Abramson, Brown & Dugan Attorneys

In their health blog today, National Public Radio examines data that shows electronic prescriptions are safer and less prone to error than the traditional, hand-written prescriptions.  Here's an excerpt from the blog post:  "1 in 7 hospitalized patients suffers some form of error in care. Nearly a third of those mistakes are related to drugs. And those mix-ups can lead to longer hospital stays, unnecessary suffering, permanent damage or death.

One way to reduce mistakes is to have doctors enter the prescriptions on a computer instead of with pen and paper. After the switch, hospitals can see error rates drop by a whopping 60 percent.

That's the result of a study, published today in PLoS Medicine, that tracked medication errors in two Australian hospitals before and after installing electronic prescription systems.

 

For starters, the old saw about doctors having illegible chicken scratches is for real. "People can actually read the prescribing orders now," Johanna Westbrook, director of the Centre for Health Systems and Safety Research at the University of New South Wales and lead author on the study, tells Shots. "You're not relying on trying to interpret handwriting."

That's a 60% drop in prescription errors!  The effects of such a reduction would be just as dramatic in terms of a real reduction in healthcare costs.  So, why not make the switch?

While the industry's steady progression toward electronic health records is generally a positive step in the right direction, it is not a cure all that will entirely eliminate medical errors.  While EHRs do indeed eliminate errors arising from illegible handwriting, human transcription errors, and the misfiling of records.  However, EHRs come with their own set of issues, according to an article published by the Digital Journal, "Unfortunately, EHRs have not worked exactly as planned. As these systems are still rather new, there have been challenges in developing software that fits the need of the end-users. Entering information can be a very time-consuming process, with doctors and physicians needing to learn proper codes for ailments and treatment plans. Additionally, there may be more of a potential for user error than with general medical records. Mistakes may be made when information is entered, for example, information from one patient could but copied and pasted into another patient's file, and this may go unreported due to unfamiliarity with the systems. Further medical professionals may then rely on this incorrect information, which could have a serious impact on patients. EHRs also have the potential for overloading doctors and physicians. The systems can be set up to send alerts when major events are soon to occur, such as a prescription expiring, which could cause problems. Instead of checking in on lab reports or determining a patient's progress, prescriptions could be automatically refilled or harmful treatment plans continued. Finally, EHRs are accessed using computer networks, which may result in unique challenges to medical facilities. Computer systems often suffer outages, leaving medical professionals unable to access a client's information, which could prove costly in situations where time is of the essence. Patients may also have privacy concerns if their medical records are easily accessible to a large number of people at a health care facility. Access to EHRs will need to comply with all HIPAA rules.

The bellwether Yaz birth control trial has been cancelled by the Judge and ordered to mediation, a full week ahead of its scheduled commencement.  According to fiercepharma.com, "Judge David Herndon, who's overseeing litigation over Bayer's birth control pills, had promised in the fall to press for settlements after the bellwether trials wrapped up. But in an order filed Dec. 31, Herndon abandoned his previous plan in favor of mediation, saying this alternative will "better serve" plaintiffs and defendants in these cases. Herndon ordered both sides to meet with Saltzburg "without delay" and negotiate in good faith."

Judge Herndon is presiding over thousands of Yaz lawsuits claiming that the once-popular birth control drug causes dangerous blood clots and the manufacturer knew about this potential danger and failed to warn consumers.

So-called Point-of-Care Testing is a relatively new program that's designed to improve more accurate, more efficient, and quicker test results that would ordinarily have to be sent to a off-site laboratory. 

Point-of-care tests—allowing common lab results to be rapidly obtained at or near the bedside or in the doctor's office—are becoming increasingly sophisticated and widely used.  However, with new technologies, there are new risks or potential for new errors.  According to Wolters Kluwer Health: Lippincott Williams & Wilkins, "In his editorial, Dr Nichols calls for a risk management perspective on POCT. Since these tests are more prone to certain types of errors than traditional medical tests, he emphasizes the need for special attention to quality control, operator training, and other steps to ensure that point-of-care tests are used appropriately, with a focus on safeguarding patient safety."

A medical malpractice lawsuit has settled for $275,000 against the Cleveland VA Medical Center.  The malpractice lawsuit came after hospital staff left behind two surgical towels during a kidney removal surgery.  The patient, a 47-year old military veteran, had to undergo two additional surgeries as a result of the medical error.

The case was brought under the Federal Tort Claims Act and the settlement was approved by the Honorable James S. Gwin.

A surgeon who inadvertently left two surgical sponges in a patient during bariatric surgery has been sanctioned by the Florida Department of Health.  The surgery took place at North Florida Regional Medical Center.  Gainesville surgeon Dr. Bruce Brient has been fined $15,000 and ordered to deliver a lecture on retained objects (leaving surgical items such as a sponge in a patient).   

According to the Gainesville Sun, "One of the sponges was discovered the day after a 56-year-old female patient had a hernia repaired and a gastric band placed around the top portion of her stomach to treat obesity. She had to be opened up again, according to state documents. Thirty-six days later, the patient came to Brient complaining of nausea and vomiting. Brient ordered a second set of x-rays and discovered the second sponge. Another operation removed that sponge."

While retained object medical errors are not common occurrences, they can cause serious medical complications.  Such errors are also expensive to correct since they more often than not require additional surgery.

The Sun concludes, "In 2008, Medicare, which often takes the lead in shaping insurers' policies, stopped reimbursing hospitals for care needed because of medical errors. And in April of this year, Medicare started making retained foreign objects, along with other hospital-acquired conditions such as pressure sores and infections, part of its routine reporting, available at healthcare.gov/compare.

Retained foreign objects are a relatively rare event, according to a 2003 study published in the New England Journal of Medicine.

That study of cases between 1990 and 2000 found that objects were retained at a rate that varied between one in 8,801 operations to one in 18,760 inpatient operations at the nonspecialty acute care hospitals."

When Richard Smith arrived at North Shore Medical Center in Miami Florida complaining of shortness of breath and stomach pain, his doctor prescribed Famotidine, a a histamine-2 blocker that reduces stomach acid, intravenously (IV) twice per day.  However, what he received instead was Pancuronium bromide, a muscle relaxant.  The medication error killed Smith.  After receiving the wrong medication, Smith died a few weeks later. 

The nurse who committed the fatal medical error was disciplined and cited for failure to perform safeguards in place to prevent medication errors such as failure to read the medication label, failure to scan the medication and failure to scan Smith’s patient ID bracelet. 

It is likely that if the nurse had performed any of these required safety measures, Richard Smith would still be alive.

The media has been abuzz this week with stories involving sexual abuse or harassment of some kind.  Perhaps the most tragic and bothersome involves the Penn State scandal where a former football coach abused young boys for a period of fifteen years.  The most disturbing aspect of this case, in my opinion, concerns the failure of officials to report the abuse to law enforcement authorities.

Failure to report the physical or sexual abuse of a child is a crime in many states.  Many states have enacted child protection laws in such a way that certain professionals have specific duties in terms of reporting the abuse of a minor.

In today's Boston Globe, there is a report concerning a study of physicians and their own reporting of suspected abuse.  The study concludes that doctors are often very adept at diagnosing the physical injuries associated with child abuse but not so good at reporting it to the proper authorities.

According to the Globe, "A group of researchers led by Dr. Robert Sege of Boston Medical Center compared how primary care providers responded in 92 child injury cases to evaluations by child abuse experts.

They found that reporting was warranted in 13 of the 63 cases doctors chose not to report to authorities. Most of those cases involved leg fractures or bruises to the face or ear, and in six cases the physicians themselves had identified a high likelihood of abuse.

Sege, professor of pediatrics at Boston University School of Medicine and medical director of the child protection team at Boston Medical Center, said most primary care providers are trained in how to identify child abuse injuries.

“We need to go the next step and talk to them about why they need to report, how they report, what information they need to provide,” he said.

Massachusetts is among states that require physicians to report suspected child abuse. But deciding when to report a case is tricky, the authors noted. Delayed reporting leaves a child at risk, while unnecessary reporting can cause family disruptions."

That's the difficulty.  None of these decisions are easy or without consequences.  That's why proper training and colleague support is so crucial if children are to be protected from injury and harm.

The latest FDA study on Bayer's birth control drug, Yaz has increased concern over the drug's connection with blood clots.  According to the study, women who use Yaz are on average at a 75% greater risk for contracting blood clots than women who use older forms of birth control. 

While there have been previous concerns and Yaz lawsuits filed over such issues, the FDA's study may lead to further regulatory action by the FDA when they convene a meeting with scientific consultants on December 8. 

According to the Boston Globe, "Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood. FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel."

One physician questioned why such a controversial drug has been allowed on the marketplace given the health concerns surrounding it. 

"At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market," said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women's health issues. "With all these different birth control options, why take the most expensive one that can also kill you?"

A 66-year old cancer patient died as a result of a fatal dosage error administered to him by a temporary nurse filling in during a nursing strike in Oakland California.  Local police officials are investigating the death and have described it as the result of a "medical error". 

According to the San Jose Mercury News, "The death "likely was caused by a medical error," said Dr. Steve O'Brien, an Oakland campus medical executive, adding that the hospital activated its patient safety analysis process to review its policies and procedures for opportunities to improve its patient care.

"While medical errors do exist in healthcare we are constantly investing in ways to improve patient care," the medical affairs vice president said in a statement. "This is a most unfortunate event for which we are very sorry."

Nurses throughout Northern and Central California went on strike Thursday, and most non-Kaiser nurses have been locked out for five days. The lockout affects at least eight hospitals run by Sutter Health, including the Oakland hospital."

Community Regional Medical Center, based in Fresno, California, has agreed to pay $250,000 to the family of Elena Silva who died after receiving a massive dosage of blood thinning medication.  Silva died as a result of the medication error. 

In December 2010, when Elena Silva was admitted to the hospital complaining of pain and numbness in her arm, she was administered 50 times the prescribed amount of heparin. 

A 2006 study by the Institute of Medicine found that the most common medical error in the United States concerns medication errors.  Such medical mistakes cost the United States economy $3.5 billion in lost wages and medical expenses each year.

A QuantiaMD survey of more than 6,000 physicians reveals the prevalence of medical errors in their own practices as well as the preventability of such errors. 

"Diagnostic errors have been a long-neglected aspect of the patient safety movement, not getting the attention they deserve," said Robert M. Wachter, MD, Professor and Associate Chairman, Department of Medicine, University of California, San Francisco and the moderator of the new series. "This QuantiaMD program, which includes presentations by many of the world's leading experts on diagnostic mistakes, lays the foundation for physicians to come together to begin discussing the challenge of improving our diagnostic acumen, and learning about the utility of new tools, including new kinds of cognitive training, systems-based decision support tools, and even artificial intelligence."

The survey found that a majority of physician respondents (64%) reported 10% of their patients had been harmed by medical errors. 

According to the survey, the five most commonly misdiagnosed conditions include pulmonary embolism, bipolar disorder, appendicitis, breast cancer, and myocardial infarction.

Good things can come from bad experiences after all.  At least in the case of Carolyn Bucksbaum, that is true.  Mrs. Bucksbaum was rudely dismissed by a physician years ago as she tried to share with him how she felt.  The experience has led her and her husband to endow The Bucksbaum Institute for Clinical Excellence at the University of Chicago Medical Center. 

The new institute will be dedicated to the training of physicians in how to improve their listening skills as well as the manner in which they treat patients.  The Institute will be led by Dr. Mark Siegler who cared for Carolyn Bucksbaum a few years ago.  The Bucksbaums were so impressed with Siegler's empathetic style and his compassionate care they decided to donate the funds necessary to train other doctors to emulate his style.

“To care for a patient,” Dr. Siegler said, “you have to care about a patient.”

Besides the good feelings produced, improved doctor-patient relationships may improve patient outcomes, according to some medical studies.  The new Institute will focus on training young doctors in the "soft skills" aspect of patient care.  Some believe these skills are as important in successful medical treatment as the hard skills of math and science. 

According to the NY Times, "Nearly all medical schools teach the importance of listening to patients and showing empathy. But the Bucksbaum Institute is an ambitious effort to put compassion and empathy, as Dr. Siegler puts it, “on the same pedestal as science and technology.”

More doctors are facing criminal charges for alleged prescription drug abuse.  While the Michael Jackson case is perhaps the most public, doctors are facing criminal scrutiny concerning how and what they prescribe their patients.  Prior to the Jackson case, doctors may have been subject to civil lawsuits for prescription drug errors or rarely, the drugs they prescribed.  Now, that seems to be changing.

According to Reuters, "Fatal overdoses from prescription painkillers more than tripled to 13,800 in the United States in 1999 through 2006, according to the Centers for Disease Control and Prevention.  Consequently, more doctors are finding themselves in the sights of prosecutors as states like Florida and Georgia confront the growth in abuse of prescription drugs. The prosecution of doctors is seen as more effective than bringing cases against their patients."

 

A $29 million verdict against a medical clinic in Erie Pennsylvania has been upheld by a federal appeals court.  The family had originally filed suit against the US government because it funded the clinic and alleged that Christian's cerebral palsy was caused by medical practitioners' failure to diagnose a brain infection.  According to court documents, the medical staff failed to recognize the signs of the brain infection, including the child's inability to see, for 12 hours.  The delay allowed the infection to spread since it was not treated with antibiotics.

According to news sources, "The U.S. government argued that Arroyo’s parents filed the case after the statute of limitations, based on when they reasonably should have known that their son’s brain damage was caused by a medical mistake. However, the U.S. Court of Appeals for the Seventh Circuit rejected that argument last week, upholding the verdict."

A Concord NH midwife who had surrendered her license last year settled a birth injury medical malpractice lawsuit for $730,000.  This is the second lawsuit Concord midwife Jeanne Browne has settled in the past two months.  In June, Browne settled a lawsuit filed against her after a woman had to undergo a hysterectomy after an infection developed while she was under Browne's care.

According to the Concord Monitor, "Browne, who founded the Concord Birth and Wellness Center, voluntarily surrendered her license last June following an investigation by the state Midwifery Council into a series of complaints about the care she provided her patients. The complaints, which came from Concord Hospital, Dartmouth-Hitchcock Medical Center and an obstetrician, alleged that Browne hadn't managed cases appropriately, failing to consult with obstetricians about high-risk pregnancies."

 

The latest edition of the Harvard Business Review offers an interesting analyis of how healthcare costs can be controlled and lowered by measuring patient quality outcomes rather than organizational groups or narrow diagnostic treatment groups.

The new healthcare model is presently being tested at the Head and Neck Center at MD Anderson, the Cleft Lip and Palate Program at Brigham and Women's Hospital in Boston. 

Costs, as everyone knows, are a hot-button issue.  Politically, medical malpractice reform has been the easy if not facile solution to the cost issue.  However the authors of this article believe the problem is systemic that requires a new way of facing the problem.

"The proper goal for any health care delivery system is to improve the value delivered to patients. Value in health care is measured in terms of the patient outcomes achieved per dollar expended. It is not the number of different services provided or the volume of services delivered that matters but the value. More care and more expensive care is not necessarily better care.  To properly manage value, both outcomes and cost must be measured at the patient level. Measured outcomes and cost must encompass the entire cycle of care for the patient’s particular medical condition, which often involves a team with multiple specialties performing multiple interventions from diagnosis to treatment to ongoing management. A medical condition is an interrelated set of patient circumstances that are best addressed in a coordinated way and should be broadly defined to include common complications and comorbidities. The cost of treating a patient with diabetes, for example, must include not only the costs associated with endocrinological care but also the costs of managing and treating associated conditions such as vascular disease, retinal disease, and renal disease. For primary and preventive care, the unit of value measurement is a particular patient population—that is, a group with similar primary care needs, such as healthy children or the frail and elderly with multiple chronic conditions."

Any one interested or concerned about the cost of healthcare and the issue of the quality of patient care must read this article.

In January 2004, 83-year old Clara Tucker entered DeKalb Medical Center to undergo aortofemoral bypass surgery.  Initially, the surgery appeared to be successful.  However, Clara continued to complain of severe abdominal pain and a foul body odor.  Four years later, on December 17, 2008, she was re-admitted to DeKalb Medical Center and a CT scan revealed a mass near Tucker's colon.  On December 21, 2008, laparoscopic surgery was performed to remove "an old laparotomy pad with some purulent material around it that smelled like anaerobic pus," according to the order. 

The surgical team had incorrectly counted the number of surgical sponges and left one sponge inside her abdominal cavity.  It took four years and severe pain, nausea, and infection to finally discover the medical error.

Last month, a DeKalb County jury found in favor of Clara Tucker and awarded her $375,000.

An Indiana doctor will now face a criminal trial after he lost a civil medical malpractice trial in March.  The jury awarded $13 million to a victim's family in that medical malpractice case. 

Dr. Mark Weinberger faces 200 years in jail if he's convicted on healthcare and criminal medical malpractice charges.  Weinberger still faces 350 medical malpractice suits in Indiana.

During the March 2011 medical malpractice trial, the jury heard horrifying details of Dr. Weinberger's failure to diagnose Phyllis Barnes' lung cancer and instead treated her for other ailments in an intentional money making scheme.

According to an attorney in the case against Weinberger, the doctor's fatal flaw is that he viewed patients as a paycheck.  The criminal trial may put Weinberger in prison for a very long time.

While anesthesia errors aren't a frequent occurrence, when they do happen they can cause significant and permanent injuries.  Anesthesia is commonly used in various surgical procedures.  A patient who is scheduled for surgery may not meet the anesthesiologist until minutes before surgery.  However, as a patient, you may want to meet with the doctor earlier and ask pertinent questions about the anesthesia as well as discuss your medical condition.

Proper anesthesia is crucial to a favorable surgical outcome.  Here are a few of the most common anesthesia errors that lead to injury:

1)Errors in anesthesia dosage-this usually occurrs when the dosage is mislabeled prior to the surgery.

2)Delayed anesthesia delivery- This kind of error may result from a vaporizer leakage, an IV error, or syringe issues.   

3)Intubation errors-a procedure doctors learn early in their training

4)Improper monitoring-close monitoring of a surgical patient's vital signs including respiration and blood pressure is crucial

5)Lack of communication-this can occur between medical staff or with the patient

Anesthesia can be a great medical benefit that allows doctors to perform surgeries and corrective procedures.  However, when anesthesia errors are committed, the consequences can be devastating.

We blogged about a related issue just a few days ago-medical schools testing prospective students on their communication skills.  Now, we're going to show why those so-called "soft" skills are so important.  According to Labmate Online, "Poorly co-ordinated care increased the likelihood by 110 per cent to 200 per cent, while cost-related barriers caused an increase of between 50 and 160 per cent." 

Those numbers are astounding but anyone who has been in the "system" of healthcare, either through a hospital admission or a battery of tests knows instinctively that the numbers ring true.  Very often the left hand doesn't know what the right hand is doing and vice versa.  Coordination of care is the most fundamental and basic core requirements of healthcare yet it's often the most overlooked.  This leads to medical errors.  The good news is that it appears this is finally being addressed by the healthcare community.

A new study of the efficiency and accuracy of electronic prescriptions concludes that they are not necessarily any more accurate than manual prescriptions.  The study found that nearly 10% of electronic prescriptions contained errors, a rate comparable to manually generated prescriptions.  Nearly two-thirds of the errors involved missing information, and more than a third of them could have led to adverse drug events, the study found. The Boston-area researchers who conducted the study reviewed 3,850 computer-generated prescriptions received by a commercial pharmacy chain in three states during a four-week period in 2008.

The study's researchers concluded ""Implementing a computerized prescribing system without comprehensive functionality and processes in place to ensure meaningful system use does not decrease medication errors."

The new study has been published in the Journal of the American Medical Informatics Association.

Presently, US military personnel who are injured as a result of the negligence of a doctor or healthcare practitioner have no legal recourse.  This may change now that the US Supreme Court is considering whether it will hear a case involving a 29-year old sergeant whose skin cancer was detected but never reported to him.  Sgt. Carmelo Rodriguez later died as a result of the skin cancer.  Since his death, Rodriguez's family has been fighting for the right to seek justice in a court of law.  However, they have had no luck in their pursuit.

Now, a new case has been brought before the Court that may allow military personnel to seek civil justice when they are harmed due to medical errors.  According to CBS, "the challenge is being brought forward by the family of Sacramento based Airman Dean Witt, who was diagnosed with acute appendicitis. He survived the surgery only to have breathing complications, where a nurse stuck a breathing tube down his esophagus instead of his trachea. Witt's brain starved for oxygen, leaving him in a persistent vegetative state."

A decision may come as early as Monday.

A new report published today in the Journal of the American Medical Association has found that almost as many medical errors occur in physicians' office as in hospitals.  The researchers found that the errors in medical offices were not trivial.  70% of such errors involved death, a permanent injury, or a major injury. 

in gathering data for the study, researchers analyzed information National Practitioner Data Bank and compared cases occuring in hospital settings with those in ambulatory care facilities or doctors' offices.  The researchers were able to conclude that the leading source of medical errors in non-hospital settings concerned diagnostic errors.  According to Medscape, "They note the conditions in physician offices that invite diagnostic errors: A patient's signs and symptoms "may be subtle or not adequately noted" by physicians seeing a constant stream of patients, and follow-up is harder than in the hospital.

"Communication and coordination of care are problems," Dr. Bishop told Medscape Medical News. "A doctor who orders a test or refers to a specialist won't be 100% sure that they happen until he gets back a report."

While it is more difficult to monitor patient safety data and quality outcomes in a non-hospital setting such as a phsycians' office, this new study reveals the importance and urgency of doing so.

Teddy Forstmann is a hard charging CEO who demands excellence and precision from his employees as well as himself.  That's why he's angry at his doctors for misdiagnosing his brain cancer.  The cancer remained undiagnosed for a year while doctors told him that he had various illnesses including meningitis.  Recently, he underwent surgery to remove the malignant brain tumor, according to a Fox Business report.  According to the article, Forstmann's cancer is the same type as the one Senator Edward Kennedy had. 

Successful recovery from such illnesses requires prompt and accurate diagnosis.  When healthcare professionals fail to make the proper diagnosis in a timely fashion, the patient's life is at risk.  “Teddy’s determined not just to roll over on this,” said one friend with first-hand knowledge of the situation “But he knows that because of the misdiagnosis, the doctors caught the cancer late and he thinks he can take IMG much further than it is today.”

Let's hope he makes a full recovery and can continue to manage International Management Group for many years to come.

The Nevada Senate has passed a patient checklist bill that requires hospitals and medical facilities to adopt and use the checklist as part of an effort to reduce medical errors and improve the quality of patient care in the state.

“Requiring medical facilities to adopt patient checklists is something more and more states are doing because they reduce costly medical errors and improve health outcomes,” said Assembly Speaker John Oceguera, sponsor of AB 280.

“Nevadans will have access to higher quality health care because of this legislation.” Oceguera noted. 

The bill is a positive response to the public outcry for better healthcare as well as an acknowledgement to patient safety advocates who've called on the industry to adopt such measures.  One leading safety advocate, Dr. Atul Gawande published a book on the subject, The Checklist Manifesto:  How to Get Things Right, a few years ago.  We've advocated such common sense measures even though they've met with some resistance from the healthcare industry.

The Nevada Senate is to be commended for legislating patient safety.  If the industry won't do it, our elected officials have a duty to protect the public and increase patient safety.  Hopefully, more states will follow Nevada's lead.

A Connecticut jury awarded Karla Rosa, mother of two children, $10.5 million for permanent and debilitating injuries she suffered in 2006 as a result of improper anesthesia care during surgery.  Rosa was left in a coma for 26 days followed by 29 days in the hospital's intensive care unit and 45 days in verbal and orthopedic rehabilitation.  She remains in need of assistance as a result of the medical event. 

According to the lawsuit, as a result of the "carelessness and negligence" of Anesthesia Associates in its pre-operative assessments, use of anesthesia equipment and patient monitoring, Rosa suffered "serious, severe, painful and permanent injuries" that caused her to be "permanently deprived of her full ability to carry on and enjoy life's activities."  Named as co-defendants in the medical malpractice lawsuit were anesthesiologists Drs. Thomas Meitt and Bart Calobrisi, who died in February, and Jean Richeimer, certified nurse anesthetist. Lawrence and Memorial Hospital in New London was originally also named as a co-defendant, but it was later dropped from the case.

The Agency for Healthcare Research and Quality has awarded grant funds to help reduce the number of birth injuries by increasing the quality of medical care primarily through better communication among healthcare professionals.  Studies have shown that there are five recurring issues which predominate in birth injury cases:  failure to initiate a timely Cesarean section; failure to recognize an infant in distress; failure to properly resuscitate a baby; inappropriate use of labor-inducing drugs; and misuse of vacuums and forceps. Injuries happen when delivery teams don't act quickly enough to deal with sudden unexpected events like shoulder dystocia, which occurs when the baby's shoulder gets stuck behind the mother's pubic bone. This can lead to muscle palsy and neurological injuries to the infant and physical trauma for the mother. 

These are preventable issues which dramatically increase the instances of birth injuries.  According to a Wall St. Journal article, "According to the latest data from the American College of Obstetricians and Gynecologists, nearly 91% of ob/gyns have had at least one liability claim filed against them, and 62% of the total claims were for obstetrics care, involving such cases as neurologically impaired or stillborn infants."

The new efforts seek to increase communication among the healthcare team as well as implement "care bundles" which have been shown to dramatically reduce birth injuries and instances of medical malpractice.

Medication errors led to a dramatic rise in hospitilizations from 2003 to 2008 according to Agency for Healthcare Research and Quality. The statistics are as follows:

• For patients admitted to the hospital, the top five categories causing side effects and injuries were corticosteroids (283,700 cases), pain relievers (269,400), anticoagulants (218,800), drugs to treat cancer and immune system disorders (234,300) and heart and blood pressure medicines (191,300).

• More than half (53%) of hospitalized patients treated for side effects or other medication-related injuries were age 65 or older, 30% were 45 to 64, 14% were between 18 and 44, and 3% were under age 18. Children and teenagers accounted for 22% of emergency cases.

• About 57% of the hospitalized patients and 61% of ED cases were female.

After a four year effort to combat hospital acquired infections in 153 VA hospitals, a new study shows that progress is being made.  According to the NY Times, the study showed a 62% drop in in the rate of infections caused by methicillin-resistant Staphylococcus aureus, or MRSA, in intensive care units over a 32-month period. There was a 45 percent drop in MRSA prevalence in other hospital wards, like surgical and rehabilitation units.  While the data is impressive, a companion study in private healthcare facilities found no such progress.  Both studies were published yesterday in the New England Journal of Medicine. 

One VA doctor is encouraged with the results.  “I think our study has shown that it is possible to make this large-scale change, even in a large system,” said Dr. Rajiv Jain, an official with the Veterans Health Administration and the study’s primary author. “If other hospitals were to follow our lead, I think it is possible to decrease these infections.”

The VA approach to curbing hospital infections employs a "bundle" approach which include screening all patients with nasal swabs, isolating those who test positive for MRSA, requiring that staff treating those patients wear gloves and gowns and take other contact precautions and encouraging rigorous hand washing.

Critics of the VA approach argue that the "bundle" approach is neither cost-effective or necessary to curb infection.

However, one issue is clear-hospitals that require and monitor certain checklist behaviors such as handwashing and the proper use of gloves are making improvements in their infection rates.  According to the NY Times, "The study of intensive care units released Wednesday, for instance, found that health care workers wore gloves only 82 percent of the time when such precautions were specified, donned gowns only 77 percent of the time and washed their hands after only 69 percent of patient contacts. The lead author, Dr. W. Charles Huskins of the Mayo Clinic in Rochester, Minn., noted that those numbers were “not woefully bad,” as previous studies had found hand-washing compliance to be as low as 50 percent."

A Burbank California jury awarded the wife and family of a 51-year old decedent $4.5 million for misdiagnosing a fatal heart attack.  Thomas Miller went to Dr. Colin Cooper complaining of chest pains.  According to the family's attorney, Dr. Cooper misdiagnosed the heart attack and administered a stress test to Miller who later died of a heart attack.

The jury awarded his family $3.5 million in general damages and $1 million in economic damages in the medical malpractice case.

A few months ago, the Boston Globe published a two-part series concerning medical alarms and patient safety.  The Globe investigation focused on the prevalence of medical alarm monitors and how often they are ignored due to a phenomenon known as "alarm fatigue" in the industry. 

According to the Globe report, "They call it “alarm fatigue.’’ Monitors help save lives, by alerting doctors and nurses that a patient is — or soon could be — in trouble. But with the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses become desensitized — sometimes leaving patients to die without anyone rushing to their bedside. On a 15-bed unit at Johns Hopkins Hospital in Baltimore, staff documented an average of 942 alarms per day — about 1 critical alarm every 90 seconds."

Alarm fatigue is a real healthcare hazard that has been linked to more than 200 hospital patient deaths in a five year span from 2005-2010.  The Globe's investigation led them to the conclusion that "the problem typically wasn’t a broken device. In many cases it was because medical personnel didn’t react with urgency or didn’t notice the alarm."

Forty percent of hospital patients report being the victim of a medical error.  Such errors cost 98,000 Americans their lives each year.  A 2006 NY Times article determined that doctors misdiagnose fatal conditions 20% of the time and according to the Journal of the American Medical Association this has not improved since the 1930's!.  

CNN has found that the most common misdiagnoses involve aortic dissection, cancer, clogged arteries, heart attack, and infection.  In reporting these mistakes, CNN notes that patients should explain their symptoms fully and clearly.  If they believe they're being dismissed, ask another doctor.  It's not very encouraging news.

According to the Pittsburgh Tribune-Review, a medical review of Westmoreland Hospital has determined that 141 impatients may have received cardiac stent implants that weren't medically necessary. 

According to the Tribune-Review, "Two teams that included nationally recognized interventional cardiologists determined that 141 patients in 2010 may not have had enough blockage in their arteries to need a stent -- a tiny wire mesh device to prop open clogged arteries in the heart, according to a letter from the hospital expected to be delivered to the affected patients today. The hospital is now reviewing the two doctors' 2009 cases and is expected to know the results by May."

Needham doctor Dr. Joseph Zolot and his nurse practitioner have been indicted in the overdose deaths of six of his patients.  The two were indicted on charges of conspiring to illegally distribute controlled substances, including methadone, oxycodone, and fentanyl; and six counts each of distribution of methadone that resulted in the deaths.  The charges claim that the drugs were medically unnecessary and were distributed in order to make a profit.

According to the Boston Globe, "Law enforcement officials said it is one of the most significant recent cases of medical misconduct to reach a criminal court nationwide." 

The misuse of pain drugs has become a nationwide problem with some states vowing to crack down on those who distribute and profit from the powerful drugs.

According to Dr. Stephen R. Grobmeyer, director of the breast cancer program at the University of Florida and senior author of the study published in the The American Journal of Surgery, too many surgical breast biopsies are being performed when the protocol calls for a needle biopsy.  While it's not clear the reason for the excessive use of surgical biopsies, it's clear to Dr. Grobmeyer too many women with abnormal mammograms are undergoing surgical procedures when a needle biopsy is safer, less invasive, and cheaper.

The new study estimates that 300,00 women in the US are having unnecessary breast surgery.  According to the front page article in the New York Times published Saturday, "The figures in the rest of the country are likely to be similar to Florida’s, researchers say, which would translate to more than 300,000 women a year having unnecessary surgery, at a cost of hundreds of millions of dollars. Many of these women do not even have cancer: about 80 percent of breast biopsies are benign. For women who do have cancer, a surgical biopsy means two operations instead of one, and may make the cancer surgery more difficult than it would have been if a needle biopsy had been done."

While the study itself draws no conclusions as to the reason for the excessive surgical biopsies, some surgeons point to a more nefarious reason.  The NY Times interviewed several surgeons in preparation for publishing the article.

"Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and a clinical professor of surgery at the University of Southern California, said it was “outrageous” that 30 percent of breast biopsies were done by surgery. He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

Silverstein's comments are especially revealing in light of the fact that needle biopsies require a tiny incision, no stitching, and less risk of infection and scarring.  Also needle biopsies are half the price of the open biopsy.

According to a medical malpractice lawsuit filed in California, a 2 year old child lost her limbs due to a five hour wait in a hospital emergency room.  In November 2010, the 2 year old was brought to the emergency room of Methodist Hospital of Sacramento with a high fever and skin discoloration.  In spite of her parents' pleas, the child was not seen by a doctor for five hours.  When she was seen she was diagnosed with streptococcus A and deemed too serious to be treated at Methodist.  She was then transferred to Stanford University's Children's Hospital. By that time, her condition had deteriorated.  Doctors at Stanford amputated both her feet, one hand and part of the other hand. 

The lawsuit alleges that the excessive delay in treatment led to the catastrophic injuries she suffered at Stanford University's Children's Hospital.

A fourth lap-band surgery death has lead to the filing of a medical malpractice lawsuit in California.  Laura Faitro of Simi Valley died July 26, 2010, five days after undergoing the weight reduction surgery procedure touted by medical clinic linked to the ubiquitous 1-800-GET-THIN marketing campaign.  In the Faitro case, her liver was lacerated during the lap-band procedure and she died five days later.  According to the LA Times, "Faitro's liver was lacerated three times during the Lap-Band procedure at Valley Surgical Center, but she was discharged from the surgery center several hours later without being informed of the injury, according to the lawsuit. Faitro's death certificate lists heart failure as the cause of death, with liver laceration and morbid obesity as contributing factors."

A lap-band is a silicone belt that loops around the upper portion of the stomach.  The band is designed to make the stomach roughly equivalent to the size of a golf ball.  The goal of the lap-band is to make the patient feel full without eating as much.  While the lap-band is FDA approved, there are health risks associated with the surgery.  These risks include:  internal bleeding, infection, band slippage, band erosion into the stomach, stomach blockage, and anesthesia complications.

The liver laceration involved in the death of Laura Faitro is not a common side effect of lap-band surgery.

A jury has ordered a Glens Falls doctor to pay $3 million for injuries sustained in a botched birth.  After 3 weeks of court testimony, a jury found that Dr. Stephen Serlin, an obstetrician-gynecologist, should pay Marlayna Kineke for a brain injury she suffered 18 years ago during her birth.  The jury found that Dr. Serlin "deviated from the acceptable standard of care" and that deviation was a "substantial factor" in the teen's health issues.  Her mother sued on her daughter's behalf.

As a result of the birth injury, Marlayna suffers from cerebral palsy as well as a host of other health issues.

According to a story in the PostStar.com, "At issue was when Serlin directed that Dawn Kineke have a C-section after her labor was induced on Feb. 24, 1993. An expert hired by the plaintiffs claimed that evidence showed Marlayna Kineke suffered "fetal asphyxia" in the womb during labor because her umbilical cord was compressed, court records show.

Serlin and Hobbs were accused of violating hospital policy by both leaving the hospital for at least four hours early on the morning of Feb. 25, according to the lawsuit. At least one should have remained at the hospital during that time period, according to court records.

Serlin ordered a C-section later that morning after he arrived at the hospital."

A medical malpractice lawsuit against Dr. Kayoko Kifuji of Tufts University has been settled for $2.5 million.  The lawsuit alleged that four year old Rebecca Riley died four years ago as a result of an overdose of psychiatric drugs prescribed by Dr. Kifuji.  Rebecca's parents were convicted last year of murdering their daughter by recklessly administering the drugs prescribed by Dr. Kifuji.

According to the Boston Globe, "According to testimony during the trials, Kifuji had been fooled by the parents into believing the children had serious psychiatric illnesses, in part so the parents could collect federal disability checks for the youngsters’ alleged behavioral and mental disorders. Many jurors questioned why Kifuji, who had indications about the parents’ dangerous conduct, did not do more to protect the Riley children.

Kifuji, who agreed to testify only after being granted immunity from prosecution, said in court that she was following diagnostic criteria and treatment protocols followed by many well-established child psychiatrists. She said she had no idea that the parents were giving extra medication to their children."

The case was settled for the maximum amount covered by Dr. Kifuji's malpractice insurance policy.

An Alachua County Florida jury awarded a woman $23 million in damages after she became severely disabled following a botched neurosurgical procedure.  In 2006, Lanette Gervato sought medical attention for severe headaches at the University of Florida's Shands Teaching Hospital in Gainesville, Florida.  Diagnostic test found an aneurysm in her brain.  Surgery was subsequently performed during which coils were inserted into her brain.  Unfortunately, one of the coils perforated one of the arteries in her brain.  Other medical errors followed after that.  According to court testimony, Gervato displayed symptoms of a post-operative stroke.  These symptoms were observed by a nurse who failed to act on the symptoms.  By the time doctors did react to the symptoms, it was too late.  Ms. Gervato suffered further neurological damage. 

As a result of the medical errors and medical malpractice, Lanette Gervato is completely and permanently disabled.  Her husband is unable to work because he has to care for his wife.  Their lives have been permanently altered.

After reading Dr. Edward R. Sobel's thoughtful piece on medical errors published by Delaware Online, I thought I'd discuss one of the items he mentioned in his article.  In discussing medical errors and how to avoid them, Dr. Sobel mentioned the prevalence of medical errors occurring during hospital shift changes, patient transfers from hospital to an extended care facility, or a patient's transfer back to the care of a family physician.  I suspect most people don't think about these times as prone to medical error through human miscommunication.  These are all preventable errors if communication protocols are followed.  However, we know through experience that many preventable medical errors still occur during these times of patient transfer. 

More than a decade ago, the Institute of Medicine estimated that 98,000 patients die each year from medical error.  I wonder how many have died due to medical error during a patient transfer or shift change in a hospital or extended care facility?  The statistic is worth examining in order to reduce the number of fatalities during this time.

Dr. Rolando Arafiles, Jr. has been arrested in Texas and charged with two third degree felonies: misuse of official information and retaliation against the two nurses who had turned him into health officials for poor healthcare performance.  The civil whistleblower case involving the two nurses was resolved earlier this year.  In addition to the criminal charges, Dr. Arafiles faces scrutiny and punishment from the state's medical board concerning allegations of poor medical practice, nontherapeutic prescribing, failure to maintain adequate records, overbilling, witness intimidation, and other violations.

A Milton Massachusetts couple were awarded a $2,000,000 jury verdict in a medical malpractice lawsuit brought against St. Vincent Hospital.  The med mal lawsuit alleged that hospital officials failed to diagnose several strokes Joseph Ginisi suffered in 2004.  The jury found the hospital liable while failing to hold any individual healthcare workers liable for failure to diagnose the stroke. 

As a result of the strokes, Joseph Ginisi is no longer able to live at home with his wife.

Micromedics Inc. has issued a Class 1 recall for its surgical sealant dispensers, nasal septal buttons, and its otological ventilation tubes.  A Class 1 recall is considered by the FDA the most serious type of recall because the product in question may cause severe injury or death.

The medical products were recalled because of weak or open seals, which may lead to contamination.  Micromedics' surgical sealant dispenser is used for the application of two liquids.  The nasal septal button is employed for the nonsurgical closure of an opening in the nasal septum.  The otological ventilation tubes are used to repair a chronic failure of the Eustachian tube which connects the middle ear to the nose.

These products were sold from February 15, 2010 until March 4, 2010 a few weeks before the recalls were issued.

A Texas jury has awarded $4,000,000 to a man who sued DeTar Hospital Navarro and surgeon John Barber.  The surgeon was cleared of negligence in the lawsuit which alleged that a surgical sponge was left in Ronald Molder after gallbladder surgery. 

According to Dr. Barber's post-surgery report, he had confirmed twice the sponge count with surgical nurses.  Nurses are ultimately responsible for sponge counts and other surgical supplies after surgery. 

As a result of the sponge that remained in Ronald Molder's body, the patient had to endure further surgeries and remained hospitalized for an additional 80 days.

A jury in Illinois awarded 30 year old Sabine Miller $11.5 million after a three week medical malpractice trial.  Ms. Miller was 14 weeks pregnant when she was rushed by ambulance to Edward Hospital in Napierville in November 2004. 

According to the Chicago Sun-Times, "Hospital personnel failed to properly monitor her "deteriorating condition," and that of her unborn baby, the release said. Nurses also failed to contact a doctor, and Miller lost consciousness due to septic shock."

The jury award is believed to be the second largest medical malpractice verdict in DuPage County for an adult woman in a medical malpractice case.

Most doctors continue to come to work even when they are sick.  Some even wear their dedication and sacrifice as a badge of honor.  However, there's mounting evidence that such an ethic may be dangerous to the people for whom the doctors are striving to serve-patients. 

According to a recent article in the New York Times, "“The culture of medicine is so completely focused on self-sacrifice that when doctors come into work so sick they need intravenous fluids, it’s considered a badge of courage,” said Dr. Eric Widera, the study’s lead author and an assistant professor of geriatrics at the University of California, San Francisco. “No one is standing up for the patient and saying, ‘This is wrong.’ ”

While in other work settings, dedication and self-sacrifice are lauded as exemplary, in the context of healthcare a sick healthcare worker can cause more harm than good.  Let's remember that the principal dictum for any physician is "Do No Harm".  Besides the very real danger of transmitting viruses and disease to patients, sick doctors are more likely to make diagnostic errors due to their ill health.  When sick, they are not performing at their best which can lead to critical mistakes.

According to the Institute of Medicine, medication errors injure 1.5 million Americans each year.  A 2006 Institute of Medicine study found that there were 400,000 preventable drug errors in hospitals alone. 

Unfortunately, the news gets worse.  According to a report in the Seattle Post Intelligencer, medication errors are the most underreported medical errors.  States that actually have medical error reporting requirements continue to miss errors that cause harm or, at the very least, if reported, could be a basis for further study as to how to avoid such errors in the future.  In some states, the reporting requirements have loopholes that allow for medical errors including medication errors to remain unreported.  A clear example of this may be found in state requirements that mandate the reporting of medical errors that cause "serious" harm or disability.  In these situations, "serious" is open to interpretation and subjective.  In other states, there are no penalties for not reporting medical errors. 

State laws should adopt the definition of medical error put forth by the National Coordinating Council for Medication Error Reporting and Prevention-any "preventable event that may cause or lead to inappropriate medication use or patient harm."

As we approach another election, we'll undoubtedly be subject to more of the same arguments regarding skyrocketing healthcare costs in this country.  Blaming the costs on medical malpractice cases is a favorite of the insurance industry.  However, there is significant evidence that such a claim is not accurate.  A new study published in Health Affairs determined that medical malpractice or medical error was responsible for only 2.4% of the country's healthcare costs.  Compare this percentage to the estimated 98,000 people killed by medical errors in this country and we put the issue in its proper perspective.

The critical issue concerning healthcare costs involves improving patient safety by reducing costly medical errors.

Tigecycline (Tygacil) has received an updated warning label from the Food and Drug Administration.  The new label states that alternatives to Tygacil should be considered in treating serious infections due to Tygacil's increased risk of mortaility in comparison with other antibiotics in treating infections. 

The increased mortality risk was most prevalent in those being treated for hospital acquired pneumonia for which Tygacil is not FDA approved.  Tygacil is FDA approved for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia.

According to an FDA safety alert, "alternatives to Tygacil should be considered in patients with severe infections."

Doctors may prescribe drugs for so-called "off label" uses ie. uses not approved by the FDA.  However, drug companies are not allowed to market their drug products for anything other than those uses approved by the FDA.

The National Vaccine Information Center is calling upon President Barack Obama and Congress to investigate the vaccine Gardasil.  The call for a federal Gardasil investigation comes two days after a new federal report on Gardasil was released.  The results of the report were published in the Journal of the American Medical Association.  While most doctors appear to agree that Gardasil is effective in stopping HPV, the adverse events associated with Gardasil give many parents pause.  According to ABC News,

"As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9 Vaccine Adverse Event Report System (VAERS) reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death."

In calling for a federal investigation of Gardasil, The National Vaccine Information Center noted the following: 

• Gardasil was fast tracked and licensed by the FDA in 2006 and immediately recommended by the U.S. Centers for Disease Control and Prevention (CDC) for universal use by all young women, ages 11 to 26.

• Merck studied Gardasil side effects in only about 1200 girls 16 years old and younger and followed-up for less than two years before obtaining a license.

• Merck was not required by federal health agencies to use a true placebo in pre-licensure clinical trials. Instead, they compared Gardasil against a placebo that contained an unknown amount of aluminum, potentially masking the true reactivity of Gardasil, which also contains aluminum.

• Deaths and serious health problems experienced by participants receiving Gardasil in pre-licensure clinical trials were written off by Merck as a coincidence.

• Thousands of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) since Gardasil has been licensed—including deaths, serious health problems, emergency room visits, hospitalizations, and permanent injuries—have been written off by federal health agencies as a coincidence.

• Comparison of serious adverse events—such as death, stroke, blood clots, cardiac arrest, seizures, fainting, lupus, and re-challenge cases—reported to VAERS after Gardasil vaccination and meningococcal (Menactra) vaccination reveal that these events are reported three to 30 times more frequently after Gardasil vaccination.

• Doctors and parents are not being informed by federal agencies or Merck about all serious adverse events associated with Gardasil so steps can be taken to monitor vaccine reactions and prevent injury and death.

Of course, the manufacturer of Gardasil, Merck doesn't view the figures in the same fashion.  Ultimately, parents contemplating Gardasil should consult the reports and speak in depth with their physician.

For the first time, a new study has linked even infrequent acetaminophen use in teens with asthma.  According to the study, conducted by Richard W. Beasley, MD, professor of medicine at the Medical Research Institute of New Zealand in Wellington, even once a month use of acetaminophen may trigger asthma in teens.  Monthly use of acetaminophen in teens was 2.5 times the asthma risk of nonusers. Once-a-year users had a 43% increase in asthma risk.

The study included 323,000 13-14 year olds from 50 different countries.  The researchers, including Dr. Beasley were quick to point out that no definitive conclusions could be drawn from the study.  "Randomized, controlled trials are now urgently required to investigate this relationship further and to guide the use of [fever-reducing drugs], not only in children but also in pregnancy and adult life," they conclude in their report.

There are now more than 2,000 Yaz/Yasmin birth control lawsuits filed against the pharmaceutical company Bayer.  The litigation is complex and made further difficult by the number of documents related to the lawsuit (10,000+).  While Bayer insists its birth control pills Yaz and Yasmin are completely safe and don't increase the risk for heart attacks and strokes, it plans to unveil a new birth control pill, Natazia, sometime in the fall.  Natazia is another birth control pill that contains a new combination of estrogen and progestin, the same chemical formula blamed for the increased health risks in Yaz and Yasmin. 

With the amount of marketing efforts and financial resources poured into Yaz and Yasmin, Bayer appears ready to fight the birth control lawsuits to the bitter end.  As with so many pharmaceutical and medical device lawsuits, what is produced during the lawsuit should reveal the truth and hopefully protect the consumer from danger.

Just a few short weeks removed from barely surviving a call to be removed from the marketplace, GlaxoSmithKline's diabetes drug Avandia has been linked to an increased risk of bone fractures in postmenopausal women.  Actos, Avandia's chief rival, was also linked to the increased risk of bone fractures. 

Both Avandia and Actos belong to the same class of drugs known as thiazolidinediones.

The study's findings were published in the Journal of Clinical Endocrinology & Metabolism.  It found that women over 50 who were prescribed these types of drugs  were 71% more likely to have suffered a bone fracture.

While Avandia has been allowed to remain on the market its sales have declined sharply due to the numerous calls for its removal from the marketplace due to safety risks including heart attacks and strokes.

An FDA advisory committee has recommended against the use of Avastin in breast cancer treatment.  The decision was based upon new drug trials that demonstrated no demonstrable benefit in the treatment of breast cancer. 

The recommendation is a set back for those who believed Avastin would prevent the disease's progression.  The FDA should make a final decision by Sept. 17. It is not required to follow the recommendations of advisory panels, but generally does.

CNN posed the question yesterday citing a recent University of California study which found that there's a 10% increase in deaths from medication errors in hospitals in July.  While not drawing a definitive conclusion, CNN noted that July is also the month when medical school students become residents in hospitals.

According to CNN, researchers from the University of California study examined 240,000 death certificates from 1979 to 2006 and found a consistent spike in the number of deaths each July.  The spike was most significant in counties which have teaching hospitals. 

"No one has been able to suggest anything else besides the appearance of new medical residents. That's the first month they start their new jobs and have expanded autonomy," says David Phillips, a professor of sociology and lead author of the study. He says although it's possible that the increase can be linked to administrative or other events specific to July, the most notable link is the start of new medical residents.

The connection between the July influx of residents and the increase in deaths is controversial and not everyone agrees with it. 

Regardless of the reason for the spike in deaths, every patient needs to be proactive about health issues, especially when hospitalized.  The following are a few tips everyone should keep in mind when entering the hospital:

1) Ask questions

2) Don't assume the medication you're receiving is correct, ask and check

3) If you're not satisfied with your level of care, ask to speak with a supervisor or an attending physician

You have to take responsibility for your own health.  Be an advocate and be safe!

With an FDA hearing looming next month, two new studies were released today that bolsters the argument that Avandia is a dangerous drug that should be removed from the market.  The new research points to the diabetes drug as a risky drug for those suffering with diabetes.  Both studies suggest that Avandia significantly increases the risk of heart attacks and strokes.

The new data adds to the mounting evidence that Avandia may be removed from the market by the FDA when government officials meet next month to decide the diabetes drug's fate. 

It also marks a precipitous plummet for GlaxoSmithKline, the manufacturer of the diabetes drug.  Avandia, approved in 1999, was once a best selling diabetes drug whose worldwide sales exceeded $3 billion annually. 

According to the Washington Post, "One analysis, involving more than 35,500 patients, found Avandia significantly raises the chances of a heart attack. The second, a federal analysis of more than 227,500 Medicare patients -- the largest such study to date -- found the drug boosts the risk for strokes, heart failure and death."

One of the earliest Avandia critics, a prominent Cleveland Clinic cardiologist reaffirmed his commitment to have the drug removed from the market noted, "There's no reason to keep this drug on the market. This is a harmful drug."

With such strong evidence against Avandia, it's hard to imagine the drug will survive FDA scrutiny in July.  However, not all industry insiders feel so confident about Avandia's demise.  GlaxoSmithKline has not been deterred by the negative attention from the new research.  GlaxoSmithKline officials remain confident that the drug is safe and effective in treating diabetes.

The Post concluded by noting, "In a paper released online by the Journal of the American Medical Association, the researchers found those who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took Actos. Based on the findings, the researchers estimate that there would be one heart attack, death, stroke or heart failure in every 60 patients who took the drug for one year."

Ultimately, what should be paramount in the FDA decision is patient safety.  If the drug is unsafe, remove it before more patients are injured.

 

 

This week has been a tragic one for motorcycle enthusiasts in New Hampshire.  As Laconia Bike Week draws to a close, three motorcyclists have lost their lives on NH roads.  Yesterday, Christopher F. Magistro of Bradford NH was killed when he lost control of his motorcycle and struck a utility pole.  Police noted that alcohol was not a factor in the crash.  Magistro was not wearing a helmet at the time of the crash.

Another serious motorcycle accident occurred in Winchester.  A motorcycle was heading west on Rte. 10 when a car unexpectedly made a left turn as the motorcycle was attempting to pass the vehicle.  Both the driver and the passenger of the motorcycle were thrown from the bike.  Both sustained serious injuries.  The driver was later flown to University of Massachusetts Memorial Medical Center with very serious head injuries. 

The third motorcycle crash in as many days happened in Meredith, NH when a group of bikers was heading north when a vehicle made a sudden U-turn.  The lead cyclist hit the driver's side door and flew over the vehicle.  The bike's driver was airlifted to Dartmouth Medical Center with serious injuries.

These motorcycle accidents underscore the importance of defensive driving for both motorcyclists and those who operate motor vehicles.  During the summer months, motorcycles are everywhere.  It only takes a split second of inattention or distraction for a fatal motorcycle accident to occur.  Be careful out there!

A new study from the University of Montreal published in the Canadian Medical Association Journal suggests that pregnant women taking antidepressants may be prone to miscarriages.  The studies, the first of its kind to delineate certain antidepressants in particular, noted that Paxil and Effexor are associated with the greatest risk of miscarriage. 

According to TIME Magazine, "The study included 69,742 women from the registry, 5,124 of whom had had a clinically recorded miscarriage. Among the women who had miscarried, 5.5% had filled at least one prescription for an antidepressant during pregnancy, compared with 2.7% of the control group. Researchers calculated that antidepressant users had a 68% higher risk of miscarriage than nonusers, after controlling for other influences that could potentially confound the association."

The study does not suggest pregnant women suffering from depression abandon pharmaceutical therapy.  However, it does offer more data for obstetricians to consider when treating pregnant women who present with depressive symptoms.

We've blogged previously about the dangers of the weight loss drug Alli.  Now, the Food and Drug Administration has issued a warning concerning Alli and its risk of severe liver injury.  The popular weight loss drug has been taken by an estimated 40 million consumers.  Xenical, which is available in prescription form, has also received an FDA warning concerning liver injury.  Both Xenical and Alli contain 60 mg of orlistat.  The FDA first approved Xenical in 1999, and Alli was approved in 2007.

Last year, the FDA began  reviewing orlistat over safety concerns.  At the time, the FDA had received 32 reports concerning serious liver injury.

Patients taking Alli or Xenical who've experienced symptoms of serious liver injury should call their healthcare professional.  Symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

When Vermont Governor James Douglas signed the legislation last week, the Green Mountain state became the latest to ban the chemical from use in the manufacturing of plastic bottles and food storage containers.

BPA or bisphenol A is a chemical that has been linked to a variety of diseases including damage to the human endocrine system.  BPA has been linked to cardiovascular disease, intestinal disorders, an increased risk to the reproductive system, and liver function. 

BPA has been widely used in the hardening of plastic materials used in baby bottles, food containers, beverage containers, nautical paint, and thermal paper.

A Las Vegas jury has ordered Teva Pharmaceutical Industries and Baxter International to pay a combined $500 million in punitive damages in a medical malpractice case.  This is a highly unusual jury finding.  The case involve a man who contracted Hepatitis C due to an unsafe medical procedure.  However, the jury found the pharmaceutical companies liable in the medical malpractice case due to the drug companies' marketing practices that encouraged the reuse of vials through their marketing practices and ambiguous labeling. 

According to www.dailyfinance.com, "Health officials have put the blame for infecting patients with the incurable liver disease on reuse of the vials. 'Each of the 63,000 possible patient exposures identified in this investigation were entirely preventable, and would not have occurred if clinic staff had adhered to well-established, safe, and common sense injection practices,' the report concludes. More than 100 cases of Hep C infection were traced to these incidents."

The jury finding was largely based upon their conclusion that the drug makers were responsible for selling the health clinic 50 ml vials of propofol, four to five times the necessary dosage for a colonoscopy.  Yet, through their marketing practices, the companies encouraged the re-use of the vials.

According to the 2009 Health and Human Service Department's quality report to Congress, the rate of hospital related infections has shown little improvement.  In fact, rates of illnesses from three of five of the major hospital related infections have seen an increase.  Rates of bloodstream infections following surgery increased 8%. Urinary infections from the use of a catheter following surgery increased 3.6%. Overall incidence for a series of common infections due to medical care increased by 1.6%.  More than 98,000 patients die each year from preventable medical errors.  It's been a decade since the Institute of Medicine launched a campaign to raise awareness concerning this issue but little improvement has occurred.  Hospital related infections can be prevented by following proper procedures and good nursing care.

This disappointing trend can be corrected.  The Wall St. Journal noted that 100 emergency rooms in Michigan have reduced the rate of central catheter infections to near zero by following good medical care procedures.

Documents submitted to the National Highway Traffic Safety Administration (NHTSA) show that Toyota knew about defective floor mats and "sticky" accelerator pedals in 2006.  Since 2006, approximately 50 people have been injured or died due to these Toyota vehicle defects.  According to the Associated Press, Toyota chose to monitor the safety situation rather than publicly disclose the public safety hazards concerning the floor mats and accelerator pedals. 

The NHTSA has decided to fine Toyota $16.375 million, the maximum penalty allowed by law, for Toyota's failure to timely disclose the defects. 

“We now have proof that Toyota failed to live up to its legal obligations,” Transportation Secretary Ray LaHood said. “Worse yet, they knowingly hid a dangerous defect for months from U.S. officials and did not take action to protect millions of drivers and their families. For those reasons, we are seeking the maximum penalty possible under current laws.”

Toyota class action lawsuits will now be consolidated and heard in Orange County CA.  8.5 million Toyota vehicles have been recalled because of the defects.

23-month-old Almariah Duque was born with a birth defect.  In December 2009, she underwent transplant surgery of her small intestine, pancreas, and liver.  Almariah was readmitted to the Nebraska Medical Center in February after an infection developed.  On March 31, the toddler died of an apparent heparin overdose. 

Heparin is a blood thinner commonly used in transplant surgeries, dialysis, and to prevent blood clots. 

A hospital statement after the toddler's death noted that a heparin overdose may have contributed to the death. 

"It appears an overdose of the blood thinner heparin may have contributed," said the statement, which called the death "a deeply troubling and emotional incident" for hospital personnel. "We all want to extend our deepest apologies to the Duque family for their tragic loss," it added.

Heparin overdoses are not that uncommon due to medical errors involving dosage errors and failure to comply with hospital dosage protocols. 

In 2007, actor Dennis Quaid’s infant twins suffered a Heparin overdose at Cedars-Sinai Hospital in Los Angeles.  In 2008, a dozen premature babies were given an overdose of heparin, two of whom died, at Christus Spohn Hospital South in Corpus Christi, Texas.

The FDA issued a heparin safety alert in 2007 advising healthcare professionals of the potentially fatal consequences of mistaking 10,000 unit vials of heparin with 10 unit vials. The FDA encouraged hospitals to review dosage procedures and protocols in the wake of three Indiana infants died after given adult dosages of heparin.

In the mid 1980's there was no single repository of information concerning a doctor's disciplinary record, medical malpractice claims filed, or a history of suspensions or license revocations.  In 1986, the US Congress passed the Health Care Quality Improvement Act in order to rectify the situation.  As a result of the new law the National Practitioner Data Bank was established, which serves as a database that includes malpractice payments, loss of clinical privileges, and medical license revocations.  The database keeps records on physicians, dentists, nurses, pharmacists, physical therapists and other professionals.

The problem with the database concerns public access to the information contained therein.  Thanks to the American Medical Association's lobbying efforts, the public can only access general statistical information.  Individuals cannot  access information on individual doctors.  Doctors may access their own files and hospital administrators and other "authorized users" have access to the files of individual doctors.

What good is such a database if it isn't transparent?  It seems that the public's right to know should  trump the lobbying efforts of the AMA. 

During the healthcare debate, we've witnessed those who want to restrict consumer access to the courts talk about the medical malpractice crisis.  In their arguments, they'd often cite doctors fleeing the practice of medicine and insurance premiums being raised as a direct result of medical malpractice lawsuits.

But the facts don't support these hyperbolic rants.  In 2009, fewer medical malpractice claims were paid than any previous year, according to the National Practitioner Data Bank.  While medical malpractice payments fell 8% last year, healthcare spending rose 83%. 

This doesn't seem like a crisis to me.

A new study published in the New England Journal of Medicine suggests doctors may be ordering unnecessary angiograms thus exposing patients to radiation that is not warranted.  The study of 400,000 patients concluded that nearly 40% of them did not need an angiogram.  According to Manesh Patel, a cardiologist at Duke University and one of the study's authors suggests better diagnostic tools are needed in order for a reduction in unnecessary procedures such as angiograms.

“We need to improve all the things we do before we get to the cath lab,” Patel said in a telephone interview. “But we need more large-scale studies to give doctors the guidance they require to make these calls.”

The spike in imaging tests exposes patients to more radiation than ever before.  According to  David Brenner, director of the Center for Radiological Research at Columbia University in New York, Americans are exposed to twice as much radiation today as they were 30 years ago. 

The increase in such invasive procedures such as angiograms has also led to an increase in healthcare costs without the benefit of improved outcomes.

A surgical tech with an admitted drug problem has been sentenced to 30 years for placing countless patients at risk for various bloodborne diseases.  Kristen Diane Parker, whose shoddy medical practices fueled by drug seeking behavior led to the infection of at least 3 dozen patients, was originally thought to be sentenced to 20 years in prison.  However, the judge rejected the plea agreement and has sentenced her to 30 years in prison.

Parker was charged with stealing Fentanyl syringes for her own use.  While she says she intended to replace the used syringes with new ones, she instead filled the used syringes with saline solution infecting at least 36 patients with hepatitis C which is transmittable through bodily fluids, especially blood.

There is no known cure for hepatitis C and the disease can be fatal.  The regulation and monitoring of surgical techs such as Parker are an issue that has gained more attention with the Parker case.

Last week, we reported a disturbing case in which a Texas nurse faced a prison term for reporting a doctor she suspected of practicing bad medicine.  We've just learned that a jury has acquitted her of any wrongdoing. 

Fortunately the jury agreed with those who believe in medical accountability and transparency.

"Fulfilling your duty as a nurse shouldn't get you an indictment," said Joyce Cunningham, spokeswoman for the Texas Nurses Association, which called the prosecution unprecedented and launched a legal fund that she said has swelled to almost $50,000. "It's about patient safety, and patient safety won the verdict."

A new study conducted by the Center for Health Services Research at Henry Ford Hospital and published in the February issue of the Journal of Clinical Endocrinology & Metabolism, suggests that a certain class of diabetes drugs known as thiazolidinediones may increase the risk of bone fracture in women.  While most consumers couldn't identify thiazolidinediones, they surely would recognize brand name drugs such as Actos and Avandia, two of the more popular members of the diabetes drug class.

The Henry Ford study was restricted to those with Type II diabetes.  The findings were striking in that women who took the thiazolidinedione for one year were 50% more likely to experience a bone fracture.  Interestingly, thiazolidinedione use in men, regardless of age, did not impact the likelihood of bone fracture.

 

An administrative nurse faces a trial and a ten year prison sentence if convicted of reporting a doctor for practicing bad medicine.  The official charge is "misuse of official information" a third degree felony in Texas.  The prosecution will argue that Anne Mitchell has a history of making inflammatory statements about Dr. Rolando G. Arafiles, Jr.  Mrs. Mitchell has stated that as a nurse, she had a professional obligation to report the doctor for improper prescribing and surgical errors-including a failed skin graft that Dr. Arafiles performed without surgical privileges.  According to the NY Times article, Arafiles also sutured a rubber tip to a patient's crushed finger which was later flagged as inappropriate by the Texas Department of State Health Services.  When informed of the complaint, Arafiles complained to his friend who happened to be the Winkler County Sheriff.  The Sheriff obtained a search warrant and seized the nurse's computer.  He found the letter and she was arrested.  It's not clear from the article how the sheriff determined Mitchell to be a suspect.

The case has received attention from the legal and medical communities in Texas and across the country.  Legal experts have argued that Mitchell appears to be protected under Texas whistle blower laws.

While Dr. Arafiles has friends in high places, the law would appear to side with a healthcare professional who reports a doctor for questionable medical practices.

Supposedly, the state of medical practice in Tennessee was so bad that the American Medical Association had declared a crisis in the state.  So in 2008 the residents voted to pursue tort reform legislation.  However, those efforts have proven fruitless in lowering malpractice insurance for healthcare professionals. 

In President Obama's meeting with Republicans in Baltimore last Friday, Obama said he was open in reviewing tort reform efforts even though the Congressional Budget Office had noted that such efforts would do little to lower healthcare costs. 

When will the insurance industry and other lobbying groups stop pushing this myth?  So-called tort reform isn't healthcare reform.

Yaz birth control lawsuits have been filed across the country because of their association with an increased risk of strokes, blood clots, and heart attacks.  However, the Yaz birth control pills are now being linked to an increased risk of gallbladder disease.  These Yaz side effects seem to be caused by the higher level of estrogen related to Yaz contraceptive use. 

In 2001, FDA approved Yasmin, which contains drospirenone, a progestin that can increase the body's potassium levels. According to the drug's label, the potassium increase may put women with liver and kidney problems at higher risk for serious side effects including blood clots, strokes, and heart attacks. Yaz, which also contains drospirenone and a lower dose of estrogen, was approved in 2006 as both a contraceptive and a treatment for premenstrual dysphoric disorder and moderate acne. Bayer, which manufactures both contraceptives, has aggressively marketed the contraceptives resulting in nearly $2 billion in worldwide sales in 2008.

In 2008, the FDA sent Bayer a warning letter about its Yaz marketing campaign.  The FDA noted that Bayer had overstated its efficacy and its promotion for uses (premenstrual syndrome) which the FDA had not approved.  In August 2009, Bayer received a second FDA warning letter concerning its quality control practices in its manufacturing plant in Germany.

The head of the Consumer Products Safety Commission, Inez Tenenbaum, has told US consumers to throw away any children's jewelry that was manufactured in China.  Tenenbaum's reaction has come in the wake of studies that have found unsafe levels of lead and cadmium in the jewelry.  The CPSC warning was published in a blog post after the Associated Press reported the dangerous levels of lead and cadmium in the jewelry.  The report included the most contaminated piece analyzed for its investigation contained a whopping 91 percent cadmium by weight. Other pieces of jewelry tested at 89 percent, 86 percent and 84 percent by weight. Overall, 12 percent of 103 pieces of jewelry contained at least 10 percent cadmium. 

This poses a serious public health risk to our children.  Cadmium is a known carcinogen that may interfere with neurological development in children.  Presently, there are no restrictions in the use of cadmium in the manufacturing of children's jewelry.

The Yaz birth control lawsuits may exceed 20,000 as they head to US District Court for the Southern District of Illinois.  The number of Yaz lawsuits underscores the popularity of the birth control as well as the aggressive marketing campaign of their manufacturer Bayer.  In spite of 3 separate FDA warnings, consumers continue to purchase and use the birth control.

Unlike other birth control pills, Yaz and its precursor Yasmin contain a type of progestin called drospirenone which have been associated with numerous adverse side effects including heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

Many of the lawsuits already filed in federal court claim that Yaz and Yasmin have caused blood clots and other serious side effects which were never mentioned in the onslaught of television advertising promoted by Yaz manufacturer Bayer.

Judge David R. Herndon (MDL No. 2100) is presiding over the MDL involving the Yaz birth control lawsuits.  In anticipation of the onslaught of birth control lawsuits, Judge Herndon has hired a law clerk to help manage the cases. 

As a new year dawns, there is hopeful news regarding patient safety.  That is the case in at least two states, Washington and Ohio, both of which took significant steps in improving patient safety by making public hospital safety data. 

In Washington state, the state Department of Health has developed a website where the state's hospitals' infection records and medical safety records are made public.  The new website has already benefited the hospitals as well as the patients.  When Washington's Swedish Medical Center, one of the largest hospitals in the state, was shown to have unusually high infection rates linked to central lines (tubes inserted into patients), the hospital responded to the bad news and began to correct the problem.  Updated state health data shows that the hospital has responded to the issue and is making corrections to resolve the infection issue.  Perhaps, this would not have happened if this data was not made public. 

In Ohio, the state Department of Health launched a website that tracks mortality rates for certain hospital procedures, compliance rates in treating common conditions, and provides three patient safety indicators. 

These new measures are positive signs that at least in some states, the fight for transparency and improvement in patient safety is making progress.

Lawsuits concerning Bayer's Yaz and Yasmin birth control products continue to mount as more women come forward after having suffered strokes, heart attacks, pulmonary emboli, and gall bladder problems as a result of taking the birth control.  The lawsuits have been consolidated in a multi district litigation in U.S. District Court for the Southern District of Illinois.  Thus far, there have been approximately 300 such lawsuits filed across the country.

Both Yaz and Yasmin are manufactured by Bayer Pharmaceuticals containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. The unique progestin has been implicated as the likely cause of the
issues surrounding both Yaz and Yasmin.

According to an August 2009 study published in the British Medical Journal, the drospirenone contained in Yaz and Yasmin carry 6.3 times increased risk of developing blood clots, deep vein thrombosis, or pulmonary embolism than other forms of birth control. 

Harrington and Sons of Williston Vermont has recalled 68 pounds of ground beef because it may be contaminated with E. coli O157:H7 bacteria.  The announcement was made in conjunction with the US Department of Agriculture's Food Safety and Inspection Service.

The recall is Class I which means that the health risk is high for those who consume the ground beef.  Class I food recalls involve serious risks to health including death in some instances.  The beef affected by the recall was produced on December 15, 2009 and was distributed to local restaurants and one retail business.

E. coli O157:H7 is a dangerous, potentially lethal bacterium that may cause bloody diarrhea, dehydration, and in the worst cases, kidney failure.  Those who are most at risk for serious illness are the very young, the elderly, infirm, and those with compromised immune systems.
Those who have questions or concerns about this recall can contact “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0:00 a.m. to 4:00 p.m. Eastern Time, Monday through Friday. Recorded food safety messages are available 24 hours a day.

A class of bone-building drugs known as bisphosphonates may actually reduce the instances of breast cancer.  While researchers aren't clear about the causal relationship between bisphosphonates and a reduction in breast cancer, new studies point to a reduction in the occurence of the cancer. 

According to a Wall St. Journal report, "In one study, researchers analyzed data from the huge National Institutes of Health-sponsored Women's Health Initiative and found that users of bisphosphonates had nearly a third fewer cases of breast cancer compared with nonusers.

A second study involving more than 4,500 postmenopausal women in Israel with and without diagnoses of breast cancer found that those who reported using bisphosphonates for at least five years were about 30% less likely to receive a breast-cancer diagnosis, even after controlling for risk factors such as family history and use of other medications." 

Now, there is a cautionary note to be considered with this class of drugs.  Hundreds of Fosamax lawsuits have been filed by those who've taken this particular bisphosphonate drug and suffered necrosis of the jaw bone.  

More research is needed before women begin taking bisphosphonates as a breast cancer prevention drug.  However, the initial results presented at the San Antonio Breast Cancer Symposium are interesting and worthy of further study.

The once popular birth control pills Yaz and Yasmin have been linked to an increased risk of blood clots, strokes, and a potentially deadly gallbladder disease.  The Yaz and Yasmin birth control pills utilize a different type of hormone than previous birth control pills which has been associated with an increased risk of blood clots, strokes, and now, gallbladder disease.  Drospirenone is the new type of hormone utilized in these birth control drugs and is perhaps boosting the level of cholesterol in bile and limiting the movement of the gallbladder associated with gallstones and gallbladder disease.  Drospirenone has also been associated with a dramatic increase in blood clots. 

Yaz and Yasmin lawsuits continue to be filed against their manufacturers Bayer and Schering.

The FDA is warning consumers not to mix certain heartburn drugs like Prilosec with Plavix, an anti-clotting drug.  Tests have shown that Prilosec (available over the counter) and Nexium (available by prescription) interfere with Plavix's ability to block platelet aggregation (it's anti-clotting effect).  Studies have shown that the drug interaction may cause Plavix's effectiveness to be reduced by 50%.  Plavix, an anti-clotting drug, is used to prevent the blood clots that typically lead to heart attacks and strokes.

The FDA noted that Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of a liver enzyme. Prilosec, which is a proton pump inhibitor designed to block acid build-up in the stomach, blocks that enzyme, thereby reducing the effectiveness of Plavix.

Yaz and Yasmin lawsuits continue to mount as more strokes, heart attacks, and blood clots are reported in those women taking the birth control pill manufactured by Bayer.  All the lawsuits allege that the progesterone used in the Bayer formulation is dangerous and causes the strokes and blood clots.  Studies of Yaz and Yasmin point to the fact that the ingredient used in these birth control pills, drospirenone, causes a potassium buildup which leads to a drop in heart rate.  The drop in heart rate may lead to clot formation.  Other studies have noted that drospirenone may also lead to an electrolyte imbalance which may trigger strokes. 

In spite of the drugs' initial popularity due to Bayer's aggressive marketing of the products, Yaz and Yasmin face mounting lawsuits.  Presently, the drugs remain on the market.  The FDA has not commented yet on the dangers of the birth control pills.

One million Maclaren baby strollers have been recalled by the company in conjunction with the US Consumer Product Safety Commission.  The recall was prompted by 15 reports of children placing their fingers in the hinge mechanism resulting in 12 finger amputations.  The affected models included Volo, Triumph, Quest Sport, Quest Mod, Techno XT, TechnoXLR, Twin Triumph, Twin Techno and Easy Traveller.  The high-end stroller retails for $100-$360.

The popular stroller is manufactured in China and is sold in the United States at Target stores as well as Babies "R" Us.  The strollers have been available for purchase on the US market since 1999.

A California hospital program has found a new way to drastically reduce medication errors in hospital settings, and it has nothing to do with purchasing expensive technology.  Healthcare officials UCSF implemented a program in which nurses who dispense medication were left uninterrupted while on rounds dispensing prescribed medications.  The result was fascinating.  The simple procedure reduced medication errors by 88% in 36 months.

"Medication errors make up the largest slice of the medical error pie," said Julie Kliger, director of UCSF's Integrated Nurse Leadership Program, which developed the medication errors' program. "Improving these numbers is a huge benefit to patient safety and, secondarily, it reduces costs."  Read more: http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2009/10/28/MNIM1AB9DB.DTL#ixzz0VNjTLYP3      

Medication errors result in approximately 400,000 preventable injuries each year at an annual cost of $3.5 billion in additional medical costs.

The low-tech strategies implemented in the program included nurses wearing bright colored vests or establishing "quiet zones" in the hospitals that indicate a nurse is not to be disturbed while administering prescription drugs.

An apparent domestic dispute turned deadly this afternoon in the Queen City.  The shootings in the 200 block of Jewett St. left one dead and at least one other person injured.  Since the incident took place near several middle and high schools, the schools were on lock down and all students were kept inside their school buildings. 

According to the Union Leader, a Manchester SWAT team was dispatched to the scene and quickly cordoned off the area.  The shooting was the second such incident in Manchester in the last 24 hours.

Medical errors account for an estimated 98,000 deaths each year in the United States.  These deaths are preventable.  However, they are rarely reported and not tracked.  These unfortunate facts remain major stumbling blocks to significant reform in healthcare today.

The Centers for Disease Control and Prevention estimate that an additional 99,000 hospital patients die from hospital acquired infections.

Because there is no national medical error reporting system, we can only rely on estimates.  However, these figures are alarming.  These estimates point to 200,000 Americans dying each year from preventable medical errors and infections.

Yet, the insurance lobby will have you believe the real problem in healthcare reform is medical malpractice.  However, the estimated statistics paint a different picture.  Medical errors and malpractice can't be addressed and resolved if there is no transparency in the system.

The national investigation undertaken by Hearst newspapers, which is available online at http://www.chron.com/deadbymistake chronicles the safety issues at the heart of the healthcare crisis in this country.

Pharmacy errors can be multi-faceted and can cause great injury to the patient.  Errors may occur in the processing or preparation of the prescription.  These pharmaceutical errors include preparing and dispensing the wrong drug or dispensing the correct drug but the wrong dosage.  The most common of these errors occurs when the wrong drug is dispensed.  Other pharmacy errors include: prescribing recalled medication, prescribing medication with known harmful effects, and mislabeled prescriptions. Other errors may occur when pharmacy technicians are not properly monitored and supervised by pharmacists and are allowed to prepare and fill prescriptions without adequate supervision. In some pharmacies, the sheer volume of prescriptions to be filled leads to medical and pharmaceutical errors.

These pharmaceutical errors can lead to serious injury and death.  Pharmacies and pharmacists are liable for such errors, since they have a duty of care to ensure that a prescription is properly and safely filled.

The Swiss government has begun a probe into the safety of birth control pills Yaz and Yasmin after a young woman died of a pulmonary embolism after taking the birth control pill for 10 months.  In the United States, the FDA has received 50 reports of deaths associated with Yaz or Yasmin since 2004. 

Yaz was approved for use in 2006 and is made with drospirenone which may increase potassium levels in certain users.  Both birth control pills, Yaz and Yasmin have been linked to an increase in high blood pressure, blood clots, and strokes.

Currently, there are 74 Yaz and Yasmin lawsuits pending across the United States.

Children's Tylenol, manufactured by McNeil Consumer Healthcare, has issued a recall of 21 of its products in cooperation with the FDA.  The recall concerns certain Tylenol products manufactured between April and June 2008.  The company explained its recall decision in a letter posted on its website,

"The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements.Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications."

The 21 Tylenol products include:

Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Strawberry
Children’s Tylenol Suspension 4 oz. Bubble Gum
Infants’ Tylenol Suspension 1/2 oz. Cherry
Infants’ Tylenol Grape Suspension Drops 1/4 oz.
Children’s Tylenol Dye Free Suspension 4 oz. Cherry
Children’s Tylenol Suspension 4 oz. Cherry
Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1/2 oz. Grape
Children’s Tylenol Plus Flu 4 oz. Bubble Gum
Children’s Tylenol Plus Cold Suspension 4 oz. Grape
Children’s Tylenol Plus Cough/ST Suspension 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Grape
Infants’ Tylenol Dye Free Suspension 1 oz. Cherry
Children’s Tylenol Pediatric Suspension 1 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Cherry
Children’s Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
Infants’ Tylenol Grape Suspension Drops H/G 1/2 oz.
Infants’ Tylenol Drops 1 oz. Grape
Children’s Tylenol Suspension 4 oz. Cherry, Hospital Govt.

The first Paxil birth defect lawsuit will commence today in Philadelphia.  The drug has been linked to birth defects in pregnant women who used the drug in the first trimester of pregnancy. There are more than 600 other Paxil lawsuits pending against the drug's manufacturer, GlaxoSmithKline PLC.

According to the results of two scientific studies, women who were taking Paxil during the first three months of pregnancy were 1.5 to 2 times as likely to give birth to a child with heart malformations than those who had taken other antidepressants.  Another study showed evidence that babies born to mothers who took Paxil were susceptible to persistent pulmonary hypertension, a rare but life threatening condition that could potentially lead to multiple organ failure and death.

In 2005, the FDA warned consumers of the potential Paxil side effects.  The studies showed cardiovascular damage such as atrial and ventricular septal defects.  Other side effects include:

Difficulties with breathing
·    Seizures
·    Vomiting
·    Low blood sugar
·    Tremor
·    Irritability

Court papers submitted by the plaintiff show that Paxil's manufacturer knew about the potential side effects as far back as 1980 but did nothing about it.

“There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.

The first Fosamax trial may end in a mistrial if the jury is not able to reach a unanimous verdict by Friday, a judge told the jury yesterday.  The trial is the first of 900 lawsuits brought against the manufacturer of Fosamax, Merck. The lawsuits allege that Fosamax leads to osteonecrosis of the jaw or jaw rot.

Fosamax was manufactured by Merck in order to treat osteoporosis. However, soon after Fosamax was introduced to the marketplace, Fosamax users began complaining of jaw problems including deterioration of the jaw bone.

While US District Court Judge John Keenan warned of a possible mistrial, he also ruled in favor of the plaintiffs in Merck's attempt to dismiss 24 other Fosamax lawsuits.  Keenan will allow the testimony of two doctors who will testify that Fosamax may cause jaw necrosis after less than 3 years of continuous use.

Approximately 220,000 Jeep Wranglers are being investigated by the National Highway Traffic Safety Administration for fire hazards.  NHTSA is investigating 2007 and 2008 Jeep Wrangler models for transmission defects.  In 3 cases, the transmissions overheated causing transmission fluid to leak and catch fire.

According to preliminary reports from the NHTSA investigation, the transmissions were manufactured at the Chrysler plant in Kokomo, Indiana.  No injuries have been reported due to the transmission defect.  It is unknown if the Jeep Wranglers will be subject to a recall at this time.

Drug manufacturer Eli Lilly settled its lawsuit with the state of West Virginia for $22.5 million.  The lawsuit was prompted by the manner in which Eli Lilly marketed Zyprexa for uses that had not been approved by the FDA.  The lawsuit also claimed that Eli Lilly downplayed such Zyprexa side effects as weight gain and the onset of diabetes.

Zyprexa is approved to treat schizophrenia and bi-polar disorder.  However, Eli Lilly had aggressively marketed its best-selling drug for unapproved uses such as dementia and depression. 

Physicians may prescribe any drug for off-label purposes.  Drug companies are prohibited from marketing their products for uses other than those approved by the FDA. 

Eli Lilly still faces lawsuits from seven other states over its Zyprexa marketing practices.

The West Virginia settlement is not the first lawsuit to be settled by Eli Lilly.  In January, Eli Lilly agreed to pay $1.42 billion, including $362 million to 30 states to settle claims against the company for its prohibited marketing practices. 

The Journal of the American Medical Association published two articles raising questions about Gardasil's safety and effectiveness as well as the way it has been marketed.

Researchers at the Centers for Disease Control and the FDA analyzed more than 12, 400 reports of adverse events related to Gardasil.  Approximately 6% of those adverse events resulted in hospitalization, permanent disability, or death.  However, the study's lead author Dr. Barbara Slade, a medical officer in the immunization safety office of the U.S. Centers for Disease Control and Prevention, stated that the study did not suggest the deaths were caused by Gardasil.  The primary adverse reports concerned a higher incidence of fainting and blood clots than those receiving other vaccines.

Perhaps more troubling was the article concerning Merck's marketing practices regarding Gardasil.  The study's authors criticized Merck for funding education campaigns that didn't provide the public with a balanced view of the drugs benefits and risks.  According to the Wall St. Journal, "Doctors have questioned how effectively the vaccine prevents cervical cancer, given that its regulatory approval was for protecting against two strains of human papilloma virus, or HPV, that can cause cancer, but not all cancer-causing strains. Also, the vaccine was tested in only a few hundred 11- and 12-year-old girls, which some doctors said was too small a number to declare it safe for that age group. Critics assailed Merck's efforts to get states to require HPV vaccination, a push Merck backed away from in 2007."

In its critique of Merck's marketing practices, the authors noted that Merck emphasized the threat of cervical cancer in adolescents and minimized the sexual transmission of HPV.

Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association, wrote an accompanying editorial in this week's JAMA calling Merck's marketing of Gardasil "pushy" and "disturbing".

The National Cancer Institute estimates that there will be 192,370 new cases of breast cancer among women this year. 40,170 women will die from breast cancer, according to the Institute. In spite of these statistics, breast cancer remains one of the more treatable forms of cancer if it is detected early through breast examination and mammography. It is estimated that between 85-90% of all breast cancer can be detected by mammography. The American Cancer Society recommends a baseline mammography before a woman reaches the age of 40 and an annual mammography every year thereafter. Still, breast cancer is the second leading cause of cancer deaths among women today. Some of these deaths occur because of a breast cancer misdiagnosis or a late diagnosis of breast cancer. A misdiagnosis may occur when a radiologist misreads a mammogram. Additionally, the rate of false negatives for mammograms is 10%. If a routine breast examination reveals a lump or mass in the breast but is not detected by mammography, the standard of care warrants follow-up diagnostic exams and testing including an ultrasound or biopsy. In cases where a breast biopsy is ordered, errors in diagnosing are an unfortunately all too common malpractice claim. In cases where the healthcare professional failed to timely diagnosis breast cancer the consequences can be fatal. The survival rate between Stage I breast cancer and Stage IV plummets 80% according to some studies. Since breast cancer is a progressive disease, any delay can have serious negative consequences. Breast cancer is one of the most commonly misdiagnosed forms of cancer. If you are presenting symptoms of breast cancer, see a doctor immediately. If you are not satisfied with your doctor, make an appointment to see another one, preferably a specialist. Be proactive.

In May 2006, Dr. David Polly testified before a U.S. Senate Committee concerning the importance of developing new medical devices to treat Iraqi war veterans, especially Medtronic’s Infuse Bone Graft. He told the committee that he was speaking on behalf of the American Academy of Orthopedic Surgeons. During his testimony, he spoke about his work at Walter Reed Army Medical Center as well as his work as a spine surgeon at the University of Minnesota. He didn’t mention that Medtronic Corp. had paid for the trip to Washington as well as his consulting services. According to the Wall St. Journal, Dr. Polly was paid $1.14 million by Medtronic from 2004-2007. Polly is a paid Medtronic consultant who is one of the doctors paid to promote Medtronic’s Infuse Bone Graft. In July 2008, the FDA issued an Infuse safety warning. Since that time, the federal government has been investigating the relationship between doctors and Medtronic. Dr. Polly is not the first paid medical consultant to come under FDA scrutiny. Dr. Timothy Kuklo, an Army surgeon, has been accused of falsifying Infuse research as well as plagiarizing the signatures of other doctors on a favorable Infuse medical journal article. These conflicts of interest demonstrate a safety concern for the general public as well as healthcare professionals who rely on scientific testimony to determine if a medical device is safe and effective. Doctors who are paid to promote a particular medical device and do not disclose such financial relationships to the public constitute a public health hazard. Scientific research on pharmaceutical drugs and medical devices must be objective and free of influence from financial gain.

Consumer watchdog group Public Citizen announced this week that diabetes drug (Rosiglitazone) Avandia increases the risk of liver failure. Avandia has already been linked to an increase in risk for heart attack. Public Citizen has called for the FDA to ban Avandia. A review of adverse events reported to the FDA found 11 deaths due to liver toxicity between 1997 and 2006. "Because of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug," said Dr. James Floyd of Public Citizen. He estimated that 1 in every 44,000 patients who take the drug develops liver failure. The concern about liver failure adds to the list of problems associated with Avandia. Studies have shown that Avandia use increases the risk of heart attack by 40%, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss. No such adverse events have been associated with the older, cheaper diabetes drugs Metformin (Glucophage) and Glipizide (Glucotrol).

Morgantown West Virginia is a sleepy community of nearly 30,000 residents and is best known as the home of West Virginia University. It’s also home to the world’s third largest manufacturer of generic drugs. Earlier this spring, Mylan Inc. halted production of its generic drugs. The May 11th discovery involved violations of government mandated quality control procedures. An internal company report obtained by the Pittsburgh Post-Gazette details reports about employees overriding computer generated warnings concerning problems with drugs they were manufacturing. The report noted that quality control procedures had been circumvented and products were adulterated. To make matter worse, the report indicated these were not isolated issues. They were happening on all shifts for the last two years. Mylan Inc. manufactures approximately 19 billion doses of medications annually that are prescribed to treat high blood pressure, diabetes, cancer, depression, among other diseases. According to an article in the Pittsburgh Post Gazette, "I've never before seen anything like this, that has reached this level of cheating," said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. "It certainly indicates a significant problem within their company." While Mylan officials contend that their products remain safe, government officials remain skeptical. "The batch record is there to tell the story, the good, bad and ugly," said Robert Lewis, a regulatory consultant in Georgia and former FDA investigator who also reviewed Mylan's report. "Whenever there is a problem [during production] it should be noted and discussed and evaluated." Experts said there was not enough information in the report to judge whether any drugs going out the door had been compromised. The report described "serious [FDA] violations, no question about that," Ms. Bennett said. "To cheat, if you will, with an electronic record and say it is pervasive on all three shifts ... is very, very serious. "But I can't determine from this report whether it's catastrophically serious," she said, meaning whether the breaches resulted in tainted medications. Read more: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MbY2isLQ

Pfizer Inc. will go to trial this Monday concerning its epilepsy drug Neurontin. It is the first case to be tried among an estimated 1,200 Neurontin lawsuits that allege the epilepsy drug increases the risk of suicide among users. In spite of the looming trial date, Pfizer hasn’t taken financial reserves to deal with litigation expenses. US District Judge Patti B. Saris stated in a July 20 pretrial hearing that the plaintiff’s case will be a tough one because of the plaintiff’s personal history of drug use and previous suicide attempts. The Neurontin trial stems from the 2004 suicide of Susan Bulger, a 39 year old woman who had ingested the drug hours before her suicide. Pfizer lawyers contend that Bulger’s suicide stems from a long history of drug use and multiple suicide attempts. Bulger’s family believes that Pfizer downplayed the drug’s dangers and its increased risk of suicide. Bulger’s lawyers cite the December 2008 FDA ruling ordering all epilepsy drugs to carry a warning label associated with the increased suicide risk as supporting evidence of its claims against Pfizer. The Neurontin lawsuit also contends that Pfizer marketed the epilepsy drug for off-label use, which is illegal. While doctors may choose to prescribe drugs for off-label use, pharmaceutical companies are forbidden from marketing drugs in such a fashion. In 2004, Warner-Lambert paid $430 million to resolve US Justice Department allegations of off-label use involving Neurontin. While Pfizer lawyers will attempt to demonstrate Susan Bulger’s past drug use and history of suicide attempts as the cause of death, the judge has refused to dismiss the case. She has described the relationship between Neurontin and the increased risk of suicide as “biologically plausible”. Industry officials and those who have legal claims against Pfizer will watch the proceedings closely. The outcome of this trial may provide an indication of the fate of the remaining Neurontin lawsuits. The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.

In spite of a 2002 FDA Consumer Advisory, kava drinks continue to be popular in the United States. In some states, kava bars have opened for business and are doing quite well. Kava users tout the calming effects of the herbal supplement while manufacturers expound on the all natural qualities of the product. Kava(piper methysticum) is an ancient herbal supplement derived from the root of a crop that grows naturally in the Pacific Islands. Kava is normally taken as a tea but may be ingested in pill form. In spite of its all natural ingredients and tranquilizing qualities, the supplement has come under scrutiny for its association with hepatoxicity. In some countries, the supplement is banned because it has been associated with liver injury including liver failure. In its March 2002 advisory, the FDA noted 25 such liver injuries around the world. In the United States, there have been reported injuries including at least two deaths associated with the ingestion of kava products. These two deaths were preceded by failed liver transplants. Kava is still under FDA scrutiny and several pending lawsuits may reveal more about the potential dangers of this all natural herbal supplement.

The makers of the highly popular cholesterol drugs Zetia and Vytorin have agreed to pay $5.4 million in legal costs to 35 states and the District of Columbia. The legal probe conducted by the states' attorneys' general centered on allegations that the drug companies' attempt to conceal the results of an unfavorable study concerning the effectiveness of the expensive cholesterol drugs. In January 2008, Merck and Schering-Plough released the results of the study and were criticized for not releasing it in 2006 when the findings had been completed. The study showed that Zetia and Vytorin were less effective in fighting plaque build-up in the neck than the older, much cheaper drug Zocor. Later studies have called into question Zetia and Vytorin's effectiveness and safety in comparison to the older cholesterol drugs. In addition to the $5.4 million, the drug companies must do the following: obtain preapproval from the FDA for all DTC advertisements, comply with FDA suggestions to modify their drug advertising,register their clinical trials and post the trials’ results, reduce the possibility of conflicts of interest involving external Data Safety Monitoring Boards for company-sponsored trials,and comply with other detailed rules to prevent the deceptive use of clinical trial results.