Abramson, Brown & Dugan Attorneys

The NY Times published an article today that is quite disturbing.  The Times reports on a recent study published in The Journal for the American Medical Association that reveals that there are no clear guidelines when it comes to opting for breast cancer surgery.  The study found that in some instances, surgery was not indicated or effective even though it was performed. 

"Nearly half of women who had lumpectomies for breast cancer had second operations they may not have needed because surgeons have been unable to agree on guidelines for the most common operation for breast cancer, a new study finds. It also hints that some women who might benefit from further surgery may be missing out on it. Rates of repeat surgery can vary widely by doctor, from zero percent to 70 percent, according to the study. The additional operations are done when pathology reports on tumor specimens suggest that the first operation may have left behind some cancer cells. But surgeons differ when it comes to interpreting those reports."

Such lack of clarity may lead to unnecessary operations in some breast cancer cases and in other cases, lack of surgical intervention when surgery would improve the chances of breast cancer survival.

According to the Times, "Nearly half of the repeat operations were done in women whose pathology reports did not indicate that any stray cancer cells had been left behind, meaning that the operations probably did not help the patients. In more disturbing findings, 14 percent of patients who did have evidence of cancer left behind did not have another operation, for unknown reasons.

Rates of repeat surgery varied by surgeon, and by hospital, from 1.7 percent to 20.9 percent. Differences in the patients did not account for most of the variation, though very thin women, who tend to have small breasts, were more likely to need second operations. Surgeons say that is because they try to remove as little tissue as possible from small breasts for cosmetic reasons.

“The number of operations women undergo definitely depends on where you’re treated, and even to a greater level on which surgeon you see,” Dr. McCahill said. “We put the math behind it and said, this is a lot of second operations that maybe don’t make a difference.”

An Indiana jury awarded $1.5 million to an Indiana woman who was injured after a surgeon opted not to perform surgery on her.  The ensuing delay coupled with a failure to carefully monitor the patient after the decision not to operate led to the jury award.

According to the News and Tribune, "Michelle Wells Fischer, 30, has short gut syndrome — caused by the removal of most of her small intestine in 2003. Jurors found her surgeon, Dr. William H. Garner III, liable for her injuries.

Fischer, then a 21-year-old Greater Clark County Schools special education teacher, checked in at Floyd Memorial Hospital and Health Services at noon June 5, 2003, complaining of abdominal pain.

She saw Garner for a surgical consultation. Her attorney, Pete Palmer, said Garner initially thought surgery was necessary and scheduled the procedure for the next day. When he met with her again the next morning, he decided to cancel the surgery based on new information.

“After changing his mind to operate, he then went out of town for the weekend and did not procure any surgical coverage,” Palmer said.

Unfortunately, Fisher's condition did worsen and emergency surgery was performed. 

Fischer had ischemic bowel disease, or dead bowel. Palmer argued Fischer’s entire bowel would not have died if they had performed the surgery as scheduled.

“We argued the standard of care in the medical community says you either need to operate in a timely fashion, or if you don’t believe operating is the best option at a particular time, you need to continue to follow that patient,” Palmer said. “It’s not enough to just say no operation.”

The case revolved around two issues related to the standard of care a healthcare provider owes a patient.  First, a proper decision about surgical intervention must be made based upon the entirety of the medical situation as supported by medical science.  Second, follow-up care must be provided so that a decision NOT to provide care (an operation in this instance) does not lead to further complications and harm to the patient. 

The jury decided that in this instance these two principles had been violated.

A new study conducted by the Inspector General of the Department of Health and Human Services estimates that only 14% of medical errors are ever reported.  If one considers that a 2004 study found that there are approximately 200,000 deaths occurring each year due to preventable medical errors, the number is staggering. 

The prevalence of medical errors and their underreporting constitutes a healthcare crisis in this country that severely impacts consumer health, consumer confidence, and the overall economy.

However, there are positive steps that can be taken by consumers.  The first and perhaps most important is knowledge.  Before undergoing a procedure or entering a healthcare facility, check out www.healthgrades.com and see how your physician and health facility fares on some standard, quantifiable measurements.  Second, ask questions and listen carefully to what the doctor or healthcare professional is saying.  Get a second or maybe a third opinion.

There are things each of us can do to minimize the potential for medical errors.

The State of California has fined 14 hospitals for serious medical errors that caused serious injury or death to patients.  Since 2007, the state has collected more than $5,000,000 in fines that are used to improve the quality of care and to reduce medical errors. 

According to the Orange County Register, "The size of each fine depends on how many times a hospital has previously been disciplined. The latest penalties were the fourth for Mission and the third for St. Jude.

Since the program started, so-called "adverse events" reported by hospitals to the state have declined by 12 percent, said Pam Dickfoss, an acting deputy director for the department. The top reason for the fines is medication errors, followed by leaving behind a "foreign object" during surgery.

"I do believe it is making a difference," Dickfoss said of the program.

State programs such as this one in California, if administered properly, can help improve accountability and transparency which are two key elements in improving the overall quality of healthcare.

Last week, the NY Times ran a front page article on the relationship between mobile devices such as smart phones, computers, and other electronic devices and medical errors.  While the proliferation of such devices has allowed physicians to more readily access important data such as a patient's medical record, it also may lead to distraction and medical errors.  As one physician who was interviewed for the story noted, "You walk around the hospital, and what you see is not funny,” said Dr. Peter J. Papadakos, an anesthesiologist and director of critical care at the University of Rochester Medical Center in upstate New York, who added that he had seen nurses, doctors and other staff members glued to their phones, computers and iPads.

“You justify carrying devices around the hospital to do medical records,” he said. “But you can surf the Internet or do Facebook, and sometimes, for whatever reason, Facebook is more tempting.”

“My gut feeling is lives are in danger,” said Dr. Papadakos, who recently published an article on “electronic distraction” in Anesthesiology News, a journal. “We’re not educating people about the problem, and it’s getting worse.”

The Times article refers to the pheonomenon as "distracted doctoring".  As with so many technological advancements, there are negative aspects to such improvements as well.  Distraction is perhaps the most obvious and most dangerous.  However, with improved technology, there is a risk of a decrease in real, human communication between the healthcare provider and the patient.  This can lead to other problems including medical errors as well.

In a document unsealed in federal court in Illinois, former FDA Commissioner David Kessler charged that Bayer, the manufacturer of the popular birth control drug Yasmin failed to report scientific data that showed the drug was associated with blood clots in women taking the medication.  Kessler also stated that Bayer marketed Yasmin for uses for which the federal agency had not provided specific approval. 

Both allegations will play a significant role in ongoing Yasmin birth control lawsuits across the country. 

According to Bloomberg News, "“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said. The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome, said Kessler."

When it became law in 2005, the federal Patient Safety and Quality Improvement Act was designed to improve overall patient safety by encouraging the voluntary and confidential reporting of adverse medical events such as medical errors. 

However, the Act is now embroiled in a lawsuit that challenges the confidentiality provisions of the Act.  According to a media report, "The lawsuit was filed in response to Illinois' Department of Professional and Financial Regulation issued three subpoenas to Walgreens in 2010, seeking documentation of medical errors associated with three pharmacists who were accused of being medically negligent, according to the report.  

Walgreens declined to submit the documentation, citing the federal act as protection for medical professionals. The company said the purpose of the act is to provide a safe exchange of information on adverse events to patient safety organizations, which in turn help inform recommendations on how to improve patient safety. Illinois state attorneys, on the other hand, argue the act is being applied too broadly."

The outcome of the lawsuit has obvious repercussions for patient safety as well as the nature of medical confidentiality and the reporting of medical errors.  Some argue that if such confidentiality provisions are taken away or changed, physicians and medical providers will be reluctant to provide data on medical errors. 

What should be paramount in this debate is patient safety.  While physician reluctance is understandable, they have a fiduciary duty to their patients and the community at large to help reduce medical errors.  Medical errors can only be reduced when they are accurately and properly reported so that they may be avoided in the future.

In what has been called the largest medical malpractice jury verdict in Wyoming history, Louis and Rebecca Prager were awarded a $9 million jury verdict in their lawsuit against Campbell County Memorial Hospital and Brian Cullison, M.D.

The medical negigence verdict concerned Dr. Cullison's failure to diagnose Louis Prager's broken neck which caused left shoulder paralysis and left him unable to work.  The jury found that Dr. Cullison, a Board Certified Emergency physician, breached the standard of care in failing to diagnose the neck fracture.

According to media reports, "On December 9, 2008, Prager, an oil field worker, was rushed to Campbell County Memorial Hospital Emergency Department by ambulance from the scene of a rollover accident, immobilized on a backboard, and wearing a neck brace. Cullison released Prager from the emergency department without a cervical collar and without performing a physical exam or taking x-rays of Prager's neck, despite the fact Prager complained of neck pain and had been in the rollover accident. Cullison ordered x-ray imaging of Prager's head and back, but failed to order x-rays of Prager's neck."

During the trial, the defendant's expert, himself a Board Certified Emergency Physician, testified that a physical examination of the patient would have revealed the fracture.

When 31-year-old mother of three Kimberly Jones fell into a permanent vegetative state after anesthesiologist Dr. Robert Lee Berry improperly adminstered anesthesia, her family sued Dr. Berry and the hospital Kadlec Medical Center.  At the time of the surgery, Berry was "under the influence".  The case was settled against both defendants.

Kadlec Medical Center then filed a lawsuit against Berry's former colleague and his former employer, Lakeview Regional Medical Center for "intentional and negligent misrepresentation" by failing to disclose Berry's drug abuse and termination. 

Prior to coming to work at Kadlec, Dr. Berry had been terminated from his position at Lakeview Regional for substance abuse.  Yet, one of his colleagues at that hospital wrote a recommendation letter for Berry that failed to mention the reasons for his termination.  According to Outpatient Surgery Magazine, "William J. Preau III, MD, a member of the practice who was involved in firing Dr. Berry, wrote an uncritical appraisal of him for a prospective employer. The appraisal didn't mention any problems with Dr. Berry, stating: "He is an excellent anesthesiologist. He is capable in all fields of anesthesia including OB, peds, C.V. and all regional blocks. I recommend him highly."

Kadlec successfully sued Dr. Preau and garnered a judgment against him for $8.2 million.  Preau's unqualified recommendation of a colleague who had been fired cost him dearly.  According to the article in Outpatient Surgery, "The court ruled he engaged in negligent misrepresentation and ordered him to pay Kadlec $8.2 million in total damages, representing the medical center's full settlement amount plus its legal bills. Dr. Preau still hoped to cover the damages through his malpractice carrier, St. Paul Fire & Marine Insurance, but the company refused to pay, noting it guaranteed payment only for "covered bodily injury." St. Paul argued that since Dr. Preau hadn't personally committed bodily injury, the coverage guarantee did not apply."

This is indeed a rare case but it demonstrates what can happen when a hospital successfully sues another for failing to disclose adverse information about a doctor being considered for privileges to practice there.

A University of New Mexico study corroborates the findings of similar studies that the presence of a pharmacist in the emergency room significantly reduces medication errors.  The University of New Mexico study found that such prescription errors were 13 times higher when a pharmacist was not present in the ER.

According to the story published in Pharmacy Practice News, "Antibiotics were most often subject to error, followed by pain medications, cardiac medications and gastrointestinal medications and antiemetics. Typical errors included wrong dose (either too little or too much), medications given or not given without regard to order status; wrong administration technique, and so on. Pharmacist interventions consisted mainly of dosage corrections, which the pharmacists carried out themselves, and alternative suggestions, which were accepted by the physicians 91% of the time.

Amy Ernst, MD, professor in the Department of Emergency Medicine and lead author of the study, noted that pharmacist intervention was simply a matter of communicating knowledge. “For example, we [physicians] use so many antibiotics, and the pharmacist will come up and say, ‘That’s not the best choice for that particular infection,’ and suggest something better.”

October 2011 marks the 25th anniversary of National Breast Cancer Awareness Month.  As most of us are aware, early detection and treatment of breast cancer is crucial for survival. 

However, a new study performed by researchers at the University of Southern California revealed some concerns about breast cancer misdiagnosis in women who've had breast augmentation surgery. 

According to one media report, "Researchers at the University of Southern California reviewed the medical records of 5,005 breast cancer patients who had received treatment over the course of the last 15 years to determine whether mammograms were any less effective at revealing breast abnormalities present in women who had undergone breast augmentations. The results were startling: among those patients with breast implants, mammograms failed to reveal an existing abnormality in 36 percent of cases. In contrast, the false-negative rate for mammogram screening among non-augmented women was just 15 percent.

Both silicone and gel implants are radio opaque to some degree; this means they appear as white "blobs" in x-rays. In a mammography, this whitening out can obscure the visualization of underlying breast tissue, making it more challenging to detect irregularities. In addition, implants may displace and compress surrounding breast tissue, potentially causing early warning signs of cancer like micro calcifications and small dense masses to be distorted in mammogram imagery."

The study's revelation that more than 1/3 of women in this category have had breast cancer misdiagnosed or not diagnosed at all is startling and troubling.  It's a concern that should focus our attention and efforts during National Breast Cancer Awareness Month.

The Arkansas Court of Appeals has upheld a $210,000 jury verdict in a case where an infant nearly lost a finger due to a nurse's error. John and Melissa Edwards sued St. Joseph's Mercy Health Center on behalf of their son Caleb who was injured due to a medical error.

According toArkansas News, "the opinion by a three-judge panel of the court, Caleb was being discharged from the hospital when nurse Sandy Reed began removing tape that secured his intravenous tubing and accidentally cut his left index finger so severely that it was left hanging by the skin on the underside of his finger.

Caleb’s finger was reattached at Arkansas Children’s Hospital in Little Rock. The parents later sued St. Joseph’s, and at trial the hospital admitted liability."

In upholding the jury verdict in the medical malpractice case, the Court of Appeals found that the medical malpractice award was not excessive given the extent and severity of the injuries suffered by the infant Caleb Edwards.

A Wareham Massachusetts hospital is the subject of a medical malpractice suit after an 87 patient died while admitted to Tobey Hospital.  Edward Harrington, 87, died from cardiac arrest after no one responded to alarms coming from his cardiac monitor.  According to the Boston Globe, "His electrocardiogram displayed a “flat line” for more than two hours because the battery in his heart monitor had died, but no one changed the battery, according to state Department of Public Health investigators."

The malpractice lawsuit concerns what has become known as "alarm fatigue".  The issue was featured earlier this year in the Globe.  It results when healthcare staff, including nurses and doctors, become immune to the sounds of buzzers and alarms going off in a patient's room.  As a result, the warning signals are ignored and patients may be injured, some seriously such as Edward Harrington.  The problem has become so acute that some hospital officials have finally begun to take steps to address the problem.

The Globe reported yesterday, "Since the death, which was first reported by the Globe in a series on alarm fatigue earlier this year, the hospital said it has taken aggressive steps to improve nurses’ responses. The Globe reported that at least 200 patients, and probably many more, have died nationwide since 2005 in cases involving alarm fatigue and other alarm-related problems."

The number of children hospitalized with MRSA-related infections acquired in the community has more than doubled since 2000, according to a new study from UC Davis and published in this month's Academic Pediatrics. 

"Often parents don't recognize that their kid's abscess or other soft-tissue infections might be MRSA because the child hasn't been in nursing homes or hospitals, where you usually think of getting staph infections," said Patrick S. Romano, a professor of medicine and pediatrics at the UC Davis School of Medicine and the study's senior author. "It's usually pretty easy to treat, if you treat it early and know what you're looking for," he added.

The study suggests the cause of the surge may be two-fold, both of which involve a general lack of awareness and prompt treatment of MRSA-related infections. 

"In the early part of the decade, clinicians generally didn't recognize the growing prevalence of community-acquired MRSA," Romano said, differentiating between MRSA cases that occur in hospital settings or nursing homes, and the growing proportion of cases that occur in the community among otherwise healthy people. "Starting around 2005, physicians began treating community-acquired MRSA more effectively."

Proper hand washing techniques is an important preventative step that parents should teach their children in order to prevent infections and the spread of potentially harmful bacteria.

A new study shows that the United States' newborn mortality rate is higher than countries such as Malaysia, Cuba, and Poland.  In fact, there are 40 countries worldwide that have a lower newborn mortality rate than the United States.  The study reveals that the US mortality rate for newborns is on par with Qatar, Croatia, and the United Arab Emirates.

Pediatrician Dr. Joy Lawn who works with Save the Children noted that the three leading causes of infant mortality are preterm delivery, asphyxia, and severe infections.  All three causes are easily preventable with standard medical care. 

Twenty years ago, the United States had the 28th lowest risk of infant mortality.  The situation has deteriorated drastically in a few decades.  This is an obvious and urgent public health concern that should be addressed and corrected immediately.

Failure to diagnose hemorrhagic shock in a man who later died resulted in a $2.5 million Maryland jury verdict. 

"According to allegations raised in the complaint, Dr. David Harding failed to notice Dixon was bleeding internally when he examined him. The family alleged that if Dr. Harding had noticed the internal bleeding he could have saved Dixon’s life, but as a result of the failure to diagnose the bleeding, Dixon ultimately died of multiple organ failure."

Since Maryland has a cap on non-economic damages, the ultimate monetary verdict may be lowered.

The Clinical Advisor published an article this month concerning a 2008 study of electronic prescription error rates that, if still true, should give industry officials some cause for concern.  According to the study, "The analysis focused on 3,850 computer-generated prescriptions received across three states over four weeks in 2008. In total, 452 prescriptions (11.7%) contained 466 errors, 163 (35%) of which were considered potential adverse drug events. None of the errors were life-threatening. Omitted information was the most common mistake, accounting for 60.7% of all errors.
"

While the article is interesting, its efficacy is limited by its date-it's already three years old and technology has made significant advances since that time.  (I would be very interested to see if a more recent study came to the same conclusions.)  Secondly, if the overwhelming majority of errors concern errors of omission, there's a reasonably easy solution-implement prescription writing software that doesn't allow for such omissions ie.  the one entering the data can not proceed until the error of omission is corrected. 

Perhaps the most significant statement in the article is this:  "Implementing a computerized prescribing system without comprehensive functionality and processes in place to ensure meaningful system use does not decrease medication errors," cautioned Karen C. Nanji, MD, and coauthors in their report for Journal of the American Medical Informatics Association.  

A medical malpractice trial involving a 79 year old Duluth dairy farmer and neurosurgeon Stefan Konasiewicz is about to begin. 

Alan Meinershagen went to St. Luke's Hospital on February 19, 2006 complaining of weakness and numbness in his left arm.  Dr. Konasiewicz examined him and recommended a brain biopsy which was performed two days later.  According to the lawsuit, "Dr. Konaciewicz’s surgical procedure turned a minor infarct (stroke) into a major hemorrhage (bleed.)”

According to media reports, "the suit claims that Konaciewicz’s work caused severe cerebral dysfunction and brain injury resulting in cognitive defects, speech impairment and inability to walk. The plaintiff alleges that Konaciewicz and St. Luke’s are legally responsible as a result of the brain biopsy and the neurosurgeon’s negligence."

Konaciewicz has been the target of nine medical malpractice lawsuits as well as a reprimand from the Minnesota Board of Medical Practice during his tenure in Duluth.

A Pennsylvania jury has awarded a woman $525,000 for negligently leaving a laparotomy sponge in her after a 2004 surgery.  The surgical sponge was not discovered for two months and by that time the foreign object had caused abdominal pains, a severe infection, bowel perforation, bowel obstruction and digestive problems. 

Unfortunately, medical malpractices cases such as leaving foreign objects in a surgical patient's body cavity is not uncommon.  The resulting damage caused by such negligence can cause significant medical complications including further surgery to remove the foreign object.  Safety protocols, when used properly, can reduce these medical errors.  Such surgical safety protocols include sponge counts, tracking bar codes and radiographic screening after operations.

In 2003, the New England Journal of Medicine estimated that there are 1,500 cases annually in which a sponge was inadvertently left in the body after surgery.  Of these, 88% were determined to be the result of an inaccurate sponge count.

A study published by Health Affairs concerning recent trends in medical malpractice lawsuits in Massachusetts shows that most cases are dropped somewhere between the filing of the lawsuit and its ultimate resolution.  In fact, the percentage of cases dropped is 59% during the period between 2006 and 2010. 

That's a very high number and reflects how difficult it is to successfully prosecute medical malpractice claims.  That's why we carefully screen all of our inquiries before we decide to represent someone in a medical malpractice case.  Each and every medical malpractice case requires extensive research and legal expertise.  Over the years, our firm has been successful in handling medical malpractice cases precisely because we engage in a rigorous screening process.  That's only fair to the potential client as well. 

If you or a loved one have a question about a potential medical malpractice claim, don't hesitate to contact us.  We'll provide you with a thorough and honest answer regarding your potential claim.

Colorado physician Manuel De Jesus Aquino had his medical license suspended for prescribing marijuana to a 20-year old pregnant patient.  Prior to writing the prescription, no physical examination was performed and no follow-up visit was made.  The patient wasn't even required to complete a medical history. 

On April 8, 2010, the patient gave birth to her child and tested positive for marijuana.  The infant did have feeding difficulties.  It's not clear whether the infant will have any long-term effects from being exposed in utero to the marijuana.

As more states allow the use of marijuana for medicinal purposes, more questions will be raised concerning the suitability of such prescriptions as well as the prescribing physician's liability for any adverse outcomes.  Marijuana is classified as a Schedule I drug, according to the Controlled Substances Act, which means it is considered highly addictive with little to no medicinal value.  Furthermore, because marijuana is considered to be a controlled substance, there are stringent requirements for those who dispense such drugs.  For instance, are doctors tracking patients who are using marijuana as well the sources from which they are using the drug? 

Since marijuana use is considered highly addictive and can lead to other adverse health effects such as cancer, pulmonary complications, and immune system suppression how can a physician who prescribes it be following an appropriate standard of care for the patient?  This may be the point at which physicians become liable for substandard care.  It may also lead to marijuana prescription malpractice. 

The issue has already come up in some New England states such as Vermont, Maine, Rhode Island, and Massachusetts.  It's pretty certain it will also become an issue in New Hampshire in the near future.

As more healthcare practitioners use electronic medical records, the benefits become more evident.  These electronic records save time and money by reducing staff time in deciphering illegible notes, tracking related medical records, and improving the quality of patient care.  Such records also track the chronology and progress of patient care in what are commonly referred to as audit trails which keep track of each instance a doctor or healthcare practitioner reviewed a chart, ordered a test, and if these operations were performed in a timely fashion.  An audit trail is essentially an electronic log book which the patient has a right to access. 

Such an audit trail can be very helpful in determining if a patient received the proper care and medical follow-up especially concerning labs, x-rays, and CT scans.  They can also help determine if a condition was misdiagnosed or was left undiagnosed.

Audit trails are an important check and monitor on a patient's care and a significant aspect to the transparent delivery of healthcare services.  Like a "black box" in the cockpit of an airplane, the audit trail allows others to determine what went wrong if a patient is injured.  It also provides healthcare workers with the information necessary to avoid medical errors in the future.

Funded by a $3 million federal grant, some medical malpractice cases are moving along faster than previous ones.  Known as "judge-directed negotiation", these medical malpractice cases are moving quickly to settlement negotations spurred on by a judge.  The effort is supported by the Obama Administration as a equitable way to curb malpractice costs while at the same time continuing to provide ordinary citizens access to the civil justice system.

According to a front page article in the NY Times, advocates believe it's working and hope to see it adopted in other parts of the country. 

“We would hope that other states across the country would look at this as a model they might want to replicate,” said James B. Battles, the official overseeing the grant at the federal Agency for Healthcare Research and Quality. By some estimates, the program could save more than $1 billion annually if state courts adopted it nationally, Dr. Battles said. The city’s public hospitals say the program, along with other changes, like sharply increased attention to safety, has helped save $66 million in malpractice costs a year. During the recent session in Justice McKeon’s chambers, the lawyers seemed more relaxed than they would be with patients watching. After he agreed to take $1.5 million for a child with cerebral palsy, a plaintiffs’ lawyer, Louis G. Solimano, seemed disappointed. “I didn’t get a grand slam,” he said.

Perhaps not, but he was able to avoid the emotional and fiscal expense of years of litigation.

The 2010 healthcare law made it federal policy that government programs such as Medicare and Medicaid won't reimburse doctors or hospitals for preventable medical errors.  Medicare, the federally funded healthcare plan for the elderly, already has such a policy in place.  Medicaid, which is a joint federal/state operation, has mandated that every state adopt the policy by July 2012. 

“These steps will encourage health professionals and hospitals to reduce preventable infections, and eliminate serious medical errors," Centers for Medicare and Medicaid Services Administrator Donald Berwick said in a statement.

"As we reduce the frequency of these conditions, we will improve care for patients and bring down costs at the same time.”

The preventable medical errors consist of so-called "never" events because they are thoroughly preventable and should never occurs.  Such medical errors as wrong site surgery, leaving a surgical sponge inside a patient, and transfusing the wrong blood type are some of the "never" medical errors that will not be reimbursed. 

If the healthcare industry can't police itself and improve patient safety, perhaps a monetary incentive from state and federal government will do it.

Researchers at Weill Cornell Medical College have been tracking 19 physicians who are transitioning from paper prescriptions to electronic prescriptions and the results are noteworthy.

"Nearly 4,000 prescriptions for more than 2,000 patients were tracked before the switch, 12 weeks after the switch, and a year after the switch. Researchers found that prescription errors dropped by two-thirds, from 36 percent to 12 percent a year after their physicians had switched to electronic record-keeping systems.

Furthermore, the rate of improper abbreviations (i.e. using the outdated "QD" instead of "once daily") dropped by three-quarters, from 24 percent to 6 percent a year later."

The doctors who participated in the study are less enthusiastic about the transition.  At this point, it's not clear if their dissatisfaction is due to difficulty adapting to new procedures or faults within the electronic prescription system itself.  However, the reduction in errors is a good sign for patients and the healthcare industry as a whole.

In March 2011, the Food and Drug Administration issued a safety announcement concerning the migraine and seizure medication Topamax.  According to the federal agency, studies have shown that pregnant women who've taken Topamax may be at a higher risk for their babies being born with certain birth defects such as a cleft palate or a cleft lip. 

The data revealed that 1.4% of infants exposed to the drug during pregnancy were born with oral birth defects, compared to .38 to .55% of those exposed to other anti-seizure drugs.  The data was based on studies by the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

On April 14, 2011, Ortho McNeil Neurologics, the manufacturer of Topamax, issued a voluntary recall of two lots of Topamax, approximately 57,000 bottles of Topamax due to an unusual odor.  The odor was thought to come from the wooden palates upon which the drug is transported and stored.  The recall is not believed to have anything to do with the previous month's FDA safety letter.

An Ohio jury found a doctor liable in a birth injury medical malpractice case.  The child, now 10 years old, developed cerebral palsy as a result of the doctor's negligence, according to the jury's findings.

According to www.seedol.com, "When the mother went to see her doctor on one of her regularly scheduled check-ups to see how her pregnancy was progressing, her non-stress test yielded results revealing her baby had a low heart rate and it was suggested that they should induce labor. The parents decided to go ahead with the emergency Caesarean section. A cesarean section is the delivery of a baby through a cut (incision) in the mother’s belly and uterus. It is often called a C-section and is used if safety of the mother or baby is in question. However, after the doctor induced labor, he decided not to perform the C-section after all and this decision would change the now 10 year old little girl’s life forever.

When the doctor chose not to perform the C-section, it is alleged that this caused a lack of vital oxygen flow to the baby’s brain which inevitably caused the birth injury known as cerebral palsy. An expert witness for the family testified that the baby also suffered additional cerebral palsy after they medically induced contractions and then used a vacuum during her delivery. However, the doctor who delivered Haley testified that she never considered performing a C-section because there was no indication that anything was wrong with the baby. The family alleged that a C-section would have prevented injury to Haley and she would not be suffering from cerebral palsy today."

In spite of the fact that the United States spends more money per capita on healthcare, the quality of care remains riddled with adverse events and serious medical errors.  Adverse events are defined as injuries caused by medical errors rather than underlying diseases or conditions. 

More than a decade ago, the Institute of Medicine found that approximately 98,000 patients die each year in hospitals from preventable medical errors.  In 2003, the New England Journal of Medicine published a study by Elizabeth McGlynn and her colleagues that US patients received only 54.9% of the recommended medical care.  If that's not serious enough, the Joint Commission reports that 40 surgeries are performed on the wrong person or the wrong body part every week. 

Yet, many still believe that the solution to the healthcare issues burdening the country is tort reform.  Of course, tort reform proponents rarely if ever cite these sobering healthcare statistics.  What's needed is a real effort to improve the quality of healthcare in the US.

A medical malpractice lawsuit alleges that a pharmaceutical dosage error has resulted in the death of six week old Genesis Burkett.  Genesis was born prematurely but was making good progress until a fatal dosage error led to his tragic death.  According to the lawsuit, the hospital pharmacy incorrectly filled a doctor's prescription that administered 60 times the level of sodium the doctor ordered.

According to the article in the Chicago Sun-Times, the IV prescription was initially filled correctly.  However, a second label was placed over the correct label before the nurse administered the fatal dose of sodium to Genesis Burkett.

The Sun-Times reported that a hospital official has acknowledged the error. "Advocate Healthcare spokeswoman Kelly Jo Golson acknowledged an “error.”

“A hospital error led to the incorrect concentration of sodium in [Genesis’s] IV solution,” Golson said. “Our prayers continue to be with the family.”

Dosage and prescription errors can be fatal as in this case.  They are just as dangerous as other types of medical errors such as failures to diagnose and misdiagnoses.

For the Burkett family, the error has resulted in untold suffering.  Our thoughts go out to them.

 

An Indiana jury awarded the family of Phyllis Barnes $13 million for failure to diagnose lung cancer.  Making matters worse, Dr. Mark Weinberger treated her for other medical issues in an intentional money making scheme, the jury found. 

Last October, Dr. Weinberger pled guilty to 22 counts of healthcare fraud in which he billed patients for nose surgeries that were never performed.  Weinberger faces 350 medical malpractice lawsuits in Indiana.

Weinberger's defense attorney unsuccessfully tried to convince the jury that the failure to diagnose lung cancer in the Barnes' case was unintentional.  Phyllis Barnes died from lung cancer in 2004 just days before Dr. Weinberger left the country for a vacation in Greece. 

Dr. Weinberger had appeared before an Indiana medical review board prior to the medical malpractice trial.  The review board found that Weinberger's actions had violated ethical standards in the Barnes' case.

Consumer advocacy group Public Citizen just dropped a bombshell on the debate over medical malpractice.  State medical boards have failed to discipline 55% of the doctors who were sanctioned by the hospitals where they worked.  The Public Citizen report has received widespread media attention and may mean that doctors who are sanctioned by their employers move on to other hospitals or health institutions with little consequence. 

According to the Washington Post, "The consumer advocacy group analyzed data in a federal clearinghouse from 1990 to 2009 for disciplinary action and medical malpractice payments against doctors.

Of 10,672 physicians listed in the National Practitioner Data Bank, about 55 percent, or 5,887 doctors, had been disciplined by hospitals but escaped any licensing action by the state during the entire 20-year period. The hospital discipline was to restrict or revoke the physicians’ clinical privileges."

More than 35% of the nearly 6,000 doctors reported to the National Practitioner Data Bank were reported for serious violations that involved immediate threats to patient health or safety.

It's a question that's being raised in Maryland thanks to a Maryland legislator's bill that would disallow a doctor's testimony in a medical malpractice case.  The legislator who's sponsoring the bill happens to be the only practicing physician in the Maryland Legislature. 

Dan Morhaim cites "communicaton problems" as the reason for such legislation barring a doctor's apology for a medical error or an unfortunate medical outcome.  Under current Maryland law, such an admission or apology is admissible in a court of law.  Some states, such as Pennsylvania and New Jersey disallow such apologies in medical malpractice cases.

While a doctor's apology may be interpreted in a variety of ways, it's open to interpretation.  Why not let a jury decide whether it's a relevant admission of culpability or a simple expression of compassion following an unfortunate medical result? 

This issue is part of a larger trend to take away from the jury an integral part of their function-decision making.  The jury system is an indispensable part of our justice system.  However, recent trends such as capping medical malpractice damages and this issue hamstrings a jury from their true role.  They are supposed to make a determination of culpability in civil trials.  That's their role in the justice system.  Once legislators start tinkering with that, it weakens the system that has worked for more than two centuries. 

Dr. Melvin Levin, accused of multiple cases of sexual abuse involving his patients as well as medical malpractice, killed himself earlier this month.  I had posted a blog about the medical malpractice case a week or so ago.  At that time, the Boston Globe had run a story on the lawsuit which involved allegations of sexual abuse as well as medical malpractice against Dr. Levine.

According to the Boston Herald, "The state Office of the Chief Medical Examiner in Chapel Hill said Monday that 71-year-old Melvin Levine committed suicide earlier this month. Levine was found near his home in Rougemont, about 40 miles north of Raleigh." 

It's not clear if the suicide is related to the medical malpractice lawsuit.

A well-known pediatrician who worked for years at Children's Hospital in Boston is facing a class-action lawsuit for sexually abusing his minor patients and for improper medical treatment. 

The lawsuit alleges that Dr. Melvin D. Levine performed genital examinations on his patients when such examinations were not medically indicated. 

According to the Boston Globe, "The suit, filed in Suffolk Superior Court, also said it sought to represent the entire group of children examined by Levine during the period 1966 through 1985, estimating that he treated approximately 5,000 boys during that period."

The lawsuit further alleges that Children's Hospital "knew, or in the exercise of reasonable care should have known, that defendant Levine was not a fit person to be placed in charge of the treatment of minor male pediatric patients, or to be allowed to provide unsupervised care."

The Boston Globe also reported that in March 2009 Dr. Levine signed an agreement with the medical board in North Carolina stating that he would never practice medicine again.  Levine, who had re-located to North Carolina to practice medicine there, signed the agreement after allegations were brought against him that he had performed unwarranted genital exams on boys in North Carolina.

The family of 3-year old Kiarra Smith has been awarded $19.2 million by a Lee County Florida jury.  In 2007, Kiarra was born premature and suffers from blindness and cerebral palsy.  However, the lawsuit concerned what happened 15 days after her premature birth when she was given 100 times the dosage of nutrients she was supposed to receive.  This, according to the lawsuit, led to cardiac arrest and severe complications.  She will need lifelong care.

In spite of the $19.2 million dollar verdict for the prescription error, the Smith family's award may be reduced to $200,000 because of sovereign immunity liability caps.  The family plans to fight the caps since the reduction would not cover the child's ongoing and future medical expenses.

The FDA announced a "possible association" between breast implants and a rare form of cancer called anaplastic large cell lymphoma (ALCL).  While the increased risk is small, it's still cancer and prompted an announcement from the FDA and a request that breast implant surgeons report cases of ALCL to the FDA.

"We've identified 60 cases of ALCL in the breast among an estimated 5 to 10 million with breast implants worldwide," Dr. William Maisel, chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, said at a press conference.

However, the connection is not insignificant either.  This particular cancer normally occurs in only 3 in 100,000,000 cases, so the new cases are important and should be monitored.

According to a report in the Boston Globe, "Besides collecting adverse event reports, Maisel says the FDA is requiring the two implant manufacturers to continue safety studies including one with more than 40,000 patients. The American Society of Plastic Surgeons announced Wednesday that it is establishing a national registry for breast implants in collaboration with the FDA to monitor safety issues."  The two implant manufacturers are Allergan and Mentor Worldwide.

An investigative report by the Hartford Courant has revealed that a number of medical malpractice cases against Connecticut physicians is missing from their files kept in the state's database.  The database, updated and maintained by the state Department of Public Health, is missing important data in approximately 1 in 6 cases.  According to the Courant investigation, there are more than 100 doctors who have missing malpractice cases.  This is important since the goal of the database is to provide consumers with accurate information concerning their physicians.  The database is supposed to include any malpractice payments made in the last 10 years. 

According to the Hartford Courant, "Anthony Anastasi, a Hartford obstetrician, fought a malpractice case all the way to the state Supreme Court, which in 2009 upheld the verdict against him, while reducing the award to $2 million. There is no record of that case in the health department's profile."  The Courant investigation lists a number of similar instances where such physician information is missing or inaccurate.

Here's an excerpt from the Courtant article: "The profiles — accessible at https://www.elicense.ct.gov/Lookup/LicenseLookup.aspx — list each physician's schooling and post-graduate training, the location of their practice, the hospitals where they have staff privileges, and any board certifications or published articles listed by the doctors. The site is also supposed to show malpractice payments, as well as state- or hospital-imposed discipline, and any felony convictions. The state legislature mandated creation of the profiles in 1999. Jean Rexford, executive director of the non-profit Connecticut Center for Patient Safety, said incomplete information on malpractice payments prevents patients from making informed choices about their medical care.

"The message in the past few years has been that the consumer has to take more responsibility for his or her health care. And so they are trying to do that," she said. "But in order to do that effectively, they have to have access to accurate and timely information."

A medical malpractice lawsuit has been filed against a Bellevue Washington medical clinic and a doctor after a 28-year old woman died after a liposuction procedure.  The lawsuit was filed a month after the state accused the doctor of unprofessional conduct. 

In May 2009, Aura Javellana paid the Sono Bello Body Contour Center $8,000 for a liposuction procedure on her abdomen and upper arms.  The medical malpractice lawsuit alleges that Dr. Marco Sobrino failed to keep track of how many bags of lidocaine solution were used during the procedure.  Medical investigators contend that Sobrino failed to monitor his patient and didn't document the amount of nitrous oxide or lidocaine used during the liposuction.  According to the investigation, Sobrino also neglected to ensure his patient was in stable condition after the surgery.

The most common medical errors that injure or kill patients are all preventable.  Dr. Barry Bialek, MD is a board-certified family physician practicing in Colorado and author of "The Ten Most Common Medical Errors in the US" published by CoverMD.  In his article, Dr. Bialek points out that doctors have a duty to prevent medical errors to improve patient safety and protect their own career.  According to Dr. Bialek, the top ten medical errors in this country are:

1)Technical medical errors which include improper or wrong medical procedures

2)Failure to use indicated tests to assist in the diagnosis of an illness

3)Avoidable delay in treatment

4)Failure to take precautions such as the standard "time out" prior to surgery

5)Failure to act on test results

6)Inadequate monitoring after a procedure

7)Inadequate patient preparation prior to a procedure

8)Inadquate follow-up after treatment

9)Avoidable delay in diagnosis

10)Improper medication dosage and/or method of use

As you can see, these are all avoidable and preventable medical errors that cost 100,000 lives in the United States.

A $20 million medical malpractice verdict has been upheld in Pennsylvania by a Pennsylvania appeals court.  The case involved a botched liposuction surgery that included punitive damages for emotional distress.  The 18 year old liposuction patient died as a result of the botched surgery.  The appeals court ruled that it was proper for the court to have introduced evidence that the clinic was not properly licensed at the time of the surgery.

The punitive damages awarded by the jury was $15 million.

A 30 year old NY woman who entered Winthrop University Hospital for what was deemed minor surgery ended up having both of her lower limbs amputated as a result of gangrene infection.  The gangrene infection resulted from surgeons puncturing her intestines. 

According to the UPI article, "Surgeons Paul Byrne and Frederic Moon, who initially treated Galette, were among doctors and other medical personnel named in the medical malpractice suit seeking unspecified damages."

Stacey Galette, a single mother with a 10 year old daughter, is unable to work and will spend the rest of her life using prosthetic limbs below both knees because doctors failed to follow accepted medical protocol.  Stacey spent three weeks in a medically induced coma for three weeks as a result of the botched surgery.

A medical expert and Florida gastroenterologist, Perry Hookman, MD has challenged a recent Op-Ed piece by former Obama Administration budget director Peter Orszag.  Dr. Hookman notes that medical guidelines are not the problem as Orszag suggested.  Rather, Hookman argues, certain medical guidelines are biased and not designed to improve patient safety but rather to shield doctors from liability when medical errors occur. 

Hookman believes that diagnostic errors are the real culprit for medical errors and the resulting medical malpractice claims.  In a recent talk in San Francisco Dr. Hookman related the following figures:

"Of 1,137 malpractice cases between 2005 and 2009, diagnostic errors-not evidence based guideline adherence- accounted for 26% of large carriers [Crico/Rmf] claims."*

• Among the 456 "high severity" cases that resulted in serious patient harm or death, nearly half were diagnostic errors" errors-not problems with evidence based guideline adherence*

• "Cases linked to diagnostic errors appear to be on the rise as primary care doctors, struggling with heavy case loads, take shortcuts or do not act on their patient's symptoms".*

• Medical professionals and organizations are finding lessons in closed malpractice cases which "are reflective of deeply rooted problems that are widespread in health care." *

• "By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, health-care providers must develop programs to avert mistakes commonly found in these medical malpractice claims.*

While New Hampshire still has no medical error reporting system in place, there are ways to find out how well your local New Hampshire hospital compares in comparison to other NH hospitals.  One source of information may be found at Health Grades website.  The website is one of a few that evaluate local hospitals and evaluate them according to various categories including patient safety. 

The information may surprise you.  For instance, Dartmouth Hitchcock Medical Center in Lebanon ranks "as expected" for back and neck surgery but receive a "poor" rank in the hip fracture repair category. 

The rankings and differences found among the hospital are significant in some instances.  The Health Grades website notes, "There can be enormous quality differences between one hospital and another, and between one doctor and another. For example, a recent study by HealthGrades found that a typical patient would have, on average, a 69 percent lower chance of dying in a five-star rated hospital compared to a one-star rated hospital."

This is Breast Cancer Awareness Month.  Breast cancer is a disease that's taken the lives of daughters, mothers, sisters, wives, and women we love.  We've all been adversely affected by this terrible disease. 

The National Cancer Institute estimates that in 2010 over 200,000 females will be diagnosed with breast cancer and nearly 40,000 women will die from the disease. The good news is that there are 2.5 million breast cancer survivors in this country.  They are heroines and examples of courage to us all.

Education and prevention are our best weapons against this aggressive form of cancer.  If you'd like more information about breast cancer and its prevention or treatment, please visit the following websites:

National Breast Cancer Awareness Month  http://www.nbcam.org

Centers for Disease Control and Prevention  http://www.cdc.gov/cancer/breast

National Cancer Institute   http://www.cancer.gov/cancertopics/types/breast

A female patient has filed a medical malpractice lawsuit against Forbes Regional Hospital in Pittsburgh, PA after hospital personnel used another patient's syringe on her.  Kimberlee Blocker had entered the hospital for surgery and found out later that another patient's syringe was mistakenly used on her to administer medication.  As a result, she was forced to undergo months of tests to make sure she hadn't contracted a disease as a result of the wrong syringe.  It's not clear how the syringe error occurred.

Medical errors such as this case of a syringe error occur all too often in hospitals around the country.  Patients die as a result of such errors and the costs associated with medical errors exacerbate the problem of skyrocketing medical costs.  These medical errors are preventable when medical staff and healthcare workers follow proper protocols and the accepted standard of care.

A Louisiana mother has sued the manufacturers of the vaccine Gardasil for serious neurological problems her daughter now suffers.  The lawsuit alleges that the neurological issues including dizziness, seizures, headaches, and motor reflex difficulties stem from the vaccine Gardasil.

Defendants in the Gardasil lawsuit include Merck, American Home Products, Aventis Pasteur Co., and Eli Lilly all of which have had an extensive history with lawsuits over their drug products.  Perhaps the largest drug lawsuit concerned American Home Products' diet drug fen-phen, which was removed from the market in the late 1990's after it was linked to pulmonary hypertension and heart valve problems. 

The US FDA has approved Gardasil as a vaccine to prevent human papillomavirus (HPV).

One of the first studies concerning the ubiquitous chemical Bisphenol A (BPA) and the human reproductive system point to a lower sperm count and sperm quality.  Researchers have stressed that the results are preliminary and more studies are necessary.  However, BPA has been banned by several states due to its potentially serious side effects. 

BPA is a chemical used in the manufacturing of all types of plastics and food and beverage containers, including baby bottles.  Six billion pounds of BPA are produced annually.

BPA enters the human body by seeping into the plastic containers.  Exposure to BPA has been linked to cardiac problems, aggressive breast cancer, and now sperm damage.  According to one study, research participants drinking from plastic containers made with BPA for one week demonstrated a 2/3 increase of BPA in their urine. 

The new study linking sperm damage with exposure to BPA is published in the journal Reproductive Toxicology.  The lead author on the study, John Meeker who noted, "We found that if we compare somebody in the top quartile of exposure with the lowest quartile of exposure, sperm concentration was on average about 23 percent lower in men with the highest BPA."

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.