Birth Defect Lawyer Blog

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" »

This blog has discussed studies that show an increased risk of birth defects for those who take certain antiepileptic drugs, such as Topamax or Depakote. These studies found that pregnant women who were prescribed Topamax during the first trimester of pregnancy were more likely to give birth to children with certain birth defects, specifically cleft lip and cleft palate. Depakote's effects were even more widespread, increasing the risk of six different types of birth defects, including spina bifida. Other studies have linked antiepileptic to lower IQs in children.

Likewise, antidepressants have also been shown to increase the risk of birth defects. Studies have linked them to everything from slower head growth to heart defects.

Because of the concerning findings, the Food and Drug Administration (FDA) reclassified Topamax and Depakote as Pregnancy Category D drugs, a downgrade from Pregnancy Category C. Pregnancy Category C meant that while the drugs showed harmful effects to animals, no controlled studies had yet shown harm to humans. Pregnancy Category D means that controlled studies have shown that Topamax and Depakote posed a health risk to human fetuses, but still had potential benefits. Meanwhile, antidepressants such as fluoxetine, sertraline, and bupropion (more commonly known as Wellbutrin) have been classified as Pregnancy Category C drugs, while paroxetine and imipramine are in Pregnancy Category D.

Although these precautions have been taken, for some like Senator Chuck Schumer of New York, it still is not enough. Senator Schumer has called for the FDA to require clearer warning labels on prescription medications that warn pregnant women about the risk these drugs pose to their fetuses. Senator Schumer's goal is to reduce the number of babies born addicted to prescription medications, but it has the effect of helping them in the area of birth defects as well.

When most people file product liability lawsuits, they often do not consider the adequacy of the product's warning label. Yet adequacy of the warning label is one of the key factors for determining whether the product is defective and its manufacturer is strictly liable for whatever damages was caused. An adequate warning label is generally in an obvious location, is easy to read, and accurately describes the product's dangers. If your child was born with a birth defect that you believe was due to your taking prescription medications, and you do not have sufficient evidence that the manufacturer could have produced a less dangerous drug, you could argue that the warning label did not provide a sufficient warning. Had the warning been sufficient, you would not have taken the drug.

Continue reading "Senator Chuck Schumer Calls for the FDA to Impose Clearer Warning Labels on Prescription Medications" »

Back in October, this blog discussed how the weight loss drug Qnexa, manufactured by Vivus, posed an increased risk of birth defects for pregnant women. Qnexa contains topiramate and phentermine, with topiramate being an ingredient in antiepileptic seizure medication. Antiepileptic drugs have been linked to a higher rate of birth defects -- such as cleft palate -- if taken in the first trimester of pregnancy. In October, Vivus had resubmitted an application to the Food and Drug Administration (FDA) after making a modification: use of Qnexa would be limited to those over 55 years of age.

The FDA staff recently turned to an advisory panel to weigh in on whether the benefits of Qnexa outweigh any harmful health effects, such as heart problems or birth defects. Trials revealed that while people who took Qnexa lost more weight than those on a placebo, they also had more health problems, such as memory loss, that could worsen with time. The FDA had previously rejected Vivus's application in 2010 out of concern over rapid heart beat and an increase in birth defects. The FDA advisory panel, the Endocrinologic and Metabolic Drugs Advisory Committee, voted by an overwhelming 20 to 2 margin to recommend approval for the drug.

Although the advisory panel expressed the same concerns that led to the first application's rejection, the panel noted that Qnexa's two main ingredients were already circulating out in the market and could be prescribed off label. One panelist commented that they couldn't "doubt the benefit of weight loss." At the same time, the advisory panel cautioned that post-approval studies be conducted to monitor cardiovascular side effects. While the FDA is not required to follow the recommendations of an advisory panel, it usually does. The FDA is expected to issue its final decision on April 17th.

Even though Qnexa is being limited to women over 55 years old, topiramate is featured in many antiepileptic drugs taken by younger women. If you took antiepileptic medication while pregnant, and your child was born with a birth defect, you could sue the manufacturer and/or your physician for relief. You would sue the manufacturer under product liability theory. You would argue that the drug manufacturer had a duty to create as safe a drug as possible, but breached that duty by creating an unreasonably dangerous drug. This drug could have been made safer without a change in price or effectiveness. It may also have lacked a warning label that adequately spelled out the dangers. The manufacturer's breach caused your injury -- exposure to the harmful effects while pregnant -- and your damage was your child's birth defect.

You could also sue your physician under medical malpractice theory. To be successful, you would need to prove that the physician knew, or should have known, about the dangers of taking antiepileptic medication during the first trimester, and that the physician failed to warn you before prescribing the drug. All physicians have a duty to warn patients about potential problems with treatment so patients can make informed decisions.

Continue reading "FDA Advisory Panel Approves of Qnexa for Weight Loss Usage Despite Evidence That It Causes Birth Defects and Other Health Problems" »

The pharmaceutical company Vivus resubmitted an application for its new obesity drug, Qnexa, with a limitation that it not be used by any woman under the age of 55 years old. The reason is fear that women of childbearing age could use the drug and end up having children with birth defects. Vivus was able to get approval of an early reapplication after making a deal with the Food and Drug Administration (FDA).

Qnexa is made up of topiramate and phentermine. While phentermine is used for a limited period of time to speed weight loss, topiramate is the generic name for drugs such as Topamax or Topiragen, which are used to treat and prevent epileptic seizures. Antiepileptic drugs have been linked to certain birth defects, particularly when taken during the first trimester of pregnancy. Even phentermine can cause health problems if intermixed with certain anti-depressants such as Paxil (paroxetine) and Zoloft (sertraline), or monoamine oxidase inhibitors. The FDA originally expressed concerns about Qnexa's use of topiramate and rejected the previous application on October 28, 2010.

Now Qnexa will be for those over 55 who register as obese on the BMI scale, or those who are overweight with a BMI of 27. It is unknown whether older woman could suffer health problems as a result of taking the drug, though so far clinical studies have shown that it does not contribute to heart disease or elevate the heart rate.

Even though women of childbearing age won't have access to Qnexa, many antiepileptic drugs with topiramate still exist and are frequently prescribed by physicians. Earlier this year, the FDA reclassified topiramate as Pregnancy Category D because of the drug's potential to cause birth defects such as cleft lip or palette. If you take a medication with topiramate and have a baby with birth defects, you may be able to sue your physician and/or the manufacturer to obtain relief. If you took topiramate during your first trimester, not knowing that it could lead to birth defects, you could sue your physician for medical malpractice. You could argue that your physician had a duty to be reasonably informed of new medical information and to warn you, the patient, of potential dangers. Your physician failed to warn you, and thus breached this duty. This breach led to your injury, and the damage was your child's birth defect. You would need to provide solid evidence that topiramate, not another source such as genetics, was the cause of the birth defect. Given that multiple studies have implicated antiepileptic drugs, that should not be too difficult.

If you want to file a products liability lawsuit against the manufacturer, you would argue that the manufacturer had a duty to create as safe a drug as possible, breached that duty by creating a drug with a design defect that made it unreasonably dangerous, that breach caused your injury, and the damage was your child's birth defect.

Continue reading "Obesity Drug Manufacturer Plans to Make Drug Available Only to Women Over 55 Years Old" »

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" »

This post will be a follow-up to our March 23 entry, "New Studies Confirm Topamax May Increase Risk of Birth Defects". Recent studies have confirmed that topiramate (brand name Topamax), a drug prescribed to treat epilepsy and migraines, is linked to an increased risk of birth defects. The most common birth defects linked to topiramate are cleft lip and cleft palate, when the lip or palate fails to properly fuse together during the first trimester of development. The defect can be anything from a notch in the lip, to a groove running along the roof of the mouth and nose. Cleft lip and cleft palate can cause difficulty with talking, eating, and lead to frequent ear infections.

A 2008 United Kingdom study that was published in the journal Neurology found that women exposed to topiramate during pregnancy had a 4.8% chance of having babies with major birth defects, compared to 1-2% in normal population. Women who used topiramate as part of a polytherapy had a 11.2% risk of having babies with birth defects.

In addition, data from the North American Antiepileptic Drug Pregnancy Registry showed a link between topiramate and birth defects. Among women who used topiramate in the first trimester of pregnancy, 1.4% of their babies were born with oral clefts (compared to 0.38% to 0.55% occurrence among women taking antiepileptic drugs and 0.07% to women not taking antiepileptic drugs.) In response to the evidence, the Food and Drug Administration (FDA) released a stronger birth defect warning for topiramate and changed the drug's pregnancy category to D - meaning there is positive evidence of risk to human fetuses, but in some cases the potential benefits of the drug may outweigh the risk. Issued in March 2011, the FDA warning recommended that health care professionals inform women who may become pregnant about the risks of taking Topamax while pregnant.

Continue reading "Studies Confirm Birth Defect Risks of Topamax " »

An estimated 64% of pregnant women use at least one prescription drug while pregnant, and on average, three to five. Recently, the Wall Street Journal reported on recent concerns regarding drugs that could increase the risk of birth defects when taken during pregnancy.

Last month, the Food and Drug Administration (FDA) issued stronger warnings about Topamax (generic topiramate), a drug used to treat seizures and migraines, due to studies linking it with a higher risk of malformations like cleft lip or cleft palate. Also, in March the Centers for Disease Control and Prevention issued precautions that opioid pain medications such as OxyContin, Vicodin, and Tylenol with codeine, can increase the risk of congenital heart defects, glaucoma and other birth defects when taken early in pregnancy. Some studies suggest that pseudoephedrine, an ingredient in many cold medicines, may lead to a higher risk of gastroschisis (a birth defect where the baby's intestines protrude from the abdominal wall.) Serotonin-reuptake inhibitors (SSRIs) are still considered safe, though new research has found that a few types of SSRIs may raise the risk of congenital heart defects.

According to the article, it is difficult to know which medications pose a risk to unborn babies, because drug labels often lack sufficient information or any information at all about birth defect risks. Studies on the effects of drugs on fetuses are also rare because it is deemed unethical to use pregnant women and fetuses for randomized-controlled clinical trials.

Continue reading "Wall Street Journal Highlights Topamax, Opioid Birth Defect Risks " »

Qnexa, a promising weight-loss drug, will require further studies before it can gain FDA approval due to concerns about birth defects. Qnexa is manufactured by the drug company Vivus Inc., based in Mountain View, California.

Qnexa was highly anticipated as an effective weight-loss and obesity drug, which also helped users to reduce blood pressure and improve lipid levels. However, in October 2010, the Food and Drug Administration (FDA) did not approve Qnexa because of concerns that the drug may cause an increased risk of birth defects, along with other health concerns such as heart problems. The FDA requested more information and studies about Qnexa's potential health risks before it could approve the drug.

One of the ingredients in Qnexa is topiramate, which is linked to higher risk of cleft lip and cleft palate in infants exposed to the drug. (Topiramate, used to treat seizures and migraines, is marketed by Johnson & Johnson under the brand name Topamax.) Last month, the FDA issued stronger warnings for topiramate in light of new studies linking the drug to certain types of birth defects.

Vivus Inc. believes the FDA's concern is due to two published reports citing six cases of cleft lip or cleft palate. However, Vivus Inc. stated that 15 pregnant women used Qnexa during the clinical trials and no birth defects were reported. According to the company, it will "assess the feasibility of analysing existing databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate" in treating migraines.

Continue reading "FDA Concerned About Birth Defect Risk of Obesity Drug Qnexa " »

Recently, the Food and Drug Administration (FDA) issued stronger warnings about Topamax (topiramate), an antiepileptic drug that is linked to a higher risk of birth defects. New studies show that using Topamax during pregnancy can lead to a higher risk of birth defects like cleft lip and cleft palate, when the lip or palate does not fuse together properly. Information from the North American Antiepileptic Drug Pregnancy Registry showed that pregnant mothers who used topiramate were 20 times more likely to have babies with cleft lip or palate, compared to mothers who did not take epilepsy medications. The occurrence of cleft lip or palate was 3-4 times higher in babies who were exposed to Topamax, compared to other antiepileptic drugs.

The FDA advises that women who are or could become pregnant should be warned about the risks. "Alternative medications that have a lower risk of birth defects should be considered," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

The FDA will now classify Topamax as pregnancy category D (meaning there is evidence of human fetal risk, but using the drug might still be warranted in some cases). Previously, the drug was classified as Category C - studies on animals had shown a possible adverse effect on the fetus, but the potential benefits of the drug may outweigh the risk.

Continue reading "New Studies Confirm Topamax May Increase Risk of Birth Defects " »