February 2011 Archives

Brain cooling treatment for neonates with HIE has progressed to the point that major neonatal centers throughout the U.S. have developed specific policies and protocols for this treatment. In California, there are currently 14 hospitals that provide this treatment, all of which have Level III Neonatal Intensive Care Units.

Each of these hospitals have developed specific requirements and eligibility criteria for patients. Since many neonates who qualify for brain cooling are delivered at other hospitals and must be then transported to a hospital that offers brain cooling within 6 hours of birth, the eligibility criteria are basically clinical features that would lead to a diagnosis of hypoxic-ischemic encephalopathy.

Not surprisingly, these criteria are similar to the ACOG criteria for a diagnosis of perinatal asphyxia and include low Apgar scores, evidence of metabolic acidosis on a cord blood gas, and neonatal symptoms including early onset seizures.

The basic eligibility criteria includes evidence of an acute perinatal event, such as a placental abruption, cord prolapse, or severe fetal heart rate (FHR) abnormalities indicative of fetal distress; an Apgar score of less than five at 10 minutes of age; a pH on a cord or subsequent blood gas that is less than or equal to 7.0, or a base deficit of 16 mEq/L or greater; and continued need for ventilation.

Although the written protocols for brain cooling are very detailed with regard to both eligibility and the details of treatment, they are relatively devoid of any specifics about informed consent. Since brain cooling must begin within six hours of birth, and many infants require transfer from the birth hospital to another hospital with a brain cooling program, there is often little time to discuss the details of brain cooling with the parents.

Upon being offered the only treatment that offers the possibility of neurologic improvement, it is highly unlikely that any parent would refuse to consent to such treatment, but the written information given to parents is generally highly optimistic about the potential benefit of such treatment, and confirms that it is a safe procedure.

Although neither the American Academy of Pediatrics (AAP) nor the American College of Obstetricians and Gynecologists (ACOG) have yet recommended brain cooling as the standard of care for a child diagnosed with HIE at birth, this lack of recommendation is based on the fact that the studies conducted have only shown improvement at 18 months of age, and there are no studies on long term outcome.

However, in light of the studies that show no harm from this treatment, and the evidence of improved neurologic outcome at 18 months, the failure to offer such brain cooling treatment to a child who meets the eligibility criteria would certainly be a strong issue before any jury.

In situations where there is insufficient evidence of negligent care in the treatment of an acute cord prolapse or placental abruption, a failure to offer brain cooling to a child may be a sufficient basis for recovery in a medical malpractice action, without the need to prove that the initial HIE was preventable.

The studies that show a significant improvement in outcome, even at 18 months, should be sufficient to prove causation in a case where brain cooling was not offered for treatment after a clear diagnosis of HIE was established at birth.

**This is an excerpt from an article written by Dr. Bruce Fagel, which originally appeared in the January/February 2011 issue of the Consumer Attorneys of California's Forum Magazine.

Cerebral palsy can be the outcome of either negligent or non-negligent obstetrical care. However, regardless of the cause, a child diagnosed with cerebral palsy faces a lifetime of required medical and attendant care. Such care places an emotional and financial burden on both the family and society. Where there is sufficient evidence of negligent obstetrical care, such "brain-injury baby" cases can result in a financial recovery that at least provides some assistance to a family faced with the lifetime care of such a child.

Until recently such financial assistance through the legal system was the only hope that could be offered to the family of a child with negligently-caused cerebral palsy. However, within the last 10 years a new treatment has been developed which may change the long-term outcome for such a "brain-injured baby." This treatment is called brain cooling, and it is based on scientific research showing that injury to a neonatal brain from hypoxia and ischemia during the birth process does not occur immediately, but occurs over several hours.

The initial lack of oxygen (hypoxia) and/or lack of blood supply (ischemia) to the brain kicks off a series of other events, as the body tries to repair itself. This natural approach may be effective when the Hypoxic-Ischemic Encephalopathy (HIE) is mild, but in moderate or severe cases the body's desperate attempts to heal can cause more brain damage. 

Brain cooling interrupts the evolution of progressive damages to the baby's brain that are thought to be caused by a complex biochemical cascade. Brain cooling is performed over a 72-hour period, but it must be started within six hours of delivery. The body temperature of the infant is reduced 3 to 4 degrees Celsius from a normal of 37 degrees to 33.0 to 34.5 degrees.

The Food and Drug Administration (FDA) has approved the Olympic Cool-Cap System for selective head cooling treatment of neonatal HIE. The first studies on brain cooling were focused on the risks of brain cooling, and they showed that brain cooling was a safe procedure, but more recent studies have shown that induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability, but "resulted in improved neurologic outcomes in survivors."

The most recent literature reviewed the status of multiple studies which have looked at brain cooling and neurologic outcomes, and concluded that "in infants with hypoxic-ischemic encephalopathy, moderate hypothermia is associated with a consistent reduction in death and neurological impairment at 18 months."

**This is an excerpt from an article written by Dr. Bruce Fagel, which originally appeared in the January/February 2011 issue of the Consumer Attorneys of California's Forum Magazine.

The US Food and Drug Administration (FDA) has announced that it recommends that clinicians not use the injectable drug terbutaline for the prevention of preterm labor or treatment beyond 48 to 72 hours. The FDA says that use of the drug could risk maternal heart problems and even death.

According to the FDA, the oral version of terbutaline should be avoided in addition to the injectable form for treatment or prevention of acute or prolonged preterm labor as it is equally risky and has yet to be proven as an effective drug.

Terbutaline may be clinically neccessary in some emergency situations, but the FDA says that injections of the drug should only be administered by medical professionals in a hospital setting.

The drug should not be injected outside of hospital settings and use of the drug for treatment should never reach beyond 48 to 72 hours. Labels for both the injectable and oral variations of the drug will be ammended to reflect the FDA's warning and an additional message further warning of the risks for use among pregnant women.

The drug terbutaline, which is an FDA-approved bronchodilator, is used in the prevention and treatment of bronchospasms that are associated with respiratory diseases such as bronchitis and asthma. However, some medical professionals use the drug for the treatment of preterm labor and other obstertrical uses.

Terbutaline has also frequently been used to prevent recurring preterm labor in women.

An outside agency's review of use of the drug for obstetrical purposes found reports of maternal death as well as severe cardiovascular effects, prompting warnings from the FDA.

The drug was first marketed in 1976. From that year until 2009, 16 maternal deaths were recorded and 12 different pregnant women suffered severe caridovascular events. In their warning, the FDA says that the risks greatly outnumber any possible benefit from use of the drug.

Contact the Law Offices of Dr. Bruce G. Fagel at (800) 541-9376 or click here to visit our website.

The Food and Drug Administration (FDA) approved a drug Friday that aims to reduce preterm births. The FDA has required the company manufacturing the drug to complete more research, but once fully-approved the drug is expected to greatly reduce the risk of premature delivery.

A synthetic form of progesterone, a hormone that is typically produced during pregnancy, is the basis of the drug which will be known as Makena. It would be injected into women who have previously had a premature birth.

The weekly injections are to be used only by women who have no other known risks of premature delivery and who are only carrying one fetus. The injections can begin as early as 16 weeks following conception up until 21 weeks.

Under the FDA's new accelerated approval program, new drugs are permitted to enter the market if they offer a beneficial clinical result that is not yet proven by studies. With Makena, the prevention of premature delivery is the result.

More studies will be required of Saint Louis-based K-V Pharmaceutical Company, the manufacturer of the drug, to prove that children born after the delayed deliveries will indeed have a lesser risk of health and developmental problems.

According to research and statistics from the March of Dimes, 10,000 of the nearly 500,000 yearly estimated premature births in the United States could have been prevented if a drug such as Makena were used on all women who are eligible.

The American Congress of Obstetricians has recommended the use of progesterone for women who are at high risk of premature delivery since 2003.

Preterm delivery can lead to serious health and developmental complications. If you believe that a premature birth has been caused by medical error or malpractice, contact the Law Offices of Dr. Bruce G. Fagel & Associates for a free legal consultation. Click here to visit our website or give us a call toll-free at (800) 541-9376.

A pregnant Colorado woman is unsure of the fate of her unborn child after a mistake at a pharmacy resulted in her receiving an aborition drug rather than the antibiotic she was originally seeking.

Mareena Silva, who is six weeks pregnant, told local news outlets that she went to her pharmacist at a Safeway store in Fort Lupton, Colo., to pick up antibiotics. Instead, she was given methotrexate, a drug used for chemotherapy treatments as well as to terminate early-stage pregnancies. The methotrexate was intented for another customer of the pharmacy.

According to Silva, she became sick after taking one of the pills. Upon checking the bottle, she was rushed to the hospital. Doctors believe that her child may be born with birth defects or that she may miscarry.

In a statement released today, Safeway said that "policies and procesdures meant to prevent medication errors weren't followed." The company says that more measures will be taken to ensure that proper procedures are followed.

Medication errors such as this can result in very serious, and unfortunately often tragic, consequences. If you have suffered an injury as a result of a medication or medical error, contact medical malpractice attorney Dr. Bruce Fagel. Call the Law Offices of Dr. Bruce G. Fagel & Associates toll free at (800) 541-9376 or click here to visit our website.

A million-dollar settlement has been reached in a medical malpractie case between the County of Los Angeles and a patient of an L.A.-area medical facility.

The patient suffered a punctured blood vessel while receiving treatment at the facility following an automobile accident. This occurred in November 2008.

The medical malpractice lawsuit stated that during treatment for the patient's injuries, she suffered a puncture to her blood vessel wall after a catheter tip was inserted.

This caused the patient, who was a minor at the time, to suffer further complications. She was treated for the injuries related to the car accident as well the punctured blood vessel and was released from the medical center just a few days later.

The California medical malpractice lawsuit, which was originally filed in June 2009, does not go into specifics on the type of complications the paitent suffered as a result of the punctured vessel.

Records show that the settlement in the medical malpractice case reached last month.

Officials for Los Angeles county stated that they felt that the medical malpractice lawsuit would be difficult to fight in court because of the Res Ipsa Loquitur doctrine. This doctrine says that as long as the device that caused the injury was in the exclusive control of the medical facility, the negligence is persumed even if no sign of an act of negligence is present.

The accident and subsequent medical malpractice lawsuit prompted officials at the medical center to re-train nurses and hospital staff on the proper use of catheters.

If you believe that you have been the victim of medical negligence or medical malpractice, consider contacting the Law Offices of Dr. Bruce G. Fagel & Associates for a free legal consultation. Visit our website by clicking here, or give us a call toll free at (800) 541-9376.

Re-argument ordered in Kansas medical malpractice lawsuit The Kansas Supreme Court has ordered re-arguments in a prominent medical malpractice case in which a doctor removed the wrong ovary from a patient during surgery.

Amy Miller went into surgery in 2002 to have her right ovary removed, but her doctor mistakenly removed Miller's left ovary. Miller went on to sue for medical malpractice, and in 2006 a jury reached a verdict in Miller's favor, awarding her $759,680.

Miller's doctor still practice today in a Lawrence, Kan., medical facility.

The award Miller received consisted of $250,000 for noneconomic loses and $150,000 for any future noneconomic losses. For current and future medical expenses, Miller was awarded a total of $184,680. An additional $175,000 was awarded for "loss or impairment of services as a spouse."

According to the Lawrence Journal-World, the noneconomic losses are given for "pain, suffering, disability, mental anguish, and physical disfigurement.

Miller's award was reduced by a district court judge based on a law that caps awards for noneconomic damages at $250,000. The judge struck down Miller's $150,000 award for future noneconomic losses and also struck down the $100,000 award for future medical expenses.

Chief Justice Lawton Nuss of the Kansas Supreme Court ordered re-arguments in the medical malpractice case because of the dispute over the caps on the awards for damages that Miller received.

Miller's attorneys claim that the cap on damages hinders her constitutional right to a trial by jury. Her lawyers also say that the cap "infringes on the constitutional authority of the judiciary."

Those who support the cap, including doctors and insurance providers, say that the cap on damages keeps the costs for health care and insurance down.

According to Miller's attorneys, she has yet to receive any compensation from her medical malpractice case.

If you or someone you know have been the victim of medical malpractice, consider contacting the Law Offices of Dr. Bruce G. Fagel for a free legal consultation. Click here to visit our website, or give us a call toll free at (800) 541-9376.

If tort reform limitations on recovery of non-economic damages do not have any direct effect on lowering the cost of liability insurance or the cost of health care, there is evidence that there has been a reduction in the number of medical malpractice claims. However, while society may feel that it is beneficial to reduce the number of medical malpractice claims, society would be better served if the incidence of actual medical negligence were reduced. Meanwhile the effect of tort reform on individual victims of medical negligence has been devastating. From the perspective of the law, such tort reform has prevented many deserving individuals from receiving any measure of justice.

Since the limitation on recovery of non-economic damages that was passed by the California legislature, and signed into law by then Governor Jerry Brown, in 1975, had no increase for inflation, the real effect of MICRA has been the reduced value of non-economic damages for each year that passes. In 1975 dollars, the current value of the CC Sec. 3333.2 limitation is less than $75,000. When the law was enacted in 1975, the cost of retaining medical experts, deposition reporters, copy costs, and even filing fees was commensurate with 1975 costs. In the last 30 years, the costs of medical experts, deposition reports, copy costs, and other litigation costs has increased significantly. 

As a result, many cases can cost more than can be recovered, and economics alone has resulted in such cases simply not being filed. When they are filed, many defense attorneys can and will run up the costs for such cases because they know that even if they lose, their client will have limited liability, and many physician-owed liability insurance carriers would rather spend more to defend a case that to settle. As a result, there are many victims of medical negligence, including the heirs of young children or the elderly, who will never be able to pursue their claims because of the economic disincentive to many Plaintiff attorneys. 

In many cases, recovery of $250,000 can never be considered as adequate compensation for the untimely death of a loved one, especially when that death was due to the medical negligence of a doctor and/or nurse. But since many such cases involve complicated facts with multiple physicians and nurses involved in causing the death, the net recovery to a Plaintiff after paying for the multiple medical experts and other costs needed to obtain a settlement, prevent the Plaintiff from ever obtaining anything close to reasonable compensation.

While it is very easy to demonize frivolous medical malpractice claims as being an unwarranted intrusion on both the practice of medicine and the cost of medical care, reality is more complicated. Claims that result in settlement, even with a limit of $250,000 for non-economic damages, usually change the behavior of negligent physicians and force changes in hospital procedures that hopefully reduce negligent care. 

But since studies have shown that less than 10% of patients who suffer harm from negligent care ever file a medical malpractice claim, any improvement in medical practice or hospital procedures will not translate into a drop the overall incidence of negligent care that result in lawsuits. Meanwhile, the incidence of cases that result in defense jury verdicts or are withdrawn prior to trial will continue to provide evidence of frivolous lawsuits.

To suppose that further restricting the rights of Americans to obtain any sense of justice and reasonable compensation, based on the myth that tort reform will reduce health care costs, is a cynical attack on the basic rights that we should have in this country. The fact that there is no evidence that limiting recovery in medical malpractice claims will ever reduce actual health care costs is even more disturbing to our sense of justice in this country.

In his recent State of the Union address President Obama seemed to renew interest in medical malpractice tort reform as a way to reduce the cost of medical care in the U.S. Referring to the need to reduce the costs of health care, which his health care reform plan did not address, President Obama stated that he would listen to ideas for tort reform as a way to rein in "frivolous lawsuits," He reminded the country that this proposal was a Republican suggestion, and implied that action on tort reform could thus be bi-partisan.

The reality of tort reform, which President Obama certainly knows, is that it would have little impact on reducing the cost of health care. The most optimistic estimates on such "tort reform" is that it might reduce health care costs by less than 3%, and that assumes that much of the cost of medical malpractice includes the ordering of otherwise unnecessary and expensive tests, commonly referred to as "defensive medicine." The main focus of this proposed tort reform is the limitation on the recovery of non-economic damages to a maximum of $250,000. This limitation, which has been the subject of legislation introduced in the House in each of the last several Congresses, is based on the model of MICRA (Medical Injury Compensation Reform Act), which was passed in California in 1975.

California Civil Code Sec. 3333.2 is the part of MICRA, that imposes a $250,000 limitation on the recovery of non-economic damages in any action against a health care provider in California. This limitation affects medical malpractice cases against physicians, nurses, hospitals, and any licensed health care provider. While such a limitation has been in effect in California since 1975, it has done little to reduce the increasing costs of health care in California. 

The reality of health care costs is that many physicians will order unnecessary and expensive tests on their patients, not because they are worried about being sued if they did not order such tests, but because such tests are routinely covered by both private health insurance, and more importantly, by both MediCare and MediCal. Physicians know that they are often paid more for their interpretation of tests than for their time spent examining or talking to patients. Also, many of the most expensive tests are either performed by physicians or performed at facilities owned by physicians.

The only cost that has been affected by the limitation on non-economic damages is the cost of professional liability insurance, because insurance underwriters claim that they can more easily calculate their risk when they know that there is a limit on non-economic damages. There is evidence that the cost of such liability insurance in California is lower than in many other states, but there is no evidence of any direct relationship between the cost of insurance and those states that have such tort reform. 

In fact, the law in California that restricts increases for all insurance rates and requires review of rate increases has probably had a greater impact on keeping the costs of professional liability insurance lower for physicians and hospitals in California. Even if physicians and hospitals are able to pay a lower amount for their professional liability insurance, there is no evidence that they ever pass on such lower costs to consumers.