Category: Surgical

Informed Consent: Premature Births

In 2010, the New England Journal of Medicine published the details of a 2004-2009 study of 1,300 severely premature infants at 23 medical institutions across the United States. The study, called the Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT), was designed to address a longstanding issue in the care of premature babies: Oxygen, considered a crucial component in preemie care, administered to an infant in too high a dose can result in blindness while too low a dose can cause severe brain damage or death. Doctors hoped to discover what level of oxygen administration was best to prevent blindness without increasing the risk of neurological damage or death by randomly assigning the infants involved to receive different levels.

Considered ethically flawed by a number of federal officials, the study resulted in much negative feedback and a 2013 lawsuit against overseers of the study at the University of Alabama at Birmingham. The suit by parents of five Alabama children claims negligence and failure to properly inform the family of the risks involved. Along with questions about the ethics of medical experimentation, publicity around the study has raised the issue of informed consent processes as they pertain to premature infants.

Informed consent is a legal procedure to ensure that patients and caregivers are aware of all the potential risks involved in a particular medical treatment.

In the case of SUPPORT, the US Department of Health and Human Services acknowledged many of the parents would not have allowed their newborns to undergo the oxygen level tests had they been aware of the potential for serious harm or fatality.

It is a doctor’s responsibility to notify pregnant patients of the risks associated with carrying and delivering a baby – including factors that may increase their chances of premature labor. Some of the most common conditions that make a mother high risk for a premature birth are:

  • Multiple babies including twins and triplets
  • History of premature birth
  • Short intervals between pregnancies
  • Smoking, drinking and/or drug abuse during pregnancy
  • Poor nutrition
  • Infections of the amniotic fluid or lower genital tract
  • High blood pressure and diabetes
  • Stress
  • Unusual shape of the uterus
  • Physical injury or trauma
  • Age of the mother, with heightened risk for those under 18 or over 35

With 500,000 cases of premature birth in the US each year, it is not always possible for a doctor to arrest early labor and prevent injury to the infant. During and post-delivery, the premature child may experience bleeding in the brain, low blood sugar, infections, severe lung damage and breathing problems that require close post-birth monitoring in neonatal intensive care units. As the baby develops, they are more likely to show signs of cerebral palsy, intellectual disability, vision and hearing problems and learning difficulties.

Failure of hospital personnel to fully disclose the treatment options
available and the risk factors involved in premature birth
may be grounds for a medical negligence claim.

While it is up to the parents to assess the quality of life their child will lead and determine if further operations and life-sustaining treatment should be administered, it remains the doctor’s responsibility to help them make educated decisions in the child’s best interest and obtain their informed consent before carrying out or withholding treatment.

When a baby is born with unexpected brain damage or physical defects, it will alter the course of their life and create significant hardship for the family. According to a report published by the Institute of Medicine in 2006, the cost of medical care in the first year of life for premature babies is 10 times higher than for full-term infants. The resulting disabilities can cost millions of dollars over a lifetime in rehabilitation fees and special education. Failure of hospital personnel to fully disclose the treatment options available and the risk factors involved in premature birth may be grounds for a medical negligence claim. If a doctor fails to notify a patient of risk factors or performs a procedure without informed consent of the patient, they may be liable for damages sustained as a result.

Okun Oddo & Babat specializes in Medical Malpractice and Medical Negligence claims. Contact us today or call or call us at 212.642.0950 to arrange an appointment with one of our experienced New York attorneys.

Sources & Resources:
www.nejm.org/doi/full/10.1056/NEJMe1304996
www.ahrp.org/cms/content/view/921/81/
www.cdc.gov/reproductivehealth/MaternalInfantHealth/PretermBirth.htm
www.marchofdimes.com/mission/the-economic-and-societal-costs.aspx
www.mayoclinic.com/health/premature-birth/DS00137/DSECTION=risk-factors

Article by Shea Bergesen for Lavery Design Associates, Ltd.
copyright 2013. This article may not be reproduced without permission from the author. 

Common Causes of Medical Malpractice Before, During and After Surgery

According to the Centers for Disease Control and Prevention, there are approximately5.4 million surgical procedures performed annually in the United States. Though all operations involve a certain degree of risk, patients should have the reasonable expectation that a high standard of care will be provided to them. Unfortunately, that is not always the case. Each year, thousands of people are affected by preventable surgical errors, a common form of medical malpractice.

Continue reading “Common Causes of Medical Malpractice Before, During and After Surgery”

New Disclosure on 2010 Hip Implant Recall

Earlier this month it was revealed in an extensive New York Times article by Barry Meier that newly disclosed court records pertaining to the 2010 Johnson & Johnson hip implant recall indicate that Johnson & Johnson did not reveal their internal analysis regarding the potential early failure rate of their all-metal hip implant device.

The first of many lawsuits filed against the company are now going to court as thousands of patients who received implants may now be facing costly and painful additional replacement procedures. The article addresses the implant’s metal hip cup design the Food and Drug Administration concerns regarding “high concentration of metal ions.” A high level of reports of premature failure of the device, over 300, received by the FDA, compared to competing implants, prompted the initial recall.

Based on the number of patients who had undergone device replacement at the time of the initial recall, it was estimated by DePuy Orthopaedics, a division of Johnson & Johnson, that 37 percent of patients who received it initially, may need replacement.

If you or someone you know has had hip replacement surgery, you should be aware of the details surrounding this hip implant recall. If you have undergone a procedure and are facing another painful replacement Okun, Oddo and Babat handles medical and medical device litigation and we can expertly evaluate your circumstances  and protect your legal rights. You may be entitled to compensation from the manufacturer. Affected patients may be entitled to compensation for injuries they have suffered as a result of the failed DePuy ASR implants.

At Okun, Oddo & Babat, we know the medical device industry and the status of cases filed against various manufacturers. Our attorneys have the experience to determine liability and obtain the maximum compensation for victims of medical device failure. We are committed to holding the drug companies to their obligation to warn about the known risks of their products. Contact us for an appointment.

Bariatric Weight Loss Surgery

Bariatric surgery is a surgical procedure performed to assist a patient in losing weight. There are different types of surgery that may be performed from a restrictive procedure where a band is placed around the stomach, or a more involved bypass procedure to modify the gastrointestinal tract. With each procedure, there may be different consequences. In the last several years the number of individuals opting for this type of surgery has greatly increased and with that increase, a number of cases and issues have been in the media including wrongful death caused by a defective surgical stapler and over 9,00 reports of complications made to the FDA.

In 1983 The American Society for Metabolic and Bariatric Surgery (ASMBS) was formed and is the largest society for this specialty in the world. Part of the Society’s mission is to provide educational and support programs for surgeons and integrated health professionals and multidisciplinary teams as well as to improve care, advance the science and understanding of the surgery, foster communication between healthcare practitioners and patients and to be an advocate for health care policy. For educational resources, visit the ASMBS website.

Yet earlier this year Deputy Clay Chandler was awarded $178 million in a lawsuit against Memorial Hospital Jacksonville for medical negligence and fraud damages. According to a January, 2012 article in The Florida Times-Union, Chandler was severely incapacitated after weight loss surgery at the hospital in 2007. Now brain damaged and confined to a wheelchair, for eight days following his surgery he showed signs of complications where fluids from the bowl leaked into the abdomen. The report sites the surgeon’s inexperience and “failure to meet the hospital’s advertised accreditation” which the jury found to be acts of fraud.

The U.S. Food and Drug Administration website details the procedure, risks and targets weight loss claims. You can register to receive Consumer Update RSS feeds and email updates. Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health stated that “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

If you or someone you know is considering Bariatric Weight Loss Surgery, you should become familiar with the standardization of bariatric surgery practices and guidelines, as well as the risks involved. If you have undergone a procedure and you have developed complications, contact Okun, Odd & Babat for a consultation.

Failure To Carry Out Emergency C-Sections

If mother or baby is at risk during delivery, medical professionals may opt to perform an emergency caesarean section, rather than continue with a potentially dangerous vaginal birth. However, what happens if an emergency C-section is needed, but is not carried out? Does this amount to medical negligence? And it is possible to claim compensation for the injuries medical errors have caused?

Why would an emergency C-section be performed?
Pregnant women are now free to choose whether they would like to have a vaginal delivery or an elective caesarean section. Studies so far have shown that in the majority of cases, women will consider their options and (unless otherwise advised by doctors) opt for a vaginal birth. However, there are occasions in which complications will arise during the course of a vaginal delivery, putting mother and/or baby in danger. This may occur if:
• The mother’s blood pressure drops to a dangerously low level;
• The baby’s heart rate shows signs of fetal distress;
• The placenta separates from the uterus prematurely (called placental abruption).
• The placenta is low down in the uterus (called placenta previa);

If mother and/or baby are at risk, doctors should be quick to assess the situation and acknowledge the need to transfer the vaginal delivery to an emergency caesarean section. This decision should be proposed to the mother and consent sought without delay.

What if an emergency C-section is not performed?
Nevertheless, there are sadly times when medical professional fail to act, even though there are obvious signs of complication. This can lead to devastating consequences, harming the health of both mother and baby. Injuries to the mother can include excessive blood loss, collapse and cardiac arrest, while injuries to the child usually arise due to oxygen starvation. These can be particularly serious and can even be fatal.

Claiming Compensation
If you or your baby has been injured because an emergency C-section was not performed when it should have been, you will have been the victim of medical negligence. We understand just how distressing this will be, as what should be a happy time for you and your family will instead be filled with pain and anguish.

As the victim of medical error, you will be entitled to claim compensation for the damage you have been caused. Although it will not undo the harm you have endured, you may want to consider taking legal action against the hospital in question. Contact Okun, Oddo & Babat for a courtesy evaluation. For immediate assistance, call us at 212-642-0950.

Author: Julie Glynn
Originally published, May 19, 2012