Abramson, Brown & Dugan Attorneys

GlaxoSmithKline, the pharmaceutical manufacturer that's been making news about its controversial diabetes drug Avandia, has settled close to 200 Paxil lawsuits related to birth injuries. 

GSK settled the cases after a Pennsylvania jury awarded a woman $2.5 million for failing to warn expectant mothers about the potential Paxil dangers such as birth defects including persistent pulmonary hypertension in babies and holes in the heart muscles. 

While GSK has settled nearly 200 Paxil birth defect cases, there were 600 pending Paxil lawsuits pending prior to the announcement of the June settlement. 

The pharmaceutical company has taken a $2.4 billion legal charge in order to settle the Paxil and Avandia lawsuits.

A Connecticut jury has awarded the estate of Margaret Mueller $2.45 million for failing to diagnose the correct form of cancer.  Mueller was treated for years for ovarian cancer, when, in fact, she had cancer of the appendix.  As a result of the wrong diagnosis, Ms. Mueller suffered through painful cancer treatments while the cancer in her appendix was left untreated and continued to grow, eventually claiming her life.

Margaret Mueller and her partner Charlotte Stacy brought a civil lawsuit against Dr. Iris Wertheim and Isidore Tepler in 2006.  The case drew attention partly because it was the first of its kind in Connecticut in that it brought a loss of consortium claim on behalf of a homosexual couple.  The consortium claim was dismissed because the couple was not married at the time.  Connecticut's civil union law was passed in 2005 and gave homosexual couples the same rights to sue as heterosexual couples.

A Danish study claims it has discovered a link between psychotropic drugs such as Ritalin, Prozac, and Haldol with birth defects in children.  The study conducted at the University of Copenhagen found 429 adverse reactions in children whose mothers had taken some form of these drugs.

“A range of serious side effects such as birth deformities, low birth weight, premature birth, and development of neonatal withdrawal syndrome were reported in children under 2 years of age, most likely because of the mother’s intake of psychotropic medication during pregnancy,” said Lise Aagaard, a researcher at the University of Copenhagen.

Another study not associated with the Copenhagen research found that antidepressants taken during pregnancy may lead to a 68% increase in miscarriages.

A new survey of pediatricians shows that half of the doctors make mistakes in diagnosing and treating their young patients.  The survey, authored by Dr. Geeta Singhal, assistant professor of pediatrics at Baylor College of Medicine in Houston, will be published in the July edition of Pediatrics. 

According to the survey of 700 pediatricians the most common errors are diagnostic mistakes ranging from medication side effects, psychiatric disorders, appendicitis, asthma and ear infections.  The most common error to which the pediatricians admitted relates to distinguishing viral infections from bacterial infections. 

Nearly half of the pediatricians surveyed noted that they make medical errors once or twice a year that could cause harm to the child. 

Those surveyed cited failure to properly take a medical history, failure to properly and thoroughly examine the patient, and an insufficient review of the patient's chart as the most significant factors leading to the medical errors.

According to the Businessweek article that published news about the survey, "Dr. Daniel Neuspiel, a liaison on the American Academy of Pediatrics' Steering Committee on Quality Improvement and Management, said the findings weren't surprising.

'We know that errors of all sorts are rampant in health care," said Neuspiel, director of ambulatory pediatrics at Levine Children's Hospital in Charlotte, N.C. "The main issue is not lack of knowledge, but that our systems in health care are set up in an antiquated way that allows for flaws to easily occur. The way we work, and I speak for myself as well in my own practice, relies too heavily on memory. Most of the time, I get things right, but not infrequently, I and other well-meaning pediatricians do make errors.'"

A South Carolina woman entered Grand Strand Regional Medical Center in January 2002 complaining of stomach and back pain.  She was seen in the hospital's emergency room by Dr. Stephen Law, an emergency room physician at the hospital.  Dr. Law diagnosed her with kidney stones, gave her some pain medication and sent her home without admitting her to the hospital.  48 hours later she died of septic shock. 

Her husband sued the doctor and the hospital for failure to properly treat his wife.  The South Carolina jury agreed with him and awarded the family $3 million.  The jury found that the doctor and the hospital failed to follow nationally recognized standards of medical care in treating Kelly Fay.

Sepsis infections may result in organ failure and severe cases can lead to septic shock and death.  Sepsis is a form of bodily inflammation as a result of infection.  Symptoms may include rapid breathing and heart rate, high or low body temperature, and an elevated white count.

A 47 year old Rochester NH woman is suing Wentworth-Douglass hospital and two surgeons after a robotic hysterectomy was performed on March 2, 2009.  During the robotic surgery, both of Sherry Long's ureters were severed.

The robotic lawsuit alleges that the surgeons who performed the hysterectomy lacked the training and experience in employing a robot during surgery.  The manufacturer of the $1.4 million robot offers surgeons 2 days of training but some surgeons who perform robotic surgery estimate that it takes hundreds of hours of training in order to successfully perform the robotic surgery.

The New Hampshire robotic surgery lawsuit comes in the midst of a growing concern that hospitals lack proper credentialing standards and surgeons should be required to have more experience using robots before operating on live human patients. 

A May 5, 2010 Wall St. Journal article noted that Sherry Long is not the first patient to be injured at Wentworth-Douglass in robotic surgeries.  One Wentworth-Douglass patient required four additional procedures to repair the damage done by the robotic surgery.  In two other robotic surgeries, patients suffered lacerated bladders.

According to the Wall St. Journal, botched robotic surgeries have happened before.  Last summer, a Florida doctor died after robotic surgery.  In that case, the surgeon had never performed surgery using a robot prior to the ill-fated procedure during which Dr. Carlos Chiriboga died.

Neither Wentworth-Douglass nor Intuitive Surgical officials were available for comment. 

Certain popular antidepressants taken by pregnant women have been linked to birth defects in children.  Zoloft, Wellbutrin, and Paxil are the drugs that have been found to have a link to birth defects. 

The link between these antidepressant drugs and birth defects has been circulating since 2005. That same year, the US FDA issued a Public Health Advisory concerning the link.  The two studies which formed the basis for the Advisory concluded that Paxil users had a greater risk of delivering babies with cardiac problems.

iThe birth defects include cardiac, pulmonary, neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull) infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus).

In the past, MRSA or methicillin-resistant staph infections have been found primarily in hospitals and healthcare related institutions.  According to the Associated Press, the potentially deadly staph infections are now moving into our communities and affecting children at a disconcerting rate.  The new trend shows that these types of infections are more often found in the community rather than hospitals. 

The study which reflected the shift in MRSA infections involved 25 children's hospitals.  According to the study, nearly 30,000 children were hospitalized in the ten year period which the study covered.  Of those 30,000 children 374 afflicted with MRSA died. 

MRSA often begins with a skin pimple or boil.  It may also spread to the bones or lungs where it can lead to pneumonia. 

These types of staph infections often become resistant to antibiotics and new research is needed to find drugs that are not resistant to MRSA.

The plant that manufactures Children's Tylenol and Motrin has been cited by the FDA for quality control and contamination issues.  The Fort Washington PA plant owned by McNeil Consumer Healthcare, the sole plant that manufactures such popular over-the-counter children's drugs, used raw materials contaminated with bacteria.  In addition to the bacteria contamination, the FDA noted that plant officials failed to respond to consumer complaints that black particles were found in some of the children's medicines.  The FDA is considering taking further action against McNeil for the plant deficiencies. 

According to the Washington Post, "The findings are serious," said Deborah M. Autor, a senior official at the Food and Drug Administration, which documented 20 problems at the Fort Washington, Pa., plant owned by McNeil Consumer Healthcare, a division of Johnson & Johnson.

Last week McNeil announced a voluntary recall of 43 over-the-counter pediatric medicines including Children's Tylenol, Motrin, and Benadryl.  The recall may affect 70% of the market for children's over-the-counter drugs. 

In its 10 day inspection of the plant, the FDA cited McNeil for failure to train employees, failure to track consumer complaints, a failure to spot trends that suggest a systemic deficiency, and a lack of written protocols.

When Yasmin entered the market in 2001 and Yaz in 2006, it was thought that the two oral contraceptives would lead to safer, more effective birth control.  The enthusiasm was grounded in the development of a new synthetic progestin, drospirenone, created to not only prevent pregnancy but to reduce the side effect of earlier contraceptives as well as treat premenstrual dysphoric disorder.

Bayer has aggressively touted the two contraceptives in slick marketing campaigns on television as well as the Internet.  The marketing campaigns were so successful in fact they drew the scrutiny of the FDA who warned Bayer that the marketing campaigns oversold the efficacy of the drugs while failing to properly relate the potential serious side effects of the drugs.

Now, Bayer is facing more than 1,000 lawsuits across the country.  The lawsuits allege that scientific studies have shown that women, even young, healthy women, are much more susceptible to a six fold greater risk of getting blood clots.  The rate of strokes is also a factor in those who take Yaz and/or Yasmin.

The LA Times quotes a leading drug safety advocate concerning the importance of such statistics, "There is reason to be concerned, I believe, about both of them [Yaz and Yasmin]," said Dr. Sidney Wolfe, founder and director of Public Citizen's Health Research Group, a nonprofit advocacy organization based in Washington, D.C. "When evidence like that comes up, people should pay attention to it."

The FDA has told Bayer Healthcare to revise its marketing materials for Yaz and Yasmin to reflect the new safety labels which emphasizes the prominent disclosure of safety information.  Bayer has previously been criticized by the FDA for incomplete safety information in its marketing materials.

In its letter approving the label changes, the FDA said: “All promotional materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement, including any new safety information. Bayer was given seven days from the date of the letter to comply with the FDA directive."

Unlike other contraceptive medicines, Yas and Yasmin are made with a type of progestin called drospirenone which has been known to elevate the body's potassium levels which, in turn, can develop into hyperkalemia.  Hyperkalemia can lead to serious cardiac and other health issues. 

Presently, there are approximately 1,100 Yaz and Yasmin lawsuits which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.

 

The second leading cause of accidental death in the US is prescription medicine overdose, according to Science Daily.  In a study that will be published next month in the American Journal of Preventative Medicine, researchers have found that prescription poisoning cases have risen by 65% in the first six years of the past decade.  That's an alarming statistic.

“Deaths and hospitalizations associated with prescription drug misuse have reached epidemic proportions,” said the study’s lead author, Jeffrey H. Coben, MD, of the West Virginia University School of Medicine, quoted Science Daily. “It is essential that health care providers, pharmacists, insurance providers, state and federal agencies, and the general public all work together to address this crisis. Prescription medications are just as powerful and dangerous as other notorious street drugs, and we need to ensure people are aware of these dangers and that treatment services are available for those with substance abuse problems,” Dr. Coben added.

The FDA has announced that it will devote two days of meetings concerning the safety of imaging equipment such as CT scans.  The meetings come in the wake of multiple reports of patients being exposed to too much radiation as well as the safety of such medical equipment.

Professor Jorge Guerra, Jr., professor of radiology at the University of Miami Miller School of Medicine, believes the problem stems from CT scan overuse. 

"Yes, there is an increased risk of cancer in the general population from the overuse of radiation," he said. "Let's work on cutting down on the overuse of radiation -- not cutting out the technology."

The US National Cancer Institute estimates that 14,000 people die each year from radiation-induced cancers.  The Institute also notes that in 1980 3 million CT scans were performed in the United States.  Now, 70,000,000 CT scans are performed.

The NY Times reported on March 28, 2010 that the FDA had ignored warnings from government experts concerning the dangers posed by routinely using CT scans to screen for colon cancer.  These claims will be discussed during the FDA meeting.

According to the NY Times article, "For patients, navigating the debate can be difficult because doctors, patient advocacy groups and manufacturers often endorse positions that are in their economic self-interest. Radiologists, who often own and use CT machines, for instance, often endorse their use; while gastroenterologists, who often own and use camera scopes, often favor their own methods. Patient groups often get financing from drug and device makers, or physician-specialty groups.

The Food and Drug Administration, charged with sorting out such competing claims, has been just as torn on the issue. The internal dispute has grown so heated that a group of agency scientists who are concerned about the risks of CT scans say they will testify at the Tuesday meeting that F.D.A. managers ignored or suppressed their concerns, and that the resulting delay in making these concerns public may have led hundreds of patients to be endangered needlessly."

There used to be very little middle ground in assigning blame when it came to dealing with medical errors in hospitals.  Either blame was assigned to an individual or blame was assigned to the system.  Now, a new model is being proposed that tries to find a middle ground in assessing blame when a medical error occurs in a hospital setting.

Just Culture, a new model developed by engineer David Marx, tries to bridge that gap and assess blame more accurately in order to such errors in the future.  In its April edition, the Joint Commission Journal on Quality and Patient Safety examines one fatal medical error in order to show how difficult this process can become.  The article focuses on one particular medical error in order to assess what went wrong and how the error can be avoided.
Four years ago, a nurse at St. Mary's Hospital in Madison Wisconsin mistook a bag of epidural painkiller for penicillin and hooked the wrong bag and hooked the painkiller into the IV of a 16 year old girl about to deliver a baby.  The girl's heart collapsed and died.  Fortunately, the baby was delivered unharmed.  Subsequently, the nurse was fired and later criminally prosecuted for the error.

A later study led by researchers at the Safe Medication Practices concluded that the case involved both human error and systemic flaws that led to the young girl's death.  The study found that the nurse failed to place an identification bracelet on the patient designed to match the right patient with the right medication.  But the bar coding had flaws and many nurses in the hospital bypassed the procedure.  The study also showed that fatigue played a factor in the case.  The nurse in question had worked two consecutive 8 hour shifts the day before and had spent the night in the hospital before coming on duty the next morning.  The hospital had no rules from preventing overwork such as in this case.

In this particularly tragic case, both human error and system flaws led to fatal medical errors.  Blame was assigned to the nurse without properly determining systemic flaws in the hospital.  Yet, both contributed to the fatal medical error.  Both have to be addressed if such medical errors are to be avoided in the future.

The Society for Pediatric Radiology is launching a nationwide campaign to highlight the CT scan risks for children as well as suggesting safety measures.  Of the 70 million CT scans performed each year, it is estimated that between 5% and 10% of those are performed on children.  The risk of radiation exposure is greater in children because of their smaller size and their longer life expectancy.

The "Image Gently" campaign is intended to urge radiologists to administer the lowest dose of radiation to children as well as suggest certain safety measures.   Safety measures include covering reproductive organs during a CT scan as well as considering other tests such as an ultrasound.

The Center for Disease Control has estimated that 435,000 children under 14 visit emergency rooms for head trauma each year.  Most of these children are administered a CT scan when ER doctors at University of California Davis Children’s Hospital determined most don't need a CT scan for minor injuries.  In response to their findings, these doctors have developed guidelines for doctors to determine who actually needs a CT scan.  Part of this determination includes an assessment of the severity of the head injury in relation to the risk of exposure cancer-causing radiation. 

New Jersey is the latest venue for consolidation of Yaz and Yasmin lawsuits.  New Jersey's Administrative Office of the Courts issued the consolidation order on February 18, 2010.  The consolidation order is typically issued when a group of plaintiffs share the same basic set of facts and the same defendant(s). 

Yaz and Yasmin lawsuits have continued to mount as women suffer serious side effects from taking the birth control.  Yaz and Yasmin both contain drospirenone which may elevate the body's potassium levels and has been associated with an increased risk of strokes.

Yaz and Yasmin consolidated litigation is in effect in Illinois, Pennsylvania, and New Jersey.  Allegations set forth in Yaz and Yasmin lawsuits already filed in these states allege failure to warn on the part of Bayer, the manufacturer of both birth control pills.  The FDA has issued warning letters to Bayer regarding the marketing of these birth control medications.

A 12 year study involving more than 58,000 women has concluded that both hormone replacement therapy (HRT) after menopause and estrogen only therapy may significantly increase a post-menopausal woman's risk for asthma.  The study compared one set of women who had never undergone HRT with a group that had received hormone replacement therapy.  In comparison, the HRT group was found to be at a 21% greater risk for asthma.  The risk more than doubles for the estrogen-only therapy group to 54%.

The study sought to learn more about the relationship between different types of hormone replacement therapies and their risk for contracting asthma after menopause. 

"Epidemiological studies have suggested that female hormones might play a role in asthma and that menopausal hormone therapy (MHT or ...HRT) might increase the risk of asthma in postmenopausal women," write Isabelle Romieu, MD, of the Instituto Nacional de Salud Publica, Cuernavaca, Morelos, Mexico, and colleagues. "The mechanisms underlying the link between hormonal factors and asthma risk are still not clearly understood. Knowing whether MHT affects this risk and if so, whether different preparations have a similar effect would provide a useful insight into the mechanisms by which the hormonal milieu acts on the airways."

Leanne Metcalf, director of research at the advocacy group Asthma UK, agreed with Romieu,""There is now a large body of evidence suggesting a link between female hormones, including the use of HRT, the development of asthma and its severity."

Prior to the 2002 Women's Health Initiative study, hormone replacement therapy had been a preferred method of treating severe hot flashes and vaginal dryness.  However, after the WHI study found HRT to be linked to ovarian cancer, breast cancer, and strokes, the method experienced a sharp drop.

The five largest health insurance companies in the United States are reporting a 56% rise in profits from 2008.  The top five, WellPoint, UnitedHealth Group, Cigna, Aetna and Humana, experienced combined 2009 profits of $12.2 billion.  The profits coincide with the same insurance companies cut the proportion of premiums they spent on their customers' medical care, committing relatively more to salaries, administrative expenses and profits.  

These profits combined with insurance companies' plan to direct more of those profits to salaries and administration at the expense of more expansive, better quality healthcare has left them vulnerable to criticism in the midst of the ongoing healthcare reform debate in Washington. 

 

The medical malpractice myth that doctors are fleeing the profession of medicine is contradicted by the facts.  The number of practicing physicians in the United States has been growing each year.  For example, in 2007 there were 941,000 physicians working in the US, an increase of more than 20,000 doctors.  The growth in the number of doctors is outpacing the population growth in the US.  According to the American Medical Association's own figures there are now twice as many doctors per 100,000 population than in 1960.  In states where nonecomonic damages in medical malpractice cases are capped, the number of physicians is less than those states who have no such damage caps.

Doctors are not leaving the medical profession en masse.  The statistics provided by the American Medical Association shows us that this is merely a myth and only distracts us from the discussion of real healthcare reform in this country.

Public Citizen, a public interest advocacy group, has noted that the Texas medical malpractice liability caps instituted in 2003 have been a miserable failure.  The caps have failed to lower medical costs and more Texans have no health insurance than in 2003.

Why is this important for the state of medical malpractice in New Hampshire?  It's crucial and relevant for Granite Staters because the Texas "experiment" has been touted as a model for the entire nation in improving healthcare and lowering medical costs.  According to the Public Citizen release:

• The percentage of uninsured people in Texas has increased, remaining the highest in the country with a quarter of Texans now uninsured;
• The cost of health insurance in the state has more than doubled;
• The cost of health care in Texas (measured by per patient Medicare reimbursements) has increased at nearly double the national average; and
• Spending increases for diagnostic testing (measured by per patient Medicare reimbursements) have far exceeded the national average.

According to the American College of Radiology and the Society of Breast Imaging, women should begin receiving mammograms at the age of 40.  Those women who are at a greater risk for breast cancer should receive their first mammogram at the age of 30.  This contradicts last year's controversial revelation from the US Preventative Services Task Force which recommended against the traditional age for mammograms. 

The new study appears in the Journal of the American College of Radiology.  Dr. Carol Lee of Memorial Sloan-Kettering Cancer Center noted that early detection of breast cancer remains the key to survival. 

"The significant decrease in breast cancer mortality, which amounts to nearly 30 percent since 1990, is a major medical success and is due largely to earlier detection of breast cancer through mammography screening," Lee said in a statement.

Both the American College of Radiology and the Soceity of Breast Imaging strongly urge women to continue to receive mammograms.  The concern over an increased number of false positives which prompted the US Preventative Services Task Force to issue their new guidelines late last year was dismissed by the new study. 

"The reason for that is there have been studies that have shown women would rather have their cancer found, even if it means having to have a biopsy. The harms, from most studies we've seen, did not seem to be all that real," noted Dr. Phil Evans of the University of Texas Southwestern Medical Center in Dallas and president of the Society for Breast Imaging.

The family of 3-year old Jason Fox received a jury verdict of $15 million in their medical malpractice lawsuit against two Boston doctors.  Jason Fox died in December 2004 as a result of the botched medical procedure intended to repair a heart birth defect.

Jason Fox was born with Tetralogy of Fallot, a cardiac birth defect which restricts the flow of blood and oxygen to the body's organs and limbs.  Before being referred to Children's Hospital in Boston where the fatal procedure was performed, Jason had undergone 8 other procedures in order to rectify the cardiac defect. 

During the Children's Hospital procedure, Jason suffered brain damage after a contrasting agent leaked into his brain.  As a result, the boy suffered brain damage and a seizure.  When he was discharged from the hospital, he had lost the ability to walk or speak.  The family has alleged that the doctors withheld information about his treatment.  The Board of Registration in Medicine is investigating those allegations.

In the wake of increasing reports of excessive radiation exposure from CT scans, the FDA has issued new guidelines to limit the risk of radiation exposure.  There are at least 250 reports of radiation exposure in California and preliminary reports of the same from other states.  The new guidelines include the following 5 recommendations:

1. Facilities should determine whether patients who received CT perfusion scanning were exposed to excess radiation.
2. To ensure that correct radiation dosing is planned for each study, facilities should review their radiation dosing protocols for all CT perfusion studies. "Some facilities use the same algorithm for multiple tests, but we're recommending making sure before each scan to check the radiation dose for each specific patient," Dr. Shuren said. "We need to go back to basics."
3. To ensure that dosing protocols are followed and that the planned amount of radiation is administered with each scan, quality control procedures should be implemented.
4. Before performing CT perfusion, radiologic technologists should check the CT scanner display panel to ensure that the amount of radiation to be delivered is at the appropriate level for the individual patient. Every facility performing CT imaging should review its CT protocols and be aware of the dose indices normally displayed on the control panel, including the volume CT dose index and the dose-length product. The values displayed should reasonably correspond to the doses normally associated with the protocol, and this should be confirmed both before and after scanning.
5. If more than a single study is performed on a patient during an imaging session, the dose of radiation should be adjusted accordingly so that it is appropriate for each study.

The symptoms associated with CT radiation exposure may include skin redness, loss of hair, and an increased risk of contracting certain cancers.

In spite of the United States Preventive Services Task Force recently released guidelines concerning breast and cervical cancer screenings, United Healthcare has announced that it will continue to cover mammography and cancer screenings as it has in the past.

Approximately one month ago, the USPSTF released new guidelines for cancer screenings.  The new guidelines suggested that regular breast cancer screening for women begin at age 50 rather than age 40.  The Task Force also recommended that women receive less frequent screening for cervical cancer. 

In making their coverage announcement, United Healthcare noted that women should continue to follow the advice of their physicians.  United Healthcare, one of the nation's largest health insurance companies, will not change its coverage policies in light of the newly published guidelines set forth by the USPSTF.  The American Cancer Society and other health advocacy groups have not commented on the new guidelines.

When the U.S. Preventive Services Task Force issued new recommendations earlier this week concerning breast cancer screenings for women, it caused quite a stir in political and healthcare circles.  The Task Force advised that women should start breast cancer screening at age 50 in order to avoid excess biopsies, anxiety, and the discovery and treatment of tumors which, if left alone would not cause additional health problems.  The Task Force cited studies that have shown “the additional benefit gained by starting screening at age 40 years rather than at age 50 years is small, and that moderate harms from screening remain at any age.” 

Soon after the new recommendations were made, Health and Human Services Secretary Kathleen Sebelius was quick to note that the Task Force does not set federal policy or determine what procedures are covered by the federal government.  Sebelius was critical of the manner in which the recommendations were publicized stating that they had caused a great deal of confusion and worry for women. 

Rep. Debbie Wasserman Schultz, a breast cancer survivor, also voice her displeasure with the recommendations. 

“At a time when we are working to reform our health care system to provide greater access to preventative care, these guidelines and the fact that they conflict with many of the recommendations from leading cancer organizations only adds to the confusion that so many women have when it comes to breast health.”

A spokesperson for the National Cancer Institute stated that the group would review the recommendations and issue its own statement.  The Institute currently recommends women have mammograms every one to two years beginning at age 40.

The publication of the new breast cancer screening recommendations has set off a firestorm on Capitol Hill as well.  Some lawmakers have charged that the new recommendations are part of the healthcare reform and will lead to rationing of healthcare.  However, White House officials have been quick to distance themselves from the new report.  The NY Times pointed to a post on the White House blog by Dan Pfeiffer, deputy communications director, that stated, "women who are currently getting mammograms under Medicare will continue to be able to get them.”

In the midst of the confusion and furor over the new recommendations, one thing remains important the prevention of breast cancer.  The healthcare industry would be well served if they keep the health and welfare of those who are at risk of breast cancer as their first priority.

A 2005 medical malpractice lawsuit in Connecticut alleged that a highly respected obstetrician/gynecologist substituted his own sperm for another man's in an artificial insemination procedure.  The medical malpractice lawsuit was quickly settled, the files sealed, and Dr. Ben D. Ramaley continues to practice medicine.  While Ramaley was fined $10,000 for using the wrong man's sperm, he can continue to hold a medical license in Connecticut.  Because the 2005 lawsuit contained a confidentiality agreement, neither side may discuss the circumstances of the case.

We do know the case began when a mixed-race couple sought the services of Dr. Ramaley. The woman went to Ramaley at Brookside Greenwich Ob-Gyn Associates to have an intrauterine insemination performed.  Nine months later, the woman gave birth to twins.  That's when the paternity questions began to surface.  The twins had fair complexion which seemed odd to the parents since the father was African American. The father submitted to a paternity test and found out that he was not the natural father.  That's when the medical malpractice lawsuit was initiated. 

Birth injuries occur in every 7 out of 1,000 babies born in the United States.  While  birth injuries may be caused by many factors, some are due in part to the negligence or medical malpractice of doctors and other healthcare professionals.  Certain complications during pregnancy and the birthing process may increase the risk that the child will develop cerebral palsy, a disorder of the central nervous system that impedes normal motor function.

We've discussed cerebral palsy birth injuries in a previous post.  It's worth noting the symptoms of cerebral palsy in a newborn child:  difficulty with balance or coordination, seizures, and mental retardation.

Birth injuries seriously affect a child's quality of life as well as the lives of the parents.  Estimates show that approximately 500,000 Americans are affected with cerebral palsy.

Halloween is tomorrow and we've just heard that certain face paints contain lead, nickel, cobalt, or chromium.  These elements can cause neurological problems and are considered dangerous. 

“Parents should not have to worry that face paint contains lead and other hazardous substances,” said Lisa Archer, national coordinator of the Campaign for Safe Cosmetics at the Breast Cancer Fund and a co-author of the report, “Pretty Scary,” quoted ENS. “Companies are not making the safest products possible for children, even though kids are particularly vulnerable to toxic exposures,” Archer added.

The CDC has urged parents to avoid any paints or cosmetics containing lead or other allergens.  They are dangerous for children and should be avoided at all costs.

For quite some time we've been told that one of the best tools in fighting breast cancer and prostate cancer was regular breast cancer screenings such as mammograms and PSA screenings.  Now, the American Cancer Society believes that the benefits of such screenings may have been overstated.  This new message comes in the wake of an analysis of the risks and benefits of breast cancer screening published in The Journal of the American Medical Association.  In a front page article this morning, the NY Times notes, "In it, researchers report a 40 percent increase in breast cancer diagnoses and a near doubling of early stage cancers, but just a 10 percent decline in cancers that have spread beyond the breast to the lymph nodes or elsewhere in the body."

Dr. Otis Brawley, chief medical officer of the American Cancer Society put it bluntly, "I'm admitting that American medicine has overpromised when it comes to screening.  The advantages to screening have been exaggerated."

Screenings fail to distinguish between cancers that if left undetected cause no harm and do not grow and cancers that are aggressive and fatal.  According to the NY Times article, "researchers are finding cancers that do not need to be found because they would never spread and kill or even be noticed if left alone. That has led to a huge increase in cancer diagnoses because, without screening, those innocuous cancers would go undetected.At the same time, both screening tests are not making much of a dent in the number of cancers that are deadly. That may be because many lethal breast cancers grow so fast they spring up between mammograms. And the deadly prostate ones have already spread at the time of cancer screening. The dilemma for breast and prostate screening is that it is not usually clear which tumors need aggressive treatment and which can be left alone. And one reason that is not clear, some say, is that studying it has not been much of a priority." 

Obviously, this is a significant shift in the detection of breast and prostate cancer and may lead to public confusion concerning the benefits of mammograms and other screenings. The cancer society has promised to issue new guidelines early next year.

Breast cancer symptoms can vary widely from lumps to skin discolorations to swelling.  Some of those who develop breast cancer have no symptoms at all. Yet, the first and easiest step in fighting breast cancer is a regular self examination.  An annual mammogram should also be a part of your plan to fight breast cancer.  Early detection of breast cancer is the key to survival.

There are many forms of breast cancer including ductal carcinoma in situ (DCIS), invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), inflammatory breast cancer, male breast cancer, recurrent breast cancer, metastatic breast cancer.  

The treatment of breast cancer may depend upon various factors including size, stage, lymph node status, hormone receptor status.

The key to this battle against breast cancer is your willingness to be informed and fight.

 

October is Breast Cancer Awareness Month and communities across the country are engaging in efforts to recognize the courage of breast cancer survivors as well as heighten awareness of the deadly cancer.  In spite of these efforts and aggressive cancer research, breast cancer remains the second leading cause of death among women in the United States.  The American Cancer Society estimates that 192,370 women will be diagnosed this year with breast cancer and 40,170 will die from the disease.  In 1994, the incidence of breast cancer grew at a rate of 1.6%.  Many experts attribute this growth to the use of hormone replacement therapy, which has been shown to increase the risk of breast cancer.  This decade, the incidence rate has declined each year by 2%.

Medical errors, including failures to diagnose and delayed diagnosis of breast cancer, have also contributed to the breast cancer mortality rate.  Mammograms remain an essential diagnostic tool in detecting the early stages of breast cancer but there have been instances in which the mammogram is read improperly.

That's why every woman must be her own best advocate. If you suspect you may have a lump in your breast, seek medical attention.  Once you've found a trusted medical provider, take an active role in your healthcare by asking questions and seeking proper support.  This month is a good time to learn about breast cancer for you and your family.

The FDA has issued a Public Health Alert concerning potential dosage errors regarding Tamiflu.  After receiving reports of medication errors regarding Tamiflu dosage, the FDA is recommending to all healthcare providers that Tamiflu prescriptions be written in milliliters and not teaspoons.  In addition, healthcare providers are advised to provide a Tamiflu dispenser that is calibrated in milliliters as well.  According to the FDA website, "The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser." 

If you have further questions or concerns, please refer directly to the FDA website or call your healthcare professional.

Yaz and Yasmin birth control lawsuits will be consolidated in Philadelphia according to a ruling by Judge Sandra Mazer Moss, Philadelphia Court of Common Pleas.  Bayer, the manufacturer of the popular birth control pills Yaz and Yasmin, is facing lawsuits alleging that the pills contain risks and side effects that traditional birth control pills do not.  These risks and side effects have been associated with drospirenone (DRSP), a hormone that increases the body's potassium levels and raises the risk for other health concerns including blood clots and strokes. Other dangerous side effects include breast lumps, depression or mood changes, heart attack, high blood pressure, kidney and/or liver damage, migraines, vaginal bleeding and severe allergic reactions including swelling, hives and difficulties in breathing.

In 2008, Bayer received an FDA warning letter concerning its promotion of the birth control pills.  As a result of the FDA warning letter, Bayer was forced to launch a marketing campaign explaining in greater detail the potential side effects of its birth control Yas and Yasmin.

Medtronic Inc. has recalled its Sutureless Connector (SC) intrathecal catheter because of faulty labeling.  According to the medical device maker, the recall was issued after Medtronic discovered that the catheter was incompatible with a certain type of pump as the labeling on the catheter indicates.  According to a report in the Minneapolis/St. Paul Business Journal, "The catheter affected is called Sutureless Connector (SC) intrathecal catheter and revision kit models 8709SC, 8731SC, 8578 and 8596SC when it is pared with the IsoMed Pump Model 8472 which is no longer made or marketed for sale. Medtronic stopped making IsoMed infusion pumps in September 2008 as part of a planned product phase out."

Thus far, the labeling error has led to 10 complaints- some of which resulted in serious medical consequences.  The Business Journal reported, "In all 10 reports, medical intervention was required to correct the condition. In one case, a patient died two days following a surgery to fix the catheter’s faulty connection to the pump, “but it cannot be determined whether the cause of death is or is not related to the device,” according to a Medtronic press release."

The so-called miracle drugs for arthritis in juveniles and teens have now received stronger FDA warnings.  TNF drugs focus and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

The stronger FDA warnings intend to highlight the risks of children and teens who take these drugs to treat such conditions as juvenile rheumatoid arthritis, inflammatory bowel disorder, and Chron's disease.

According to Medical News Today, the stronger warnings come after an investigation found that children and adolescents who take these drugs are at an increased risk of developing cancer, some of which were fatal.

The FDA reported the following regarding their findings:

Hepatosplenic T-cell lymphoma, 10 cases
Non-Hodgkin’s lymphoma, 7 cases
Hodgkin’s lymphoma, 6 cases
Leukemia, 6 cases
Malignant Melanoma, 3 cases
Thyroid cancer, 3 cases
Basal cell carcinoma, 1 case
Lymphoma and AML, 1 case
Leiomyosarcoma, 1 case
Nephroblastoma, 1 case
Renal cell carcinoma, 1 case
Metastatic hepatocellular cancer, 1 case
Malignant mastocytosis, 1 case
Neuroblastoma, 1 case
Colorectal cancer, 1 case
Yolk sac tumor, 1 case
Myelodysplasia, 1 case
Bladder cancer, 1 case

Remicade was implicated in 31 of the cases, 15 cases involved Enbrel, and 2 cases concerned the drug Humira.

Medical errors made by doctors and hospitals will result in 200,000 deaths in the United States this year, according to a report compiled by Hearst newspapers.  These deaths will occur due to preventable errors such as illegible handwriting, poor communication between healthcare professionals, misdiagnoses, wrong-side surgeries, and failures to diagnose. 

The Centers for Disease Control and Prevention (CDC) notes that 99,000 patients die each year due to preventable infections including MRSA.  While the CDC is supposed to track such deaths, the agency admits that most medical errors go unreported.  The Seattle Post-Intelligencer reports that if these medical errors were reported, medical errors would be the leading cause of accidental deaths in the United States.

These medical mistakes have caught the attention of journalists across the country who've worked together to investigate issues of medical errors, medical malpractice, medical misdiagnoses, and the overall breakdown in the healthcare system.  The team of journalists, in collaboration with graduate journalism students from Columbia University, have published a report entitled, "Dead by Mistake".  The report is available online at

http://www.chron.com/deadbymistake

Phil Bronstein, editor-at-large of Hearst Newspapers and the San Francisco Chronicle, explained that the project arose from an urgent need for greater public awareness as well as better healthcare industry accountability.

"The idea for the story first came in an informal discussion among reporters and editors from several papers; we were looking at topics to investigate that would have a significant impact on people's lives. We decided that focusing on the plague of fatal but preventable hospital errors would be a public service. Our team, which during the course of the project involved over 35 people - and an entire class of graduate journalism students at Columbia University, read thousands of pages of documents, disciplinary files, lawsuits, governmental, medical and other public and private reports. Dates of birth, death certificates, "adverse events" statistics and whispered hints of information were reported out, studied, reviewed and translated into verifiable fact. We conducted several hundred interviews across the country, concentrating on a half dozen states. Journalists 3,000 miles apart coordinated their work and their findings. Part of the problem in seeking some solution to the unrelenting number of preventable deaths each year was that there was no comprehensive reporting of medical errors around the country. We set out to gather information not available and/or accessible to the public, or even to health care professionals."

New research suggests that breast cancer patients who experience even the slightest spread of the cancer to a lymph node may have a much higher risk of the cancer recurring years later and may require more treatment than surgery. The new study contradicts current medical practice and will undoubtedly lead to a change in treatment regimens. Presently, women with “micro tumors” are given estrogen-blocking drugs, chemotherapy, or a combination of both. The new findings challenge that treatment method since it suggests a recurrence of cancer somewhere in the body in the subsequent five years. According to the Associated Press article, several doctors believe the findings are significant. "This took an area that was very gray and I think made it black and white," said Dr. Linda Vahdat, director of breast cancer research at Weill Cornell Medical College and an adviser for the breast cancer patient Web site of ASCO, the American Society of Clinical Oncology. "I think it will influence treatment," she said of the study. "If we're considering treating the patient, we probably should." Dr. Daniel Hayes, director of breast cancer treatment at the University of Michigan, agreed. "It really does look like our biases are wrong," he said. "For the first time, it suggests that isolated tumor cells or micrometastases do have biological significance." Results of the study are published in today’s edition of The New England Journal of Medicine.

Medical malpractice is the failure of a medical care provider to act within the standard of reasonable professional practice applicable to his or her profession or specialty. The plaintiff, or injured patient, must prove the relevant standard of care for each profession or specialty through expert testimony. For a suit to be governed by the medical injury statute, and thus be a “medical malpractice” suit, the claim must arise from any adverse, untoward or undesired consequences arising out of or sustained in the course of professional services rendered by a medical care provider, whether resulting from negligence, error, or omission in the performance of such services; from rendition of such services without informed consent or in breach of warranty or in violation of contract; from failure to diagnose; from premature abandonment of a patient or of a course of treatment; from failure properly to maintain equipment or appliances necessary to the rendition of such services; or otherwise arising out of or sustained in the course of such services. In New Hampshire, there is a three year statute of limitations that governs when medical negligence claims may be brought. All fifty states have similar limitations periods, but they can range from one to seven years. In short, if a patient does not file suit within three years of suffering an injury caused by medical negligence, the patient is later prohibited from doing so. There are exceptions to this three year period, such as with claims brought on behalf of minors or persons with permanent disabilities, but most claims are governed by the general three year statutory period.

Bayer Healthcare Pharmaceuticals is facing federal civil lawsuits relating to its popular birth control pills Yaz and Yasmin. The lawsuits follow an FDA warning letter issued to Bayer stating that the pharmaceutical company had failed to warn prospective patients about the pills' risks while at the same time overstating the drugs' benefits. Last year, Bayer ran a $20 million corrective marketing campaign as part of its agreement with the FDA to correct its aggressive and misleading ads. Yaz and Yasmin have been associated with an increased risk of blood clots, pulmonary embolisms, heart attacks and strokes. Currently, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation in order to consolidate and centralize the pending 132 lawsuits against the drugs’ manufacturer Bayer. The lawsuits all contain similar allegations concerning Bayer’s failure to warn consumers about the potentially life threatening side effects associated with Yaz and Yasmin such as increased risk of high blood pressure, strokes, clots, gallbladder disease, deep vein thrombosis, pulmonary embolism, and sudden death. The motion requests that the lawsuits be consolidated before Judge James G. Carr of the U.S. District Court for the Northern District of Ohio, in Toledo. Both Yaz and Yasmin are oral contraceptives that contain ethinyl estradiol and the progestin drospirenone, which are not found in any other contraceptive except for the generic Ocella. If the motion is granted and an MDL (multidistrict litigation) is formed, the Yaz and Yasmin lawsuits would remain individual cases and not part of a Yaz/Yasmin class action suit. A hearing on the MDL motion is expected to be heard in September 2009.

A federal judge in Arkansas has ordered pharmaceutical company Wyeth to release its files concerning ghost written medical journal articles. These articles were used in promoting its menopause drugs Prempro and Premarin. The document production request was sought by the NY Times and PLoS, a medical journal. Wyeth is facing more than 8,000 lawsuits from women who contend the menopause drugs caused their breast cancer. Wyeth had made $2 billion on the menopause drugs prior to a 2002 study that linked Prempro and Premarin with breast cancer. More than 6 million women have taken hormone replacement drugs to treat menopause symptoms such as night sweats, mood swings, and hot flashes. The subject of ghost written medical journal articles is not new but has received renewed attention since last year when Senator Charles Grassley asked Wyeth to reveal the nature of its relationship with ghost writing companies and their marketing efforts concerning menopause drugs. The firms hired to write the articles are typically marketing firms. Once they write the favorable articles about a particular drug, a doctor is hired to sign the article, giving it credibility in the medical community. The practice is highly controversial and Congress is reviewing the practice. This is not the first time Wyeth has been accused of hiring ghost writers as part of their marketing efforts. In 1996, Wyeth hired Excerpta Medica, Inc. to write favorable articles about its notorious diet drug fen-phen. As a result of fen-phen diet drug use, thousands of consumers suffered and died after using the dangerous drug. Fen-phen was subsequently removed from the market and its maker Wyeth was the subject of lawsuits, some of which continue to this day.

While cervical cancer is one of the more preventable and treatable forms of cancer among women, the rates of occurrence and death remain high. The National Cancer Institute estimates that in 2009 11,270 women will be diagnosed with new cases of cervical cancer. The Institute estimates that 4,070 women will die from cervical cancer this year. There are two principal reasons why these 2009 estimates remain grim. Too many women will not avail themselves of gynecological exams and pap smear evaluations. Secondly, some of the gynecological exams and pap smears will be incorrectly performed or the diagnoses will be incorrect. The latter may constitute medical negligence on the part of healthcare professionals. Cervical cancer forms in the tissues of the cervix. It is normally a slow growing cancer that may not display symptoms. It is most likely to occur in women between the ages of 30 and 55. Various strains of the human papillomavirus (HPV) are responsible for 95% of cervical cancer cases. If left undetected by a pap smear, cervical cancer grows and becomes invasive. Symptoms of the invasive stage include unusual vaginal discharge, abnormal vaginal bleeding not related to a normal period, and bleeding or pain during intercourse. The pap smear remains a woman’s best defense against this cancer. The pap smear was developed in the early 1940’s by New York physician Dr. George Papanicolaou. In theory, the pap smear should virtually eliminate the chances of a woman developing an invasive form of cervical cancer. However, in 1989 the American Medical Association noted that 15% to 30% of all supposedly “clean” pap smears had cancerous or cancer-like cells present that required medical intervention. This estimate may indicate medical errors in the administration of the pap smear, mistakes in the gynecological exam, or misinterpretation of the pap smear results by the lab reviewing the pap smear or the biopsy. Tragically, these medical errors and negligence are the leading cause of the death or disability of women found to have invasive cancer in spite of regular pap smears and gynecological examinations.