Birth Defect Lawyer Blog

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" »

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" »

The struggle against birth defects has seen many celebrities and politicians step up to inform the public about potential causes. Now a quarterback bound for the Super Bowl can be added to the list. Colin Kaepernick, quarterback for the San Francisco 49ers, has another focus: a camp for children born with heart defects.

Camp Taylor was formed near Turlock, California after Kimberlie Gambino gave birth to a son with half a heart. As her son grew up, Gambino realized that he could not keep up physically with other children from school, and that he needed a place where he could interact with children who were like him. There was no such place in Northern or Central California, so Gambino created one. Her camp attracted Kaepernick, who grew up in Turlock, in part because Kaepernick himself had two older siblings who died of heart defects shortly after their birth. Kaepernick's parents later adopted him when he was five weeks old.

According to Gambino, Kaepernick has not only made at least one donation to the camp, but he also visited and met with the children. Last July, he attended a heart education class, and otherwise spent six hours playing, swimming, and being climbed on by the 150 children in attendance. Once Kaepernick became the starting quarterback for the 49ers, he began inviting camp children to games, and has donated some of the proceeds from his "Kaepernicking" T-shirts to the camp. Now that Kaepernick is Super Bowl-bound, Camp Taylor's profile will continue to rise, and hopefully more camps like it will be formed.

While it is encouraging to see programs set up to help children with heart defects, it is still better if birth defects could be avoided altogether. Heart defects have a variety of different causes, including environmental factors. For instance, heart defects have been linked to use of certain antiepileptic medications, like Depakote. Depakote has been labeled by the Food and Drug Administration as pregnancy Category D, which means that there is some risk to human fetuses associated with taking the medication.

If your child has a heart defect that you believe is due to your taking Depakote while pregnant, you have the option of filing a medical malpractice lawsuit and/or a product liability lawsuit. For the medical malpractice suit against your physician, you would argue that your physician had a duty to inform you of all of the risks associated with Depakote, but failed to do so. As a result, you were exposed to the medication while pregnant, and your child was born with a birth defect. For a product liability suit against the manufacturer, you would argue that the manufacturer had a duty to consumers to create as safe a drug as possible, but instead created a drug that was unreasonably dangerous. As a result, you were exposed to the drug while pregnant, and your child was born with a birth defect.

Continue reading "Super Bowl-Bound Quarterback Raises Awareness of Camp For Children With Heart Defects" »

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" »

Recently the federal Food and Drug Administration (FDA) approved a plan in which women who had received organ transplants would be informed that certain transplant drugs could cause miscarriages and birth defects. The plan would be focused on drugs that contained mycophenolate as an active incredient, which includes CellCept and Myfortic. CellCept prevents the body's rejection of liver, kidney, and heart transplants, while Myfortic prevents rejection of kidney transplants. Both drugs are typically used in combination with other medications.

The new plan would be comprehensive, including the establishment of a pregnancy registry, a program that would give health care providers proper training, and a medical guide that would inform patients of the heightened risk of both birth defects and miscarriages. Although the medications have labels warning of these risks, the FDA did not consider them sufficient, pointing out that 20% of babies exposed to mycophenolate in the womb developed a birth defect that was structural in nature. The FDA hopes that the plan will lead to fewer unplanned pregnancies among women who have had organ transplants, since they would now understand the risks involved. The training given to health care providers would include information about available birth control options, types of pregnancy testing, and the risk of a first trimester miscarriage or a birth defect. The pregnancy registry is optional, and any woman may opt out if she wishes to do so.

It is commendable that the FDA is taking such steps, since living with a transplanted organ is enough of a challenge without the added burden of caring for a child with a birth defect. Medication to prevent rejection must be taken for the rest of the person's life. While the lifespan of those with transplanted organs can vary from person to person, a transplanted kidney, for instance, typically only lasts nine years. These medications are no doubt expensive, and coupled with the medications and therapies a child with a birth defect so often needs, expenses can become crippling. If you are in this position, what can you do to find relief? One option would be to file a product liability suit against the drug's manufacturer, as well as a medical malpractice suit against your physician.

In the product liability suit, you would argue that the drug was designed to be unreasonably dangerous and had an inadequate warning label. After all, why would 20% of women on this medication get pregnant if the warning label were sufficient to inform them of the dangers? In a product liability suit, you do not need to prove that the manufacturer was negligent -- although many choose to make this claim -- in order to find it strictly liable, just that the product was unreasonably dangerous. For a medical malpractice suit, you would argue that your physician failed to inform you of the risks of taking the medication, including a heightened risk of miscarriages and birth defects.

Continue reading "FDA Approves of Plan to Inform Women Who Have Received Organ Transplants of the Higher Risk of Giving Birth to Babies With Birth Defects" »

Recently, this blog mentioned that Grunenthal, the German manufacturer of Thalidomide, apologized to victims who suffered birth defects from the drug for the first time in 50 years. Thalidomide was prescribed in the 1950s and early 1960s to mothers during the first trimester of pregnancy. Intended to combat morning sickness, the drug was pulled from the market after research showed that babies born to mothers who took it had severe birth defects. Those children now claim that Grunenthal knew about the birth defects as early as 1955, but chose to take no action. Thalidomide was never approved for sale in the United States, but many charge that physicians were able to obtain samples anyway, which they then prescribed to American women who were pregnant.

A new study from John Hopkins University found that while Thalidomide might cause severe birth defects, the drug may be a benefit in other areas -- including treating multiple myeloma, Crohn's disease, leprosy, and a deadly lung cancer known as idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis is a type of disease that affects people over the age of 40, where over time, the lungs become stiff and scarred. The only known cure is a lung transplant. Otherwise, those with idiopathic pulmonary fibrosis live on average just three to five years longer.

John Hopkins conducted a small trial consisting of 20 patients with idiopathic pulmonary fibrosis. The patients were given either Thalidomide or a placebo for three months and told to report information about their symptoms. Of those who were given Thalidomide, 63% described a decrease in the debilitating cough that is frequently a feature of the disease. The Thalidomide did not cure the disease, but it did reduce the symptoms and enable those with the disease to lead a more productive life.

Researchers cautioned that the drug was not without side effects, including dizziness, malaise, and tingling. Furthermore, all of the participants were over the age of 50, which meant that none would ever be having children.

If you have birth defects resulting from Thalidomide -- or, for that matter, from any drug that your mother was prescribed during pregnancy -- it is important to note that just because the drug has beneficial uses in one situation does not mean that you cannot sue over it being unreasonably dangerous in another situation. If a drug has multiple uses, whether to treat cancer or to stop epileptic seizures or to prevent morning sickness, it needs to be safe in all those situations. If it is not safe, you have the option of filing a product liability lawsuit against the manufacturer. You would charge that the drug came off the assembly line with an "unreasonably dangerous" design, or had an insufficient warning label. Any defense by the manufacturer that the drug is safe "in other situations" would have no bearing, because what matters is that the drug is safe in your situation.

Continue reading "New Study Finds That Drug Linked to Birth Defects Might Help Treat Deadly Lung Cancer" »

Students at Brigham Young University (BYU) recently published research that could lead to the prevention of certain birth defects and how certain types of cancer were treated. Guided by one of their professors, the students' research was aimed at birth defects caused by Fetal Alcohol Syndrome or Andersen Tawil Syndrome, which include cleft palates, small or missing teeth, and misshaped fingers and toes. The students discovered that both syndromes impacted a potassium channel by blocking instructions that, in essence, told cells where they should be located. By blocking the instructions, these syndromes prevent instructions for patterning and an organism from emerging. This, in turn, may result in birth defects.

The students also determined that these instructions could lead to cancer under different circumstances. Once a baby is born, the cell pattern instructions should ideally be turned off so that the cells remain in place. In cancer cells, however, the signals turn back on, allowing cells to invade other tissues and grow into tumors. The BYU students hope to be able to develop a way to block the signaling pathway that leads to cells metastasizing, preventing cancer cells from spreading through the body.

This research is exciting both for the possibilities it holds for cancer and for birth defects. Someday, perhaps sophisticated tests could be developed that would allow expectant couples to find out whether their developing fetus has impacted potassium channels or other cases of blocked instructions that could lead to birth defects. Perhaps treatments could be developed that would make cell instructions normal again, before birth defects had the chance to set in.

Such possibilities are years, if not decades, away. In the meantime, if your child has a birth defect, you and your family live with it now, every day. While some birth defects are minor, others require extensive treatments and come with large medical bills. With Fetal Alcohol Syndrome and Andersen Tawil Syndrome, the culprits are personal habits and genetics respectively, but many birth defects are caused by outside sources. These sources can consist of a wide range of threats, from toxic herbicides to products you use in your household, from certain medications that you have been prescribed to mercury emissions from a power plant. If you believe that one of these sources is responsible for your child's birth defect, you might consider filing a lawsuit.

Generally, such lawsuits fall into two categories: toxic tort and product liability. In both cases, you would argue that the source had a duty, that duty was breached, the breach caused your injury, and there was damage. The "duty" is to anyone who could be foreseeably impacted by the source's actions. So if the source is a power plant, the duty might be the surrounding community; if the source is a household cleaner, the duty might be to the consumers who purchase and use the product. The breach usually consists of unreasonable behavior.

The major difference between a product liability lawsuit and a toxic tort case is that under product liability, a manufacturer can be found strictly liable even if the manufacturer's behavior was not negligent. The manufacturer just needs to have created an unreasonably dangerous product. By contrast, a toxic tort breach involves some sort of negligence. In both cases, you can seek a money award that can help you with your child's lifelong care.

Continue reading "Brigham Young Students Find a Potential Cause For Birth Defects and Cancer" »

Birth defects are a part of everyday life for many. We probably all know at least one person with a birth defect, and many of us have one ourselves. Too often, however, popular culture likes to pretend that birth defects don't exist, preferring to shower television, film, and print media with images of "perfect" people who make even people without birth defects feel inadequate.

Until recently, one could have argued that Here Comes Honey Boo Boo fell into that category. Honey Boo Boo is a spinoff of another The Learning Channel (TLC) show, Toddlers & Tiaras. The show follows June Shannon and her daughters in McIntyre, Georgia as Shannon tries to enter her seven-year-old daughter, Alana "Honey Boo Boo" Thompson, in numerous beauty pageants. The oldest of Shannon's three other daughters, 17-year old Anna Shannon, gave birth to a baby girl in June. Baby Kaitlyn was born with an extra thumb on her right hand, and the family is -- surprisingly -- resistant to having it removed.

The Shannons claim that having an extra thumb "makes Kaitlyn more special" to them. Their attitude has drawn some sharp criticisms from those who think that the baby's extra thumb should be removed to prevent later abuse from her peers. It remains to be seen whether the extra thumb would pose a problem with basic finger movement, or whether Alana Shannon's daughter would eventually adapt. Regardless, it is rare for any television family to be so accepting of birth defects, and it serves an important purpose of making society in general more accepting. While it is true that birth defects are a part of many people's lives, our tendency is to hide the things about us that make us stand out.

At the same time, even when people accept birth defects, they still might have to contend with health problems that could accompany them. Oftentimes, these health problems can be severe, costing thousands of dollars each year for families that don't have comprehensive health insurance -- or any insurance at all. If that is the case, one option that a family might have is to sue the entity believed to be responsible for the birth defect. If the family is successful, they could receive a monetary award from a jury that could cover the costs.

While genetics and lifestyle can often dictate whether a baby is born with a birth defect, environmental toxins or prescription drugs can also be culprits. If you believe that your child's birth defect could be the result of your exposure to one of these sources while pregnant, you might consider filing either a toxic tort lawsuit or a product liability lawsuit. If the source is a product, you would file a product liability suit, whereas if the source is chemicals released by a power plant or a mountaintop removal mine, you would file a toxic tort lawsuit. In both cases, your greatest challenge would be proving causation -- that there is strong evidence of a link between the source and your child's birth defect. Often, this depends upon where the source is located -- in your home or several miles away? -- and when the exposure to toxins or prescription drugs occurred. If it was several years before the birth of your child, you will have a tougher case.

Continue reading "Family in Popular Reality Show Learns to Adapt to Baby Born With a Birth Defect" »

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 previously discussed lawsuits filed against Grunenthal, the German manufacturer of Thalidomide, which was a morning sickness pill linked to severe birth defects. Thalidomide was prescribed in the 1950s to many pregnant women in the United States and throughout the world during their first trimester. While Thalidomide was never approved for use in the U.S., many believe that physicians were still given the drug to prescribe. The drug was taken off of the market in 1961 after evidence of severe birth defects was revealed. However, those who filed the lawsuits -- primarily those who were born with severe birth defects -- have claimed that Thalidomide knew about the birth defects as early as 1955, yet chose to keep them a secret.

For a long time, Grunenthal has strongly denied that it knew about the birth defects sooner, even refusing to be part of a settlement with an Australian whose mother had taken Thalidomide. However, recently, Grunenthal might have changed its tune. The company issued a rare apology to those whose mothers took Thalidomide during the 1950s and early 1960s. Grunenthal's chief executive apologized for not "reaching out" all these years and said it was due to "the shock that your fate has caused in us."

Those who had been adversely affected by Thalidomide refuse to be placated. Freddie Astbury, who was born without arms or legs, claims that not only should Grunenthal apologize, but that it should also offer compensation to those with birth defects. Another person affected by Thalidomide pointed out that while Grunenthal settled one lawsuit in Germany in the 1970s, the fund that was set up was too small to help those expected to live, on average, into their 80s.

While Thalidomide is no longer sold on the market, other potentially dangerous drugs are still sold and prescribed in the U.S. every day. The antidepressant Depakote, for instance, has been linked to a variety of birth defects. If your child was born with a birth defect that you believe was due to prescription medication that you were prescribed while pregnant, you have the option of filing both a medical malpractice lawsuit and a product liability lawsuit. In both cases, your main objective will likely be to receive a money award that will help pay for your child's care for the rest of his or her life. It is therefore important that you provide an accurate assessment of your child's physical and mental limitations for the jury. Calculating someone's care for a lifetime can be difficult, since it means projecting costs decades into the future. Oftentimes, medical malpractice and product liability lawsuits settle before they reach the point of a jury verdict. If you decide to settle, you still need to have those calculations ready to ensure that you are getting an amount that will serve your child's needs.

Continue reading "German Manufacturer of Pregnancy Drug Linked to Birth Defects Issues First Apology in Fifty Years" »

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" »

A new article reports that more frequently, doctors are turning to a simple solution, readily available, to cure a number of ills: light. Among other problems, such as back pain or cancer, targeted light can also help those who suffer from epileptic seizures, whose condition is not well served by antiepileptic drugs. This could be a substantial benefit for pregnant women with epilepsy, who may fear that taking antiepileptic drugs will result in birth defects.

University College in London is conducting a trial whereby patients are exposed to a light box that emits a bright white light for a half-hour each day for three months. Researchers conducting this study are basing their theory on evidence that fewer people suffer seizures on bright, clear days, and that there are more seizures in northern Europe than in southern Europe. One reason for this may be because light increases the amount of Vitamin D in our system, which in turn produces more brain chemicals that put a damper on seizures.

Scientists are also using light to treat a host of other problems. Ultraviolet light is being used to treat skin conditions. Photodynamic therapy, which involves the person ingesting a special drug and then being exposed to blue light, is being used to treat skin cancer. Infrared light is being used to speed recovery after a stroke and help heal pressure ulcers. While the light treatment might not be successful in every case, the extent to which it is successful means that patients will need to take fewer prescription drugs for their problems, which could reduce the risk of giving birth to a child with a birth defect.

In the meantime, if you have epilepsy or depression, and have been prescribed medication to take while pregnant, you could be at risk for having a child with a birth defect. Studies have shown that antiepileptic drugs or antidepressants, especially when taken during the first trimester of pregnancy, can increase the risk. If your child has a birth defect that you believe may be due to medication that you were prescribed, you could choose to file a medical malpractice suit against your physician and/or a product liability suit against the manufacturer. Your physician could be guilty of negligence if he or she failed to inform you of the drug's potential dangers. A physician has a duty to inform the patient of all risks of treatment so that the patient can make an informed decision. Likewise, a manufacturer could be held strictly liable if the drug's design was found to be unreasonably dangerous. In both cases, if you were successful in your suit, you would be able to collect a monetary award for general and special damages -- that is, for specific items, such as medical bills, and for harder to calculate items, such as pain and suffering.

Continue reading "Light Therapy Treatments May Lessen the Need for Prescription Medicines and Decrease the Risk of Birth Defects" »

In the past, this blog has discussed American lawsuits against the German manufacturer of Thalidomide, and attempts to force the Food and Drug Administration (FDA) to release records of those who used the drug. Thalidomide is a morning sickness drug that was prescribed to pregnant women during their first trimester in the 1950s and 1960s. The drug was pulled from the market in 1961 after evidence was revealed that its use led to severe birth defects. Many believe that that the manufacturer might have known sooner, as evidence of birth defects existed as early as 1955.

Thalidomide use had worldwide consequences, as the latest news from Australia demonstrates. Lynette Rowe, who was born without arms or legs after her mother took Thalidomide, recently reached a multi-million dollar settlement with the British distributor of the drug. Grunenthal, the German manufacturer, refused to settle, continuing to insist that its actions were consistent with the scientific knowledge that existed at the time.

Rowe sued Grunenthal, Distillers Company (Biochemicals) Ltd., a British-based company that sold Thalidomide in Australia, and the successor company to Distillers, Diageo Scotland Ltd. In the lawsuit, Rowe claims Thalidomide's manufacturer should have known the drug was linked to birth defects while it was on the market. The lawsuit sought compensation for Rowe's pain and suffering, lost wages, and future medical care. Rowe was part of a class action containing at least 100 people, each of whom will have their claims heard by Diageo and the chance for a potential settlement.

Money is no substitute for the lower quality of life caused by certain birth defects. However, a money award -- otherwise known as "damages" -- can go a long way toward making your life easier by paying for the medical care and extra daily care that you need to lead a full, productive life. If your mother took Thalidomide while pregnant and you are not part of one of the existing lawsuits, you might consider filing your own product liability lawsuit against the manufacturer. If your birth defects are consistent with those of people whose mothers took Thalidomide, and there is evidence that your mother took the drug before you were pregnant, you could argue that there is a sufficient link to establish that Thalidomide caused your birth defects. Therefore, the manufacturer should be strictly liable for designing an unreasonably dangerous drug.

For those whose mothers did not take Thalidomide, there is still reason to be wary of drugs that could cause birth defects. Studies have shown that antiepileptic or antidepressive drugs, especially if taken during the first trimester, can increase the risk of your child being born with a birth defect. If that is a case, you, too, could file a product liability lawsuit against the manufacturer.

Continue reading "Australian Woman Gets Multi-Million Dollar Settlement in Thalidomide Lawsuit" »

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" »

This blog has discussed previous studies showing how certain antiepileptics, especially when taken during the first trimester of pregnancy, can lead to an increase in birth defects. Now a new study points to another troubling consequence: those who take antiepileptics are more likely to fall and suffer from fractures. What is worse: too few people prescribed antiepileptic drugs are aware of this consequence.

Researchers in Melbourne, Australia who conducted the study noted that antiepileptics have a history of affecting people's balance, leading to high numbers of falls. Women who take antiepileptic drugs are especially vulnerable, as they are twice as likely to fall and injure themselves as women who are epileptic, but do not take medication. While falling could lead to fractures and osteoporosis, it also has the consequence of possibly hurting a fetus or causing a miscarriage.

The researchers' study involved 150 drug users and 506 non-users, and concluded that their results demonstrated how little awareness there was about the affects of antiepileptic medication. Of those who had been diagnosed as epileptics, 70% claimed to be unaware that antiepileptic medication increased their possibility for falls, fractures, and decreased bone density. When so informed, people who took the medication expressed a desire to know more. Professor John Wark, leader of the study, stated that this showed people with epilepsy should be regularly assessed for their tendency to fall or suffer from fractures, and management strategies should be provided.

It is not clear whether antiepileptic medication in general, or just certain antiepileptic drugs, affect users' balance. It may be that the medication in general, based on its effect on the brain, can impact balance. This means that if you have epilepsy and are pregnant, you may have to be extra cautious about taking antiepileptic medications, even those that supposedly do not cause birth defects. Your physician has a duty to inform you of any known dangers, and thus you should speak to him or her about what medication is right for you.

If you have a child with a birth defect, or suffered a miscarriage, and you believe it was due to taking antiepileptic medication while pregnant, you might consider filing a product liability lawsuit against the manufacturer, and possibly a medical malpractice suit against your physician. For a product liability lawsuit, you would argue that the manufacturer had a duty to consumers to make as safe and effective an antiepileptic medication as possible. The manufacturer breached that duty by designing a medication that was unreasonably dangerous, when it would not have been too difficult or expensive to design a safer drug. The breach led to your injury -- exposure to the medication's effects -- and as a result, you suffered a fall that injured your fetus or caused a miscarriage, or your child was born with a birth defect as a result of exposure in the first trimester. In defense, the manufacturer might argue that it truly was not possible to create a safer drug, and that it followed all applicable safety rules.

Continue reading "An Australian Study Focuses On the Link Between Antiepileptic Drugs and an Increase in Falls and Fractures" »