Prescription Medication May Cause Birth Defects

Certain drugs taken by pregnant women are known to increase the danger of birth defects. In a closely watched case, a Philadelphia jury found that the anti-anxiety/anti-depressant drug Paxil, manufactured by GlaxoSmithKline, and taken by a pregnant woman, was the cause of her newborn’s heart defects. The baby has undergone several surgeries and will need more surgery as he gets older. The jury awarded the baby’s family $2.5 million to compensate for medical expenses and other injuries. The family asked for only $1.2 million.

GlaxoSmithKline is currently defending approximately 600 Paxil birth defects cases. In the Philadelphia case, the baby’s family argued that the manufacturer initially ignored Food & Drug Administration requests that it warn doctors of studies showing a potential of increased birth defects, specifically to the heart, and continued to sell the drug without any such warnings. At trial, lawyers for the baby’s family presented e-mails and memos showing that the company knew that Paxil had a link to birth defects. Some evidence suggested that GlaxoSmithKline even promoted Paxil to pregnant women even after they suspected a risk. Indeed, the jury found that GlaxoSmithKline negligently failed to warn the doctor treating the newborn’s mother.

GlaxoSmithKline plans to appeal the verdict.

This case is yet another example of the pharmaceutical industry putting profits ahead of safety. Sources report that Paxil sales totaled $849 million last year. According to this jury, a simple warning label to doctors could have prevented this baby’s heart defect. But had GlaxoSmithKline put the warning label on sooner, how many drug sales would it have lost? 

How can I ensure that my child with a birth injury is cared for after I can no longer can provide care?

I recently received a phone call from a mother whose son suffered a severe birth injury. She wanted to know how she could be sure that her son would be cared for after she no longer could take care of him. This question is one which many parents will ultimately face.

Assuming that malpractice can be proven as the cause of the birth injury, the answer is pretty straightforward. First the parent must obtain a recovery. Second, the parent must have legal documents drawn up that spell out who will take care of the child and who will manage the recovered funds for the child’s benefits.

Parents can pursue claims on behalf of themselves and their child to recover a variety of damages which will ensure the child is cared for over the course of his or her life.

This article is not meant to examine all the types of damages available to parents and injured children, but focuses on the specific area of future needs of the child. As a child passes through various stages of life – infancy, young child, teenager, young adult, etc. – the child’s needs will change and differ. And, of course, every child’s needs will not be the same. Needs might include such things as surgery, medical treatment, medication, doctor’s visits, medical tests, physical therapy, assisted living, medical devices, special living facilities, and specialized education. The costs of these could be hundreds of thousands, or millions, of dollars over the course of a lifetime.

A life care planner is usually employed to assessing a child’s future needs. The planner will chart out the life of the child as he or she passes from infancy through adulthood. The planner will interview the child’s doctors, interview parents, meet with the child, speak with medical professionals, and conduct research. Finally, the planner will use this information to create a “life care plan” that lays out the types and costs of all future needs.

Once a monetary recovery is made to cover a the child’s future needs, there are numerous options available to parents to plan for their needs after they can no longer care for the child. Depending on the circumstances, sometimes a recovery is made to the parents, sometimes to the child, and sometimes to both. If the recovery is made to the child, the court will require that the funds be placed in a restricted account and that they be used only with court permission for the child’s needs. This way the funds will be safe and available when needed. Where parents recover the costs of future needs, parents will want to ensure that the funds are kept safely and securely for the child. While the parent remains capable of caring for the child, the parent will manage the use of the funds. To plan for the day when the parent may no longer be able to care for the child, a parent may wish to meet with an attorney, preferably one who has experience drafting wills, trusts, and estate plans. This attorney can draft legal documents for the parent appointing a guardian for the minor child, appointing a person to manage the child’s funds, making arrangements for the child to live in an assisted living facility (if necessary), and placing any of the parent’s fund in trust for the child. In this way, parents can have a say in who is taking care of their child and can ensure that the funds for their child’s future needs are available.

Shouldn't a premature baby have a chance to live?

I am helping a mother whose baby boy died just after being born.  He was just over 6 months gestation and premature by about 3 months.  Due to complications during labor, his mother was sedated. 

When she woke up, she was told that her baby had died.

It turns out that the neonatologist - the doctor who attends babies after birth - decided it was not worth trying to save the baby. So he did nothing. He let the baby die. The baby lived thirty minutes.

The doctor’s excuse was that the baby was too young to live. But, is that a reason for not trying?  And how does he know? Statistics show that this baby had more than a 50% chance of survival. Even if the chances were 1%, didn’t the baby deserve a chance? Didn’t the parents of this baby have the right to ask the doctor to save their child?

An expert neonatologist who is helping me has shed some very important light on the rights of parents and the duties of doctors when babies are born prematurely.

Babies born within a certain age range, generally 23 – 25 weeks gestation, are deemed to be on the "cusp of viability". This means that they are on the borderline of being able to live even with medical attention. Tremendous improvements in medical knowledge and technology have greatly improved the ability of premature babies to survive. Today, premature babies that would have died even 10 years ago are surviving and living healthy and happy lives.

The standard of care requires that before a doctor decides whether or not to try to save a premature baby born on the "cusp of viability", the doctor must consult the parents and follow their wishes.

Here, even though the mother was unconscious, the father was present at the hospital. And even if the doctor could not have spoken to the father, shouldn’t he have done whatever he could to save the baby until the mother awoke? You know she would have asked him to do everything he could.

Why shouldn't the medical profession be responsible for its errors?

If you or I rearend someone in a car accident, and we injure somebody, we are going to be held accountable for the injuries we cause. Yet many don’t want medical professionals to be held responsible for injuries they cause. Does that seem right?

A recent study claims that about 250,000 Americans die each year due to medical errors. If you think about it, that is an average of 5,000 people per state. Another study puts the number at about 90,000. That’s a better number, but still unacceptable. At the average rate, this conservative study means over 1,000 people will die in Arizona this year due to medical malpractice. 

The current system in some states still holds doctors and hospitals fully accountable for errors. States that have enacted tort reform allow medical professionals to escape full responsibility, by capping what they owe when they make mistakes.

The reason that medical professionals should be held fully accountable for their errors is because it forces them to meet accepted standards of care. The American tort system used to hold the medical profession liable. You know what the result was? Better medicine. Because the profession was held responsible, doctors and hospitals were forced to improve the quality of their service, to institute procedures and protocols, to have checks and balances, and to review and supervise staff. Do you know why the profession improved itself? Because money talks. Forcing the profession to pay for its mistakes incentivizes it to reduce mistakes and to improve the quality of care. 

As stated above, up to 250,000 people still die each year due to medical negligence. That’s the number after decades of malpractice suits have forced the profession to improve itself. Imagine what that number would be if doctors and hospitals did not know that they would be held accountable. A legal system that allows full recovery provides a very important check and balance on the medical system.

Does Arizona have caps on medical malpractice cases?

With all the talk lately about "tort reform", healthcare reform, and the problems of too many lawsuits against hospitals and doctors, this is a good time to address some of the questions I frequently receive on these issues.

A number of states have enacted laws capping damages in medical malpractice cases. Arizona has not. So in Arizona, an injured patient is free to recover his or her entire medical damages. The reasons, so far, that Arizona has not capped damages is that the Arizona Constitution prohibits caps. Unlike in other states, this prevents the legislature from passing a law to cap damages. The only way Arizona could implement a cap is if the public to vote to amend the Arizona Constitution to allow it. This is a complicated and difficult process, but not completely unattainable. However, it might be possible for the federal government to pass allow capping medical malpractice awards that would trump Arizona’ constitutional prohibition against caps.

That was the easy answer. But, let’s not end the discussion there. Let’s take a moment to address how caps work in other states, because there are some misconceptions. The states that do cap medical malpractice awards cap only "non-economic damages". Caps seem to range from $250,000 to $750,000. What this means is that a victim of medical malpractice can receive all of his or her past and future "economic damages", such as medical bills and lost earnings. These damages are not subject to caps. The "non-economic damages" subjected to the cap include such things as pain and suffering and loss of enjoyment of life. 

Are caps fair? That can be debated. But, for example, it hardly seems fair that the person injured due to malpractice who can no longer walk, who has undergone medical procedures to correct medical errors, and who requires a lifetime of medical care should be capped at $250,000 for all he or she has and will go through.  

My child has cerebral palsy. How do I know if this is natural or due to a doctor's mistake?

The answer is not simple. A conservative estimate says cerebral palsy is diagnosed in 2 to 2.5 out of 1,000 people. The Center for Disease Control and Prevention estimates that each year 10,000 new born babies will eventually be diagnosed with cerebral palsy. Currently, the United Cerebral Palsy Foundation estimates that 800,000 people are living with cerebral palsy in the United States. Were all these people the victim of medical malpractice? No. A recent study indicate that only about 10% of cerebral palsy cases can be blamed on medical malpractice. 

So, let’s look a little deeper a cerebral palsy. 

Cerebral palsy can result from a brain injury or from a lack of oxygen to the baby’s brain prior to birth, during birth, or as a young child. It cannot be cured. The medical terms used are hypoxia and anoxia. Hypoxia refers to a complete lack of oxygen to the brain. Anoxia refers to decreased or deprivation of oxygen to the brain. 

In some cases, cerebral palsy is diagnosed shortly after birth, which makes determining a cause somewhat easier. Other times, it is not diagnosed until a child is several years old. This makes it more difficult to pinpoint a cause, because so many things could have occurred during the child’s young lifetime that might have caused cerebral palsy.

What causes cerebral palsy? Sometimes there is no identifiable cause. In other cases, cerebral palsy could be caused by issues not related to malpractice. Research suggests that infections in expectant mothers pose a significant risk to the fetus because, in response to the infection, the body produces toxins which might harm the baby’s brain. Fever in the mother could cause it.  Low birth weights are also known to cause cerebral palsy. Between 40-50% of cerebral palsy cases occur in babies born prematurely. This is because babies born prematurely do not have fully developed organs, and this can contribute to a lack of oxygen getting to the brain even before delivery.

Cerebral palsy can result if an unborn baby suffers trauma or an injury, for example the mother is in a car accident, fell, suffered some sort of injury, or where the baby has had a stroke and suffered internal brain bleeding. Other conditions such as a ruptured uterus, detached placenta, or umbilical cord problem can cause cerebral palsy. 

After birth anything that decreases the flow of oxygen to the brain can cause cerebral palsy, for example, near drowning or choking.  Certain toxins, lead poisoning and severe jaundice are also known causes of cerebral palsy.   Infections, such as meningitis, or a head injury sustained in a car accident or from a fall could cause cerebral palsy. There are also rare congenital conditions which might cause cerebral palsy.

Other times, medical malpractice may cause cerebral palsy. 

Doctors and hospitals are educated on what to do in certain situations. Not only should they follow specific procedures in the course of a "normal" baby delivery, but they should be prepared and know how to act when certain foreseeable circumstances or complications arise. Because of the well understood situations that can occur before, during, and after delivery, there is no excuse when medical personnel do not make proper decisions and fail to take proper action. 

Mistakes that can cause cerebral palsy during labor include failure to administer certain medications, administering wrong medications, improper fetal monitoring, improperly inducing labor, absence of the obstetrician during certain parts of labor, improper monitoring of the mother, and failing to note and address fetal distress.

Other obstetric decisions that can be problematic, such as failing or delaying to perform a c-section when circumstances require it. Sometimes, the positioning of the baby, or the condition of the baby (i.e. fetal distress, abnormal heart beat, or prolapsed umbilical cord) may mandate a c-section.  When physicians fail to make a proper decisions, the complications that ensue can cut off oxygen to the brain and lead to cerebral palsy to perform a c-section may have alleviated all harm to the baby.

A smaller percentage of babies diagnosed with cerebral palsy are so due to malpractice after birth.  Oxygen deprivation can occur where a baby with a high fever or who is in respiratory distress is not properly cared for.

To end were we began, to understand whether cerebral palsy was caused by medical malpractice or something else will require the analysis of an obstetrician. The expert obstetrician has a complete understanding of the multitude of medical and scientific issues involved, as well as the standards of care which doctors and hospitals should follow. Armed with this knowledge, the obstetrician can review the entire history of the pregnancy, examine the child, audit the medical records, analyze the actions of the doctor and hospital, and interview the parents. Only then can the question of the cause of the cerebral palsy be answered.

What is a brachial plexus injury? What is Erb's Palsy?

Most people have never heard of the brachial plexus or Erb’s Palsy. If you are reading this, you may have a reason to know, and you would probably like to know more about whether medical malpractice might be the cause.

Babies or children who have weak, uncontrollable, or paralyzed arms, decreased feeling in an arm, or misalignments of the elbow, arm or shoulder may have suffered a brachial plexus injury and may have Erb’s Palsy. But what does this mean? Let’s examine three main terms involved in this type of injury. They are "brachial plexus", "shoulder dystocia", and "Erb’s Palsy".

The brachial plexus is an area of the neck where nerves are centralized. This network carries electrical signals from the brain, through the neck, down the arm, and into the fingers. Damage to this complex of nerves is called a brachial plexus injury. As with any injury, severity can vary. Injury to the brachial plexus can occur during vaginal delivery when this network of nerves is stretched or torn. Sometimes during birth a baby’s shoulder or shoulders will get caught behind a part of the mother’s pelvis. This is called "shoulder dystocia". If the doctor pushes, pulls, or twists the baby, the baby’s head, or the baby’s shoulders, the nerves of the brachial plexus can be stretched or torn. 

Older children, teens, and adults, may suffer a brachial plexus injury in a car accident, while playing sports, or after other violent trauma.  However, a newborn baby who suffers a brachial plexus injury is likely the victim of a doctor who committed malpractice by stretching or tearing the nerves.  In many cases, a baby who suffers a brachial plexus injury during birth can recover within several months.  In severe cases, where the nerves were completely severed or torn from the spinal cord, recovery is impossible.  This condition is called "avulsion".  Where the damage is permanent and the child suffers permanent and lifelong paralysis, weakness, and/or numbness, the condition is frequently also called "Erb’s palsy". The less severe, but still temporary or permanently debilitating injuries to this network of nerves are ruptures (nerves are torn, but not separated from the spinal cord), neuropraxia (the nerves are stretched, but not torn), and neuroma (scar tissue forms as a result of a stretch injury).

Treatment of a brachial plexus injury or Erb’s Palsy include physical therapy and surgery. Again depending upon the exact nature and severity of the injury, the condition may or may not be significantly improved. And in some cases, surgery will not reverse the injury to any degree.

Obstetricians understand the potential for a brachial plexus injury, and should take certain actions when certain medical signs and conditions are present before or during delivery. One option is a c-section. Another option involves employing known maneuvers to deal with shoulder dystocia while at the same time protecting the baby from brachial plexus injury. A reason that these types of injuries occur is that once the baby’s head is out, the baby wants to breathe. If the baby’s shoulder then gets stuck, the doctor may frantically try to deliver the rest of the baby.  As a result, the doctor may twist, push and pull incorrectly, causing a brachial plexus injury. If the baby has difficulty breathing at this stage, the baby may suffer a loss of oxygen to the brain and may develop cerebral palsy. Click here to visit a brief article on cerebral palsy.