Birth Defect Lawyer Blog

Recently, there were two stories, seemingly unrelated, of physicians on either side of the country being investigated or indicted for their actions. In one case, a doctor specializing in pain had his office raided in a drug abuse probe. In the other case, 44 physicians and other health care workers in Macomb County, Michigan were indicted by a federal grand jury for allegedly committing fraud. Despite the fact these cases have no direct connection, they are connected by a common theme: prescription of painkillers such as Vicodin or OxyContin despite no evidence of injury or pain. Both types of painkiller have been known to increase the risk of birth defects.

In the first case, the physician, John Dimowo, is a pain doctor who was previously at the center of a criminal probe into prescription overdose deaths. According from an affidavit attached to the search warrant, he wrote as many as 37 prescriptions for Vicodin per day. Dimowo, who is board-certified in pain management, argues that it is often difficult to tell when someone is truly in pain and when someone is faking, because everyone's experience with pain is different.

Meanwhile, in Michigan, 44 people were arrested and subject to a 13-count indictment having to do with selling prescription drugs. The federal government alleges that those charged were part of a scheme to bill insurers and the government for unnecessary prescriptions, and that they accepted bribes and kickbacks for writing prescriptions for painkillers like Vicodin or OxyContin that were later sold on the street.

This is a serious situation nationwide that is either growing, or has at least gained wider attention from state and federal law enforcement. Besides being extremely addictive and increasing the risk of death, OxyContin and Vicodin use may also increase the risk of birth defects. A pregnant woman who takes OxyContin has an increased chance of giving birth to a baby with heart defects, including atrial septal defects, hypoplastic left heart syndrome, and pulmonary valve stenosis. Meanwhile, a woman who takes Vicodin has an increased risk of having a baby born with spina bifida, cleft lip or palate, congenital heart defects, genital defects, and more.

If your child was born with any of the above defects and you believe that it was due to your taking OxyContin or Vicodin, you may file a medical malpractice lawsuit against your physician. However, your success depends upon the circumstances. If you knowingly bought your painkillers from a "pill mill," then a jury might believe that you were equally responsible for your child's birth defect, because patients usually go to pill mills so they do not have to prove an injury. Most states have "comparative negligence" laws where the injured party can be found partially at fault for the injury. Some states even have laws that forbid the injured party from collecting an award if that party was at least 50% at fault. On the other hand, if you went to your usual physician seeking relief from pain, and he prescribed OxyContin or Vicodin without informing you of the risks, you might be successful in getting a jury to determine that he committed medical malpractice.

Continue reading "Across the Nation, Law Enforcement Is Cracking Down on Physicians Who Illegally Prescribe Painkillers" »

A recent report found that the number of drug overdose deaths has risen for the eleventh year in a row. Most of the overdoses involved painkillers such as OxyContin and Vicodin. One reason, experts say, is because these more powerful painkillers are being prescribed for conditions that could be managed by less powerful painkillers, and many physicians are ignorant of just how addictive these painkillers can be.

In 2010, the latest year that information was available, there were 38,329 deaths, with prescription drugs representing 60% of those deaths. Of those drugs, anti-anxiety drugs, like Valium, accounted for 30% of them. However, three out of four deaths could be attributed to OxyContin or Vicodin. The number of overall deaths is 3.6% higher than in 2009.

Experts warn that while OxyContin and Vicodin may be satisfactory for serious illnesses like cancer, they are too powerful for conditions such as a bad migraine or back pain. Even more concerning are the number of physicians across the country who operate "pill mills," where the physician issues prescriptions for medications even with little to no evidence that the patient has a health problem. The physicians who operate pill mills generally do so for profit only, and federal and state authorities are trying to shut them down. However, sometimes the physicians are simply ignorant of a patient's attempt to con them into more medication. The University of Colorado Hospital in Aurora is considering a rule that would prevent emergency room doctors from prescribing pills to those who claim that they lost theirs. Last month, a federal panel recommended that Vicodin be subject to the same restrictions as other narcotics like oxycodone.

Besides being powerfully addictive and increasing the risk of death, OxyContin and Vicodin also increase the risk of birth defects. A pregnant woman who takes OxyContin has an increased chance of giving birth to a baby with heart defects, including atrial septal defects, hypoplastic left heart syndrome, and pulmonary valve stenosis. A woman who takes Vicodin has an increased risk of her baby being born with spina bifida, cleft lip or palate, congenital heart defects, genital defects, and more.

If your child was born with any of the above defects and you believe that it was due to your taking OxyContin or Vicodin, you have the option of filing a medical malpractice lawsuit against your physician. Whether you are successful in your lawsuit depends upon the circumstances. If your prescription came from a "pill mill," then a jury might believe that you were equally responsible for your child's birth defect, because patients usually go to pill mills so they do not have to prove an injury, or so they can obtain more medication than their usual physician would prescribe. Most states have what is known as "comparative negligence" laws, and some states even have laws that forbid the injured party from collecting an award if that party was at least 50% at fault. On the other hand, if you went to your usual physician for migraines or back pain, and he prescribed OxyContin or Vicodin without informing you of the risks, you might be successful in getting a jury verdict that he committed medical malpractice.

Continue reading "New Study Finds That Number of Drug Overdose Deaths Has Risen 11 Straight Years, Fueled Largely By Prescription Drug Overdoses" »

A new study from the University of Colorado has found that teenagers are abusing prescription pain medication at a much higher rate than previous generations -- as much as 40% more. Why is this such a problem? Because among other things, if a teenage girl were to become pregnant, she would be more likely to have a child with a birth defect.

While certain prescription drugs, such as Oxycontin, are classified as Pregnancy Category B by the Food and Drug Administration -- which means that they are not considered to pose a risk of birth defects -- the Center for Disease Control and Prevention has found that taking Oxycontin, Vicodin, Tylenol-3, or other opioid pain relievers either early in pregnancy or just before pregnancy increases the risk of babies being born with congenital heart defects. Specifically, opioid pain killers were found to double the risk of hypoplastic left heart syndrome, one of the most significant heart defects.

Researchers from the University of Colorado examined data from the National Survery on Drug Use and Health taken between the years 1985 and 2009. They found that teenagers' use of prescription drugs was "higher than any generation ever measured." This was true regardless of gender or ethnicity. Researchers believe that the vast increase may be due to a variety of factors. Pain medicine prescriptions in general are on the rise, from 40 million in 1991 to 180 million in 2007. With more drugs available, that makes it easier for today's youth to get their hands on prescription medications. They might conclude that if their parents use the drugs, they must be safe. Instead, prescription drug abuse has led to an increase in accidental deaths.

Without significant education, these trends are likely to persist, with the disturbing side effect that they will lead to an increase of babies born with birth defects. Yet until prescription pain killer use is curtailed in general, teens will still be able to use and abuse them fairly easily.

If you took prescription pain medication and your child was born with a birth defect, could you file a lawsuit in order to get monetary relief? It depends upon the circumstances. If, as described above, you were using medication that was not prescribed to you, then the answer is likely no. Normally a patient might be able to file a medical malpractice suit against his or her physician based upon the physician's duty to inform the patient of all risks associated with taking a certain medication. However, if you were never prescribed the medication, you could not sue the physician for failing to warn you that taking opioid drugs increased your baby's chance of being born with a birth defect. On the other hand, if the one who was prescribed the medication gave it to you without explaining the risks, you might be able to sue that person for negligence.

Continue reading "New Study Finds That More Teens Are Abusing Prescription Drugs, Which Could Mean More Babies Born With Birth Defects" »

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" »

In some disturbing news, researchers have found that more babies than ever are suffering from withdrawal symptoms due to an increase in women taking narcotics while pregnant.

The study -- the first to examine the issue -- found that more pregnant women were taking Vicodin, OxyContin, and a variety of illegal narcotics, including heroin. As a result, the number of babies suffering from narcotics withdrawal has tripled. Between 2000 and 2009, the number of newborns with withdrawal symptoms increased from just over one per 1,000 babies released from the hospital to more than three per 1,000 in 2009. As a result, more than 13,000 infants in the study were affected in 2009.

While the babies experience withdrawal, they are not addicted to the narcotics the way their mothers are. However, their bodies become dependent on the narcotics because of their mothers' use. As a result, some scientists advocate giving babies small doses of the narcotics to wean them off, rather than cut them off entirely. Doing so could cause seizures and possibly even death for the baby. Many believe that even though withdrawal symptoms are serious, they do not result in long-term health problems. Even so, weaning babies off of drugs can be both time consuming and very expensive -- requiring weeks or months in intensive care units. The cost of treating these infants rose from $190 million to $720 million between 2000 and 2009.

Some believe that the problem is not due to women simply being irresponsible, but to physicians pushing them to take powerful painkillers. Many women might start taking narcotics for legitimate reasons, such as an injury from a car accident, and then become addicted, turning to street drugs once the prescription runs out. Nonetheless, some states have taken a hard-line approach to mothers' drug use, jailing them if their babies suffer from withdrawal symptoms.

In any event, it is a growing problem in the United States, one that requires a systematic and compassionate approach. If you are one of the unfortunate individuals described above, and your child suffers from withdrawal symptoms, you might consider filing a medical malpractice lawsuit against your physician. You would argue that your physician was the one who urged you to take a prescription painkiller such as OxyContin or Vicodin.

A physician has a duty to inform patients of the possible risks of treatment so that patients can make an informed decision. Your physician may never have informed you about the risks associated with such drugs, claiming that the narcotic was safe, and that the levels you were prescribed would not result in addiction. If you took the narcotics while you were pregnant, a doctor prescribed them for you, and your baby was born with symptoms of drug withdrawal, it should not be difficult to link a baby's withdrawal symptoms to powerful drugs that your physician prescribed for you.

Continue reading "New Study Finds That More Newborns Than Ever Suffer From Narcotics Withdrawal" »

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 " »

Opioid painkillers such as codeine, oxycodone, and hydrocodone can be risky to take during pregnancy, according to a Centers for Disease Control and Prevention (CDC) study that was published in the American Journal of Obstetrics & Gynecology. Opioid medications include prescription drugs such as OxyContin, Vicodin and Tylenol-3.

The CDC study found that babies exposed to opioid drugs before or early on in the pregnancy were twice as likely to have hypoplastic left heart syndrome, a life-threatening condition where the left side of the heart is extremely underdeveloped. Infants with this serious heart defect often do not survive past one year; others must undergo expensive, invasive procedures and long hospital stays to save their lives. In many cases, even if the child survives, he or she requires lifelong medical treatment and is unable to lead a normal life.

Women who take opioid drugs during pregnancy are also more likely to deliver babies with other serious birth defects such as spina bifida, gastroschisis (an abdominal wall defect where the intestines protrude out of the body), hydrocephaly (abnormal fluid buildup in the brain), and congenital glaucoma.

The CDC study points out that the overall number of birth defects is relatively low. However, a woman who is pregnant or may become pregnant should discuss the risks with her doctor before using opioid pain relievers. "With very serious and life-threatening birth defects like hypoplastic left heart syndrome, the prevention of even a small number of cases is very important," said the study's lead author, Cheryl S. Broussard of the CDC's National Center on Birth Defects and Developmental Disabilities.

Continue reading "Use of Opioid Painkillers Linked to Serious Birth Defects" »