricians and Gynecologist ("ACOG"), a group that represents America’s obstetricians, recommended that women who are pregnant or plan to become pregnant, should avoid the antidepressant Paxil.

To learn more about Paxil birth defects,
please visit www.paxilbirthdefect.com
.

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If you believe your child's birth defects
or PPHN may be related to the use of Paxil
or other antidepressants during pregnancy,
Contact Baum, Hedlund, Aristei & Goldman
today for a free consultation.


PPHN (Persistent Pulmonary Hypertension of the Newborn)

Baum Hedlund represents numerous families whose children were born with Persistent Pulmonary Hypertension of the Newborn (PPHN) after their mothers' ingestion of Paxil during pregnancy.

Persistent Pulmonary Hypertension of the newborn (PPHN), is a life-threatening disorder in which the newborn’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream. Ten percent to 20 percent of infants with PPHN will end up dying even if they receive treatment.

A recent study published in the New England Journal of Medicine (NEJM) by Christina Chambers of the University of California, San Diego, found a sixfold increased risk of persistent pulmonary hypertension (PPH) in infants born to mothers who took an antidepressant in the last trimester of pregnancy. On July 19, 2006, the FDA issued a Public Health Advisory for Paxil and several other antidepressants based on this study.

To learn more about Paxil and PPHN,
please visit www.paxilbirthdefect.com
.

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Paxil and Other Birth Defects

The firm is also investigating the link between Paxil and other types of birth defects. A study published in Teratology Society Abstracts in 2005 reported that women who took Paxil were more likely than those who were not exposed to have an infant with omphalocele (a fetal malformation in which variable amounts of abdominal contents protrude into the base of the umbilical cord) and craniosynostosis (the early closing of one or more of the sutures of an infant’s head, resulting in malformation of the skull). The strongest effect was reported to be with Paxil.

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Baum Hedlund’s Extensive Experience Litigating Injury and Death Cases Against GSK

Our law firm filed its first Paxil injury lawsuit against GSK in 2001. In that litigation, Baum Hedlund was appointed lead counsel in charge of the Plaintiffs’ Steering Committee for the Paxil Products Liability Litigation (Multidistrict Litigation MDL-1574) in which Baum Hedlund represented more than 3,000 people across the United States in personal injury cases against GSK.

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Paxil Suicide and Suicide Attempt Cases

The firm has been litigating Paxil suicide and suicide attempt cases for the past several years and has a number of cases pending in courts across the United States. Baum Hedlund has collected hundreds of thousands of pages of internal GSK documents and conducted dozens of depositions of GSK executives, employees, physicians, researchers and academics. As a result, we know how GSK operates, we know its tactics, the key players and how to get the evidence needed to effectively litigate cases against GSK. 

Key preemption win in Paxil suicide case.We have seen the harm antidepressants can cause and the extent to which drug companies will go to protect their enormously profitable drugs and we and our clients have testified about this to the FDA. Baum Hedlund has accumulated a considerable body of evidence demonstrating that Paxil is associated with an increased risk of suicidality in all age groups, not just children and young adults, and that GSK was aware of the risk and yet chose not to warn the public of this serious risk. Instead, GSK over promoted the benefits of the drug while downplaying the risks.

On October 15, 2004, the FDA asked antidepressant manufacturers to add a black box warning to their labels to alert health care providers to an increased risk of suicidality caused by antidepressants in children and adolescents.  On May 2, 2007, the FDA announced that it had asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults, but only ages 18 to 24.  Based on our own 18-year investigation into the harmful side effects of antidepressants, we believe this warning should include people of all ages.  

The first Paxil suicide case is scheduled to go to trial in 2009.

The Truth About Antidepressant-Induced Suicide

To learn more about the adverse reactions associated with Paxil,
please visit www.a-paxil-lawyer-source.com/index.shtml.


For more information and resources concerning antidepressants, visit

antidepressantadversereactions.com.



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Consumer Class Action Lawsuits

Since 2004, Baum Hedlund has been litigating Private Attorney General consumer fraud class action lawsuits against GSK on behalf of individuals and entities (insurance companies, state medical welfare agencies)  in California, Florida, Massachusetts, Nevada, New Jersey, Pennsylvania, Texas and Washington. 

The cases are based on internal GSK documents showing that GSK falsely promoted Paxil as an effective medication for children and adolescents despite internal communications acknowledging that Paxil’s pediatric depression clinical trials failed to out-perform sugar pills, yet had higher suicidality rates than sugar pills. Notwithstanding, GSK promoted Paxil as being “remarkably safe and effective” for depressed children. A settlement was reached in April 2007 wherein GSK agreed to reimburse parents for all of the money they paid for their children’s Paxil prescriptions. To learn more about this settlement please visit
http://www.baumhedlundlaw.com/bhl2_press/paxil_pediatric_class_action.php.

Baum Hedlund’s consumer fraud cases on behalf of the entities class (state agencies, insurance companies) will be continuing in cases filed in Minnesota and California with insurance companies as class representatives to recover funds they paid for pediatric Paxil prescriptions.

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