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SSRI LawsuitPrenatal Exposure to Antidepressant Linked to Birth Defects

SSRI Lawsuit: Prenatal Exposure to Antidepressant Linked to Birth Defects

Selective serotonin reuptake inhibitors (SSRIs) are medications prescribed to treat depression and other mental illnesses. They’re the most widely prescribed antidepressant medications, but there is evidence that links the use of SSRIs during pregnancy to birth defects which has lead to an SSRI lawsuit being filed.

Litigation Updates

Awaiting Court’s Ruling on Future of Paxil Cases

August 2018 - Both the prosecutors and defendants have fully briefed the defendants' motion to dismiss or transfer of plaintiffs' cases. We are currently awaiting the Court's ruling on whether or not to dismiss these cases.

Lawsuits Move Forward in Cook County

April 2018 - Lawsuits moving forward in Cook County after the Supreme Court refused to hear the Defendant's appeal. TorHoerman Law has been actively involved in court appearances since a new judge was appointed in January and the firm expects to receive an updated court soon.

U.S. Supreme Court Refuses to Restrict Personal Jurisdiction in Landmark Paxil Case

October 2, 2017 - The U.S. Supreme Court denied cert on M.M. ex rel. Meyers v. GlaxoSmithKline LLC, letting stand an Illinois appellate court case that held that GlaxoSmithKline, a UK company with U.S. headquarters in Philadelphia, would need to defend itself in Illinois state court for catastrophic birth defect injuries resulting from pregnant mothers’ use of its anti-depressant, Paxil. Read more about the personal jurisdiction verdict here.

GSK Refuses to Pay Families Injured by Paxil

2013 - GlaxoSmithKline refuses to pay families of children severely injured as a result of their mother's use of Paxil antidepressant pills during pregnancy.

Zoloft Litigation Moved Forward

January 30, 2013 - Since the first Case Management Order, setting the initial policies and protocols for the litigation, was entered in October 2012, Zoloft litigation under the honorable Cynthia M. Rufe in the Eastern District of Pennsylvania has continued to move forward.

On November 15, 2012, the Court issued a Joint Discovery and Scheduling Plan. Thus, discovery has already begun, with Pfizer beginning the process of producing documents and identifying witnesses for trial. Furthermore, the scheduling for Daubert motions (arguments for admissibility of expert testimony) have been set, as has the date for the first trial, which is to begin no later than September 12, 2014.

On January 17th, the Court issued Pretrial Order No. 17, which established that an initial discovery group of 25 cases was appropriate. Selection of these 25 cases will be divided among Plaintiffs’ Counsel and Defense Counsel and will serve as the initial group for discovery and trial preparation.

While this does not mean that all 25 of these cases will be tried, or even that the initial 25 selected cases will be the final ones evaluated for trial, it does mean that a framework is in place that will significantly advance this litigation.

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What are Selective Serotonin Reuptake Inhibitors (SSRIs)?

SSRIs are drugs commonly prescribed anti-depressants used to treat conditions such as depression, obsessive-compulsive disorder, panic disorder, anxiety disorder, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Specifically, SSRIs are a class of drugs that work by increasing serotonin levels in the brain. Serotonin, a naturally occurring chemical in the brain, has been known to affect mood. Our bodies naturally regulate the levels of serotonin, but SSRI drugs prevent the absorption of serotonin thus increasing the levels of serotonin in the brain.

Approved for use in the 1980s, SSRIs have become the most widely prescribed antidepressants on the market. Unfortunately, research has found serious side effects associated with the drugs, such as birth defects, withdrawal complications, and suicidal behaviors and thoughts.

In 2006, a drug safety communication was issued by the U.S. Food and Drug Administration related to a possible link between the drugs and birth defects. In 2011, the FDA again issued a drug safety communication alert following an increased number of studies suggesting a greater link between the use of SSRIs during pregnancy and rare heart and lung conditions in babies.

 

Which Drugs are Considered SSRI Drugs?

  • Paxil (paroxetine)
  • Zoloft (sertraline)
  • Prozac (fluoxetine)
  • Effexor (venlafaxine)
  • Celexa (citalopram)
  • Lexapro (escitalopram)
  • Symbyax (olanzapine/fluoxetine)
  • Wellbutrin (bupropion)
  • Cymbalta (duloxetine)

 

Women and Depression – Are SSRI’s Worth the Risk?

Women who find themselves at crossroads in their life in terms of career and family often find themselves depressed and looking for help which often leads to the use of antidepressants. In fact, women between the ages of 25 and 44 incur a higher rate of depression than any other group and studies have shown that one in 10 women in America is taking antidepressants. The most widely prescribed antidepressants belong to a class of medication known as selective serotonin reuptake inhibitors (SSRIs).

Although SSRIs have been known to help when combined with therapy and exercise, women of this age have the added complexity of potentially risking the health of a yet unborn child when using these antidepressants. The awful truth is that many women don’t know of the risks when they are prescribed the medication.

Certainly, women are not lacking in information about the “benefit” side to this analysis. Turn the TV on and you will come surely across a well-produced SSRI commercial showing depressed women who find their way towards happiness when they take this miracle pill. After a complete change in lifestyle of the commercial’s actress, women are then encouraged to “ask your doctor about (fill in the blank) medication to see if it is right for you.”

It is important for women to take a look at the other side of the analysis. Are manufacturers advertising or warning about the risk of women in child-bearing years take when they use SSRI’s? Sadly, the same manufacturers who continue to increase their budgets for consumer-directed advertising of these drugs do not spend nearly the same amount of time or effort warning about the risks. A few seconds of rattling off the potential risks at the end of a well-produced TV commercial seems highly unlikely at actually getting the public’s attention.

It is imperative that women get full disclosure of the risks of fetal birth defects In order to do a proper risk-benefit analysis of whether or not SSRI’s are the answer they have been looking for.

 

Injuries We’re Pursuing in SSRI Lawsuit

For years now, we have been working with children and families suffering from terribly deforming and debilitating malformations. All of these injuries were avoidable, resulting from the expecting mother innocently taking one of these pills during pregnancy. Warnings should have been given. It angers and saddens us to learn that these medications could cause such terrible side effects.

The science surrounding the injuries that these drugs cause to the unborn child has evolved over the years. TorHoerman Law is pursuing SSRI lawsuit cases for the following injuries:

  • Structural heart defects when taken during the first three months of pregnancy,
  • Persistent Pulmonary Hypertension of the newborn (PPHN) when taken during the last half of pregnancy,
    • Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after the birth of a newborn. Infants born to mothers who took selective serotonin inhibitors (SSRIs) after the 20th week of pregnancy are six times more likely to have PPHN, according to a February 2006 study in the New England Journal of Medicine.
    • Newborn babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. Babies that have PPHN often need intensive medical care, and the condition can lead to marked developmental delays and can also be fatal.
    • About one to two babies per 1000 babies born in the U.S. develop PPHN shortly after birth. However, in the case of a mother’s use of SSRI after the 20th week of pregnancy, this percentage increases six times.
  • Anencephaly – a birth defect that affects the brain and skull,
  • Craniosynostosis – a birth defect that affects fibrous sutures on the head, and
  • Omphalocele – a birth defect that affects the abdominal organs.

 

If you took an SSRI while pregnant and your child had one of these injuries, please reach out to TorHoerman Law to see if our birth injury lawyers can help you with a birth defect lawsuit.

 

Injuries Resulting from SSRIs and Zofran

There are many side effects associated with SSRIs, but when the drug is combined with Zofran, an anti-nausea medication, the interaction can cause serotonin syndrome, a potentially severe or life-threatening condition.

If you have any questions regarding a Zofran lawsuit, please reach out to the office of TorHoerman Law.

 

SSRI Lawsuit: What Can be Done?

Millions of young women have turned to prescription antidepressants such as those listed above.   Lacking adequate warnings from drug manufacturers, women have in the past and unfortunately continue to this day, to take the drugs while they are pregnant, without being given adequate warning about the risks involved with taking these drugs during pregnancy.

Paxil has received the most attention regarding injuries relating to its use during pregnancy.  However, more and more information is being learned about all of the drugs in this class of medication and the effects they have on the fetus.

Each situation needs to be balanced on a patient by patient basis.  In fact, any medication taken by pregnant women, including SSRI medications, should be taken only if needed and with careful consideration of all the risks.  Unfortunately, we don’t believe that all of the real risks have been disclosed to physicians and patients, making such a risk-benefit analysis very difficult, if not impossible.

As we have said before, we need to fight back against the efforts at corporate protectionism. We need to hold these companies responsible for the harm they are causing and fight against those seeking methods to shield corporations from responsibility. There is no more perfect example of the type of innocent victim we need to protect than these innocent children that are being born with such terrible injuries.

If you have any questions regarding an SSRI lawsuit, call our office or send us an email at info@thlawyer.com.

 

Timeline

Mirapex Drug Safety Communication Issued for Risk of Heart Failure in Parkinson’s Disease and Restless Leg Syndrome Patients

September 19, 2012 - The FDA issued a Safety Communication warning of the potential risk of heart failure with use of Mirapex (pramipexole), a prescription drug used to treat the signs and symptoms of Parkinson’s disease and restless leg syndrome. Mirapex is also sometimes used off-label as a treatment for a cluster headache and to counteract problems with sexual dysfunction experienced by some users of selective serotonin reuptake inhibitor (SSRI) antidepressants.

The FDA is continuing studies to clarify the risk of heart failure and will warn the public when that information is available.

Patients should continue to take Mirapex as directed by their doctors. However, if any of the following side effects are experienced, you should consult your doctor immediately: shortness of breath, swelling of the feet, ankles, legs or abdomen, fatigue and weakness, rapid or irregular heartbeat, chest pain, persistent cough or wheezing with blood-tinged phlegm.

In addition to contacting your doctor, if you experience any of these side effects, you should submit an Adverse Event Report to the FDA to assist in their efforts to determine the safety of Mirapex.

Manufactured by Boehringer-Ingelheim, Mirapex went off-label in 2012 and is now available as a generic drug.

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SSRI’s Risk Child Malformation for Pregnant Women

March 15, 2012 - The Danish National Board of Health is reporting that data from a large registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with a selective serotonin reuptake inhibitors (SSRIs) antidepressant.

As a result of this study, the Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.

The review of earlier studies showed an increase in birth defects affecting the in the cardiovascular system in newborns whose mothers had been treated with Prozac and Paxil in the first trimester. Based on the present knowledge, the conclusion was that similar defects, especially heart malformations, could be associated with Zoloft, Celexa and other SSRIs.

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Middle-Aged Women on SSRI’s Face Increased Stroke Risk

August 12, 2011 - The UK Daily Mail reported that scientists completed a study looking at the long-term effects of SSRI's on middle-aged women.

The report concluded that middle-aged women who took Prozac or similar SSRI's are almost 40 percent more likely to suffer a stroke. It was unclear whether the SSRIs or other factors linked to depression definitively caused the strokes. However, the study found that over a six-year period middle-aged women who were depressed were 29 percent more likely to have a stroke. The patients taking Prozac or other similar SSRI's were 39 percent more likely to have a stroke.

The researchers did not suggest middle-aged women stop taking the medications because other depression factors such as obesity, smoking, or lack of exercise could be causing the increased risk of stroke. Middle-aged women should talk to their doctors before making any decisions concerning the use of SSRI's.

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SSRI’s May Not be Best Choice for Those over 65

August 4, 2011 - Research published in the British Medical Journal suggests that popular SSRI's such as Prozac and Effexor may not be the best choice for an antidepressant for seniors. According to the study of 60,746 patients diagnosed as having a new episode of depression in the United Kingdom, there was an increased risk of several adverse outcomes with SSRI’s as opposed to tricyclic antidepressants.  The study further cautioned that the choice of antidepressants is a complex decision and the risks and benefits of any antidepressants should be discussed with a qualified physician.

Study Links SSRIs to Autism in Children

July 5, 2011 - A study from the Archives of General Psychiatry points to a link between the use of selective serotonin reuptake inhibitors (SSRIs), the most widely prescribed antidepressants, and the occurrence of autism in unborn kids.

 

 

 

 

+ - References

"Drug Safety and Availability - FDA Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant Use during Pregnancy and Reports of a Rare Heart and Lung Condition in Newborn Babies.” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, 4 Aug. 2017, www.fda.gov/Drugs/DrugSafety/ucm283375.htm.

Gardner, Amanda. “Popular Antidepressants Not Always Best Choice for Seniors.” U.S. News & World Report, 3 Aug. 2011, health.usnews.com/health-news/family-health/heart/articles/2011/08/03/popular-antidepressants-not-always-best-choice-for-seniors.

Reefhuis J, Devine O, Friedman JM, Louik C, Honein MA, and the National Birth Defects Prevention Study. Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports. BMJ. 2015. [epub ahead of print].

“SSRI Anti Depressants and Birth Defects.” Pubmed.gov, National Center Biotechnology Information, Dec. 2006, www.ncbi.nlm.nih.gov/pubmed/17167929.

“Treating for Two.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 8 July 2015, www.cdc.gov/pregnancy/meds/treatingfortwo/features/ssrisandbirthdefects.html.

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