Birth Defect Lawyer Blog

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 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" »

To add fuel to the fire about whether antidepressants are appropriate for pregnant woman to take, a new study has alarming information: certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), increase the risk of a brain bleed. SSRIs are commonly prescribed, and include familiar brands such as Prozac, Zoloft, Celexa, and Paxil.

After past studies offered conflicting evidence of whether SSRI users had a higher risk of brain bleeding and stroke, researchers from Western University in Canada decided to put the findings from 16 past studies together. The studies involved over 500,000 people who were SSRI users. What the researchers found was that SSRI users were 40 to 50% more likely to suffer from a brain bleed. While that number might sound alarming, it is actually an "extremely low" risk, representing one incidence of brain bleed for every 10,000 people who took SSRIs over the course of a year.

Researchers also cautioned that evidence did not show that SSRIs were directly responsible for brain bleeds. The cause might be the users' lifestyles, such as if they had a tendency to smoke or drink. At the same time, studies show that the danger of a brain bleed is greatest within the first six months of SSRI use, possibly because SSRIs make it harder for blood platelets to come together and clot. A person's platelet function may drop significantly during the first few weeks of SSRI use.

While the likelihood of brain bleeds may be small, it is still a concern, especially if the SSRI user is pregnant or thinking of becoming pregnant. As this blog has noted, there is already concern about the other potentially harmful effects of SSRIs and other antidepressants. Studies have shown that use of certain antidepressants during the first trimester of pregnancy can increase the risk of birth defects. At the same time, as noted recently, leaving depression untreated could also cause problems for the child developmentally, such as delayed speech.

What these studies underscore is how important it is for you to have a thorough discussion with your physician before agreeing to take antidepressants. Physicians have what is known as a "duty to inform," meaning that they are expected to inform patients of all possible risks associated with a specific course of treatment, so that the patient can then make an informed decision about whether or not to move forward. If you were prescribed a certain antidepressant, then later had a child with a birth defect, you could sue your physician for medical malpractice if he or she never informed you of the risks. Much would depend upon when you were first prescribed the medication and at what point you took it during your pregnancy.

Continue reading "New Study Finds That Certain Antidepressants Increase the Risk of a Brain Bleed" »

A Louisiana family joins the growing number of families that have filed lawsuits against Zoloft for causing birth defects. Zoloft is a selective serotonin reuptake inhibitor (SSRI) manufactured by Pfizer and designed to treat major depression, obsessive compulsive disorder, and social anxiety disorders. Terry and Nelda Rolling of Louisiana claim that Pfizer failed to provide an adequate warning of Zoloft's risks, and also of concealing, suppressing, and failing to disclose dangers.

The Rollings' child was born with a congenital heart defect. They claim that Pfizer had information as early as 1996 that Zoloft could increase the risk of birth defects if prescribed to a pregnant woman, but failed to provide a proper warning to would-be consumers or physicians. The information only grew between 2002 and 2006 that Zoloft use could harm fetal development. The Rollings claim that if nothing else, Pfizer knew or should have known the risks by 2007, when the New England Journal of Medicine published a study on Zoloft use during pregnancy. The 2007 study showed that Zoloft doubled the risk of septal heart defects.

Zoloft is just one of several SSRIs linked to a higher risk of birth defects. Prozac, Paxil, and Celexa, among others, were also considered to be responsible. Pregnant women who took Zoloft received a warning in 2006 from the Food and Drug Administration that if they continued to take it after 20 weeks, they were six times more likely to give birth to a child with persistent pulmonary hypertension. Since the New England Journal of Medicine's study was published, other studies have confirmed its findings, such as a study out of Sweden, linking SSRIs to persistent pulmonary hypertension.

If you took SSRIs and have a child with a birth defect, how could you file suit against the pharmaceutical company? You could do what the Rollings did and file it under your state's Products Liability Act, if there is one. The Rollings accused Pfizer of violating the warranty of redhibition. All products come with what are called "warranties," or assurances. The warranty of redhibition is specific to Louisiana: it gives consumers the ability to file suit against the manufacturer of a defective product. However, there are other warranties, such as an express warranty, where the merchant makes a stated guarantee about the product, and implied warranties. Implied warranties include the warranty of merchantability, which states that the product must reasonably conform to the buyer's expectations. Breach of warranty tends to used in contract claims rather than a tort claim, but many who file product liability lawsuits include breach of warranty.

Otherwise, you would file a lawsuit against the SSRI manufacturer under strict liability theory. You would claim that the manufacturer had a duty to produce as safe a product as possible, but the manufacturer breached that duty by creating a product that was not only unreasonably dangerous, but also failed to provide a proper warning. As a result of the breach, you were injured (took SSRIs while pregnant), and the damage was your child's birth defect.

Continue reading "Louisiana Family Becomes the Latest to Sue Zoloft Over Birth Defects" »

Families from several different states are getting together to sue the Zoloft manufacturer, Pfizer for failing to warn about the harmful effects of the prescription antidepressant. Because of Pfizer's failure to warn, eight couples used Zoloft throughout their pregnancies, resulting in their children being born with birth defects.

Their children's birth defects range from heart defects to neural tube defects to craniosynostosis. The families are spread across the United States, from Illinois, Indiana, Minnesota, Florida, Wisconsin, Texas, and New York. They believe that Pfizer knew that Zoloft could cause birth defects, but chose not to make the news public. Their charges against Pfizer include products liability, breach of warranty, negligence, fraud, and misrepresentation.

Zoloft is not the only prescription antidepressant charged with causing birth defects. If your child has a birth defect that you believe may be due to your taking Zoloft -- or any prescription antidepressant -- you have the option of filing a products liability lawsuit and/or a medical malpractice lawsuit. You would file the products liability suit against the manufacturer, arguing that the manufacturer was strictly liable for creating an unsafe product. To prove that the manufacturer was strictly liable, you would argue that the manufacturer had a duty to make as safe an antidepressant pill as reasonably possible. The manufacturer breached its duty by designing a pill that was unsafe, despite there being options for creating a safer pill that was just as effective and not much more expensive. Or else, like the manufacturer of Zoloft, the manufacturer failed to provide an adequate warning of the dangers. The breach led to your injury (exposure the ill effects of the drug) and the damage you suffered was your child's birth defect.

If enough women are in a similar situation (prescribed the same antidepressant while pregnant, and now mothers of children with birth defects), you could form a class action lawsuit. To be certified as a class, you don't need to have all taken the antidepressant the same year, or your children all have the same birth defect. You don't even have to live in the same area. You just need to have enough strong similarities (took the same prescribed antidepressant in the first trimester and gave birth to a child with a birth defect) to be able to make the case that you were all harmed by the drug manufacturer.

If you choose to file a medical malpractice suit, you would do so against your physician. You would argue that your physician was negligent in that he or she had a duty to inform you of possible ill effects of the prescription drug (the your physician knew about or reasonably should have known about) yet chose not to. As a result of this breach, you were injured (exposed to the harmful effects, as was your child in utero), and your damage was your child's birth defect.

Continue reading "Families Across the United States to Sue Maker of Zoloft for Not Warning About Birth Defects" »