Depakote Lawsuit filed after Child born with Major Heart Defect

In Illinois, another birth defect lawsuit against the makers of the anti-seizure drug Depakote has been filed on behalf of a child who was born with a serious cardiac defect.

In her Depakote birth defect lawsuit, Michelle Cowin-Gantz claims that the child referred to as “J.G.”, on whose behalf she sues as “next friend”, was born with a severe heart defect as a result of the mother’s use of Depakote during pregnancy. According to this claim, the child will suffer permanent injury, life-long medical care and monitoring, emotional distress, the loss of a normal life, and additional psychological and financial damages as a result of this Depakote birth defect. This plaintiff also claims that the makers of Depakote, Abbott Laboratories Inc., failed to adequately test this allegedly dangerous drug and failed to provide proper warnings of the risk of Depakote birth defects.

Depakote (valproic acid, valproate) has been approved by the FDA since 1983 to help prevent seizures associated with epilepsy. Since then, this anti-epileptic drug has also been approved to treat some cases of depression and bipolar disorder. While women who suffer from seizure disorders must often take a drug like Depakote to help prevent potentially harmful or fatal seizures, they must also work with their doctors to evaluate all possible risks of the drug in relation to the perceived benefits. In the case of Depakote and other seizure medications, one risk women must be fully aware of is the increased chance of giving birth to a child with a severe birth defect after taking Depakote during pregnancy.

In the past decade alone, mounting evidence in the form of scientific studies and adverse event reports has suggested that use of Depakote during pregnancy may substantially increase the risk of numerous serious birth defects, including the heart defect noted in the above-mentioned Depakote lawsuit. In fact, a study published in the journal Neurology in 2006 concluded that of all anti-seizure drugs, “valproate poses the highest risk to the fetus. For women who fail other antiepileptic drugs and require valproate, the dose should be limited if possible. The results of this study led the FDA to issue a Black Box warning about Depakote birth defect risks later that year. In addition to heart defects, use of Depakote during pregnancy may also increase the risk of neural tube defects like spina bifida, skull malformations, extra digits, oral cleft defects like cleft lip and cleft palate, pulmonary stenosis, and even potentially decreased IQ.

While the FDA did issue the Depakote birth defect Black Box warning in 2006, many parents of children born with serious birth defects after exposure to Depakote in the womb now allege that Abbott Laboratories knew or should have known of this risk long before that and willfully failed to warn of it. Again, women must carefully weigh all benefits against all known risks of any medication they take during pregnancy—but this is only possible if the woman is informed of these risks.

When pharmaceutical companies fail to disclose known birth defect risks associated with their drugs, innocent patients and their babies may suffer catastrophic and devastating results. If a child you love was born with a serious birth defect after his or mother used a seizure medication such as Depakote or Topamax during pregnancy, you may be owed compensation for medical expenses, pain and suffering, and other damages. To learn more about your rights, please contact us to schedule a free legal consultation.

Another Epilepsy Drug linked to Birth Defects

In recent years, multiple drugs prescribed to prevent seizures in patients with epilepsy have been associated with a higher risk of birth defects when used during pregnancy. Specifically, the drugs Topamax and Depakote have been linked to cleft lip, cleft palate, spina bifida, and other serious malformations. Now, research out of Switzerland suggests that a newer drug sometimes prescribed for epilepsy, Lyrica (pregabalin), may also cause serious birth defects when taken by pregnant women.

This research was led by Ursula Winterfeld of the Swiss Teratogen Information Service and Lausanne University Hospital in Switzerland and was published yesterday in the journal Neurology. Winterfeld and her team studied medical records on women from seven countries, 164 of whom used Lyrica while pregnant and 656 of whom did not use Lyrica or anther anti-seizure medication during pregnancy. Of the women they studied who used Lyrica during pregnancy, roughly 6% gave birth to a child with a major defect. The women who did not use Lyrica during pregnancy had a birth defect rate of 2%. Overall, these researchers concluded that the women who used Lyrica during pregnancy were roughly three times more likely to have a child with a birth defect. Birth defects noted in the babies born to these women included heart defects, organ malformations, and defects of the central nervous system.

While this research may be cause for caution, Winterfeld was careful to point out its limitations in an interview with a Forbes reporter and to suggest that additional research is necessary. Still, she says, the results of this study suggest that women may be wise to seek alternative treatments for conditions for which Lyrica is prescribed if they become pregnant. “The significant increase in the rate of malformations observed in this study presently implies that pregabalin prescription be avoided whenever possible during pregnancy,” she said. “In patients of childbearing age, effective contraception should be advised when prescribing pregabalin, and its indication must be carefully re-examined in cases of desired or established unexpected pregnancy.”

Perhaps not surprisingly, a spokesman for the company behind Lyrica, Pfizer, was also careful to point out the limitations with this study. U.S. News & World Report quotes spokesman Steven Danehy saying, “The study has significant limitations and cannot be used to draw definitive conclusions.” Danehy goes on to say that the study was small, did not account for other medical conditions or medications, “and the women taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes.”

For women with seizure disorders such as epilepsy, it is especially important to plan pregnancy because many anti-seizure drugs have been associated with birth defects and these defects are especially common during the first trimester, when some women may not yet realize they are pregnant. However, if a pregnant woman has a seizure this can also cause significant harm to a developing fetus, so it is vitally important that women with epilepsy work closely with their doctors to evaluate all risks and benefits of medications they use on a case-by-case basis to protect the health of both mother and baby. Of course, this is only possible when women and their doctors are fully informed about the risk of birth defects associated with their medications.

A number of women and families have already filed birth defect lawsuits against the makers of Topamax and Depakote, highly prescribed anti-seizure medications, claiming that the drug makers failed to provide adequate warning of known birth defect risks. If your child or a child you love was born with a severe birth defect after his or her mother used a seizure medication during pregnancy, you may be entitled to compensation which can help you provide the best care for that child. To learn more about your rights, please contact us to schedule a free legal consultation.

Judge Limits Testimony of Medical Witnesses in Depakote Birth Defect Lawsuit

Last week, the federal judge overseeing a Depakote birth defect lawsuit ruled that two pediatric experts would have their testimony substantially limited.

Bloomberg reports that U.S. District Judge Charles A. Shaw ruled on May 6 to limit the testimony of two doctors called as witnesses to support the claims of Beth Forbes. In her lawsuit, Forbes alleges that the makers Depakote, Abbot Labs, failed to provide adequate warning that use of Depakote during pregnancy may cause spina bifida birth defects, and that this failure to warn led directly to her child’s condition.

According to her lawsuit, Forbes and her husband claim that their son was born with spina bifida after she was prescribed Depakote as a mood stabilizer and used the drug during the early stages of her pregnancy. Though she stopped taking Depakote when she realized she was pregnant, Forbes still claims exposure to this drug in the womb caused her son’s birth defect.

The first witness, Dr. Godfrey P. Oakley, was meant to testify that Abbott was negligent in failing to establish a "pregnancy registry" to monitor birth defects and other adverse events when pregnant women use Depakote. According to Judge Shaw, this registry would not have necessarily provided Forbes or her prescribing physician with the information linking Depakote to potential birth defects any more than current Depakote warning labels already provide. Thus, the testimony would only serve to prejudice Abbott.

The second witness, Dr. Jack Land, is a pediatrician who was meant to testify as to Forbes’ child’s condition. Now, he is only allowed to speak to the child’s current and past condition, and not allowed to prognosticate about future surgeries or issues the child may face as a result of spina bifida.

This is not the first time this case has made the news. In April, Judge Shaw denied Abbott’s motion to dismiss the case and he also denied Abbott’s motion to bar Forbes from seeking punitive damages. Also last month, Judge Shaw ruled that, although Forbes’ physician disclosed that she was aware of potential Depakote birth defect risks, this does not mean that Abbott took adequate steps to warn of this risk. He said, "In particular, it is questionable whether warning the patient of one to two percent chance of having a baby with spina bifida if taking Depakote fulfills Abbott’s duty under Missouri law to properly warn the doctor of the dangers involved."

Although the testimony of key witnesses may be severely limited by recent rulings by Judge Shaw, the Forbes family is cleared to proceed with the lawsuit based on claims of negligence and strict liability. Other families have also claimed that their children were born with severe Depakote birth defects of which they were not warned. If your child was born with spina bifida, a cleft palate or lip, or another birth defect which may have been caused by exposure to Depakote or another seizure medication during pregnancy, you may be entitled to compensation. Please contact us today to learn more in a free legal consultation with an experienced personal injury lawyer.

Judge Denies Abbot’s Motion to Dismiss Depakote Birth Defect Lawsuit

Last month, a federal judge in Missouri denied a motion filed by Abbott Laboratories for summary judgment in a Depakote lawsuit based on claims of failure to warn of spina bifida birth defect risks. The judge also recently denied Abbot’s motion for summary judgement regarding the plaintiffs’ claim for punitive damages.

According to U.S. District Judge Charles A. Shaw, Abbott’s argument that the plaintiff in this case, Beth Forbes, cannot prove that her doctor would not have prescribed Depakote if she had been adequately warned of spina bifida birth defect risks. In her Depakote lawsuit, Forbes and her husband allege that Abbott Laboratories is liable for their son’s spina bifida birth defect because they did not provide sufficient information on the risk of birth defects on Depakote warning labels.

Beth Forbes was first prescribed Depakote by Dr. Raziya Mallya in 2003 as a mood stabilizer after she was diagnosed with bipolar disorder, and she was also prescribed other medications at the same time to treat this condition. She became pregnant in 2005, and stopped taking Depakote when she realized she was expecting, but her son was stillborn in September 2005wtih spina bifida and multiple secondary conditions. Both she and her doctor claim that her child’s suffering could have been avoided with adequate spina bifida birth defect warnings by Abbott.

Abbott, however, says that Dr. Mallya has testified that she already knew of the risk of spina bifida birth defects associated with Depakote so the company is not liable for the child’s congenital defects.

Dr. Mallya says that she would have prescribed a different drug to Forbes if Abbott’s warnings had clearly stated that women should only take Depakote during pregnancy if it is essential to managing their conditions. Still, Judge Shaw does note that Depakote labels at the time of Forbes’ pregnancy did feature a black box warning about neural tube birth defects like spina bifida.

According to Judge Shaw, the fact that Dr. Mallya knew of a risk of Depakote spina bifida does not automatically mean that Abbott’s warnings were legally adequate. He said, “In particular, it is questionable whether warning the patient of one to two percent chance of having a baby with spina bifida if taking Depakote fulfills Abbott’s duty under Missouri law to properly warn the doctor of the dangers involved.” Essentially, it is not a question of whether Abbott warned of the risk, but whether their warning was strong enough.

Beth Forbes and her family are not alone in claiming that Abbott was negligent in their duty to warn of and protect against Depakote birth defect risks. If a child you love was also born with a birth defect after the mother used Depakote during pregnancy, you may be owed compensation. Contact an experienced Depakote birth defect lawyer to learn more in a free consultation.

Colorado Girl Courageously Draws Attention to Cleft Lip Issues

Every year, thousands of babies are born with oral cleft defects in the United States, but most Americans don’t realize that the process of fixing a cleft lip or cleft palate is often painful and lasts many years. A girl from Colorado recently stepped into the spotlight to draw attention to issues that she and other children with this birth defect deal with every day.

Anissa Ibarra, 14, recently told a reporter from a local Denver ABC affiliate 7News that the damage done by her cleft palate is far more emotional than it is physical. “People can be so ignorant about it. They don’t know how hard it is to go through all of it,” she said through tears, “I had this picture on my notebook of me and my mom and my dad. And [kids] would make fun of me because of it.”

Roughly 1 in 700 children is born with an oral cleft defect, where the lips (cleft lip), palate (cleft palate), or both do not fully fuse together. This is much more than a cosmetic issue, and can cause speech problems, frequent ear infections, difficulty feeding and other issues. In most cases, oral cleft defects may be fixed with one or more surgical procedures when a child is young.

Anissa has been a patient in the Cleft Lip and Palate Clinic at Children’s Hospital Colorado in Denver, which has a unique approach to treating kids with this birth defect. Here, doctors and other specialists work together to provide the most comprehensive treatment possible for children with oral cleft defects. According to team member Dr. Allen, at Colorado Children’s “ENT, plastic surgery, orthodontics, dentistry, speech therapy, audiology, multiple different specialists will see the kids in one day.”

In addition to the physical aspects of oral cleft defects, though, this team also makes it a point to treat the emotional challenges these kids face. Every summer and every winter, they gather children ages 8 to 18 who have suffered from an oral cleft for Cleft Camp, an experience “designed to help kids understand that they are not facing the world alone.” Here, children are able to meet other kids who have similar birth defects as they engage in sharing, outdoor activities, and other traditional camp pastimes.

According to Anissa, Cleft Camp made a big difference in her life because it helped her understand that she’s not alone. “I feel like there’s actually other people like me. I’m not the only one”. Now, she plans to become an otolaryngologist (ENT) just like Dr. Allen so she can help other children affected by cleft lip or cleft palate.

In some cases, oral cleft birth defects are caused when a developing baby is exposed to a medication his or her mother uses while pregnant. Anti-seizure medications like Topamax and Depakote have both been associated with a higher rate of oral cleft defects. If you believe that your epilepsy medication may have caused your child’s oral cleft birth defect, you may be entitled to compensation. Contact an experienced personal injury lawyer to learn more in a free legal consultation.

Another Seizure Drug Birth Defect Risk: Autism

Women who suffer from epilepsy or similar seizure disorders often struggle with the decision to take or not to take anti-seizure medications while pregnant. On the one hand, having a seizure while pregnant could be very harmful or even fatal to mother and child. On the other hand, multiple studies have lined seizure medications to serious birth defects which may also be fatal for the child. Women must weigh these risks with their doctors and decide on an individual basis the best way to treat their epilepsy while pregnant, and it is crucial that they are aware of all possible seizure drug birth defects so that they may make an educated decision.

Cleft lip and cleft palate birth defects are amongst the most commonly reported seizure drug birth defects. However, women who use seizure medications while pregnant may also risk giving birth to a child with spina bifida, heart defects, and other serious congenital issues. Additionally, some studies have shown that women who use Depakote during pregnancy are more likely to give birth to a child with autism.

One such study was published in April 2013 in JAMA, the Journal of the American Medical Association, by researchers from Denmark. These researchers evaluated data on more than 665,000 Danish children over the course of 10 years, from 1996 to 2006. Of the children studied, 5,500 had been diagnosed with autism, and 508 of the autistic children had mothers who used Depakote or a related valproate drug while pregnant. The researchers concluded. “Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy. For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.”

Amidst mounting evidence and Depakote birth defect lawsuits, the FDA admitted in 2014 that the drug may be linked to autism when taken by pregnant women and ordered the company behind this drug, AbbVie Inc. to add autism warnings to Depakote labels.

In Depakote birth defect lawsuits, parents have claimed that they were not given proper warning of the severity or likelihood of Depakote birth defects including autism and seek compensation for medical expenses and other damages. If you believe you may be entitled to compensation in a Depakote or Topamax birth defect lawsuit, please contact an attorney you can trust for a free legal consultation.

Study says Topamax may increase Glaucoma Risk

Topamax is an anti-seizure drug which has been associated with a number of serious side effects including cleft lip birth defects when taken during pregnancy. Now, a new study is showing that patients who use Topamax to help prevent epileptic seizures may also be at an increased risk for glaucoma.

The study was conducted by researchers at the University of British Columbia and was published in the July 9 edition of the journal JAMA Ophthalmology. The team relied on data from U.S. health claims database including records of more than 6 million patients between January 2006 and March 2014. They determined that individuals who use Topamax may be up to five times more likely to develop angle-closure glaucoma. They also found a link between glaucoma and the antidepressant Wellbutrin.

The Mayo Clinic states that “In angle-closure glaucoma, the angle formed by the cornea and the iris closes.” This may cause a rapid increase in intraocular pressure because fluid within the eye is not able to drain properly, and may lead to the formation of blind spots, tunnel vision, or even complete blindness if not treated properly. Symptoms of angle-closure glaucoma may include eye pain, the appearance of halos around lights, blurred vision, red eyes, or visual disturbance.

This is not the first time Topamax has been linked to glaucoma. In 2001 the FDA added glaucoma warnings to Topamax labels after receiving 23 cases where patients were diagnosed with the ocular condition as a possible Topamax side effect.

Topamax has been proven to be beneficial in reducing or preventing dangerous seizures in patient with epilepsy, but patients and doctors need to be aware of all side effects and risks of this medication and carefully weigh them against these benefits. When taken during pregnancy, Topamax has been associated with a higher risk of a number of birth defects including cleft lip and cleft palate, and some women believe that they were not sufficiently warned of this side effect. In Topamax birth defect lawsuits, women have claimed that they would not have taken this drug and endangered their baby if they had known of the risk of cleft palate and cleft lip defects linked to this drug. For more information on Topamax side effect lawsuits, contact an attorney for a free legal consultation.

Epilepsy Increases Risk of Maternal Death in Childbirth

All pregnant women run some risk of experiencing a difficult or dangerous delivery or giving birth to a child with a serious birth defect. However, substantial research has shown that women who struggle with epilepsy face extra risks, including a much higher risk of having a child with a birth defect if they must use epilepsy medications like Topamax or Depakote while they are expecting. Now, a new study suggests that simply having epilepsy may make a woman more likely to die during childbirth.

The study, led by Sarah Mac Donald of the Harvard T.H. Chan School of Public Health in Boston, was published in the July 6 edition of JAMA Neurology. Here, MacDonald and her team evaluated medical records from hospital births from 2007 to 2011. These records reflected nearly 4.2 million deliveries in the United States, with more than 14,000 of those deliveries among women diagnosed with epilepsy. What they found was that women with epilepsy are more likely to die during childbirth, and are also more likely to experience complications like preeclampsia, preterm labor, stillbirth, prolonged hospital stays, and C-sections.

Despite the fact that the “relative risk” of death during hospital delivery is higher in women with epilepsy, MacDonald still stressed that it is still very rare, according to an article covering the study results in US News & World Report. Additionally, Dr. Jacqueline French, neurology professor at the Langone School of Medicine ad New York University in New York City and co-author of an editorial published with the study, says that the study should not cause fear amongst women with epilepsy, saying, “If you have epilepsy, the great likelihood is that you are going to have a healthy, normal pregnancy and delivery.”

MacDonald and her team state that the study shows a need for further research into how epilepsy affects pregnancy. It is unknown whether conditions commonly seen in women with epilepsy such as diabetes, kidney disease, depression, and drug and alcohol abuse, contribute to the risk or morbidity during childbirth. Additionally, further studies must be conducted to evaluate the role of anti-epilepsy drugs like Topamax and Depakote on maternal health during delivery.

While researchers prepare to further evaluate the risks faced by women with epilepsy who are pregnant, MacDonald says “it may be necessary to consider pregnancies in women with epilepsy as high risk.” It is also very important for women with epilepsy and their doctors to carefully weigh the benefits of anti-seizure medications against all risks, including the risk of serious congenital birth defects. Recently, a number of women have filed personal injury lawsuits after their children were born with birth defects like cleft lip and cleft palate due to their use of an anti-seizure medication while pregnant. For more information on Topamax cleft lip lawsuits, please contact an experienced lawyer for a free legal consultation.

Janssen Appeals another Topamax Cleft Lip Lawsuit

Last month, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, stated that they would appeal a recent $3 million verdict awarded to a mother who claimed their drug Topamax caused her daughter’s birth defects.

In March 2014, a jury awarded $3 million to Kelly and Brian Anderson, who claimed that Kelly’s use of Topamax to treat migraines during pregnancy led to their daughter being born with a bilateral cleft palate and lip in 2008. At the time of the trial, the child had already undergone 14 surgeries to correct the birth defects.

In 2008, researchers published a study in the journal Neurology where they found that use of Topamax during pregnancy makes a woman 11 times more likely to have a child with an oral cleft defect. Additionally, an expert quoted in a corresponding CBS News article stated that women who used this drug, originally approved for epilepsy, to treat migraines likely had safer options. American Academy of Neurology spokesman Shlomo Shinnar, MD, PhD told reporters, “The tolerance for risk is different for epilepsy patients, because uncontrolled seizures are a clear risk to the fetus. Migraines can be quite debilitating for the mother, but they do not generally pose a risk to a fetus.”

The jury ruled that Janssen was negligent in their failure to adequately warn of the risks oral cleft birth defects associated with use of Topamax during pregnancy.

According to the Legal Intelligencer, Judge Ramy I. Djerassi of the Philadelphia Court of Common Pleas slammed Janssen’s appeal, stating that the defendant failed to file the papers appropriately. “Defendant Janssen has waived all issues on appeal for failure to comply in good faith with Pennsylvania Rule of Appellate Procedure 1925 by filing a multi-page, multi-paragraph statement that defies a court order redirecting that appellant should not file a statement that is ‘redundant, frivolous, or so lengthy as to defeat the purpose of the rule.'”

The judge also stated that the appeal was inappropriately lengthy, improperly worded, and redundant. However, the court did attempt to address the issues Janssen raised in the document, including insufficient evidence brought by the plaintiff and federal pre-emption.

Regarding allegations that the Andersons presented insufficient evidence about Janssen’s failure to warn of Topamax birth defects, the judge stated, “According to her testimony, Topamax warnings actually received by Dr. [Traci] Purath left her unaware of the full extent of the risk of cleft lip and palate birth defects associated with Topamax use by pregnant women. When she prescribed Topamax to Mrs. Anderson, Dr. Purath knew the drug was Category C, meaning that some birth defects had been reported in animal studies but there was no known birth defect risk of cleft lip and palate in humans. Ultimately, the jury believed that Janssen failed to disseminate known test findings in humans associating Topamax use by pregnant women with direct risk of birth defects.”

The judge also chided Janssen for using pre-emption claims in a number of previous Topamax lawsuit appeals, saying that state failure-to-warn claims cannot be pre-empted by federal law.

Despite this very strong opinion voiced by Judge Djerassi, Janssen reports that they plan to move forward with the appeal. Still, given the fact that the company has already settled more than 70 Topamax birth defect lawsuits out of court and has lost multiple costly appeals, some believe it likely that this verdict will stand.

If you believe your child’s birth defect could be related to exposure to Topamax in the womb, it is important that you learn more about your possible right to compensation. Contact our experienced dangerous drug lawyers today for a free consultation.

Pennsylvania Court sides with Plaintiff in $11M Topamax Birth Defect Lawsuit Appeal

When Johnson & Johnson’s Janssen Pharmaceuticals appealed a recent Topamax birth defect lawsuit verdict which required them to pay nearly $11 million to a family, the Philadelphia Superior Court ruled in favor of the plaintiff.

According to an article in Reuters, the original ruling was reached in November 2013, when a jury found that Janssen failed to warn of Topamax birth defect risks in the lawsuit brought by Haley Powell and Michael Gurley. The plaintiffs’ son, Brayden Gurley, was born with severe gum defects and a cleft lip in 2008 after Ms. Powell used Topamax during pregnancy. The child will require at least five surgical procedures to correct these defects before he reaches adulthood.

In this case, the jury agreed with Powel and Gurley that Janssen did not provide adequate warnings of the risk of an oral cleft defect on Topamax. It was also determined that if Ms. Powell and her doctor had been fully aware of this risk they would have made different treatment decisions and Brayden would not have been exposed to Topamax in the womb.

J&J appealed this verdict, claiming that the $10.9 million award was excessive. The pharmaceutical giant also claimed that federal laws pre-empted this lawsuit and that lawyers representing Brayden’s family did not successfully link Topamax to his birth defects.

Topamax oral cleft birth defect warnings were not added to labels until required by the FDA in 2011, but studies pointed to this risk much earlier than that. In 2008, the journal Neurology published research where a team of doctors found that women who use Topamax during pregnancy are up to 11 times more likely to give birth to a child with cleft lip or cleft palate birth defects.

In 2014, Johnson & Johnson settled at least 76 Topamax birth defect lawsuits for an undisclosed amount, and families have continued to file personal injury lawsuits based on claims that this company hid the risk of Topamax oral clefts from consumers. If you believe your child’s cleft lip, cleft palate, or birth defect may have been formed when his or her mother used Topamax during pregnancy, please contact a personal injury lawyer for a free legal consultation.