Birth Defect Lawyer Blog

A new study finds that pregnant women who take the antiepileptic medication valproate (brand name Depokate) are at a higher risk of having children who develop autism. Previous studies have also linked Depakote use to a higher risk of birth defects.

The study, conducted in the UK and published in the Journal of Neurology, Neurosurgery & Psychiatry, looked at over 500 pregnant women between 2000 and 2004. Of that number, roughly half had epilepsy, and all but 34 women took medication to keep their seizures under control. These women took carbamazepine (brand name Tegretol), valproate, and lamotrigine (brand name Lamictal). Later, researchers studied the potential effects of these medications on the women's children. Of the 415 available, 19 had been diagnosed with a developmental problem by the age of six years old, and three also had a physical disability. Of these 19 children, 12 children had a form of autism, and one had also been diagnosed with attention deficit disorder. Three children had attention deficit disorder by itself, and four children had a condition known as dyspraxia, where the individual suffers from a lack of physical coordination.

Children born to mothers with epilepsy were more likely to develop these physical and mental problems than children born to mothers without epilepsy -- 7.46% compared to 1.87%. Roughly 12% of children whose mothers who took valproate had developmental disorders, and 15% of children whose mothers took valproate plus other medication. Moreover, the higher the dose of valproate, the more likely the children were to have a neurodevelopment disorder. Overall, children of mothers who took valproate were six to 10 times more likely to develop physical or mental problems compared to children born to mothers without epilepsy, with boys being diagnosed three times more often than girls.

Experts throughout the world have expressed concern about the overuse of valproate. In the United States, only half of valproate prescriptions are for the treatment of epilepsy. The rest are for the treatment of migraines and psychiatric disorders.

By now, the dangers posed by valproate/Depakote, and even lamotrigine/Lamictal, should come as no surprise, given the other studies involving the drugs. However, it is possible that many pregnant women are completely unaware of these drugs' harmful effects and rely upon their physicians to inform them of the dangers. If you are one of those women and your child was born with a birth defect, you have the option of filing a medical malpractice suit against your physician. In order to be successful, you would need to make the case that your physician knew of the dangers -- or could have reasonably obtained the information -- of taking valproate while pregnant, but failed to inform you. Since physicians have a duty to inform, that would be a breach of duty to you, the patient. You would argue that as a result, you were exposed to valproate while pregnant and your child was born with a birth defect or has autism or attention deficit disorder.

Continue reading "A New Study Finds That Pregnant Women Who Take Depakote Are More Likely to Have Children With Autism and Developmental Delays" »

A recent press release by a drug research firm has found that the "epilepsy market" is set to increase by nearly $1 billion by 2016. That may be good news for manufacturers of antiepileptic drugs, but may be bad news in terms of birth defects risk. Some studies have suggested that pregnant women who take certain antiepileptic drugs, especially during the first trimester, are at a greater risk of having babies with birth defects.

The press release announces that the market will increase from $2.9 million in 2011 to $3.7 million in 2016, thanks to the expanding number of "third generation" antiepileptic drugs, including lacosamide (brand name Vimpat), perampanel (brand name Fycompa), eslicarbazepine acetate (brand name Zebinix/Stedesa), and ezogabine/retigabine (brand name Potiga/Trobalt). However, "second generation" antiepileptic drugs such as evetiracetam (brand name Keppra/E Keppra) and lamotrigine (brand names Lamictal or Lamictal XR) will remain dominant on the market through 2021.

The press release notes that an "unmet need" remains with regard to seizures in 20 to 30% of epilepsy patients that are inadequately controlled by current medication. New research will be performed to determine how best to serve these patients' needs.

Currently, the evidence linking newer antiepileptic drugs to a higher risk of birth defects is mixed. One Danish study in 2011, for instance, found that there was no connection between the drugs and a higher risk of birth defects, but noted that the "number of individual exposures are too small" to make a conclusive finding. However, other studies have found that there is a higher risk of birth defects when taking certain antiepileptic medications, particularly valproate (brand name Depakote). It remains to be seen whether further research will find that more second and third generation drugs pose a risk.

If your child has a birth defect that you believe is due to your having taken antiepileptic medication while pregnant, you have the option of filing a lawsuit against both the manufacturer and your physician. You would file a medical malpractice suit against your physician if you had reason to believe that he or she was aware of the dangers -- or should have been aware -- and never informed you. A physician has a duty to inform his or her patients of all of the risks associated with treatment, so that the patient can make an informed decision about whether or not to go forward. In a medical malpractice suit, you would argue that the physician breached his duty to inform you of the birth defects risk, that this breach resulted in your injury (through exposure), and the damage that resulted was your child's birth defect.

Continue reading "Epilepsy Drug "Market" to Increase to $3.7 Billion By 2016" »

For those who suffer from depression, bipolar disorder, or other imbalances of the brain, one doctor proposes using acupuncture as an alternative to antidepressant medication. Pregnant women who choose this approach may have the added benefit of reducing the risk of their children being born with birth defects.

Dr. Patrick Massey argues that recent research has found that while antidepressants can help those with severe depression, they have less obvious benefits for those with milder depression. In clinical tests, antidepressants were no more effective for people with milder depression than sugar pills functioning as placebos. Dr. Massey thinks that this is due to many factors contributing to depression besides brain chemistry.

Dr. Massey points to a recent study in the Canadian Journal of Psychiatry, which looked at a compilation of studies that examined the effectiveness of acupuncture at relieving moderate depression for people across a broad age span. The study ultimately found that acupuncture was at least as effective as antidepressants, and when coupled with antidepressants, might reduce some of the side effects. Dr. Massey cautions that the weight of medical research on the subject is not conclusive, but notes that at the very least, it shows that acupuncture is an effective therapy for those with depression. In addition, exercise and meditation have also been shown to be effective alternatives.

While the studies on acupuncture as an alternative are promising, those with depression should do their research before making the choice to go with acupuncture over antidepressants. That includes working with their physician to get an accurate assessment of their mental health so that they can make an informed choice. However, if you are pregnant with moderate depression, and you opt to use acupuncture instead of antidepressants, you might have the benefit of lowering your child's risk of being born with a birth defect. That is because certain antidepressants have been linked to causing a variety of birth defects, especially if women take them during the first trimester. Antidepressants like Depakote have been classified as Pregnancy Category D drugs - evidence of harm to human fetuses - by the Food and Drug Administration as a result.

If your child has a birth defect that you believe could be due to your taking antidepressants while pregnant, you might consider filing a product liability lawsuit against the manufacturer and/or a medical malpractice suit against the physician who prescribed you the medication. For the product liability lawsuit, you would make the argument that the manufacturer had a duty to consumers to create as safe a drug as possible, and the manufacturer breached that duty by designing a drug that was unreasonably dangerous. The breach caused your injury (through exposure to the antidepressant's harmful effects) and the damage was your child's birth defect. For the medical malpractice lawsuit, you would argue that your physician had a duty to inform you, the patient, of all of the potential harms of your course of treatment. Your physician breached this duty by failing to inform you of all of the harmful side effects of your antidepressants, even though he or she knew that you were pregnant. As a result, you would argue that you were injured through exposure, and the damage was your child's birth defect.

Continue reading "Doctor Points to Studies Suggesting That Acupuncture As Effective at Treating Moderate Depression As Antidepressants" »

In a new study, researchers determined that antiepileptics were the drugs most commonly prescribed to those newly diagnosed with bipolar disorder, as one of three lines of therapy. While their findings are promising in that they show how antiepileptics bring relief to bipolar patients, they are also cause for concern. Other studies have shown that certain antiepileptics increase the risk of birth defects if taken by a woman while pregnant, especially during the first trimester.

Researchers from the healthcare advisory firm Decision Resources examined the claims of more than 95,000 diagnosed, drug-treated bipolar disorder patients. They found that antiepileptics such as lamotrigine (also known by its brand name Lamictal) are popular first-line options for treating bipolar symptoms, and can be more tolerable than lithium, while valproic acid (also known by its brand name Depakote) can be effective for treating patients who experience acute manic episodes.

Physicians have also prescribed "atypical antipsychotics," or second-generation antipsychotic tranquilizing drugs, to treat bipolar disorder. The most common atypical antipsychotics prescribed were quetiapine (also known by its brand name Seroquel) and aripiprazole (also known by its brand name Abilify).

Both Abilify and Seroquel have been classified by the Food and Drug Administration as Pregnancy Category C, which means that studies conducted on animals have found evidence of harm to the fetus, but no controlled studies have yet been conducted on humans. Therefore, the benefit of the drug might outweigh the risk. However, Depakote has been classified as Pregnancy Category D, which means that there has been positive evidence of human fetal risk based on adverse reaction data from studies or investigations. A Category D drug could still have benefits in spite of the risks. This blog has discussed possible links between Depakote and birth defects.

If you were prescribed Depakote or one of the atypical antipsychotics while pregnant, and your child was born with a birth defect, you could file a lawsuit. You could file both a medical malpractice suit against your physician and a product liability suit against the manufacturer. For the medical malpractice suit, you would claim that your physician had a duty to inform you, the patient, of the possible problems associated with your course of treatment so that you could make an informed decision as to whether or not to proceed. By not informing you, your physician breached this duty. Because of the breach, you were injured through exposure to the harmful effects of the medication, and the result was your child's birth defect.

Continue reading "Study Finds That Antiepileptic Drugs Are Frequently Prescribed to Treat Bipolar Disorder" »

In a follow-up to "New Epilepsy Drugs May Have Lower Birth Defect Risk," a different study published by The Lancet Neurology in June concludes that four of the most common antiepileptic drugs may increase the risk of birth defects if taken by women early in their pregnancy, and even more so if the dosages are higher.

While the Danish study from May examined lamotrigine (Lamictal), oxcarbazepine (Trileptal), gabapentin (Neurontin), and levetiracetam (Keppra), the current EURAP study focused on valporic acid (Depakote), carbamazepine (Tegretol), Lamictal, and phenobarbital. Researchers in the new study found that of the four antiepileptic drugs, Depakote posed the greatest risk to fetal health.

Though past studies have noted the threat of Depakote, this is the first study to examine the threat of antiepileptic drugs based on the dosage prescribed. It examined women who received antiepileptic treatment in their first trimester: 1,402 women were exposed to Tegretol, 1,280 women to Lamictal, 1,010 to Depakote, and 217 to phenobarbital. With each drug, an increase in birth defects corresponded with an increase in the dosage. When prescribed at 300 mg, Lamictal produced the lowest rates of birth defects. Tegretol had the lowest rate of birth defects below 400 mg. Depakote and phenobarbital had the highest rate of birth defects regardless of dosage.

Antiepileptic drugs have been linked to cleft lips and cleft palates. This study is significant in being the first to give physicians insight into which dosage levels are safe. Thus, physicians can help prevent more birth defects by prescribing a safe dose for pregnant women.

If your physician has prescribed an antiepileptic drug that you believe to be the cause of your baby's birth defect, you might consider filing a lawsuit for medical malpractice and/or for products liability. For a medical malpractice lawsuit, you would need to show that your physician had a duty to you as a pregnant woman to prescribe a safe dose of medication. By failing to do so, he or she breached that duty, and the breach was the actual or proximate cause of your baby's birth defect. Establishing the duty should not be a problem, but establishing breach may be more difficult. You would need to show that your physician did not act reasonably according to the standards of the medical community. He knew or should have known that the dosage he prescribed was dangerous, yet he failed to alter the dose or to warn you of the dangers. Since studies examining dosage levels are just starting to emerge, you might have trouble establishing that your physician did not act with due care.

Continue reading "New Study Finds That Larger Doses of Epilepsy Drugs Can Cause Birth Defects" »

A new Danish study published in the Journal of the American Medical Association found that using newer, second-generation antiepileptic drugs seemed to cause no increased risk of birth defects. The study, conducted by epidemiologists Ditte Molgaard-Nielson and Anders Hviid of the Statens Serum Institut in Copenhagen, used Denmark's health registries to study 837,795 live births from January 1996 through September 2008.

However, according to WebMD, one major limitation of the study was that it did not include many women who were taking the medication Topamax (topiramate). Only about 100 out of the 800,000 women in the Danish registry had taken topiramate, said Hviid. "We cannot conclude anything or make any recommendations on [Topamax], based on this study."

The most common drug taken by women in the study was Lamictal (lamotrigine), and the birth defect risk from this drug was found to be only a little higher compared to women who were not taking any epilepsy drugs. About 1000 women in the Danish study took Lamictal, about 400 took Trileptal (oxcarbazepine), about 60 took Neurontin (gabapentin) and about 60 took Keppra (levetiracetam). Some women studied were taking more than one epilepsy medication. 3.2 % of infants whose mothers were taking one of the drugs in early pregnancy were born with major birth defects, compared to 2.4% of infants whose mothers were not taking any antiepileptic dugs. About 4.6% of babies whose mothers took topiramate and 3.7% to 4% of babies exposed to Lamictal were born with major birth defects.

In March, the FDA issued a stronger warning that using Topamax early in pregnancy could lead to a higher risk of delivering babies with cleft lip and cleft palate. The FDA warning cited new drug registry data that associated Topamax with a 16-fold increase in birth defect risk.

NYU professor of neurology and epilepsy specialist Jacqueline A. French, MD, said to WebMD that the new Danish study was somewhat reassuring, but that studies based on registries of women taking the drugs are more informative. "The findings are reassuring because if the rates of fetal malformation were as high as with Depakote, even with the small sample sizes in this study we would see it...But the findings are not reassuring enough to say that we are out of the woods with all of these drugs."

In birth defect lawsuits, an important issue is the admissibility of scientific evidence to show that a particular medication caused the plaintiff's birth defects. Federal courts follow the Daubert standard (from the case Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 [1993]) to determine whether expert scientific testimony is admissible. Under this standard, courts use several factors to decide whether to admit expert scientific testimony: whether the theory or technique used by the expert is generally accepted in the scientific community; whether the theory or technique has been subjected to peer-review and publication, whether it can be or has been tested, and whether the rate of error is acceptable.

Continue reading "New Epilepsy Drugs May Have Lower Birth Defect Risk" »