Birth Defect Lawyer Blog

In addition to antidepressants, it is becoming more common for physicians to prescribe antipsychotics for patients combating depression. However, new evidence shows that antipsychotic drugs provide few benefits and significant side effects to those who take them.

Since the mid-1990s, prescriptions for antipsychotic medications as "adjunct therapy" have nearly doubled. In a recent study, researchers from Metropolitan State University in St. Paul, Minnesota examined 14 previously conducted randomized clinical trials that used a combination of antidepressants and antipsychotics. The antipsychotics consisted of olanzapine/flueoxetine (brand name Symbyax), quetiapine (brand name Seroquel), aripiprazole (brand name Abilify), and risperidone (brand name Risperdal).

While researchers found that there was a slight benefit in using antipsychotic medication to relieve symptoms that do not respond to antidepressants alone, the patients' overall quality of life did not improve. In fact, patients who took antipsychotics were more likely to experience weight gain, sleepiness, akathisia (a sense of restlessness), and abnormal results on metabolic-related laboratory tests. Instead, the "adjunct therapy" that proved to be most helpful appeared to be cognitive behavioral therapy, which involved communicating with the patient. The combination of antidepressants and cognitive therapy led to not only a decrease in depression, but also a significant improvement in patients' quality of life. Researchers state that if these findings appear in more studies, it may be better for physicians to prescribe cognitive therapy in place of antipsychotics to treat depression.

Not only are antipsychotics associated with weight gain and sleepiness, but also there is some evidence that pregnant women who take them are at a higher risk of giving birth to a baby with birth defects. For example, in 2011, the federal Food and Drug Administration issued a warning about the newer antipsychotic drugs after receiving 69 reports of problems with newborns. Perhaps it is not so surprising, given that some antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), are also linked to birth defects.

If you are pregnant and have depression, it is important that you and your physician discuss a course of treatment that would be as safe as possible. Your physician has a legal duty to discuss the potential dangers of taking any type of medication, so that you can make an informed decision about whether to move forward with, or decline, that form of treatment. If your physician fails to do so -- for instance, if he or she prescribes you antipsychotics without telling you the potential danger to your fetus -- he or she has breached that duty. If you then have a child with a birth defect, you would have the option of suing your physician for medical malpractice. You would argue that had your physician fully informed you of the risks, you never would have taken that medication. By taking it, you exposed yourself and your fetus to the harmful effects, and as a result, your child was born with a birth defect. As always, the strength of your case lies in your being able to show that the medication, and not another cause, was responsible.

Continue reading "New Study Finds That Antipsychotics Have Significant Side Effects and Little Benefit" »

Another new study has findings revealing a link between antidepressant usage and a heightened risk of problems with normal birth. This study, an analysis of 23 different studies, found that pregnant women who took antidepressants were more likely to give birth to babies prematurely and/or with low birth weight. However, researchers emphasize that the risk remains very low compared to the risk of untreated depression.

The antidepressant usage studied included usage of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and monoamine oxidase inhibitors. The results found that babies who had been exposed to these antidepressants in the womb had a shorter gestational period (around three days), a lower Apgar score (which is used to assess the health of newborns), and were more likely to be delivered before their term. Researchers noted that this differential was found only in babies born to depressed women who took antidepressants.

That said, researchers noted that the study only focused on the difference between babies born to mothers who took antidepressants and those whose mothers did not, as opposed to babies born to depressed mothers who took medication versus those who did not. Researchers thought that a more revealing study would be one that measured just the effects of depression -- specifically the effects on babies born to mothers who took antidepressants versus those who took nothing, or used other forms of "treatment" such as smoking. They also noted that although there was a difference, it was still slight, which meant that even babies born prematurely to those who took antidepressants were still within a normal range of time. Researchers did not want women to take what could be a greater risk -- leaving their depression untreated -- because they feared it would lead to premature birth or cause their child to be born with a birth defect.

The researchers are wise to note that women should be cautious in determining whether to stop a treatment because they want to be pregnant. Regardless, women and their physicians should have a frank discussion about any possible risks associated with taking or not taking medications. In fact, physicians have a legal duty to inform a patient of the risks of treatment, so that the patient can make an educated decision whether or not to undergo that treatment. If the physician fails to inform you of the risks of antidepressants, and your child is born with a birth defect, you could sue him or her for medical malpractice. You would argue that your physician breached his or her duty to you, the patient. As a result, you were exposed to antidepressants without realizing the potential harm. Your child was then born with a birth defect.

Continue reading "New Study Finds Slightly Higher Risk of Premature Birth For Pregnant Women Who Take Antidepressants" »

A recent French study found that there is a higher risk of neurological birth defects for babies born to women who took efavirenz. Efavirenz-based medication is used to treat those infected with HIV.

The study looked at 13,124 babies born at Hospital Louis-Mourier in Colombes, France between 1994 and 2010. Researchers found that there was a "significant" link between exposure to efavirenz (also known as Sustiva) during the first trimester of pregnancy and neurological defects. In fact, the risk was three times higher. Birth defects observed included a cerebral cyst, hydrocephaly (abnormal accumulation of fluid in the brain), pachygyria (a malformation of the cerebral hemisphere that causes developmental delays and seizures), and an agenesis of the corpus callosum (a complete or partial absence of the corpus callosum, which allows for communication between the left and right hemisphere of the brain).

Results from other HIV-related drugs were not any more promising. Pregnant women who took zidovudine (more commonly known as AZT) were 2.5 times more likely to have babies with congenital heart defects, and the overall birth defect risk increased 1.2 fold. Babies who had been exposed to didanosine or lamivudine during the first trimester were 1.93 times and 1.96 times more likely to have birth defects of the head and neck.

While these findings were cause for serious concerns, experts in the field did not think it would change current practice. One noted that efavirenz-related birth defects were overall very rare, and if a woman on efavirenz wanted to get pregnant, the physician would switch her to a different form of treatment -- presumably after discussing it with the patient first.

Thanks to modern medication, women with HIV can get pregnant and have healthy children when the condition might have posed a serious risk even 20 years ago. However, as with any health condition, you need to take necessary precautions, especially concerning prescription medication. It is absolutely essential that your physician go over the possible risks involved with taking medication during pregnancy. If he or she does not, and you have a child born with one of the above birth defects, you have the option of suing your physician for medical malpractice. You would argue that your physician had a duty to inform you, the patient, yet breached that duty by withholding necessary information. Had you known that information, you might have sought a different medication or tried to wean yourself off of medication altogether, if possible. Instead, you were exposed to a drug like efavirenz during your first trimester, and as a result, your child was born with a birth defect. Should you file a suit, you would most likely seek "damages" or a monetary award, for pain and suffering, medical bills, loss of future income, and more.

Continue reading "New French Study Finds That Women Who Take Certain HIV Drugs Are More Likely to Have Children With Birth Defects" »

There has been a lot of media focus on what expectant parents -- especially expectant mothers -- can do to prevent their children from being born with a birth defect. Mothers have been advised to take certain levels of folic acid, to avoid certain prescription medications, and to not smoke or drink or work in occupations that could possibly affect the fetus inside them. One mother finally had enough of all of the criticism and struck back.

After reading a New York Times article, "Too Many Pills in Pregnancy," Louise Kinross wrote her own opinion piece, noting that many mothers of children with birth defects or developmental delays probably did exactly what their physicians and health manuals instructed them to do. She noted that according to the March of Dimes, up to 70% of birth defects have no known cause; therefore, in most cases, how can a mother know whether her health habits were the cause?

Kinross took particular issue with what she saw as physicians' tendency to blame parents, especially mothers, for their choices even as they acknowledged that the choices resulted from receiving erroneous information from their physicians. She cited one example where a mother blamed herself for her son's cerebral palsy, because she did not get to the hospital soon enough. Later, the mother learned that her son's brain damage and cerebral palsy came about due to the hospital's failure to treat him for jaundice. She felt relieved to know that her choices were not responsible, but angry that physicians had made her feel that they were. Kinross notes other cases where not just physicians, but other people in the community, subtly blamed the mother for not getting the right test or for not aborting a fetus with severe birth defects. She notes that her son's birth defect, a rare genetic abnormality, occurred at conception, so her behavior during pregnancy would have been irrelevant.

With so much more information available now about what can cause birth defects, it is easy to feel overwhelmed and guilty, especially if you have a child with a birth defect. Yet as Kinross notes, many birth defects have genetic or unknown origins. Furthermore, while both parents have some control over the outcome based on their lifestyle choices, there are many things that are simply out of their control. These include toxins from the environment, such as mercury from a power plant or pesticides from a nearby golf course. If these toxins have any part in causing your child's birth defect, you have every right to file a toxic tort lawsuit against them.

As for prescription medications, even if you ultimately chose to take them while pregnant, your physician had a responsibility to inform you of the risks that certain medications posed. If your physician has failed to do so, the fault lies with him or her, not with you, and you would be within your right to file a medical malpractice lawsuit.

Continue reading "Mother Strikes Back at Critics Who Blame Pregnant Women For Their Children's Birth Defects" »

This blog has discussed environmental toxins and antidepressants as potential causes of birth defects, but never the two being combined. Yet that appears to be the situation in Europe, where there are reports of antidepressants contaminating rivers and streams. The amounts lead to a build up of concentrations that are then absorbed by fish, causing them to behave erratically. Such behavior includes straying from the group where normally they would stay put, or eating faster than usual.

The antidepressants contaminating the waterways include "significant" amounts of Oxazepam and Valium, benzodiazepine drugs used to treat anxiety. Although these amounts are not considered great enough to harm human health, they are enough to harm fish like the European perch. One Swedish study found that the River Fyris contained 21 different pharmaceuticals in the water. The concentrations were "comparable" to the amounts of drugs found in other European and American rivers.

Researchers note that the behavior of the fish could have an untold effect on underwater ecology. Yet the option was not to stop providing people with necessary medications, but to develop sewage treatment plants that could capture environmentally hazardous drugs. Right now, there is little research on what happens when small amounts of drugs get into the water supply. While the concentrations of drugs -- individually or combined, it is not clear -- do not harm human health, they may alter human behavior as well. Or at least they might affect human biology in a way that might not be immediately "harmful," but could alter an individual's health down the road. Furthermore, it is unknown how absorbing traces of anxiety medication could affect those who do not need to be treated for anxiety.

It is also unknown whether absorbing water, or aquatic life, exposed to antidepressant medications can result in birth defects. However, it has been documented that exposure to other toxins in the water, such as mercury, can produce this result. Many pregnant women have absorbed mercury into their bloodstream as a result of eating fish from certain contaminated waters. In that case, they are within their rights to file a lawsuit against the offenders allegedly responsible for the mercury. Frequently the source of mercury emissions is a coal-burning power plant or a coal/mineral mine. If your child has a birth defect and you believe one of these is the source, you could argue that these entities violated a duty to the surrounding community by ignoring health and safety regulations. As a result, you were exposed to the mercury through consumption of fish in the local waters (or merely by drinking water, or by inhaling polluted air), and your child was born with a birth defect. It may well be that concentrations of antidepressants in the water can also cause birth defects, since certain prescribed antidepressants can increase the risk, but more research needs to be done.

Continue reading "New Reports Find That Antidepressants Are Contaminating Streams in Europe" »

There has been a lot of controversy about antidepressants, specifically whether the benefit outweighs some substantial risks. Antidepressants have been linked to internal bleeding, weight gain, and birth defects. Now, a new study reports another potential risk: irregular heartbeat.

Selective serotonin reuptake inhibitors (SSRIs) such as Celexa or Lexapro may lengthen the electrical activity in the heart, which is known as a QT interval. A long QT interval typically is a sign of cardiac risk. In men, a normal QT interval is less than 420 milliseconds, while in women, it is less than 440 milliseconds.

The Center for Experimental Drugs and Diagnostics at Massachusetts General Hospital decided to test how many users of SSRIs had long QTs compared to those who did not take antidepressants. Researchers collected information on more than 38,000 adults who had an ECG after using antidepressants between February 1990 and August 2011. What they found was that those who took Celexa, Lexapro, Elavil, and methadone had a small, yet significantly longer, QT interval. Furthermore, the higher the patient's dose, the longer the QT interval. Of those who took the antidepressants, nearly one in five had a longer QT interval. At the same time, researchers found that different antidepressants, such as Wellbutrin or Zyban (brand names for bupropion), actually experienced a shorter QT interval. Researchers have not yet determined whether a shorter QT interval is any healthier than a long one.

Researchers cautioned that just because a QT interval was long did not mean the patient had heart problems -- the QT interval would need to be longer than 500 milliseconds to be of concern. Also, the findings could be affected by any pre-existing heart conditions among those taking the antidepressants.

What the study shows is that the decision to take antidepressants can never be made lightly. Other studies have shown that depending upon your level of depression, antidepressants may be no more helpful than other forms of treatment, such as acupuncture. Taking antidepressants can lead to significant health problems, and your physician has a duty to inform you of all known dangers so that you can make an informed decision about whether to move forward. Failure to inform you of potential problems could make your physician liable for medical malpractice.

Continue reading "New Study Finds That Certain Antidepressants Are Linked to an Irregular Heartbeat" »

Recently in the British Medical Journal, a physician from Glasgow criticized the high number of antidepressants prescribed throughout the UK. He complained that antidepressants were used "too easily" for too long periods of time, and that they were effective only for a small minority. His criticisms mirror some findings in the United States, and could be significant, given that certain antidepressants -- especially selective serotonin reuptake inhibitors (SSRIs) -- have been linked to birth defects.

Dr. Des Spence claimed that the UK's current definition of clinical depression -- two weeks of "low mood" -- is too broad, leading to an overdose of prescriptions. This in spite of the fact that the National Institute for Health and Clinical Excellence guidelines do not support the use of antidepressants to treat mild depression, or as the first means of treating moderate depression. Dr. Spense also questioned the notion that depression is purely chemical, as opposed to a sign of social ills. He claimed that even if antidepressants were effective, they were only effective for one in seven people, which meant that millions underwent "at least six months of ineffective treatment."

Of course, many physicians dispute his claims. Ian Reid, Professor of Psychiatry at the University of Aberdeen, argued that the rise in the use of antidepressants reflected increases in the duration of some people's treatment, not necessarily in the number of users.

In the United States, antidepressant use rose 400% between 1988 and 2011. If Dr. Spense's claims are accurate of the UK, then they would be no less accurate of the U.S. While not all antidepressants have been linked to birth defects, SSRIs like Effexor have. SSRIs can be especially dangerous if taken during the first trimester of pregnancy. If you took an SSRI while pregnant and your child was born with a birth defect, you have the option of filing a medical malpractice suit against your physician. You could argue that your physician prescribed the antidepressant even though your depression was mild, and without warning you of the potential harmful effects. All physicians have a duty to inform their patients about any risks of treatment, so that the patient can make an informed decision about whether to proceed. You could argue that because your physician failed to inform you, you were injured through exposure to the antidepressants. The result was that your child was born with a birth defect.

You might also consider filing a product liability suit against the manufacturer or the antidepressant. You would argue that the manufacturer had a duty to consumers to create as safe a drug as possible, but instead designed an unreasonably dangerous drug. As a result, you were injured through exposure and your child was born with a birth defect.

Continue reading "UK Study Finds That Antidepressants Are Overprescribed" »

Evidence from various studies has linked antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), to birth defects. Yet some studies suggest that the harmful effects of antidepressants are overstated -- the recent Swedish study found there was no connection between SSRIs and stillbirths. This debate is part of a larger one over whether antidepressants are necessary at all. Some studies have found that those with mild or moderate depression do not benefit from taking antidepressants. Then there are other studies, like this most recent one, which suggest that taking certain antidepressants, like Prozac, may actually create new brain cells.

The most recent study, published in Neuropsychopharmacology, found that fluoxetine, an SSRI that goes by the brand name Prozac, Sarafem, or Fontex, stimulated the production of new neurons from "Layer 1 Inhibitory Neuron Cells" in the cortex of adult mice. Researchers claim that this suggests fluoxetine has a "neuroprotective response," and in the future may be used to treat or prevent neurodegenerative disease or psychiatric disorders.

At the same time, the possible benefits of antidepressants do not override the possible risks. Should those without severe depression be prescribed antidepressants, especially when those antidepressants come with side effects and may be addictive? The director of the Placebo Studies Program at Harvard Medical School found that the difference between the effects of the antidepressant and the effects of a placebo was "statistically insignificant." Other experts have argued that even though placebos show a positive effect, the positive effects from antidepressants are far more pronounced in patients with moderate to severe depression. Then there is the charge that antidepressants only seem more effective because pharmaceutical companies only publish the positive trials. An article in the New England Journal of Medicine found that 74 studies registered by the Food and Drug Administration (FDA) were reviewed for bias, and the FDA found that positive clinical trials were published 31% more often than trials with poor results.

Regardless, it is a very important concern if you are pregnant and suffer from depression, especially if it is mild to moderate, because it could mean the difference between your child being born healthy and your child being born with a birth defect. If your child has a birth defect that you believe could be due to your being prescribed antidepressants, you might consider filing a medical malpractice and/or a product liability lawsuit. If you knew that there was a possibility that your child could have a birth defect, yet took the antidepressants anyway, you will likely not succeed in a medical malpractice suit, at least. On the other hand, those who had no information about the risks, and could not reasonably obtain the information, have the best chance of success. That is because physician has a duty to inform his or her patient about the risks of treatment so that he or she could make an informed decision.

Continue reading "New Study Finds That Antidepressants May Stimulate New Brain Cells" »

While some recent studies have shown a connection between birth defects and antidepressants - particularly selective serotonin reuptake inhibitors (SSRIs) - one new study has muddied the waters. A study out of the Karolinska Institutet in Sweden has found that there is no evidence that antidepressant use is linked to a higher rate of stillborns or newborn deaths.

The Swedish study examined more than 1.6 million births in five Nordic countries between 1996 and 2007, including those born to 30,000 women who had a prescription for an SSRI. Researchers found that the 1.79% of women who took an SSRI experienced higher rates of stillbirth - 4.62, as opposed to 3.69, per 1,000 - and postneonatal death -- 1.3, compared 0.96, per 1,000 -- than those who did not. However, researchers do not believe that the antidepressants were responsible for the uptick - rather, the underlying depression was the cause. The study notes that between 7 and 19% of women suffer from depression during pregnancy.

The study's results were not universally accepted. One expert in the United States noted that the results were based upon drugs dispensed in a prescription, rather than drugs ingested, and that the statistics were often quite different. Even if the Swedish study's results are found elsewhere, there remains evidence that SSRIs are associated with an increase in birth defects, neonatal withdrawal syndrome, and persistent pulmonary hypertension in newborns. The risk of birth defects is thought to be greatest when SSRIs are taken during the first trimester of pregnancy.

If your child has a birth defect that you believe was due to your taking an SSRI while pregnant, you have the option of filing a product liability suit against the drug manufacturer, as well as a medical malpractice suit against the physician who prescribed you the medication. In a product liability suit, you would argue that the manufacturer had a duty to consumers to create a drug that was as safe as reasonably possible while still being effective. The manufacturer breached that duty by designing a drug that was unreasonably dangerous, and without providing a proper warning label. As a result, you were injured through exposure to the SSRI while pregnant, and the damage was your child's birth defect.

You could also file a medical malpractice lawsuit against your physician, arguing that he or she had a duty to inform you of the dangers of the SSRI so that you could make a fully informed decision about whether to take it. Your physician failed to inform you, and as a result, you were injured through exposure to the medication, and your child was born with a birth defect.

Continue reading "New Swedish Study Finds That SSRIs Are Not Linked to a Higher Risk of Stillborns, Baby Deaths" »

Few people would connect workplace bullying with birth defects. Yet a new study has found that people who are the victims of workplace bullying are more likely to be prescribed antidepressants and tranquilizers. Other studies have linked certain antidepressants -- especially selective serotonin reuptake inhibitors (SSRIs) -- to birth defects.

While most people think of bullying as something that happens on the school level, it is not uncommon in the adult world. The new study focused on men and women in Finland, where 10% to 14% claimed to have been bullied at work. Of those who reported bullying, they were 50% (women) to 200% (men) more likely to have been prescribed an antidepressant or tranquilizer.

The Finnish study asked more than 6,600 employees in Helsinki about their workplace experiences between 2000 and 2002. Of the total, 5% reported being bullied at present, with 18% of that amount being women and 12% being men. In addition, 10% of employees reported seeing workplace bullying. Of those who merely witnessed bullying, women were 53% more likely, and men 200% more likely, to use antidepressants or tranquilizers.

It is not unlikely that workplace bullying is more frequent in the United States, where people spend more hours at work and are under much greater pressure to succeed. Therefore, if the Finnish study is in any way representative of trends across the globe, it is quite possible that antidepressant use among working adults is much higher in the U.S. than in Finland. That is a concern, because as mentioned above, pregnant women who take certain antidepressants like SSRIs, are more likely to give birth to babies with heart defects, spina bifida, cleft palate, and other birth defects. The risk seems especially great if the mother takes antidepressants during the first trimester.

If you take antidepressants as a result of workplace bullying, and your child was born with a birth defect, you could file a lawsuit not only against the drug manufacturer and your physician, but also the coworkers or employer responsible for harassing you. First, you could file a product liability lawsuit against the manufacturer, claiming that it should be strictly liable for manufacturing a drug that was unreasonably dangerous and did not have an adequate warning label. Second, you could file a medical malpractice lawsuit against your physician, arguing that he or she had a duty to inform you of the dangers of the drug so that you could make a fully informed decision whether to take it. Your physician failed to inform you of the dangers, so you were injured through exposure, and your child born with a birth defect as a result.

Continue reading "Adults Bullied at Work More Likely to Take Antidepressants, Which Could Lead to More Birth Defects" »

Over the years, Pfizer, the manufacturer of Zoloft, has been the target of many lawsuits. That is because Zoloft, a selective serotonin reuptake inhibitor (SSRI), has been linked to birth defects after pregnant women took the medication during their first trimester. The birth defects attributed to Zoloft use include abdominal and cranial birth defects, persistent pulmonary hypertension, and congenital heart defects, specifically atrial and ventricular septal defects.

The family of a seven-year-old-girl in Springfield, Illinois became the latest to file a suit against Pfizer over Zoloft. The suit claims that the girl was born in 2005 with an abnormally narrow large intestine and rectum after her mother took Zoloft that was prescribed to her during pregnancy. The suit further claims that Pfizer marketed Zoloft to treat pregnant women with depression, even though Pfizer allegedly knew, or should have known, as early as 1991 that Zoloft was unreasonably dangerous both for the women and for their fetuses. By allegedly failing to properly warn the public, physicians, and the Food and Drug Administration, the suit claims that Pfizer was liable for negligence.

The suit argues that the girl's mother only took Zoloft during her pregnancy in 2004 because she was informed that it was safe. Her daughter's condition has required numerous procedures and will require constant medical treatment throughout her life. In all likelihood, the suit will be combined with 200 other cases in an existing class-action lawsuit. Meanwhile, Pfizer -- not surprisingly -- denies that Zoloft causes birth defects, claiming that extensive scientific research backs the finding that it is safe. Pfizer spokesmen claim that despite the large number of people taking Zoloft, the number of people suing is quite small.

That may change as more information about Zoloft's link to birth defects surfaces. If your child has a heart defect, a cranial defect, or some other congenital birth defect and you believe that it could be due to your taking Zoloft or some other SSRI, you could file a product liability suit against Pfizer or any other manufacturer.

When you file a lawsuit relating to a product, you can seek to find the manufacturer both negligent and strictly liable. Under negligence theory, you would argue that Pfizer did not use reasonable care when marketing the product, and therefore did not provide customers and physicians with enough information. As a result, you took Zoloft while pregnant without knowing the consequences, and the damage was your child's birth defect. Strict liability has nearly the same elements as negligence, except that you can find the manufacturer liable even when it has not acted negligently. Strict liability applies to the product itself -- you would argue that even if the manufacturer were not negligent, the product was still unreasonably dangerous by design. As a result, you were injured through exposure to the product, and the result was your child's birth defect.

Continue reading "Family of Seven-Year-Old With a Birth Defect the Latest to Sue Manufacturer of Zoloft" »

In Canada, the Supreme Court has certified a class for a class-action lawsuit against UK company GlaxoSmithKline, the manufacturer of Paxil. While in the United States, there have already been more than one class-action lawsuit against Paxil, this would be the first class-action lawsuit against any antidepressant manufacturer in Canada involving birth defects.

The class-action suit began with the case of one individual, Faith Gibson of British Columbia, whose daughter was born with a hole in her heart in 2005. Gibson was prescribed Paxil by her physician in 2002 and took it throughout the duration of her pregnancy. In 2005, GlaxoSmithKline informed Health Canada, Canadian physicians, and other relevant parties of a study of 3,581 women that found double the risk of birth defects for women exposed to generic Paxil, paroxetine, compared to those who took other antidepressants. Although information about the risks of taking antidepressants during pregnancy was published two weeks after Gibson's daughter's birth, Gibson and other mothers in her position argue that GlaxoSmithKline knew, or should have been aware, of the risks before then. They argue that the company then failed to inform physicians in a timely manner about the risks. Gibson claims that had she known about the potential for birth defects, she would never have taken the antidepressant.

With the class certification, Gibson became what, in the United States, at least, is known as the "class representative." She will represent any person in Canada born to a woman who took Paxil while pregnant, as well as the mothers of those persons.

A class-action lawsuit is often an important way to not only help affected individuals get relief, but also to send a message to the offender that it cannot get away with such behavior. In the United States, a group is usually considered a "class" if it contains more than 40 people, while a group of more than one million has been, in other contexts, considered too large to be a class. The class is composed of "similarly situated" individuals, consisting of those who have claims that are "sufficiently alike" that they can be grouped together. The class must be certified by a court before any class-action lawsuit can proceed. From there, the lawsuit mainly follows the same guidelines as an individual lawsuit. This includes the type of relief given -- just as an individual may receive a monetary award, a successful class typically receives a "common fund," or one giant award out of which the individual claims are paid.

If your child has a birth defect that you believe could be due to your taking Paxil while pregnant, you don't need to join a class-action lawsuit to get relief -- you can simply file an individual lawsuit. It would require you to hire your own lawyer and make your own case, but you might get an outcome more tailored to your specific situation.

Continue reading "Canadian Supreme Court Certifies Class For First Class-Action Lawsuit Against Paxil Involving Birth Defects" »

This blog has discussed the potential risks posed to pregnant women by certain antidepressant medication. Those who take antidepressants, especially during the first trimester of pregnancy, have a higher risk of having a baby with a birth defect. Pregnant women with depression would be wise to talk to their doctors about how to proceed. However, as a recent review demonstrates, finding the right approach is not always easy.

In a review of over 100 studies published in the journal Human Reproduction, researchers from Tufts University School of Medicine and Boston IVF found that there was no conclusive evidence that taking antidepressant medication led to better birth outcomes than not taking the medication. In fact, many women with mild depression tended to avoid selective serotonin reuptake inhibitors (SSRIs) such as Celexa, Paxil, and Prozac. At the same time, many doctors are reluctant to take any woman with depression off of antidepressants, believing that it is better for the fetus to be exposed to the effects of antidepressants than to higher stress hormones and other physiological problems the woman could have without the medication.

However, the researchers and many experts note that while there is no evidence connecting depression to problems with delivery or birth defects, there is evidence connecting antidepressants to these problems. For instance, for those who take the medication while pregnant, the rate of miscarriage increases from 8% to 12 to 16%. Moreover, women who take medication while pregnant double their risk of having their babies prematurely, which can lead to health and developmental problems. Finally, the effects of antidepressants could be found in many newborns' behavior. One third of newborns exposed to antidepressants in the womb developed "newborn behavioral system," which consisted of jitters, difficulties with feeding, and ceaseless crying. Researchers note that this condition is rare in babies who have not been exposed to antidepressants. While it clears up after a short time, it is unknown whether the condition leads to long-term effects, though animal studies suggest that it can change brain chemistry.

Researchers also note that it is mainly women with mild to moderate depression who do not show any major benefit from staying on antidepressants. It is not necessarily the case for women with severe depression.

It is a situation that deserves a lot of careful consideration. If you are pregnant and have concerns about whether to stay on your antidepressant medications, you should talk to your doctor and determine whether your depression is mild enough to permit a break from antidepressants if you so chose. In any event, your physician has a responsibility to discuss all possible risks and benefits so that you can make an informed decision. If he or she fails to do so, and you have a child with a birth defect as a result of your taking antidepressants while pregnant, you would have grounds to sue your physician for medical malpractice.

Continue reading "Researchers Find That For Women With Mild to Moderate Depression, Not Taking Antidepressants During Pregnancy May Provide the Best Outcome" »

In a new study from Case Western Reserve University, researchers found a way to produce three-dimensional maps of circulating blood and its effect on the developing heart. Researchers hope that this could help them understand what causes birth defects of the heart.

The new technology is meant to determine how certain factors affect heart development, such as the mother's alcohol or drug consumption, or other factors, genetic or environmental. Researchers believe that changes in heart development are linked to what is called "shear stress," where passing blood cells drag on cells that line the developing heart, but are unsure how the link occurs.

In addition to using a three-dimensional model to study this phenomenon, researchers also add the dimension of time, allowing them to make movies of the blood flow to the heart during a "shear stress" episode. The researchers intend to take images of the heart at the first two days, then three days, then finally eight days, when the wall between the left and right sections of the heart have formed. The team of researchers will be testing the reaction of a quail heart to alcohol and to antidepressants known as select serotonin receptor inhibitors (SSRIs). The researchers hope that if they can screen a fetus for abnormal formation of the heart, they can develop intervention strategies that could possibly repair the heart before the baby is born. One such technique could include flashing an infrared light at the heart to make it contract so that defects can be prevented or repaired.

While heart defects can be the result of the mother or father's personal choices -- such as consuming alcohol, certain foods, or illegal drugs, it is also possible that heart defects are caused by factors completely beyond the parents' control or beyond the parents' knowledge. For instance, as noted above, one contributing factor to heart defects is antidepressant medication. It is unlikely when a pregnant woman takes antidepressants that she is aware of the damage they can do to her fetus, especially if she takes them during a certain trimester. That is why it is up to her physician, the one who prescribes the antidepressants, to inform her of all of the risks before prescribing them to her. A physician has a duty to inform the patient of all possible dangers so that the patient can make a responsible choice. If a physician prescribes the antidepressants knowing that the woman is or could become pregnant, and the baby is later born with a heart defect, the woman might be able to sue successfully for medical malpractice. The woman could argue that if she had been properly informed, she never would have taken antidepressants, or at least that specific class of antidepressants. As a result of the physician's failure to inform, the woman was "injured" and the result was her child's birth defect.

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In the past, this blog has often discussed new findings that show that pregnant women who take certain antidepressants are at greater risk of having children with birth defects. Now a new study has come out that provides more evidence of the dangers of antidepressant use.

The study, which was published in Human Research online, finds that those who take selective seretonin reuptake inhibitors (SSRIs) while pregnant are at a greater risk of miscarriage, preeclampsia, having children prematurely, or having children with autism. The class of SSRIs includes well-known brands such as Paxil, Prozac, Zoloft, and Celexa. At present, up to 13% of women are believed to take antidepressants, and use of the medication is most frequent among those between the ages of 18 and 44.

The study also found that Paxil use during pregnancy was linked to an increased risk of fetal heart defects. Paxil has been classified by the Food and Drug Administration as a Pregnancy Category D drug since 2005 -- meaning that studies have shown potential risks to the fetus, but that the risks may be outweighed by the benefits. Yet the study's senior author noted that while the results showed clear dangers to those who used Paxil and other SSRIs, it did not show that there was a benefit for women with mild to medium depression.

Not everyone agreed with the study's conclusions. Dr. Currier at the University of Miami argues that there is no specific evidence linking antidepressant use to miscarriage or a higher rate of preeclampsia, although there is some evidence of a connection to low birth weight. The study's authors cautioned that this study was not intended to discourage women with severe depression from taking antidepressants.

The study's results illustrate why it is important for women with depression who are thinking about becoming pregnant to have a serious discussion with their physicians. A physician has duty to each patient to inform him or her of all of the risks of a potential medication, so that the patient can make a responsible decision as to whether to take the medication. If you were prescribed Paxil or another SSRI while pregnant and had a child with a birth defect, you may be able to successfully sue your physician for medical malpractice. You would need to prove that your physician failed to warn you about the dangers of taking that medication, even though the information was within reasonable access. Therefore, your physician breached his or her duty to you, and as a result, you were injured and the damage was your child's birth defect.

Continue reading "New Study Provides More Evidence That Certain Antidepressants Increase the Risk of Miscarriage and Birth Defects" »