10 Tips Patients Can Do to Make Your Hospital Stay Safer

By Catherine Bertram

According to the Centers for Disease Control and the Agency for Healthcare Research and Quality, these ten tips are actions patients and their families can do during hospital stays to try to make their hospital stay safer:

  1. "SPEAK UP"
    Talk to your doctor about any worries you have about your safety and ask them what they are doing to protect you.
  2. "KEEP YOUR HANDS CLEAN"
    If you do not see your healthcare providers wash their hands, please ask them to do so. Also remind your loved ones and visitors. Washing hands can prevent the spread of germs.
  3. Ask if you still need a central line Adobe PDF file [PDF - 191KB] catheter or urinary Adobe PDF file [PDF - 226KB] catheter. Leaving a catheter in place too long increases the chances of getting an infection. Let your doctor or nurse know if the area around the central line becomes sore or red, or if the bandage falls off or looks wet or dirty.
  4. ASK YOUR HEALTH CARE PROVIDER "Will there be a new needle, new syringe, and a new vial for this procedure or injection?" Healthcare providers should never reuse a needle or syringe on more than one patient.
  5. BE CAREFUL WITH MEDICATIONS
    Avoid taking too much medicine by following package directions. Also, to avoid harmful drug interactions, tell your doctor about all the medicines you are taking.
  6. Photo: A healthcare professional preparing to vaccinate a patient.GET SMART WITH ANTIBIOTICS
    Help prevent antibiotic resistance by taking all your antibiotics as prescribed, and not sharing your antibiotics with other people. Remember that antibiotics don't work against viruses like the ones that cause the common cold.
  7. Prepare for surgery Adobe PDF file [PDF - 207KB].
    There are things you can do to reduce your risk of getting a surgical site infection. Talk to your doctor to learn what you should do to prepare for surgery. Let your doctor know about other medical problems you have.
  8. Watch out for C. diff. Adobe PDF file [PDF - 179KB] (aka Clostridium difficile)
    Tell your doctor if you have severe diarrhea, especially if you are also taking an antibiotic.
  9. Know the signs and symptoms of infection.
    Some skin infections, such as MRSA, appear as redness, pain, or drainage at an IV catheter site or surgical incision site. Often these symptoms come with a fever. Tell your doctor if you have these symptoms.
  10. GET YOUR FLU SHOT
    Protect yourself against the flu and other complications by getting vaccinated."

By following these 10 steps, you can help make healthcare safer and help prevent healthcare-associated infections.

Continue Reading Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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DECODING MEDICAL RECORDS IN MALPRACTICE CASES


By Catherine Bertram, partner (cbertram@reganfirm.com)


One of the key tasks we initially perform when investigating a case involving malpractice or abuse at a health care facility is a thorough review of the medical records.  At our firm we have two attorney who have both worked in hospital settings so we are quite familiar with medical records.  Catherine(“Katie”) Bertram is a partner at the firm and was previously the Director of Risk Management at Georgetown Hospital.  Jackie Colclough is a nurse-attorney with the firm who has a wealth of experience including work as labor and delivery nurse in a local hospital.

Here are a few basic tips to keep in mind when looking at records:

COMPLETE  CHART

The first task is to review the records and try to make sure you have a complete set.  Often, the records are incomplete.  We check to make sure we have an initial History & Physical, Orders, Physician Progress Notes, Nursing Notes, Laboratory Data, Radiology Reports, Operative Notes, Operative Records/Consent Forms, Pathology, and a Discharge Summary.

Medical Records for pregnant patients are quite different.  We have extensive experience with these types of cases as well.  In childbirth cases you will also have to review the prenatal records from the mother’s office visits before the delivery. It is key to obtain the Fetal Monitor Strips (FMS) or Fetal Heartrate Strips (FHR) which demonstrate the baby’s heart rate relative to the mother’s contractions.  This is often critical in determining if the doctor acted promptly to deliver the child and avoid injury to the child.  You will also need the child’s chart and the operative delivery records.

INITIAL HISTORY & PHYSICAL


Doctors are required to write a detailed note within 24 hours of a patient’s admission. This note is often referred to as the “H&P.”  This is a good place to start in your review since it usually provides a history of the patient’s present condition and symptoms, past medical and surgical history and any significant labs or imaging results.  The note also usually includes a detailed plan for the patient.

ORDERS

Physicians have the responsibility and authority to order medication, labs, imaging and other services that the patient or nursing home residents need.  We check these orders to see what medication or services or consults have been ordered for the patient.  The orders should have a time and date and should be legible.  It should also have some indication that the R.N. acknowledged receipt and review of the order and that it has been carried out.  Some special order sheets may also be included like a patient controlled analgesia record (“PCA”) which is utilized if the patient has a pain pump which allows medication to be self-administered at regular intervals.

PROGRESS NOTES


There is another section of the medical record that includes entries by doctors and nurses, and sometimes others like consultants, physical therapists, pharmacists and medical residents.  This section often looks like a diary or a log.  Most doctors were trained to write their notes in a SOAP format. The first section should detail the “subjective” concerns of the patient.  The “objective” section follows and this  is where the physician performs a physical examination of the patient and records the findings.  The doctor usually goes through each system of the body and records the important findings or any changes.   The third section is “assessment” - which is the where the doctor records his or her thoughts about what is going on with the patient after considering the subjective complaints and the findings on physical examination along with any test results or images.  The final section is the “plan.”   Here, the doctor writes out the plan of action which should address the concerning findings and include a plan consultations by other specialists, medication changes, labs or imaging that is necessary and other follow up.

NURSING NOTES

In some facilities the nurses also write in the progress notes along with the doctors, but in many hospitals the nurses have their own checklists and flow sheets where they record their nursing assessments and interventions from their shift.  There may also be other specialized forms for medication administration (MAR) and for treatment (TAR).    

In long term care facilities (nursing homes) we check the skin sheet to verify if the patient is being turned and the skin integrity is being checked.  *Families are reminded that you must also check your loved one’s skin yourself.  It is key not to let any concerning new “hot spots” progress.  If you see a red spot or a pressure point that is concerning you need to ask questions and get the staff to act on it right away.

If a patient has a fall or any other abnormal event, the facts and circumstances should be clearly documented in the progress notes along with a plan.   In most cases, a fall requires prompt physician assessment.  

LABORATORY REPORTS

The laboratory report can also give you clues about what is happening with the patient and what needs to be addressed.  A high white blood cell count (WBC) can be a sign of an infection.  The lab usually provides the normal range for each value on the report so that you can compare the patient’s value to the normal population.   In most labs the patient’s value will be followed by an “H” or an “L” if the value is abnormally HIGH or LOW.   For lab values that are critical, or an emergency, the lab also usually includes documentation that the result was called into either the physician or the nurse assigned to the patient and the time of that conversation.   It is often the case that you can have the facility print out a laboratory summary report for the patient  that shows the results of the lab data over many days, an entire hospital stay or over the course of many hospital stays. This can be quite helpful in terms of tracking trends.  

RADIOLOGY REPORTS

Many patients also have x-rays, CT scans, MRIs, mammograms, sonograms or other diagnostic imaging performed as a part of their hospital stay. The written reports from these tests should also be included in the hospital chart.  You can often determine the date and time the image was obtained, which physician read the image and also if the image is very concerning, the radiologist often documents that the results were called into the patient’s doctor or nurse directly and the time of such a call.   The written reports may also suggest additional follow up testing or imaging that may be required for the patient given the clinical circumstances.  You also need to be careful because occasionally there are initial preliminary reports of the results and then final reports. If this is the case, you want to carefully compare the two for any significant differences.  

Sometimes imaging is obtained before, during or after surgery while the patient remains in the operating room so it is important to  make sure you obtain all of that imaging and those reports as well.  

OPERATIVE RECORDS

If the patient has had a surgical procedure, as an in-patient or in a same day setting, there are certain required records that will be present.  First, the pre-operative assessments, including anesthesia assessment and the consent form for the procedure. In some circumstances the patient will have had an x-ray, a cardiac clearance or certain blood work performed to make sure it is safe for the surgery.  The anesthesia provider will meet with the patient and obtain a history and assess the patient for anesthesia risks.   Also, the surgeon will talk to the patient about the surgery and obtain a written consent from the patient.

During the surgery, the healthcare team documents many things.  The nursing staff  document on records often called “perioperative” records that include safety checklists performed prior to surgery, including patient placement, verification of the surgery to be performed including which side and which surgery and other safety factors.  The nursing team keeps track of which surgical instruments are used during the surgery and must account for all instruments at the end of the surgery before the patient is closed to make sure no instruments or sponges are left in the patient.   The nurse also documents which nurses are in the operating room and when they leave. At some hospitals the doctor’s entrance and exit are also noted.

The anesthesia providers keep a very detailed log of the patient’s vital signs during surgery, the medication that are given and any response the patient has to medications.

The surgeon does not take notes during the surgery but is required to dictate a detailed operative note following the surgery.

The patient is moved to the post anesthesia care unit (PACU) following most surgeries. This used to be called the recovery room.  In most hospitals the patient is monitored by nurses and the anesthesia team in this area for a certain amount of time until the anesthetic wears off and the patient is either ready to leave based on certain discharge criteria or the patient is transferred to the hospital floor if it is a more involved surgery.   

PATHOLOGY

If a patient has cultures take, a biopsy or a surgery that involves removal of tissue, the patient should have a pathology report.   If the report involves growth results of a culture it can take a few days or several weeks for the final report to be issued.  Oftentimes we have to call and obtain those final reports as they may not make it to the final paper version of the hospital record.

DISCHARGE SUMMARY/AUTOPSY RESULTS

Once a patient leaves the hospital, the attending physician is required to dictate a discharge summary. Most hospitals require the discharge summary be completed and signed within 30 days of the date the patient leaves the hospital. This is also true if a patient dies in the hospital. In that case, you will also want to request any autopsy report or findings.   There are certain circumstances involving patient deaths where the facility is required to conduct an autopsy based on state law.  In other circumstances a physician may ask for an autopsy or a family may request one.  Again, certain testing may be done as part of an autopsy and the results may take a few days or have to be sent to a separate lab so make sure you obtain all of the results that accompany the autopsy.   In a medical case, we often request the entire autopsy file which may include photographs, tissue blocks and/or pathology slides with special staining.  


About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a Top Lawyer for Washingtonian Magazine. Ms. Bertram has over 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes a majority of her practice to the representation of patients and families who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Brain Damage/Cerebral Palsy Can Be Caused By Malpractice

       By Catherine Bertram, Partner & Senior Trial Attorney 

                       

"Some people come into our lives, leave footprints on our hearts, and we are never the same." -Franz Peter Schubert

The medical staff at the Mayo Clinic define "Cerebral palsy" (CP) is a general term for a group of disorders that appear during the first few years of life and affect a child's ability to coordinate body movements. Cerebral palsy can cause muscles to be weak and floppy, or rigid and stiff.

In the United States, cerebral palsy occurs in about two to four out of every 1,000 births. The disorder is usually caused by brain injuries, including lack of oxygen, also called hypoxia or anoxia. Cerebral palsy isn't curable.  Medical evidence supports theories that infections, birth injuries, and poor oxygen supply to the brain before, during, and immediately after birth result in up to 15% of cases.

Between 35% and 50% of all children with CP will have an accompanying seizure disorder and some level of mental retardation. They also may have learning disabilities and vision, speech, hearing, or language problems.  Often parents are overwhelmed when their child is given this diagnosis and rightly so.  There are many questions and no clear answers.  As a parent of a child with special needs, you may be asking:

  • Why did this happen to my child?
  • How am I going to pay for what my child needs now and in the future?

Every circumstance is unique, just like very child and every family.   If you have questions about that care you received or the birth experience or the care your child received after birth and you think it may be a factor in your child's condition, you can get answers.   We have significant experience handling these types of cases and have many nationally known experts who are willing to review your child's case and determine what happened.  I was Director of Risk Management at a major teaching hospital in DC and have experience reviewing these cases from both the patient's side and the hospital's side.   We also have a nurse-attorney on staff at my firm who worked in a local hospital on the labor and delivery unit so she has special expertise in reviewing the records and determining what happened. 

As a parent, and as a patient advocate,  I urge you to get answers if you have these questions.  You owe it to yourself and your child.  Click here for some great quotes for families with special needs children and pass this on to other parents you know who have children with special challenges for those days when a few words may lighten our hearts.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Birth Injury , Cerebral Palsy , Medical Malpractice , Obstetrics , Patient Safety , Women's Health Issues
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$58.6 Million Awarded in Malpractice Suit

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

A Connecticut jury has awarded a local couple $58.6 million in a medical malpractice lawsuit, a record for a single incident of medical malpractice in the state of Connecticut. The lawsuit was against a physician and his practice, and it was shown that the doctor waited too long to perform a cesarean section during the wife's labor, which caused the child to be born with permanent brain damage. The boy suffers from cerebral palsy and is unable to eat, walk or talk. 

The recovery will allow the boy and his family to cover medical expenses and other losses the boy will endure for the rest of his life.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Cerebral Palsy , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Are Doctors Ordering Risky C-Sections Too Frequently?

Posted by: Salvatore J. Zambri, founding member and senior attorney     


The CBS Evening News (8/30, story 9, 0:40, Smith) reported that a recently released study reveals that "one in three first-time mothers" in America "has a c-section these days," a trend that's not likely to "reverse in the near future, because once a woman has a c-section she's more likely to have future babies delivered the same way."   The study claims that the rate of c-section is worrisome because "Caesareans pose a risk of surgical complications and research has found that they are more likely than normal births to cause problems that can put the mother back in the hospital and the infant in intensive care," the New York Times (8/31, D7, Grady) reports. "Caesareans also increase the risk of dangerous abnormalities in the placenta during later pregnancies, which can cause hemorrhaging and lead to a hysterectomy." What's more, "costs for a Caesarean are nearly twice those for a vaginal delivery."

Indeed, "C-sections are necessary sometimes to save the baby or the mother or both," according to the Washington Post's "The Checkup" blog. "But experts think they're being done far too frequently." The current study authors "stress that the study can't determine exactly how many of the C-sections were really unnecessary and could have been avoided," but it "does provide new evidence that more could be done to avoid women getting C-sections the first time around, and more could at least try a regular birth even if they have had a previous C-section."

Before reaching those conclusions, researchers at the Eunice Kennedy Shriver National Institute of Child Health & Human Development looked at data on "230,000 deliveries at 19 hospitals across the country," according to the Los Angeles Times' (8/30, Roan) "Booster Shots" blog.  The paper in the American Journal of Obstetrics & Gynecology revealed, "not surprisingly, that the major reason for undergoing a cesarean was due to the woman having a prior C-section.  Still, almost half of the cesareans that took place after labor had started were due to 'failure to progress,' and the study suggests that doctors aren't acknowledging that labor takes time and doesn't follow a predictable pattern in women, especially first-time mothers."

In preparing for child delivery, it is important for women to speak with their physicians to best understand the safest available options.  Natural delivery may be the healthiest method for a mom.  However, it should always be remembered, that during natural delivery, the baby or the mother may suffer distress, which will require a c-section under the applicable standards of care. Doctors, nurses, and hospitals must be prepared to take whatever action is necessary and appropriate to protect the mother and child. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Obstetrics , Patient Safety , Public Health , Women's Health Issues
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Is Patient Safety Really ACOG's Priority? ACOG relaxes guidelines for VBAC

By Catherine Bertram

                                                                                                             

The American Congress of Obstetricians and Gynecologists has issued revised guidelines regarding when to offer a woman a vaginal birth when she had previously delivered a baby via cesarean section, or VBAC.  Nationally, less than one in ten women undergo VBAC; the rest undergo an elective c-section.  While the revised guidelines require the physician to discuss each procedure's risks and benefits with the patient, there are subtle changes in the wording of the guidelines that patients will not notice that could impact the safety of the mother and baby.

The ACOG guideline states as follows in part:  "Women and their physicians may still make a plan for a TOLAC in situations where there may not be "immediately available" staff to handle emergencies, but it requires a thorough discussion of the local health care system, the available resources, and the potential for incremental risk. 'It is absolutely critical that a woman and her physician discuss VBAC early in the prenatal care period so that logistical plans can be made well in advance,' said Dr. Grobman. And those hospitals that lack "immediately available" staff should develop a clear process for gathering them quickly..."

VBAC carries a recognized but rare risk of uterine rupture which is a serious complication for the mother and the child.   Uterine rupture requires emergency surgery and can  threaten the life of the mother and the child.  ACOG previously recommended that VBAC only occur in hospitals with emergency anesthesiologists and surgeons immediately available to deal with uterine rupture.  In this revised guideline the language has changed, but what about the risks for the mother and the baby?  Have those changed or is this relaxed new guideline a result of pressure on hospital and physicians to allow this procedure to be performed in hospitals where trained anesthesiologists and surgeons are not physically present in the hospital.   Are parents being told about this subtle but important change? How soon can the anesthesiologist get to the hospital?  Minutes matter for both baby and mother in these rare but extremely serious circumstances.

ACOG attributes this to "the onerous medical liability climate for ob-gyns".   There is only a claim for liability when a mother or baby are injured due to the negligence of the physician or hospital staff.   In fact, if a physician adequately explains the risk of uterine rupture in VBAC including the alternatives and her delivery is appropriately managed then the physician is not liable for any uterine rupture that is beyond his or her control. What this new relaxed guideline does is tries to allow hospitals without anesthesiologists and surgeons in the hospital at all times to perform VBAC.  The question is whether families understand the risk that this provides and whether they are being allowed to choose to go where surgeons and anesthesia teams are readily available in the hospital.  The goal of ACOG should be to educate physicians about when VBAC is clinically appropriate and also teach them how to counsel patients about their options.  Of course parents should be completely informed of their options and the risks associated with those options, including whether the anesthesiologist and surgeon are immediately available.  All of the risks need to be discussed with the patient or they have not been provided a fair chance to make the best choice for their family.  Even if that means the safest choice for baby and mom is to deliver at another hospital. 

Continue Reading Posted In Obstetrics , Tort Reform , Women's Health Issues
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Cerebral Palsy Can Be Caused By Medical Errors

Posted by: Salvatore J. Zambri, founding partner     

“A happy life consists not in the absence, but in the mastery of hardships.” - Helen Keller

Cerebral palsy is a condition that can involve brain and nervous system functions, limiting a person's ability to move, learn, hear, see, and think.  Palsies develop due to damage to the developing brain.  Cerebral palsy usually develops by age two or three, and it is a non-progressive brain disorder, which means that the brain damage does not continue to worsen throughout life. However, the symptoms due to the brain damage often do change over time; sometimes getting better and sometimes getting worse. Cerebral palsy affects between two and four children out of every 1,000 live births. The United Cerebral Palsy Association estimates that more than 500,000 Americans have cerebral palsy. 

It is estimated that between 35% and 50% of all children with cerebral palsy will have an accompanying seizure disorder and some level of mental retardation.  Affected children also have a tendency to develop learning disabilities, along with vision, speech, hearing, or language problems. 

Symptoms are usually seen before a child is 2 years old, and sometimes begin as early as 3 months. Parents may notice that their child is delayed reaching certain developmental stages such as sitting, rolling, crawling, or walking.  There are several different types of cerebral palsy. Some people have a mixture of symptoms.

Symptoms of spastic cerebral palsy, the most common type, include:

  • Muscles that are very tight and do not stretch, which may tighten up even more over time;
  • Abnormal gait with arms tucked in toward the sides, knees crossed or touching, legs make "scissors" movements, walk on the toes;
  • Joints are tight and do not open up all the way (called joint contracture); and
  • Muscle weakness or loss of movement in a group of muscles (paralysis).
     

Although there is a wide spectrum of symptoms, some other common symptoms of cerebral palsy include:

  • Abnormal movements (twisting, jerking, or writhing) of the hands, feet, arms, or legs while awake, which gets worse during periods of stress;
  • Tremors; and
  • Loss of coordination.

Decreased intelligence or learning disabilities are common, but intelligence can be normal.  Many people with cerebral palsy have speech problems, hearing or vision deficits, seizures, and suffer pain and discomfort.

Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb or during the delivery process, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.  Sometimes, these injuries are preventable, yet brought about by medical errors.

Examples of cerebral palsy caused by the failure of medical providers to meet applicable standards of care, include:

  • Undiagnosed or untreated infections during pregnancy that may damage a fetus' developing nervous system;
  • Undiagnosed or treated jaundice in the infant;
  • Bleeding in the brain that goes untreated;
  • Severe oxygen deprivation to the brain or significant trauma to the head during labor and delivery;
  • Leaving the child in the birth canal too long causing a lack of oxygen to the brain;
  • Failure to detect a prolapsed cord (the umbilical cord can wrap around the child's neck, cutting off oxygen to the brain);
  • Failure to perform a cesarean section in the presence of fetal distress;
  • Improper use of forceps during delivery;
  • Excessive use of vacuum extraction;
  • Failure to recognize and treat seizures following delivery;
  • Not responding to changes in the fetal heart rate; and
  • Failure to plan a cesarean with a high birth weight infant.

Although life can be extremely challenging for  those with cerebral palsy, as well as the parents, siblings, and other family members, there are many organizations and support groups that can help people face and overcome those challenges.

The following is a list of readings, organizations, and special agencies whose purpose is to provide education about cerebral palsy and other disabilities and information to assist families with their needs, which I hope you find useful:

United Cerebral Palsy
http://www.ucp.org/
1660 L Street, N.W., Suite 700
Washington, DC 20036
(800) 872 – 5827/(202) 776-0406
E-mail: info@ucp.org


UCP is a national organization for people with cerebral palsy and their families. Through its local chapters, it provides a variety of services, including information and referral, parent support, advocacy, and educational and work programs for people with cerebral palsy. Fact sheets on selected issues related to cerebral palsy are available, as well as publications from a variety of publishers and organizations. Many publications can be downloaded from the website at no charge.

Association of University Centers on Disabilities
http://www.aucd.org/
1010 Wayne Avenue
Suite 920
Silver Spring, MD 20910
(301) 588-8252


The Association of University Centers on Disabilities (AUCD) is a membership organization that supports and promotes a national network of university-based interdisciplinary programs.  Through its members, AUCD is a resource for local, state, national, and international agencies, organizations, and policy makers concerned about people living with developmental and other disabilities and their families. Members engage in a range of interdisciplinary activities including: exemplary services for children, adults, and families; academic training; basic and applied research; training and technical assistance to schools, communities, and all levels of government; policy advocacy; program evaluation; and dissemination of best practices and new information.  AUCD programs also train the next generation of leaders in disability-related research, training, service delivery, and policy advocacy to insure that this essential work continues.

American Physical Therapy Association
http://www.apta.org/
1111 N.  Fairfax Street
Alexandria, VA 22314
(800) 999-2782/(703) 684 - 2782


The APTA has a free list of publications, "Publications of Interest to Parent and Educators of Handicapped Children." They can also direct you to the APTA chapter in your area.

ABLEDATA
http://www.abledata.com/
8455 Colesville Road, Suite 935
Silver Spring, MD 20910
(800) 227 - 0216


ABLEDATA is a national database covering information on assistive technology and rehabilitation equipment. Those interested can search the database free of charge from the ABLEDATA web site, or can have an information specialist perform a search for a small fee.  ABLEDATA publishes an assistive technology fact sheet and consumer guides.

Brian Injury Association of America
http://www.biausa.org/
1608 Spring Hill Road
Suite 110
Vienna, VA 22182
(703) 761-0750


The Brain Injury Association of America (BIAA) is the leading national organization serving and representing individuals, families and professionals who are touched by a life-altering, often devastating, traumatic brain injury (TBI). Together with its network of more than 40 chartered state affiliates, as well as hundreds of local chapters and support groups across the country, the BIAA provides information, education and support to assist the 3.17 million Americans currently living with traumatic brain injury and their families. 

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

 

Posted In Cerebral Palsy , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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There Are Various Types of Cerebral Palsy

Posted by: Salvatore J. Zambri, founding partner

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Cerebral Palsy is a medical condition that often confuses both parents and doctors.  With thorough testing, however, a physician can determine the exact type of  cerebral palsy your child has.  The proper classification depends on the severity of the child's symptoms, as well as the parts of the brain and body affected by the condition.

Here is a list of the fundamental categories of cerebral palsy:

Spastic Cerebral Palsy

This is the most common form of CP.  A child with spastic CP has muscles that are rigid, making it very difficult to move about.  There are three forms of spastic CP:

  • Spastic diplegia — Legs typically cross at the knees ("scissoring"), and leg and hip muscles are tight.
  • Spastic hemiplegia — One side of body affected only.  Affected side may have rigid limbs  and limbs that fail to develop fully.  
  • Spastic quadriplegia — The severest type of CP.  Child likely to have mental deficits along with rigidity and difficulty moving legs and arms.  Often difficult for child to walk and talk.  Seizures common, too.

Athetoid Dyskinetic Cerebral Palsy

This is the second most frequently diagnosed type of cerebral palsy.  This type of CP does not affect the brain.  Although intelligence may be normal, muscle movement throughout the body may be severely limited. Muscles tone may be either tight or weak, making it challenging to walk, talk, or move about.  Drooling is common, as it is often difficult for a child with this type of CP to control facial muscles.

Ataxic Cerebral Palsy

This is the least diagnosed type of Cerebral Palsy.  ACP affects a child's fine motor skills, making it difficult for the child to perform tasks such as tying shoes, using a scissors, manipulating parts of toys, etc.  Problems with coordination and balance are typical.  You may notice your child walking with his or her legs further apart than other children at the same age.  And when a child engages in an act, "intention tremors” may occur.  For example, if a child reaches for a toy, the child's arm may begin to tremor, and the tremors may get more prono8unced as the child approaches the toy.

Hypotonic Cerebral Palsy

This type of CP is diagnosed early in a child's life. Symptoms include a "floppy" head when the infant attempts to sit up, and delayed motor development. Experts believe that this type of CP results from brain damage.

Mixed Cerebral Palsy

It is common for doctors to determine that a child's CP does not "fit" into one of the above categories.  As a result, the physician may consider the child to have "mixed" CP.

 

Cerebral palsy can be inherited or the result of a lack of development.  Sometime, it is caused by medical errors.  For instance, if a child is in distress in utero (before birth), but no appropriate action is taken by the hospital staff to alleviate the distress, the child may suffer CP.  This is just one example of the many ways medical errors lead to CP.  Fetal monitoring strips and other diagnostic tools are used to monitor an unborn child's health.  They must be used and monitored effectively.

If you have any questions about your child's health, please consult with your child's physician immediately. 

If you want to learn more about CP, please read an earlier blog I wrote about the condition.  Also, if you are wondering whether your child's condition was caused by a medical error, feel free to contact me at 202-822-1899 or email me at szambri@reganfirm.com.  Our medical and legal professionals are here for you, and our investigation is done at no charge.

CONTACT ME  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Cerebral Palsy , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Resources for Cerebral Palsy, Including Information in Spanish

By Catherine Bertram                                                  

Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. 

A recent CDC study shows that the average prevalence of CP is 3.3 per 1,000 8-year-old children or 1 in 303 children.   Click here to listen to a podcast on Cerebral Palsy.

What Are Some of the Signs of Cerebral Palsy?

According to the CDC, "the signs of cerebral palsy vary greatly.  The main sign is a delay reaching the motor or movement milestones. Click here for a milestone checklist and here for the spanish version.

A child over 2 months with cerebral palsy might:

  • Have difficulty controlling head when picked up
  • Have stiff legs that cross or "scissor" when picked up

A child over 6 months with cerebral palsy might:

  • Continue to have a hard time controlling head when picked up
  • Reach with only one hand while keeping the other in a fist

A child over 10 months with cerebral palsy might:

  • Crawl by pushing off with one hand and leg while dragging the opposite hand and leg
  • Not sit by himself or herself

A child over 12 months with cerebral palsy might:

  • Not crawl
  • Not be able to stand with support

A child over 24 months with cerebral palsy might:

  • Not be able to walk
  • Not be able to push a toy with wheels"

What Causes Cerebral Palsy?

Cerebral palsy is caused by a problem in the brain. There are multiple possible causes including problems with the blood supply to the brain before or during child birth, bleeding in the brain, lack of oxygen, and head injury.  

If you think your child has cerebral palsy talk to your pediatrician right away to get a thorough evaluation.  If you think the cause may be a result of child birth you can contact us for a free confidential medical-legal evaluation.

 

Continue Reading Posted In Cerebral Palsy , Medical Malpractice , Obstetrics , Pediatrics
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Congress Deals With Radiation Safety, Doctor Kick-Backs

Posted by: Salvatore J. Zambri, founding partner     

The New York Times, in a front-page report, announced, "To help ensure that medical radiation is safe, Medicare insists that certain highly technical cancer treatments be administered only when a patient's radiation oncologist is present or nearby." Federal officials say physicians who fail to adequately supervise technicians during radiotherapy risk patient safety. But, the issue also "raises questions about financial incentives and the overuse of high-tech, and highly reimbursed, treatments" when "less advanced and cheaper ones would have served just as well."

As a result, "Congress passed an antikickback law designed to stop doctors from" unnecessarily ordering "tests or procedures in which they have a financial interest," according to the report.  In addition, "radiation safety will be the subject of a Congressional hearing Friday." For its part, "the American College of Radiology has said that self-referral endangers patients because doctors tend to order more tests."

Before undergoing any diagnostic test or invasive procedure, your doctor should describe all benefits and  risks of the procedure and he or she should explain all alternative options as well.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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New Wand Detects Surgical Instruments Left In Patients

By Catherine D. Bertram                                                     

According to an article in the Chicago Tribune, a company called RF Surgical Systems of Bellevue, Wash., created the RF Surgical Detection System which is essentially a scanning wand that can be used by surgeons to find any tagged items remaining in a patient. Tags (or seeds) about the size of a rice grain are imbedded in gauze, sponges and the like. One wave of the wand over the patient will reveal if the coast is clear.

According to an article in the New England Journal of Medicine, retained objects were reported "1 in 8,801 to 1 in 18,760 inpatient operations" which essentially is the equivalent of one case or more each year for a large hospital.  Unfortunately, this study was based on malpractice claims not just reported events,  so some experts say those numbers are most likely an underestimate. 

Does it work?  According to the article, more than 100 hospitals are using the system at a cost of about $15 per surgery.

Our firm has extensive experience with local cases involving surgical errors, including local hospitals where retained objects caused patient death. If you have any questions about this type of case feel free to email me at cbertram@reganfirm.com or call me at 202-822-1875.

Posted In Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Two Million Defective Huber Needles Recalled by Nipro

 Posted by: Salvatore J. Zambri, founding partner     


The AP (1/27, Perrone) reports, "Federal health officials announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies." The FDA "said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009."   Doctors, nurses, and patients should not be using these needles under any circumstances.

Bloomberg News (1/27, Peterson) reports that the "defect...might lead to fatal blockages of the main artery of the lung, the [FDA] said." The needles, which are intended "to give food and medicine to chronically ill patients," can "dislodge 'cores,' or slivers of silicon, from 'ports' under the skin and release the material into the bloodstream, FDA officials said." Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA's Center for Devices and Radiological Health, said the "defective needles...may cause tissue damage and inadequate drug delivery."

Regulators have not received reports that the needles released silicon or other foreign chemicals into patients, but the defect is difficult for doctors to detect, Dow Jones Newswire (1/27, Favole) reports.

CNN (1/27, Young) reports that the FDA "said anyone using the products should stop immediately and return any unused needles to Exelint." The agency indicated that it is conducting investigations "of needles from 20 companies," of which 10 have already been completed. "The FDA said it has sent letters to all Huber manufacturers asking them to address any design or manufacturing problems."

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Trailblazer Support Catheter Recalled, Dangerous

 Posted by: Salvatore J. Zambri, founding partner     

ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. According to the recall, "This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death."

If using a catheter, please contact your doctor immediately to be sure it is not part of the recall.  If you know you are using a Trailblazer Support Catheter, please stop using it right away, and obtain an alternative product.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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States Without Damage Caps Have More Doctors

 Posted by: Salvatore J. Zambri, founding partner     

In a blog at the California Progress Report (1/6), J.G. Preston wrote, "One of the arguments the 'tort reform' crowd uses to justify putting a cap on the amount of money a jury can award to a victim of medical negligence is their assertion that increases in the cost of malpractice insurance are driving doctors out of the business." But "there are more doctors per capita in states that don't limit the amount that can be awarded to victims of negligence than there are in states that have implemented caps. The American Association for Justice broke down the numbers and found there are 21% more doctors per capita in states that don't restrict compensation that there are in states with caps." 

And there are more doctors than ever in America.   Take a look at the most recent data published by the American Medical Association, which confirms this fact.  The publication considers data through 2008.  There were 309 doctors for every 100,000 people that year.   Compared to the 1960s, that's twice as many.  So, not only are there more doctors per capita in states without damages caps, there are also more doctors everywhere in this nation.

The lesson:  Don't let the corporate greed of certain special interest groups convince you that you need to abandon your constitutional rights to pad their pockets.  Victims of the carelessness of others need their rights. 

Be safe, and don't be fooled by well-worn rhetoric.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice, product liability, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (2010)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding civil litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Tort Reform , Women's Health Issues
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800,000 Swine Flu Vaccine Doses Recalled

 

 Posted by: Salvatore J. Zambri, founding partner     


A massive recall of swine flu vaccine doses drew national attention recently when it was announced by the Center for Disease Control.  ABC World News (12/15, story 6, 0:20, Gibson) reports that federal health officials "are recalling 800,000 children doses of swine flu vaccine...made by Sanofi Pasteur." NBC Nightly News (12/15, story 2, 0:35, Williams) reported that the doses "are less potent than they should have been."

The Los Angeles Times (12/16, Maugh) reports that Centers for Disease Control and Prevention director Dr. Anne Schuchat said the recall was "non-safety-related," and was "part of a routine quality assurance program." Schuchat emphasized that "children who received the vaccine do not need to be re-immunized," but the agency "wanted to make sure that doses that weren't already given won't be." The Washington Post (12/16, Stein, Laris) reports that "most of the vaccine, which was distributed nationwide in November, has probably already been used."

Bloomberg News (12/16, Randall) reports that Sanofi "began delivering swine flu vaccine in the US in September, with the bulk of deliveries expected in the fourth quarter." The United States "has ordered 75 million doses from the Paris- based company." CQ HealthBeat (12/16, Norman) reports that the problem was identified during "ongoing quality assessments" made by the drugmaker. The New York Times (12/16, A28, Mcneil) reports that Dr. Schuchat "said the vaccine was fully potent at release but dropped by about 12 percent in follow-up tests." In a story appearing in some form on over 320 news websites, the AP (12/16, Stobbe) reports that Jesse Goodman, the FDA's deputy commissioner for science and public health, said the problem may be related to the antigen sticking to the walls of children's pre-filled syringes.

USA Today (12/16, Sternberg) reports that the affected vaccine, "packaged in half-dose amounts meant for children 6 months to nearly 3 years old, represents about 1% of the nation's H1N1 vaccine supply." Sanofi spokesman Len Lavenda said the doses comprise roughly "18% of the 4.5 million doses in prefilled syringes made by Sanofi for children in that age group." Lavenda commented that officials were "baffled" by the weakened vaccine, adding "we can't remember a time when flu vaccine lost potency." The Wall Street Journal (12/16, Dooren) reports that Sanofi will be notifying providers to return any unused doses.

Reuters (12/16, Fox) also reported on this story, while Time (12/16, O'Callaghan) mentioned the recall in their "Wellness" blog.

Please be careful when taking a vaccine or allowing a loved one to be injected.  We urge you to speak with your doctor about all pros and cons of any drug before ingesting it.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Cerebral Palsy Can Be Caused by Improper Care Before, During and After Childbirth

Posted by Catherine Bertram, Partner                                                

"Some people come into our lives, leave footprints on our hearts, and we are never the same." -Franz Peter Schubert

The medical staff at the Mayo Clinic define "Cerebral palsy" (CP) is a general term for a group of disorders that appear during the first few years of life and affect a child's ability to coordinate body movements. Cerebral palsy can cause muscles to be weak and floppy, or rigid and stiff.

In the United States, cerebral palsy occurs in about two to four out of every 1,000 births. The disorder is usually caused by brain injuries, including lack of oxygen, also called hypoxia or anoxia. Cerebral palsy isn't curable.  Medical evidence supports theories that infections, birth injuries, and poor oxygen supply to the brain before, during, and immediately after birth result in up to 15% of cases.

Between 35% and 50% of all children with CP will have an accompanying seizure disorder and some level of mental retardation. They also may have learning disabilities and vision, speech, hearing, or language problems.  Often parents are overwhelmed when their child is given this diagnosis and rightly so.  There are many questions and no clear answers.  As a parent of a child with special needs, you may be asking:

  • Why did this happen to my child?
  • How am I going to pay for what my child needs now and in the future?

Every circumstance is unique, just like very child and every family.   If you have questions about that care you received or the birth experience or the care your child received after birth and you think it may be a factor in your child's condition, you can get answers.   We have significant experience handling these types of cases and have many nationally known experts who are willing to review your child's case and determine what happened.  I was Director of Risk Management at a major teaching hospital in DC and have experience reviewing these cases from both the patient's side and the hospital's side.   We also have a nurse-attorney on staff at my firm who worked in a local hospital on the labor and delivery unit so she has special expertise in reviewing the records and determining what happened. 

As a parent and as a patient advocate I urge you to get answers if you have these questions.  You owe it to yourself and your child.  Click here for some great quotes for families with special needs children and pass this on to other parents you know who have children with special challenges for those days when a few words may lighten our hearts.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Cerebral Palsy , Medical Malpractice , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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State Tort "Reforms" Don't Lower Insurance Premiums

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published an article that establishes what we have known now for some time--that state tort "reforms" have provided a boon to insurance companies, while physician and patient premiums continue to skyrocket.  The winner:  insurnace companies, whose profits have hit record levels.  The losers:  doctors and, especially, patients, whose fundamental rights have been taken from them.

"An analysis of data from the National Association of Insurance Commissioners (NAIC) and company annual statements shows malpractice insurer profits are 24 percent higher in states with caps.  In these cap states, insurers took in 3.5 times more in premiums than they paid out in 2008.  In contrast, insurers in states without caps took in just over twice what they paid in claims."

98,000 people die every year from preventable medical errors, yet the insurnace industry and the chamber of commerce want o place nonsensical limits on patients' rights simply to pad insurance companies' profits.  This profits-over-people model is anti-American and unethical.

The report establishes that the "medical malpractice insurance industry has seen a 47 percent increase in profitability in the last 10 years. Overblown 'reported' losses were used by the insurance industry to justify new measures restricting the rights of those injured by medical negligence."

Americans need to fight back against the myths spread by special interest group.  Over 30 states have been fooled into thinking caps on daages will help pemiums.  They haven't. In the meantime, though, "the average profit of the 10 largest medical malpractice insurers was higher than 99 percent of Fortune 500 companies and 35 times higher than the Fortune 500 average."

To view a copy of Insurance Company Handout: How the Industry Used Tort Reform to Increase Profits While Americans' Premiums Soared, visit http://www.justice.org/clips/Insurance_Company_Handout.pdf.

As I mentioned, It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Malpractice Accounts for Far less than 1% of Overall Healthcare Costs

 

 Posted by: Salvatore J. Zambri, founding partner     

According to a study from Public Citizen,  medical malpractice payments to patients who have been injured due to medical errors declined for the third year in a row.  The study further shows that the payouts total between merely 0.18% and 0.6% of the overall medical costs in this country. 

Is this decline the result of better medical care?  Unfortunately, no, according to the study.   Instead, fewer injured patients are being compensated.  Approximately 98,000 people are killed every year in this country due to medical mistakes, but payouts only go to about 11,000 of them.  If there is a medical malpractice crisis in this country, the core of the crisis is sloppy medicine, not frivolous lawsuits, notes the study:

More than 80 percent of the money paid out for medical malpractice in 2008 was for cases involving "significant permanent injuries"; "major permanent injuries"; injuries resulting in quadriplegia, brain damage or the need for permanent care; or death, according to NPDB [National Practitioner Data Bank] reporting.

Despite the hysteria surrounding debates over medical malpractice litigation, experts have repeatedly concluded that several times as many patients suffer avoidable injuries as those who sue. The best known such finding was included in the Institute of Medicine’s (IOM) seminal 1999 study, "To Err Is Human," which concluded that between 44,000 and 98,000 Americans die every year because of avoidable medical errors. Fewer than 15,000 people (including those with non-fatal outcomes) received compensation for medical malpractice that year, and in 2008, the number receiving compensation fell to just over 11,000.

Patient safety needs to become a priority in this country.  Unless it does, thousands upon thousands of Americans will be needlessly killed or seriously injured each year. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (2009-2010)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Errors Should Be Reported to Improve Safety

 Posted by: Salvatore J. Zambri, founding partner     


The AP (12/11, Tanner) reports that "in 2005, Illinois legislators...passed a measure requiring hospitals to report the deadliest kind" of medical errors, but "the law has yet to be implemented -- and it likely won't be for at least another year." Illinois "budget woes and foot-dragging by special interests are among reasons cited for the long delay." However, "there are finally glimmers of progress. That includes the recent launch of a related state website that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

Ten years ago, a landmark report proved that medical mistakes kill up to 98,000 Americans yearly. Only a handful of states have decided to do something about it, Minnesota being the first in 2003.  In 2005, Illinois modeled a law after Minnesota's.  Four years later, the law has still not been implemented.  Why?  Foot-dragging by special interest groups.  Finally, though, some progress is being made, including " the recent launch of a related state Web site that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

According to the AP report, "The law will require hospitals to publicly report so-called "never" mistakes. These are mostly preventable errors with potentially life-threatening consequences -- like the wrong-knee surgery Krzysztof Kordes says Chicago-area doctors performed on him last year or the forgotten sponge left inside a Plainfield woman during breast tumor surgery."

A few things the law requires:

  • hospitals required to report major medical errors within 30 days to the state's public health department
  • list of hospitals and mistakes will be posted online
  • hospitals required to determine cause of errors and to develop corrective plan

These kinds of laws should be in every state in our country.  Medical providers should not bow to special interest groups.  Sharing more, not less, following an adverse event is the only way to truly minimize future medical errors. 

Encourage your legislators to work hard to implement strong laws that clearly work to open communication and spur better, safer health practices.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (2009-2010)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , Women's Health Issues
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Evaluating a Medical Malpractice Case

 Posted by: Salvatore J. Zambri, founding partner     

As a consumer justice attorney, I have the privilege of representing and helping people through difficult times every day. Oftentimes, my clients are horrifically and permanently injured due to no fault of their own. Other times, I represent families of those who have died as a result of someone else's carelessness.

This may surprise you, but it is widely accepted that approximately 98,000 Americans die each year as a result of medical negligence, more than deaths caused by guns and automobile collisions.  The yearly death toll from medical errors equates to the number of deaths that would result from two 747 airplanes crashing to the ground every day.  This alarming statistic does not even include those who have not died, but have nevertheless suffered serious permanent injuries due to a lack of appropriate medical care.

I have published a paper that addresses some fundamental, but extraordinarily important, steps necessary to properly and thoroughly evaluate a potential medical malpractice claim. By no means does the article include all investigative efforts required to analyze a case, as every claim is different and deserves special attention. 

To read my article, entitled "Evaluating a Medical Malpractice Case", please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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American Associate for Justice Publishes Primer on Medical Negligence Debate: A Must Read

 

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a primer on the medical malpractice debate.  It comprehensively shows how special interest groups have perpetuated myths in an effort to strip Americans of their rights in order to pad their profits.  Here are some of the findings:

  • Myth #1: There are too many “frivolous” malpractice lawsuits
  • Myth #2: Malpractice claims drive up health care costs.
  • Myth #3: Doctors are fleeing.
  • Myth #4: Malpractice claims drive up doctors’ premiums.
  • Myth #5: Tort reform will lower insurance rates.

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

To read the publication, please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Paper Debunks Medical Malpractice Myths


 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a paper that concisely and clearly debunked the myths about medical malpractice which has been spread by business interest groups aimed at putting profits over people.  In the first of a series of papers, Public Citizen debunks the following "five myths: 

  • Myth #1: There are too many “frivolous” malpractice lawsuits.

Fact: There’s an epidemic of medical negligence, not lawsuits.  Only one in eight people injured by medical negligence ever file suit.  Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket.  A 2006 Harvard study found that 97 percent of claims were meritorious, stating, “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

  • Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

  • Myth #3: Doctors are fleeing.

Fact: Then where are they going?  According to the American Medical Association’s own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth.  Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

  • Myth #4: Malpractice claims drive up doctors’ premiums.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies’ financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors’ premiums and misled the public about the nature of medical negligence claims.  A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

  • Myth #5: Tort reform will lower insurance rates.

Fact:  Tort reforms are passed under the guise that they will lower physicians’ liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates."

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limitibg their recoveries, instead of focusing on preventing future errors. 

Don't let your legislative representatives takes your rights away just so some special interest groups can pad their profits.  Fight for safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drug Warning: Vials of Genzyme Drugs Potentially Contaminated

Posted by: Salvatore J. Zambri, Esquire

The New York Times reported that according to the US Food and Drug Administration (FDA), "Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients."  However, "the FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than one percent of the vials."  Although Dr. Jason Woo, an FDA official, stated, "We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope," patients and doctors are concerned.

According to the report, the FDA has confirmed that "the products would remain on the market, because there are few alternative treatments," the AP (11/14, Perrone) reported. The agency has strongly advised physicians to "closely inspect vials for particles before injecting them into patients."  If exposed to contaminated vials, patients may experience "potential allergic reactions, blood clots, and other problems," states the report. 

 About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Bayer Sued Over Its Oral Contraceptive--Yaz

Posted by: Salvatore J. Zambri, Esquire

Bayer reached an agreement with the Food and Drug Administration (FDA) in 2008, forcing the company to pay for a $20 million ad campaign to correct the company's history of overstating the benefits of its oral contraceptive--Yaz--and downplaying its risks.  The FDA determined that Yaz carries additional risks as compared to other contraceptives because the drug contains drospirenone, a progestin, which can increase a woman's potassium to dangerous levels.  Increased levels of potassium can lead to many adverse side-effects including blot clots, which can then lead to stroke, heart attack, or other serious condition. 

Before taking any drug, please be sure to consult with your doctor and pharmacist.  Physicians must take affirmative steps to be aware of all side-effects of the medications they prescribe so their patients do not suffer adverse, otherwise avoidable, consequences.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve dangerous medical products.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Surgery Technician Exposes Thousands of Patients to Hep-C

Posted by: Salvatore J. Zambri, Esquire

According to a Colorado Springs Gazette report, and other reports, a surgery technician, who worked at Rose Medical Center in Denver and Audubon Ambulatory Surgery Center in Colorado Springs, gave patients dirty syringes filled with saline solution and stole clean ones filled with Fentanyl to feed her drug addiction.  Fentanyl is a morphine-based drug that is used as a surgical anesthetic.  Since the technician stole the drugs, the patients were left to suffer.  The technician has been recently charged in a federal criminal complaint.

4,700 patients at Rose and 1,000 patients at Audubon are receiving letters from the medical facilities, advising them of the horrific conduct of the technician and further urging them to get tested for Hepatitis-C. The testing is necessary because the technician was later tested positive for the virus.  Unfortunately, according to reports, several patients have tested positive.

Hepatitis-C is terrible virus that can lead to serious liver problems and even liver cancer. There is no known cure for Hep-C.

Not very long ago, a rogue technician did the same sort of thing at a local, reputable hospital here in the District of Columbia.  Several patients who contracted Hep-C retained me to represent them in an action against the hospital, which I proudly advanced for them.  The technician in the case I pursued should never have been hired, was improperly trained and supervised, and was able to swap syringes for a protracted period of time.  Regrettably, lives were greatly impacted by the technician's wrongful conduct and the hospital's carelessness.

 About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, inlcusing medical malpractice actions.   He has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009).  Our firm has experience pursing cases for patients that involve tragic medical errors.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Doctors Fail to Report Abnormal Test Results At Alarming Rate

Posted by: Salvatore J. Zambri, Esquire

Doctors fail to report clinically significant findings to their patients in more than seven percent (7%) of the cases, according to the Associated Press, relying on a new study published Monday in the Archives of Internal Medicine.  Physicians' use of electronic medical records tended to lower instances of failures to inform.  The frequency of errors is higher in practices that used a combination of electronic and paper records, as opposed to practices that relied on only paper or only electronic records, reports Nicholas Bakalar of the New York Times.    

We encourage doctors to utilize the electronic technology now available to better communicate with patients and other physicians regarding a patient's symptoms and conditions.  Reckless record-keeping leads to needless deaths and injuries.  There is a crisis in this country--too many Americans die each year as a result of hospital and doctor errors.  Nearly 100,000 people die every year as a result of hospital mistakes alone.  Safety needs to be a priority as we move forward.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters.  He has successfully litigated multiple cases against Metro and other automobile owners.  He has also been named a "Super Lawyer" by Super Lawyer magazine.  Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly inform patients of abnormal test results.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Matrixx Withheld Consumer Complaints

Posted by: Salvatore J. Zambri, Esquire

Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.

According to the report, "Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning 'a surprise,' during a conference call with analysts."

The 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May.  William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that  his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn't apply. 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.

When companies withhold critically important information it smacks of putting profits over people.  Safety and public health should always be the paramount concern of drug companies. 

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warns of Dangers of Sirolimus (Rapamune) for Liver Transplant Patients

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Recently, MedPage Today reported that "The FDA issued an alert regarding the risk of increased mortality in stable liver transplant patients who switch from a calcineurin inhibitor-based (CNI) immunosuppressive regimen to sirolimus (Rapamune)."  It was noted, however, "that a causal relationship has not been established and that" the FDA "is not recommending discontinuation of the drug, which is indicated for prevention of organ rejection in kidney transplant recipients older than 12."

The label for the drug "already carries a boxed warning of excess mortality and graft loss associated with the use of" sirolimus "in combination with tacrolimus (Prograf) in de novo liver and lung transplant recipients."  And it also warns that it is not clear that the drug is safe for liver or lung transplant patients.  Doctors, therefore, should heed those warnings, comments the FDA.  Prescribing medication in a way that is contrary to the labeling may lead to serious permanent injury or death.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warnings About Clarcon Skin Products

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The AP recently reported that  "The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon." This warning followed a recent inspection which revealed high levels of disease-causing bacteria in the products.  According to the report, the FDA has said that the findings are "particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases."  Yet, according to the report, some of the bacteria found in the products "can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage," the report comments.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.


 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck & Co., Schering-Plough Accused of Fraud

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Bloomberg News reports that "Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia [ezetimibe] and Vytorin cholesterol pills."  The Pennsylvania Employees Benefit Trust Fund alleges in a complaint that "the companies have known for years -- and failed to make public -- that Zetia doesn't reduce fatty arterial plaques that can cause heart attacks and strokes."  The reports commenst that two studies last year showed that "the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin." Nevertheless, the companies allegedly withheld the the finding and "used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic," according to the report.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Window for Clot-Busting Drug tPA Opened

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The American Heart Association/American Stroke Association has established a new guideline, based on European studies,  concerning when a clot-busting drug known as tPA can be given intravenously to stroke victims. Previously, the guideline in America was to provide the drug only within three hours of the onset of symptoms,; otherwise, it could do more harm than good.  This posed a problem to patients who, for one reason or another, could not get to a hospital quickly enough following the start of stroke symptoms.  The new guideline extends the time in which the drug can be administered to four and one-half hours after symptoms begin.

It is important, however, to recognize that the widening of the window does not mean that doctors should act slowly when treating patients with stroke symptoms. The faster the clot in the brain is relieved, thereby restoring normal blood flow, the greater the likelihood of recovery.

The following is the American Stroke Association's list of "warning signs of stroke:

  • Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
  • Sudden confusion, trouble speaking or understanding
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking, dizziness, loss of balance or coordination
  • Sudden, severe headache with no known cause"

If experiencing any of the warning signs of stroke, seek immediate medical attention, as time is of the essence.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Atypical Antipsychotic Medications Effective But Risky for Children

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the The Wall Street Journal, staff from the Food and Drug Administration (FDA) indicate that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." As a result, the FDA is now "considering applications for AstraZeneca PLC's Seroquel [quetiapine] and Eli Lilly and Co.'s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.'s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17," comments the report.  In fact, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotic medications, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."  The report goes on the add that the FDA and the drug-makers announced that "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but also warned that "all had side effects."  These sides effects include "sedation and weight gain."

We encourage our readers to speak with their doctors before taking any medication.  Mixing drugs can be particularly dangerous.  Some drugs pose greater health risks than others.  Relying, too, on what the FDA reports and what the drug-makers themselves state about their own medications may not be sufficient.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Propylthiouracil Poses Serious Liver Injury

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An U.S. Department of Health and Human Services (HHS) report confirms that, two days ago, the U.S. Food and Drug Administration (FDA) "warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease."  Citing the FDA, HHS reports that: "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

Graves' disease is an autoimmune disorder which causes the thyroid gland to be overactive. The thyroid gland releases hormones that regulate the rate of the body’s metabolism.  These hormones "are critical for body temperature control, energy, weight, mood, and blood calcium levels."

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Screen Pregnant Women for Syphilis, USPSTF Reaffirms

Screening for Syphilis Infection in Pregnancy: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

"Screen all pregnant women for syphilis, preferably at their first prenatal visit, the U.S. Preventive Services Task Force reaffirms in Annals of Internal Medicine. According to one study, almost 15% of U.S. obstetricians/gynecologists do not routinely screen pregnant women for syphilis.


The USPSTF engaged researchers to find published evidence updating its 2004 recommendation. No evidence contradicting the recommendation was found, and a study among women in China found a decrease in congenital syphilis after implementation of a screening program."

Continue Reading Posted In Obstetrics , Patient Safety , Women's Health Issues
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FDA Recalls Biosite'sTriage Cardiac Panel

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel.  This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction).  However, according to the FDA, the "use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have."

All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately.  Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.

To read the entire recall, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Tainted Equipment at VA Hospitals Cause HIV Infections

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Former patients at several Veterans Administration Hospitals have been tested positive for HIV or hepatitis following exposure to dirty medical equipment.  According to a recent report at Chron.com, "[f]ive patients have tested positive for HIV and 33 have tested positive for hepatitis since February, when the VA started notifying more than 11,000 people treated at three VA medical centers to get follow-up blood checks because they could have been exposed to infectious body fluids." The specific VA hospitals involved are located in Miami, Fla., Murfreesboro, Tenn., and Augusta, Ga.

The VA determined last December that its equipment used for colonoscopies and ear, nose and throat procedures "was either not properly cleaned or set up", states the report.  Despite the medical errors, Dr. Jim Bagian, the VA's chief patient safety officer, boldly proclaimed that patients will never be able to prove that they were infected by the tainted equipment, the report comments. Congress is not satisfied with this statement and wants more information.

Senior partner Salvatore Zambri has handled many cases involving patients becoming infected with HIV as a result of medical errors.  There are clear standards that apply to hospitals governing the sterilization of medical devices and products.  If these procedures are not followed, the consequences can be severe.

If you think you have been injured by a defective or unclean device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Women's Health Issues
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FDA Too Lenient On Device Approval

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An editorial from yesterday's New York Times challenges the Food and Drug Administration (FDA) , suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman's "surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled."

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with "vaginal-sling"-like devices, according to the report.  About one-fourth of the complaints concerned "ObTape" specifically.  "The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy."

To read the entire article, please click here.

Medical devices can be extremely dangerous, and the FDA often does a poor job screenign defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Revelations on Genetic Risks of IVF

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

For nearly thirty years, in-vitro fertilization (IVF) has been consider relatively safe.  A recent report in the New York Times, however, reports that new epidemiological studies and scientific techniques have revealed findings that suggest that "there may be some abnormal patterns of gene expression associated with IVF and a possible increase in rare but devastating genetic disorders that appear to be directly linked to those unusual gene expression patterns."  The report also states that, with IVF, there "appears to be an increased risk of premature birth and of babies with low birth weight for their gestational age."

To read the entire article, please click here.

If you are considering an IVF procedure, we encourage you to speak with your doctors about all potential risks and benefits, so that you can make fully informed decisions.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cerebral Palsy , Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Asthma in Pregnancy

Posted by Victor E. Long, Esq.

According to a recent study published in the April 2009,  New England Journal of Medicine, although uncontrolled asthma may increase the risk of adverse perinatal outcomes, women with well-controlled asthma in pregnancy generally have good outcomes.  The recommendations in the article are consistent with the guidelines published by the American College of Obstetrics and Gynecology in 2008.

Avoiding allergens and irritants, such as tobacco smoke, that exacerbate asthma can improve maternal well-being and lessen the need for medication. Additional information is available thourh American College.

Continue Reading Posted In Obstetrics , Public Health , Women's Health Issues
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Bacterial Infections May Contribute to Sudden Infant Death Syndrome (SIDS)

Bacterial infections such as E. coli and Staphylococcus aureus -- sometimes acquired in medical facilities -- may be responsible for many cases of sudden infant death syndrome (SIDS).  The finding is the result of new research published in a recent edition of the British medical journal The Lancet.

Continue Reading Posted In Medical Malpractice , Obstetrics , Patient Safety , Public Health , Women's Health Issues
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New State Rankings for Physician Discipline Highlight Significant Differences From State to State

A newly updated annual ranking of state medical boards by the consumer advocacy group Public Citizen has revealed widespread discrepancies in both the numbers of disciplinary actions taken against physicians' licenses, and the rates of those disciplinary actions from state to state.  Though the specific numbers have changed again this year, a pronounced trend of significant discrepancies between individual states has held constant for years.  Unless geography influences a physician's competence, these state-by-state discrepancies point to a dangerously inadequate national system of physician oversight -- one that could conceivably allow dangerous, incompetent physicians to continue to practice medicine by moving from state to state.

Continue Reading Posted In Cerebral Palsy , Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Head and Neck Cancers in Young Men Traced to HPV Infection

Human Papillomavirus (HPV) -- the sexually-transmitted virus responsible for cervical cancer in thousands of women -- has now been implicated in a rapidly increasing rate of mouth and throat cancers among young men.  Researchers are hoping that a recently-approved HPV vaccine will soon be approved for boys, and tested for its effectiveness in preventing head and neck cancers.  A news article in a recent edition of the Baltimore Sun features Dr. Maura Gillison, an oncologist at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, whose research has been credited with linking the virus and tumors.

Continue Reading Posted In Medications , Men's Health Issues , Obstetrics , Public Health , Women's Health Issues
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February is National Prenatal Infection Prevention Month

Health complications during pregnancy can be scary and complicated, not to mention fatal.  Fortunately, there are a number of well-understood pregnancy-related health risks that can be eliminated through education and careful prevention measures.  The U.S. Centers for Disease Control and Prevention (CDC) offer the following infection prevention tips to ensure prenatal health, in observance of National Prenatal Infection Prevention Month:

Continue Reading Posted In Medical Malpractice , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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OB-GYN Group Advises Physicians to Adopt Sleeping Guidelines of Highway Safety Organization

Although 8 hours of sleep is recommended for all adults, the average American receives only 7, and obstetricians and other physicians may receive much less, particularly during training.  As a result of increasing awareness of the danger of physician fatigue, the American College of Obstetricians and Gynecologists (ACOG) has issued an opinion related to OB-GYN working hours in the latest issue of Obstetrics & Gynecology.

Continue Reading Posted In Medical Malpractice , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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New Mothers Not Obtaining Enough Information Regarding CMV Prevention

Congenital cytomegalovirus (CMV) infection affects 1 in 150 live births in the U.S., and 1 in 750 newborns suffer lifelong, debilitating injuries such as hearing loss, vision loss or cognitive impairment as a result of those infections.  Preventing CMV infection in babies can be as simple as instructing new mothers to wash their hands thoroughly after diaper changes -- 90% of OB-GYNs report their knowledge of this fact, but only 60% routinely counsel patients regarding hand-washing.  Only 44% counsel their patients specifically about CMV prevention.  These findings are the result of research published recently in the Morbidity and Mortality Weekly Report (MMWR), a publication of the U.S. Centers for Disease Control and Prevention (CDC). Continue Reading Posted In Medical Malpractice , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Unnecessary Caesarean Deliveries Linked to Increased Risk of Breathing Problems: New Study

An elective caesarian delivery can quadruple the odds that the delivered baby will suffer breathing problems when compared against those babies delivered vaginally or via emergency caesarian section.  The finding is the result of research conducted in Denmark and recently published in the British Medical Journal. Continue Reading Posted In Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Preeclampsia Linked to Heart Disease Risk

According to studies conducted by British and Norwegian researchers, women with cardiovascular risk factors are at increased risk of developing preeclampsia during pregnancy, and pregnant women who do develop preeclampsia are at higher risk for developing heart disease later in life. Preeclampsia, a condition in which abnormally high blood pressure develops during the second half of pregnancy, affects about 5 percent of all first pregnancies and presents serious risks to both mother and child. The findings of these studies are published in the November 2, 2007 online edition of the British Medical Journal.

Continue Reading Posted In Obstetrics , Women's Health Issues
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Poor Judgment, Lack of Teamwork, Insufficient Skills Cause Most Trainee Medical Errors: New Study

Most medical errors made by young physicians can be blamed on poor judgment, teamwork breakdown, and / or inadequate technical skill, according to a new study recently published in the Archives of Internal Medicine.  The study involved a comprehensive review of the closed medical malpractice claims of 5 major insurance companies, collected from 1984 to 2004.  Continue Reading Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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National Interstitial Cystitis Awareness Day

The first-ever National Interstitial Cystitis Awareness Day was observed on October 31 this year.  The event was sponsored by the National Association of Nurse Practitioners in Women's Health (NPWH) to draw attention to a frequently misdiagnosed and misunderstood pelvic condition.  Interstitial Cystitis (IC), a painful and frequently debilitating chronic illness, is often incorrectly diagnosed as endometriosis, overactive bladder or recurrent urinary tract infection.

Continue Reading Posted In Obstetrics , Women's Health Issues
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Low-Fat Diet Late in Life May Protect Against Ovarian Cancer

A low-fat diet may contribute to a lowered risk of ovarian cancer in post-menopausal women, according to new research published in the Journal of the National Cancer Institute (JNCI).  The findings square with previous research linking a healthy diet to a reduced risk of breast cancer and colorectal cancer in women of the same age group. Continue Reading Posted In Obstetrics , Public Health , Women's Health Issues
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AHRQ Announces 10 Patient Safety Tips for Hospitals

The Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services (HHS), recently issued a 10-item advisory for hospitals and healthcare facilities designed to improve patient safety and reduce medical errors.  Though AHRQ primarily supports research designed to assist health administrators and medical personnel, this knowledge of best practices in patient safety can also benefit the public by enabling patients and their families to advocate for safer medical care.  Following are the 10 recommendations, re-posted in their entirety:

Continue Reading Posted In Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Standard Pregnancy Weight-Gain Guidelines Don't Apply to Obese Women: New Study

Very obese women should work to lose weight and slightly obese women should gain only a little weight during their pregnancies, according to new research published in Obstetrics & Gynecology, the official journal of The American College of Obstetricians and Gynecologists (ACOG). 

Continue Reading Posted In Obstetrics , Patient Safety , Women's Health Issues
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Shoulder Dystocia: Is Your OB Ready for this Medical Emergency?

Was your obstetrician prepared for this potential emergency?  Some Hospitals are now requiring that obstetricians practice for this type of emergency on a regular basis, just like they practice CPR or Advanced Life Support techniques so that they are well prepared should they encounter this situation.   If a shoulder dystocia is not handled properly it could result in permanent damage to your child's brachial plexus muscles and this could mean the child will have limited or no use of the arm.  In many situations, this tragic outcome can be avoided by identification of mothers who are at high risk for this situation and by making sure that hospitals require obstetricians to regularly practice the accepted maneuvers.

Shoulder dystocia is when the baby's shoulder gets trapped in the pelvis and the baby cannot move down the birth canal safety.  If the doctor pulls too hard it can cause permanent injury to the child and is often called Erbs Palsy or a brachial plexus condition.  Shoulder dystocia occurs between 5-19% in cases where the baby weighs more than 8.5 pounds.  Also, women with diabetes have a greater risk of having this condition.

Calm and effective management of this emergency is critical for the baby.   The key is that the physician must be trained and ready to employ specific proven maneuvers in order to allow the baby's shoulder to be delivered without injury to the child's brachial plexus.   Prompt recognition of the condition followed by institution of specified maneuvers, such as the McRoberts maneuver, suprapubic pressure, internal rotation, or removal of the posterior arm  relieve the impacted shoulder and allow for safe delivery of the baby.

The "HELPERR" mnemonic from the Advanced Life Support in Obstetrics course can be a useful tool for addressing this emergency. All maneuvers in the HELPERR mnemonic aid physicians in completing one of three actions: enlarging the maternal pelvis through cephalad rotation of the symphysis and flattening of the sacrum; collapsing the fetal shoulder width; or altering the orientation of the longitudinal axis of the fetus to the plane of the obstruction.

Continue Reading Posted In Obstetrics
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First Comprehensive Survey Of Maternal Depression


A recent study conducted by Kaiser Permanente shows that more than one in seven women are depressed at some time during the nine months before becoming pregnant, during pregnancy, or in the nine months after childbirth. The study is the first integrated survey of maternal depression and appears in the October 2007 issue of The American Journal of Psychiatry. It also found that more than half of the women who experienced postpartum depression had also been depressed before becoming pregnant or during pregnancy.

Continue Reading Posted In Obstetrics , Public Health , Women's Health Issues
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Nursing Mothers Should Use Codeine with Caution: FDA Warning

Women who are ultra-rapid metabolizers of codeine may inadvertently expose their babies to lethal levels of morphine if they take the drug while breastfeeding.  At least one infant has recently died from a morphine overdose linked to contaminated breast milk -- the mother had been taking codeine for episiotomy pain.  The U.S. Food and Drug Administration (FDA) recently issued a warning related to the potential dangers of the drug for nursing mothers and babies. Continue Reading Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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IUDs Safe and Effective, Even for High-Risk Candidates: New Study

Intrauterine devices (IUDs) are a safe and effective method of birth control for women at high risk of sexually transmitted diseases and pregnancy, according to a study published recently in the American Journal of Obstetrics and Gynecology.  Previously, it had been believed that an increased risk of pelvic infections meant the devices were only appropriate for use by married, monogamous women.  With this study, researchers at Virginia Commonwealth University have demonstrated that IUDs are appropriate methods of birth control for all women, except those suffering from an acute inflammation of the cervix.

Continue Reading Posted In Obstetrics , Public Health , Women's Health Issues
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Many New Mothers Unprepared for Hospital Discharge: New Study

Approximately 17% of new mothers and their babies are prematurely discharged from the hospital, according to a study recently published in the journal Pediatrics.  Researchers polled 4,300 new mothers, their obstetricians and pediatricians to determine whether hospital discharges were occurring at appropriate times.  Eleven percent of new mothers said their discharge came before they were prepared to leave, 5% of pediatricians said babies in their care were discharged too early, and 1% of obstetricians said discharges of their patients had run afoul of good medical judgment.  Continue Reading Posted In Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Pre-Pregnancy Obesity Increases Birth Defect Risk: New Study

The individual health consequences of obesity are well-established, but a recent study published in the Archives of Pediatrics and Adolescent Medicine suggests that a pregnant woman's obesity can jeopardize the health of her fetus, as well.  Researchers in the study found that pre-pregnancy obesity was associated with an increased incidence of birth defects -- a finding with significant public health implications, as 51% of non-pregnant American women of childbearing age are classified as overweight.  Continue Reading Posted In Obstetrics , Pediatrics , Public Health , Women's Health Issues
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Institute for Healthcare Improvement Issues Guidelines To Prevent Five Million Injuries in Hospitals

On December 12, 2006, the Institute for Healthcare Improvement (IHI) announced a national campaign intended to dramatically reduce the incidents of medical harm in healthcare institutions in the United States.  The 5 Million Lives Campaign, if successful, would be "the biggest improvement in patient safety in the history of modern health care" according to Donald Berwick, MD, MPP, President and CEO of IHI.  The campaign will focus on matters such as the adoption of various improvements in care that can save lives and prevent injuries, such as decubitus ulcers (bed sores), surgical complications and infections. Continue Reading Posted In Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health
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ACOG Urges Against Paxil (paroxetine) Use During Pregnancy

"The American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant women and those wishing to become pregnant refrain from taking Paxil (paroxetine) because of the risk for birth defects.

The college's Committee on Obstetric Practice made the recommendation in an opinion published in the December issue of Obstetrics & Gynecology. It noted unpublished data from two registries suggesting a 1.5- to 2-fold increased risk for atrial and ventricular septal defects associated with paroxetine exposure in the first trimester. Based on these data, the manufacturer has changed the drug's pregnancy category from C to D.

The ACOG committee recommends that decisions about treating depression in pregnancy be individualized and that fetal echocardiography be considered for women exposed to paroxetine early in their pregnancies.

Journal Watch Psychiatry Associate Editor Dr. Deborah Cowley cautioned that the evidence reported so far is not strong enough to definitively conclude that Paxil raises the risk for cardiac malformations, but, she says, "For now, I would avoid using Paxil in pregnancy if possible." "

According to the statement by Glaxo-SmithKline, doctors should advise their patients of the potential harm to the fetus and recommend discontinuing paroxetine therapy or switching to another antidepressant.


 

 

 

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Pregnant Women With Placental Infection Have Doubled Risk Of Recurrence

As reported by Medical News Today, pregnant women who develop chorioamnionitis, an infection of the placenta or nearby membranes, in their first pregnancy have twice the risk of getting it in their second pregnancy, researchers at the UT Southwestern Medical Center in Dallas, Texas (UT Southwestern) have found. Continue Reading Posted In Cerebral Palsy , Obstetrics , Pediatrics , Women's Health Issues
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One in Eight Babies Born Premature

More than 500,000 babies a year are now born prematurely, a 30 percent rise in the last twenty years. CNN reports that this has translated into more than $26 billion a year in added healthcare costs. 

Researchers are calling for more studies on premature babies because, frankly, doctors do not always know what causes preterm births or how to prevent them.  Doctors do know, however, that the following characteristics put babies at higher risk for premature birth:

  • Previous preterm births (doubles the risk of a second);
  • Twins (increases the risk by 40%);
  • Poor women are at greater risk, as are those who are under 16 or over 35;
  • African-American women are 6% more likely (17.8%) to deliver prematurely than Caucasian or Hispanic women (11.5% and 11.9%). Continue Reading Posted In Obstetrics
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Medical Induction of Labor Doubles Risk of Amniotic Fluid Embolism

As reported by Medical News Today, researchers in Canada have concluded that medical induction of labor doubles a woman's risk for developing amniotic fluid embolism (AFE), a rare but often fatal complication of delivery.  AFE occurs when amniotic fluid, fetal cells, hair, or other debris enter the maternal circulation, causing cardiopulmonary collapse.  Approximately one in five births in the United States involves medical induction, and researchers believe the practice may be responsible for as many as 40 cases of AFE and 15 deaths each year in this country.  Labor induction is often medically necessary, such as when the baby is full-term and continuing the pregnancy presents a risk to either mother or baby.  However, labor induction is increasingly performed when there is no medical indication, typically for the convenience of either the physician or the parents-to-be. Continue Reading Posted In Medications , Obstetrics , Women's Health Issues
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FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older

On August 24, 2006, the U.S. Food and Drug Administration (FDA) announced approval of Plan B, a contraceptive drug often called the “morning after pill”, as an over-the-counter (OTC) option for women aged 18 and older. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. It will remain available as a prescription-only product for women aged 17 and under. Plan B is manufactured by Duramed Pharmaceuticals Inc., a subsidiary of Barr Pharmaceuticals, Inc., headquartered in Pomona, New York.

The FDA Release notes that the approval concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees.  The process also provided an opportunity for public comment on issues regarding the scientific and policy questions associated with the new status of Plan B as an OTC medication. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package. With this in mind, the FDA has further noted that it remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans. 

For additional information about Plan B, please see WebMD.

Posted In Obstetrics , Patient Safety , Public Health , Women's Health Issues
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Brachial Plexus Injuries: Did Your Doctor Handle the Emergency Properly?

When a child is born with a brachial plexus injury or is diagnosed with Erbs Palsy, it may be as a result of improper management of the infant during delivery.  If you believe your child's brachial plexus injury may have been a result of improper management by the doctors or nurses, please click Regan Zambri and Long to contact us by email or call us (202) 463-3030 to discuss the situation. 

The medical term for the condition when the baby's shoulder gets stuck in the mother's pelvis is "Shoulder Dystocia."  When this occurs, it is a medical emergency.   Obstetricians should be trained and ready to deal with this situation in a calm and effective manner.  According to the American Academy of Family Physicians, a proper response begins with immediate recognition of the situation and institution of specified maneuvers, such as the McRoberts maneuver, suprapubic pressure, internal rotation, or removal of the posterior arm, to relieve the impacted shoulder and allow for spontaneous delivery of the infant. These maneuvers aid physicians in completing one of three actions: enlarging the maternal pelvis through cephalad rotation of the symphysis and flattening of the sacrum; collapsing the fetal shoulder width; or altering the orientation of the longitudinal axis of the fetus to the plane of the obstruction.  Physicians should regularly train and practice for this emergency situation so that when they are faced with it they can react appropriately and prevent this tragic injury.

In addition to arm and shoulder injuries, you should also look out for:
  •  A baby that is slow to start and may require assistance with breathing;
  • Fractures of the baby's collar bone (clavicle) or humerus (arm);
  • Repairs to the mother's vaginal area (an episiotomy) or tearing done during the birth;
  • Maternal  hemorrhage (bleeding);
  • Uterine rupture (tears in the uterus that require surgical repair).
The risk of shoulder dystocia increases when babies are larger. In fact, in babies who weigh less than 8 pounds the incidence is between 0.6 and 1.4 percent.  However, in babies weighing 8 pounds 13 ounces (4000 grams) or more, the incidence rises to 5 to 9 percent.  The single most common risk factor associated with an increased incident of shoulder dystocia is use of a vacuum extractor or forceps during delivery.
Posted In Obstetrics
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Communication is Key to Preventing Deaths or Serious Injury of Infants During Childbirth

In the past 10 years, hospitals have voluntarily reported 47 cases of infant death or disability during childbirth to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for review under the Sentinel Event Policy.  Forty of the cases resulted in infant death and seven cases involved permanent disability. The mothers ranged in age from 13 to 41. 

According to the Joint Commission, in the cases studied, communication issues were identified as the most common root causes of the death (72 percent), with more than half of the hospitals (55 percent) citing organization culture as a barrier to effective communication and teamwork, i.e., hierarchy and intimidation, failure to function as a team, and failure to follow the chain-of-communication.

Other causes include:

  • staff competency (47 percent),
  • orientation and training process (40 percent),
  • inadequate fetal monitoring (34 percent),
  • unavailable monitoring equipment and/or drugs (30 percent),
  •  credentialing/privileging/supervision issues for physicians and nurse midwives (30 percent),
  •  staffing issues (25 percent),
  • physician unavailable or delayed (19 percent), and
  • unavailability of prenatal information (11 percent).

 The risk reduction strategies identified by JCAHO included:

  • Revise orientation and training process (70 percent)
  • Physician education and counseling (36 percent)
  • Revise communication protocols (36 percent)
  • Reinforce chain-of-communication policy (28 percent)
Posted In Obstetrics
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Having Twins and Triplets Means Higher Risks: Is Your Doctor Prepared?

If you are wondering whether you have been seeing more twins and triplets in the past 15 years, you can stop wondering. You are.  The rate of multiple births in the U.S. has increased by more than 30% since 1990.  The increase in twins and triplets has been dramatic and according to the American College of Obstetricians and Gynecologists (ACOG), this increase is due to the use of advanced assisted reproductive techniques, also commonly called "fertility treatment".

With the rising number of multiple births, comes a rise in preterm deliveries and low birth weight babies.  Twins have a 50% chance of being born with low birth weight.   Triplets have a 90% chance of being born with low birth weight.  Pregnancies with more than one infant also have a greater likelihood of other serious complications for both mother and the infants.

If you or someone you know is facing a twin or triplet pregnancy make sure they consult with an obstetrician who has significant experience in delivery and management of multiple gestation pregnancies.   Make sure the obstetrician has explained, and the expectant mother understands, the signs of preterm labor and the importance of calling her doctor immediately if she believes she is experiencing any concerning sign.

Ultrasound is also a critical tool in evaluating a pregnancy with twins or triplets. Make sure the mother is sent to an accredited facility with sonographers who have experience and training with twin and triplet pregnancies.   If your obstetrician has the sonogram equipment in his or her office make sure the staff using the equipment and those reading the sonograms are properly trained and licensed to do so.

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Lab Errors Can Result in Patient Harm: Does your OB/GYN track your labs?

Tracking Lab Test Results and timely follow-up by your physician in terms of reviewing and acting upon all concerning outpatient tests is of paramount importance in avoiding medical errors.

According to the American College of Obstetrics and Gynecology (ACOG), every physician's office should have the appropriate procedures in place to ensure that patient's results are obtained for each test ordered.

According to Dr. Karen L. Bruden, a member of ACOG's Committee on Quality Improvement and Patient Safety, OB/GYN offices should be able to answer the following questions about their lab and testing tracking systems to ensure patient safety:

"1. Is a log kept of all cytology samples submitted to different labs? By whom?
2. Is there a mechanism for tracking delayed reports or those that were never received?
3. As a secondary safety net, are all patients instructed to contact the office regarding Pap results within a specific time period?
4. Who is responsible for receiving the cytology reports?
5. Does the physician see and initial all reports before they are filed in the patient's chart?
6. Is the cytology report attached to the chart at the time it is triaged by the physician (rather than put in a stack of "loose" reports)?
7. Are all reports triaged by the physician, or only abnormal reports?
8. If the physician reviews only the abnormal reports, who determines what constitutes an abnormal report? Are there written guidelines for the office staff?
9. What are the level of education and qualifications of nonphysician office staff who participate in the triage process? RN? LPN? colposcopy nurse? medical assistant? clerk?
10. Does the office have a "no-show" policy and mechanism in place?
11. At the end of the workday does the physician personally review the medical record of all patients who "no-show?"
12. Who is responsible for the recall of patients with abnormal cytology? Is a log kept to ensure that the patient was seen and the abnormal results addressed?
13. Is there a policy for the recall of patients who are not accessible by telephone?
14. Does the laboratory have a policy for notifying the clinician about abnormal results?
15. Is there a system for the physician to discuss results directly with the pathologist if needed?"

For more information on this topic, please visit the ACOG  website for more information regarding patient safety issues. The reader may also read more about this in the January 2006 policy statement issued by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
Posted In Cancer Misdiagnosis , Obstetrics , Patient Safety
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ACOG Position on First-Trimester Screening Methods

According to a Committee Opinion issued by The American College of Obstetricians and Gynecologists (ACOG), first-trimester screening for genetic defects is a real option for pregnant women, but only if certain criteria are met. New technologies, such as measuring nuchal translucency (NT), have allowed for earlier, noninvasive screening for chromosomal abnormalities. When combined with screening blood work in the first trimester, these methods have detection rates that are comparable to current standard second-trimester screening.

There are many advantages offered by screening in the first-trimester. When test results are negative, maternal anxiety may be reduced at an earlier point in the pregnancy. If positive, it allows women to take advantage of first-trimester prenatal diagnosis by chorionic villus sampling (CVS) at 10-12 weeks or second-trimester amniocentesis (15 weeks), as well as allow women to prepare for a child with health problems.

Continue Reading Posted In Obstetrics , Pediatrics , Women's Health Issues
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Beyond the Baby Blues: New Mothers Require Early and Frequent Evaluation for Postpartum Depression

After having a baby, many women experience mood swings - one moment they feel happy, and the next they start to cry. They may feel a little depressed, lose their appetite, have a hard time concentrating, or find that they are unable to sleep well, even when their baby does. These symptoms usually start 3 to 4 days after delivery and may last several days. This mild form of depression is called the "baby blues," and it is considered a normal part of early motherhood. Some women, however, develop symptoms that are more severe and pronounced or that last a significant amount of time. This is called "postpartum depression."

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FDA: New Implantable Contraceptive Approved

According to its press release of July 18, 2006, Organon has received FDA approval for Implanon, a new implantable contraceptive .  Organon's announcement was also cited recently on WebMd Medical News, and labeling requirements are listed at FDA's website.

Implanon claims to be effective for up to three years and is implanted by a health care worker inside a woman's upper arm.  Organon, the maker of Implanon, says the device works "to continually release  a low, steady dose of progestin . . . for a period of up to three years via a unique, state-of-the-art implantable technology.  It can be removed at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level." 

The contraceptive, which has been in worldwide use since 1998 by more than 2.5 million women runs the risk of the following potential side effects: irregular bleeding, headache, acne, and mood swings.  Clinical studies report "less than 4% of participants had complications such as redness, swelling, and pain at the spot where Implanon was implanted.  Removal complications were seen in less than 2% of participants and included broken or damaged implants and implants that had shifted slightly from their original placement."

As with other contraceptives, the use of cigarettes can raise the risk of heart disease and stroke in women who use hormonal contraceptives.  Organon strongly advises these women not to smoke.  Similarly, like other hormonal contraceptives, Implanon does not protect against AIDS or other sexually transmitted diseases.

Organon plans to sponsor a U.S. training program to instruct health care workers on how to implant the device.  Organon stated that Implanon should "become more widely available in the U.S. in 2007 with implementation of the training program."

Posted In Obstetrics , Women's Health Issues
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Deaths Following Medical Abortion: April 10, 2006 Update

It is remarkable how quickly pharmaceutical products can move through the regulatory approval process, so much so that one might question the effectiveness of research and development by manufacturers. Since the approval of mifepristone (marketed as Mifiprex) in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of six deaths in the United States following medical abortion with mifepristone and misoprostol. Of the two most recent deaths reported to FDA in March 2006 (see DC Metro Area Medical Malpractice Law Blog, Deaths Following Administration of Medical Abortion), one has been determined to be unrelated to an abortion or to the use of these medications, while the other, with symptoms of infection, continues to be under investigation. According to previous FDA reports, four women in the United States have died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. All four women were infected by the same type of bacteria. While sepsis is a known risk of abortion in general, the symptoms in these four cases were not typical of sepsis. FDA has tested batches of mifepristone and misoprostol and has not found any contamination with the type of bacteria involved in the four cases. FDA recommends that women who have taken these medications for medical abortion contact a healthcare professional immediately if they develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Deaths Following Administration of Medical Abortion

The Food and Drug Administration (FDA) recently received verbal notification of two deaths in the United States following medical abortion with mifepristone and misoprostol. The notification was given by the drug's manufacturer, Danco Laboratories. While the FDA investigation is ongoing and the causes of these deaths have not been confirmed, the FDA has recommended that all providers of medical abortion and their patients be aware of the specific circumstances and directions for use of the drug as well as all attendant risks, including sepsis. In particular, providers and their patients should fully discuss early signs and symptoms that may warrant immediate medical evaluation, such as nausea, vomiting, or diarrhea, weakness with or without abdominal pain, all without fever or other signs of infection more than 24 hours after taking misoprostol.

As previously reported in its July 19, 2005 Public Health Advisory, updated on November 4, 2005, the FDA is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone and misoprostol.

Information pertaining to these medications can be found at the FDA's Drug Information Page. For additional information regarding medication warnings in general, please visit the FDA's Medwatch site.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pregnancy and Paxil: Not in the First Trimester

According to The Center for Drug Evaluation and Research of the U.S Food and Drug Administration, preliminary results of two important studies indicate that the popular antidepressant Paxil (also known as Pexeva or paroxetine) increases the risk of congenital defects, particularly cardiovascular malformations, when taken during the first trimester of pregnancy. Based on these findings, Paxil's pregnancy category has been changed from "C" to "D," indicating that studies show that its use in pregnant women have demonstrated an associated risk to the fetus. For these reasons, Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant. Women already taking Paxil who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus and counseled regarding whether Paxil should be discontinued and possibly replaced by another antidepressant. For certain women, however, the benefits of continuing Paxil may outweigh the potential risk to the fetus. The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of Paxil in pregnancy in order to better characterize its associated risks. The FDA will provide updates as new information becomes available.

Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings
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Lupus and Rheumatoid Arthritis Raise Pregnancy Risks

According to a study presented at the annual scientific meeting of the American College of Rheumatology in November 2005, pregnant women with lupus or rheumatoid arthritis may experience more pregnancy complications and longer hospitalizations than other women. Stanford University researchers compared delivery outcomes and hospitalizations for nearly 3,300 women with lupus and more than 1,400 women with rheumatoid arthritis to women in the general obstetric population. The study revealed that women with either lupus or rheumatoid arthritis had higher rates of hypertensive disorders, such as pre-eclampsia, than pregnant women in the general obstetric population. These women also faced higher rates of intrauterine growth restriction, premature rupture of membranes, and Cesarean delivery. As a result, women with either lupus or rheumatoid arthritis require careful monitoring throughout pregnancy, labor, and delivery beyond what is routinely undertaken.

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New Study Reports Effective First-Trimester Screening for Down Syndrome

Down syndrome is a disorder that includes a combination of birth defects, such as mental retardation, characteristic facial features, heart defects, and vision and hearing impairments. It is one of the most common genetic birth defects, affecting approximately one in 800 to 1,000 babies. It is generally caused by an extra chromosome, the structures in cells that contain the genetic information (genes).

According to a recently released study, a first-trimester screening test can reliably detect fetuses likely to be born with Down Syndrome, providing women with reliable information much earlier in their pregnancies than current testing permits. The $15 million study, funded by the National Institute of Child Health and Human Development, spanned eight years and involved 38,000 women.

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Ortho Evra Birth Control Patch Found Dangerous

The U.S. Food and Drug Administration (FDA) recently acknowledged what experts have been saying for months: Ortho Evra (manufactured by Ortho-McNeil) birth control patches are dangerous. The agency warned that "women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill." Increased estrogen means increased risks, including the increased risk of life-threatening blood clots.

Continue Reading Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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VBAC: Trends and Continued Debate

Vaginal birth after previous Cesarean delivery, known as VBAC, has been the subject of great debate among health care professionals for many years. According to The American College of Obstetricians and Gynecologists (ACOG), the Cesarean delivery rate in the United States increased dramatically, from 5 to nearly 25 percent, between 1970 and 1988, attributable in part to physicians' reluctance to perform certain complicated vaginal deliveries as well as increasing reliance on continuous electronic monitoring of fetal heart and uterine contraction patterns.

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