Abramson, Brown & Dugan Attorneys

The August Issue of Pediatrics reports that more than 70,000 children are injured by medical devices each year.  Almost 25% of the injuries are associated with ophthalmic devices such as contact lenses.  However, many of the injuries come from invasive medical devices such as catheters, tubes, and shunts.  One expert noted that the majority of medical device injuries are linked to tubed placed in the stomach such as shunts or IV tubes.

"We see a few of those a week," said Dr. Valerie T. Thompson, an assistant professor of clinical pediatrics and division director of pediatric emergency medicine and medical director of the pediatric emergency department at the University of Miami Miller School of Medicine.

Researchers from the FDA's Centers for Devices and Radiological Health examined data gathered from pediatric emergency room visits.  The study is the first of its kind to focus on medical devices and pediatric injuries.  The study may result in device warnings for certain medical devices used in pediatric patients.

GlaxoSmithKline's diabetes drug Avandia will be the subject of a two-day FDA advisory panel debate beginning today.  Since 2007, the federal government and the public have known that scientific research has suggested that the diabetes drug poses an increased risk of heart attacks for those taking Avandia.  Additionally, studies have shown that Avandia is not effective in treating diabetes.

Those facts are just the tip of the iceberg concerning GlaxoSmithKline's problems with Avandia. Today's NY Times reports that Glaxo officials have known about Avandia's safety issues since the drug's arrival on the marketplace in 1999.  According to the Times' article, Glaxo ordered a secret study of the drug's safety and efficacy in comparison with its chief rival Actos in 1999.  Avandia failed miserably.  The internal study showed Avandia did indeed pose greater risks of heart attacks than Actos and was ineffective in treating diabetes.  The NY Times front-page article notes that the pharmaceutical company spent the last 11 years hiding the results of that study.

This week, the FDA advisory panel may call for the drug's removal from the marketplace.  Thus far, it has been slow to react to studies showing Avandia's safety concerns.  This week may be the week in which the FDA acts in favor of public safety.

In spite of more than 1,000 lawsuits filed against Bayer, the company's newest birth control pills Yaz and Yasmin continue to be best selling products.  Bayer launched an aggressive and effective marketing blitz targeting young women that was later flagged by the FDA for claims Bayer made concerning its use and effectiveness.

More importantly, Yaz and Yasmin have been associated with an increased risk of heart attacks and strokes in otherwise healthy, young females.  While the data is controversial, the FDA has approved an updated warning label for the birth control pills that notes the drugs' increased risk of blood clots.  The updated warning was influenced in part by a British medical study that associated the active ingredient in Yaz and Yasmin, drospirenone as the culprit.

Drospirenone is a new progestin only found in Yaz, Yasmin, and Ocella birth control pills.  Drospirenone affects the body's ability to regulate levels of salt and water, which may result in elevated potassium levels.  This condition is known as hyperkalemia, which can lead to life threatening cardiac problems.

Presently, federal Yaz and Yasmin lawsuits are consolidated in multi district litigation (MDL) in the Southern District of Illinois.  There are also consolidated state lawsuits in Pennsylvania and New Jersey.

Recent medical statistics put wrong site surgery events at 13% of medical errors.  This is a high percentage given the protocols and procedures the Joint Commission has enacted in order to prevent these wrong site surgeries.  The Joint Commission, a patient advocacy group, introduced the Universal Protocol in 2003 in order to prevent such medical errors.  The Joint Commission's Universal Protocol has been widely acclaimed by the American Medical Association and other health industry groups. The Protocol consists of three important steps to avoid such errors:  1)pre-op identification and confirmation that the procedure matches the patient, 2)marking the operation site with a permanent marker, and 3)taking a "time out" immediately prior to the procedure to check once again that the patient is correct and the procedure and site match.

However, nothing has stemmed the tide of wrong site surgical errors.  Of course, the human factor is a component of this problem.  Some wrong site surgeries occur in emergency situations where a patient has to be rushed to surgery in order to save a life.  On other occasions, multiple doctors add to the operating room confusion. 

None of these circumstances excuses the fact that all wrong site surgeries are preventable.

Silvia DeSilva is planning to file a medical malpractice lawsuit against King Edward VII Memorial Hospital and Brighan and Women’s Hospital in Boston after she was given a gadolinium-based contrast agent in preparation for an MRI.  DeSilva is a kidney dialysis patient who contracted the painful and potentially fatal condition known as nephrogenic systemic fibrosis (NSF) as a result of the contrast agent.

In 2006 and 2007, the FDA issued warning to healthcare professionals that gadolinium-based contrast agents used in MRI procedures significantly increase the risk of NSF, especially in patients with known kidney problems.  The FDA warnings resulted in a black box warning for all gadolinium-based contrast agents.  The black box warning is the most severe warning issued by the FDA.

In spite of the warning and Mrs. DeSilva's known kidney problems, the hospital administered the contrast agent resulting in her NSF condition.  NSF is associated with a hardening and thickening of the skin tissue as well as internal organs.  There is no known cure for the progressive disorder.

Actor Dennis Quaid has filed a lawsuit against the drug company that manufactures heparin after his newborn twins nearly died from a heparin overdose two years ago.  The suit was filed against Baxter Healthcare Corporation and alleges that the drug packaging caused the drug error in the overdose.

Both heparin and a lower dose version Hep-Lock are packaged in similar blue vials.  The drug labeling on the packages has very small print which can lead to confusion over the two drugs.

A bill that would reverse a 60 year old Supreme Court ruling banning military service members from suing the federal government for medical errors or medical malpractice has gained the influential support of the Military Officers Association of America.  Presently, those in our armed forces can not sue for medical negligence.

“Your legislation would remove an inequity,” retired Vice Adm. Norb Ryan, president of the 370,000-member Military Officers Association of America, wrote in a Friday letter to Rep. Maurice Hinchey, D-N.Y., the lead sponsor of the bill.

Rep. Hinchey's bill, the Carmelo Rodriguez Military Medical Accountability Act, would allow service members to bring lawsuits against the federal government for damages arising from medical errors or medical negligence.  According to Vice Admiral Ryan, the bill would be particularly appropriate since members of the military often have little choice in selecting their medical providers. 

The bill is named after a Marine Corps platoon leader Carmelo Rodriguez, an Iraq war veteran who died at age 29 from a melanoma that was not properly treated.  Initially, the melanoma was correctly diagnosed but not treated.  It was later misdiagnosed as a birthmark.

The bill was approved by the House Judiciary Committee and is pending a full House floor vote.

A deep vein thrombosis is a serious, potentially fatal condition where a blood clot forms in the deep veins of the lower extremities or the pelvis.  The real danger occurs if the clot breaks away and travels to the lungs.  The clot may block the main artery of the lung putting pressure on the right ventricle of the heart.  This can be fatal if not diagnosed in a timely fashion. 

A patient suffering from deep vein thrombosis may be misdiagnosed with a less serious ailment such as a leg cramp.  If the DVT is not diagnosed and treated promptly, it may lead to death.  Symptoms of a DVT include:  pain and/or swelling of the leg, redness surrounding the swollen area, and dilation of the surface veins.  Diagnostic tests can and should be performed to rule out a DVT.  Failure to perform such diagnostic tests may constitute medical negligence depending on certain circumstances. 

DVTs may arise from invasive surgical procedures such as knee and hip replacements.  Since deep vein thrombosis is such a serious condition, doctors have a duty to diagnose and treat such conditions promptly.

McNeil Consumer Healthcare, a division of Johnson & Johnson, has issued a voluntary recall of popular children's over-the-counter drugs including Children's Tylenol, Motrin, Zyrtec, and Benedryl due to manufacturing issues.  The manufacturing issues may affect the quality, potency, and/or purity of the drugs.

While it's not yet clear how many children, if any, may be affected by the product recall, it's a public relations blow to a company that prides itself on safety and effectiveness.  The recalled products include:

http://www.mcneilproductrecall.com/images/mcneil_recall/Final_list.jpg

The largest health insurance provider in the country, WellPoint, has developed a strategy for dropping insurance coverage for breast cancer patients and others who have to use their insurance to pay for health care.  In fact, WellPoint has a software program that flags insurance customers who've been diagnosed with illnesses such as breast cancer.  According to government regulators, the health insurance company uses the software to find a pretext under which policy holders can be dropped from their coverage, even if they've paid their premiums faithfully and on time.  WellPoint may not be the only health insurance company to employ the practice of "rescission" but a congressional committee deemed WellPoint the worst offender.

In one particularly egregious 2008 case highlighted by Reuters, Robin Beaton had to delay her breast cancer surgery for five months because her insurance was canceled after she received a diagnosis of breast cancer.  During that time, the tumor in her breast grew from 2 centimeters to 7 centimeters.  The Friday prior to her Monday surgery, her insurance company said it wouldn't pay for her surgery.  The insurance company told her that they were launching a fraud investigation and would sue her if they found she had made a fraudulent breast cancer claim.  Her doctors told her the slightest delay could threaten her life.  Because of the delay, she had to undergo a radical double mastectomy and her survival rate is only a fraction of what it would have been if the original surgery had not been delayed.

This is a woman who had paid for health insurance and yet her insurance company refuses to pay for a procedure her doctors say is necessary for her very survival.  Perhaps it's time we start talking about insurance reform.

Prompted by recent articles concerning radiation errors by the NY Times, the FDA has announced that it will no longer allow new radiation equipment to enter the marketplace through a quick, streamlined process involving third party reviewers.  The prior approval process was instituted in the 1990's to quicken approval time but led to radiation errors and patient suffering.

The FDA found that 74% of the radiation errors involved linear accelerators, computer controlled machines that generate high powered beams of radiation intended to destroy cancer cells.  Computer software problems were most frequently cited as the cause of radiation errors.

The more rigorous approval process for new radiotherapy equipment presupposes continuous FDA follow-up and enforcement of the guidelines. 

Radiation errors have caused debilitating injuries and even death in some instances.

In what is believed to be the largest medical malpractice settlement in the state's history, the family of Diane Rizk McCabe settled their lawsuit against Albany Medical Center Hospital and two obstetricians, Dr. Sean Yong-Il Lee and Dr. Cheryl Burack.

A month after the Illinois Supreme Court repealed a law capping damages in medical malpractice cases in that state, the Georgia Supreme Court followed a similar path.  In ruling that the state legislature may not put restrictions on medical malpractice awards determined by juries, the Court overturned a 2005 state law that capped malpractice awards at $350,000 for pain and suffering.

“The very existence of the caps, in any amount, is violative of the right to trial by jury,” Chief Justice Carol W. Hunstein wrote in the decision.

Since the 1980's several states have also rejected damage caps in malpractice cases including New Hampshire, Oregon, Washington, and Wisconsin.  These are important rulings for consumers that restore the rightful role of the judicial system as well as the crucial role of juries in our system.

The Georgia case involved a 71 year old woman, Betty Nestlehutt, who was permanently disfigured after a botched surgery. 

Fosamax, a popular osteoporosis drug that belongs to the bisphosphonates family of drugs, has been linked to jaw necrosis and increased risk of femur fractures.  Merck's patent for the drug expired in 2008. 

Bisphosphonates are designed to increase bone mass but research has shown that this class of drugs may make them more brittle thus increasing the risk of bone fractures. 

According to a recent Wall St. Journal report, "Two studies presented Wednesday at the American Academy of Orthopaedic Surgeons' annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur, or the main bone in the thigh, when used for four or more years."

The federal agency didn't provide a timeline for its review of Fosamax.  However, the number of Fosamax complaints and Fosamax injuries may compel the FDA to move in a timely fashion as to the safety of the osteoporosis drug.

In response to concern that some CT scans have provided patients with excessive radiation, The Medical Imaging & Technology Alliance has announced that it will install safety controls on its CT scans.

Recent news reports, including an article in the NY Times, has focused attention on dangerous dosages of radiation emitted by CT scans.  Last October, the FDA launched an investigation concerning the issue at Cedars Sinai Hospital in Los Angeles confirmed that 206 patients had received 8 times the normal radiation for brain scans. 

Last week, James Parks told a US House panel about his son's death of a radiation overdose.  The Parks' tragic case was the subject of a lengthy NY Times article last month and my partner Kevin Dugan's blog post. 

News that an industry trade group such as The Medical Imaging & Technology Alliance has decided to step forward and address the issue is a good first step.  Such radiation overdoses and radiation errors have led to too much tragedy and suffering already.

The Joint Commission has released its report card on the nation's hospitals in what industry officials view as an important step in improving the quality of healthcare in the United States.  The report card issued by the Joint Commission focuses on the healthcare quality measurements that hospitals consider the gold standard of care.  The hospital report cards should serve consumers with the level of transparency and knowledge concerning their hospitals' standards of care.

The Joint Commission is a nonprofit organization that accredits most U.S. hospitals, publishes a consumer-friendly report called Quality Check. It grades hospitals on how well they follow care practices that are considered industry standards, ranging from infection control standards to educating patients.

The health grades also serve as an important educational tool for hospitals seeking to improve their level of care or resolve deficiencies in care.  For instance, a hospital may receive a failing grade in one area of care such as heart failure.  The report gives hospital officials the tools with which the problem can be discovered, a solution offered, and an action plan implemented that reduces the deficiency.

Several news outlets are asking whether Congressman John Murtha's recent death after gallbladder surgery was caused by a medical error.  This morning Politico.com's reporter Dr. Davis Liu wrote, "Perhaps Murtha, 77, was one of the unlucky 2 out of 100 to have died from this elective surgery. It is also equally likely that he died of a medical error or omission."

It's noteworthy that Liu, a doctor himself, focuses his attention on the problem of preventable medical errors and hospital deaths.  Liu opens his article by stating, "With the ongoing debate in Washington about the nature of health care reform, Murtha's passing shines light on one area that hasn't had enough scrutiny, how to make our health care system safer. As the American health care system has been labeled by some as the most advanced in the world, others are critical of the fact that so many people die in hospitals annually due to preventable medical errors."

 

 

The Checklist Manifesto is an important new book authored by surgeon Atul Gawande.  In the book, the author discusses the importance of preparation (using a checklist) to ensure that such things as medical errors are avoided.  Gawande makes the point that it takes a system of redundancy to avoid common medical errors.  While the book is not solely intended for the healthcare profession, doctors and hospitals should read this book and incorporate his ideas on how to improve healthcare and avoid errors in the future.

Some of his suggestions may appear obvious.  For instance, he notes that in a surgical setting those in the room should know each others' names.  That may be obvious, but what procedures are in place in operating rooms across the country to ensure this happens?  Checklists help us recognize what's important and what needs to take place in each and every situation.  Completing such checklists helps busy professionals avoid common errors that may be taken for granted in the absence of such a checklist. 

The checklist idea is the brainchild of Dr. Peter Pronovost, a critical care specialist at the Johns Hopkins medical center in Baltimore.  According to a December 2009 NY Times book review,

"In 2001 Dr. Pronovost borrowed a concept from the aviation industry: a checklist, the kind that pilots use to clear their planes for takeoff. In an experiment Dr. Pronovost used the checklist strategy to attack just one common problem in the I.C.U., infections in patients with central intravenous lines (catheters that deliver medications or fluids directly into a major vein). Central lines can be breeding grounds for pathogens; in the Hopkins I.C.U. at the time, about one line in nine became infected, increasing the likelihood of prolonged illness, further surgery or death.

Dr. Pronovost wrote down the five things that doctors needed to do when inserting central lines to avoid subsequent infection: wash hands with soap; clean the patient’s skin with chlorhexidine antiseptic; cover the patient’s entire body with sterile drapes; wear a mask, hat, sterile gown and gloves; and put a sterile dressing over the insertion site after the line was in."

While these seemed obvious to everyone, they involved the leading causes of infections in the ICU because they weren't being followed.  The Times continued,

"But Dr. Pronovost knew that about one-third of the time doctors were skipping at least one of these critical steps. What would happen if they never skipped any? He gave the five-point checklist to the nurses in the I.C.U. and, with the encouragement of hospital administrators, told them to check off each item when a doctor inserted a central line — and to call out any doctor who was cutting corners. As Dr. Gawande relates it, “The new rule made it clear: if doctors didn’t follow every step, the nurses would have backup from the administration to intervene.”

The final medical malpractice myth has political overtones.  It's the myth that tort reform will lower insurance rates in this country.  Tort reform, as it is understood in the political realm, is really all about limiting citizens' access to the courts by capping the damages awarded to victims of malpractice cases.  The argument is spun by insurance company lobbyists who spend millions trying to convince the public that medical malpractice cases are all about greedy lawyers.  
The facts tell a different story.  States that cap damage awards are very similar to states that don't cap damages in terms of insurance premium rates.

In fact, in 2009, the average liability premium in states without caps damages were lower than the average premium in states with caps on damages, with premiums of $43,709 and $44,799 respectively.

While lobbyists continue to point to tort reform as the way to lower insurance premiums, the insurance industry has admitted there's no correlation between the two.  Dennis Kelly of the American Insurance Association (AIA) has said, “We have not promised price reductions with tort reform.” In addition, an AIA press release stated: “Insurers never promised that tort reform would achieve specific premium savings...”

According to Bob White, President of First Professional Insurance Company, the largest medical malpractice insurer in Florida, “no responsible insurer can cut its rates after a [medical malpractice tort ‘reform’] bill passes.”

If the insurance industry admits there's no relationship between tort reform and lower insurance premiums, why does the myth continue?  Perhaps, because it makes for good political theater.  However, good political theater does little to protect the consumer.  Access to the courts is a basic fundamental right that shouldn't be attacked to score political points.

The American Association for Justice published "5 Myths About Medical Negligence" last November.  In the next few blog posts, we're going to discuss these myths.  The first one is "There are too many frivolous lawsuits".  This myth is easily dispelled by looking at the facts and not the rhetoric from the insurance industry.  According to the Institute of Medicine, 98,000 patients die each year from preventable medical errors.  However, the number of medical malpractice lawsuits remains very low.  Many states require that any medical malpractice claim be submitted to a review board prior to the filing of a lawsuit.  Furthermore, medical malpractice lawsuits are extremely expensive and labor intensive.  Experts have to be hired and countless hours of staff labor go into each case.  Any law firm that pursued frivolous lawsuits would soon find itself out of business.

According to the Harvard study, researchers found that 97% of closed medical malpractice claims are meritorious and that 80% involved death or serious injury.

Medication errors are a serious and growing problem in the United States.  Such errors kill one person a day and injure another 1.3 million people each year.  Those statistics prompted the formation of a new network to prevent medication errors.  The two medical organizations, the American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP), have joined forces to reduce medication errors.  The new coalition will be called the National Alert Network for Serious Medication Errors and will be triggered when a harmful medication error has occurred. 

"This rapid system of sharing information with physicians, nurses, pharmacists and others in health care sets this alert system apart from previous efforts,” Henri R. Manasse, Jr., ASHP Executive Vice President and CEO, said in the press release. “It is heartbreaking and frustrating to see the same mistakes happen again and again. This alert system is a significant and imperative step – creating more transparency and breaking the chronic cycle of medication errors.”

As a New Hampshire medical malpractice lawyer, I've been helping victims of medical errors and malpractice for the past 35 years.  I've handled all types of cases involving failures to diagnose cancers, heart attack, and strokes.  My cases have also included birth injuries caused by healthcare professionals.  In each of these cases, I've had to establish and prove duty, breach, causation and damages.  If any of these elements isn't proven, I lose.  Medical malpractice cases are difficult because the entire burden of proof rests on the victim.  This means that my law firm only takes meritorious cases.  The notion that medical malpractice lawyers accept and win so-called "frivolous" lawsuits is simply not true.  Medical malpractice cases are expensive and time consuming.  My firm has a good reputation because we are selective in the cases we accept and the diligence with which we treat each and every case we handle.

It's a debate that's intensifying as victims of medical malpractice and wrong-site surgeries are demanding to know what happened in the operating room that caused the medical errors.  The topic has been broached on Kevinmd.com blog.  Interestingly, the author of the blog post is a surgeon himself.  In the post, Dr. Martin Young notes that airline pilots have cockpit flight recorders that record their work.  So, why shouldn't surgeons have their procedures recorded and/or videotaped to ensure transparency and review for errors?  It would seem a logical question to ask if the medical community is interested in reducing instances of medical malpractice and medical errors. 

Dale Ann Micalizzi is the mother of an 11-year old boy who died during a routine surgical procedure in a hospital in Albany.  She left a comment on the blog post that is well worth quoting:

"I believe in real time recorded surgical procedures for educational and ethical reasons and I think they will fix some of the wrong site surgeries that are continuing to occur. Staff will think...or check... twice and hopefully an open dialogue will result. The patient and family deserves to see the recording-all recordings and become actively involved in the root cause analysis when things go wrong. No, the recordings should not be edited just as medical records are not supposed to be edited. There are still bugs to work out to make this system idea work efficiently. This is not big brother watching you. It is a safety monitor. In the future world of IT, the recording and records would belong to the patient."

Her argument makes sense and would afford her and countless others a sense of what went wrong during the surgical procedure.

Now that it appears likely that some form of healthcare reform legislation will be enacted this year, it's important to remember that true healthcare reform begins with an increased emphasis on patient safety.  This is not accomplished by tort reform measures that only serve to penalize the injured.  Medical malpractice cases will be reduced when medical errors are reduced.

The American Association for Justice is highlighting this fact with a new patient safety website.  The new site notes that 98,000 people die each year from preventable medical errors.  According to the website, that's equivalent to two 737 jetliners crashing every single day.  Would we blame the passengers for such an airline crash?  Of course, we wouldn't so why would we penalize patients when they are the victims of medical errors?

The NY Times published an article today about the current status of patient safety.  The article, written by a doctor, notes that there are still issues that are unresolved some ten years after the publication of the groundbreaking study "To Err is Human: Building a Safer Health System”.  That study concluded 98,000 patients die each year from preventable medical errors. 

In her NY Times article, Pauline W. Chen, M.D. notes that the "To Err is Human" study prompted a review and focus on system errors in hospital settings that lead to medical malpractice.  Ten years after the study, some doctors are calling on their own colleagues to be accountable for their own human errors that lead to medical errors. 

One of those doctors,Dr. Robert M. Wachter, a professor at the University of California, San Francisco and a leading health safety expert, has been critical of the safety movement for its failure to recognize the human element in medical errors. 

“A blame-free culture carries its own safety risks, he writes, “As we enter the second decade of the safety movement, while the science regarding improving systems must continue to mature, the urgency of the task also demands that we stop averting our eyes from the need to balance ‘no blame’ and accountability.” 

In his interview with the NY Times, Dr. Wachter is clear on the role fellow doctors play in patient safety.  Here's an excerpt from the interview:

"If I were a patient or a loved one, I would do what everyone recommends — have a loved one by your side, look for signals that a hospital is safe, check that a physician is board certified. But I am also intensely ambivalent about how responsible patients should be for safety and the prevention of error. Medical mistakes are our bad. Why should patients bear the responsibility to receive the right medication or to have the correct leg amputated? When I get on a plane, I don’t worry about safety and errors.

As for doctors, patient safety can’t happen if physicians aren’t smack in the middle of it. We can either facilitate safety or we can stand its way. We will stand in its way if we embrace our historical approach to these problems, if we instinctively engage in finger-pointing, if we aren’t willing to listen to others.

We have a huge role in creating the kind of environment where people will feel comfortable questioning anything that seems strange or out-of-place and where doctors are open to different opinions from others.

As doctors, we have to admit first that we don’t deliver care that is of the quality and safety our patients deserve. Then we have to get past our professional arrogance. We don’t have the answers to all of these issues, and we have to be open to others who may have the answers or who can approach it from different angles."

If you've ever been hospitalized, did you know what medicines you received?  A new survey published in the Journal of Hospital Medicine found that an appalling 96% of hospital patients were unable to name medications they received during their hospital stay.  This has an obvious and dangerous impact on the rate of medication errors in hospitals.

"I don't think that's surprising at all. I think that that's the natural consequence of the way in which hospital culture is designed. Patients are given their medicines and they take their medicines," said study author Dr. Ethan Cumbler, an assistant professor of medicine at the University of Colorado Denver and director of the University of Colorado Hospital Acute Care for Elderly Service.

Dr. Cumbler notes that this hospital culture is the opposite of the one which exists in the outpatient setting where patients are expected to know what pills they're taking, when they're taking them, and the purpose for the pill.

How can hospital patients act as their own best advocate and help eliminate medication errors if they don't even know what pills they're taking and for what purpose?  This is a problem that exacerbates medication errors and makes patients victims rather than advocates in their own health.

However, there are methods to combat this hospital culture.  First, ask the person dispensing the medication the name of the medication and its purpose.  Second, ask if there are any side effects.  Third, consult with your treating physician about medication treatment options. 

This medical malpractice lawsuit in Rhode Island didn't make headlines because of the financial settlement.  Most likely, it didn't even make the news because the victim was Michael Woods, the brother of famed Hollywood actor James Woods.  The medical malpractice case was newsworthy because the hospital administrator admitted its emergency room staff had made fatal mistakes in the 2006 Woods' case and committed to correcting those errors by establishing  the Michael J. Woods Institute at Kent Hospital.  The five year project will cost $1.25 approximately and its stated goal is the reduction of medical errors such as those that led to Michael Woods death.

According to the Providence Journal,

"Michael Woods, a two-time Warwick mayoral candidate, was 49 years old when he went to the emergency room at 4:25 p.m. July 26, 2006, complaining of a sore throat and vomiting that came on suddenly. An electrocardiogram showed he had an abnormal heartbeat. He suffered a heart attack at about 7:10 p.m. and was declared dead at 7:30 p.m.

The doctor who treated him, Kelli A. Naylor, testified she’d ordered that he be put on a heart monitor, but that the nursing staff never followed through. Woods was sent to the x-ray department, and when he was brought back to the emergency room, instead of being put in a room, his gurney was parked by a wall near a nurses’ station. It was there he suffered his fatal heart attack."

The impetus for the unexpected settlement came after weeks of heated trial testimony.  The Kent Hospital administrator Sandra Coletta called the Woods' family and apologized for their loss.  As a result, the hospital will now make a real effort to reduce such medical errors and preventable tragedies. 

I've blogged before on the relationship between physician fatigue and medical errors.  Now, a new report commissioned by the American College of Surgeons and conducted by Johns Hopkins University School of Medicine and the Mayo Clinic notes the significant correlation between physician burnout and depression and the self-reporting of medical errors.  The new findings suggest that physicians suffering burnout or depression may have a higher rate of making and reporting medical errors.  The report notes that mental health factors may lead to more medical errors than physician fatigue. 

This new survey underscores the real need for standardized, universal medical error reporting.  This is a huge patient safety issue that has been thus far ignored in the healthcare debates in Washington.  However, accurate medical error reporting could save lives and increase patient safety.

The biopsy results revealed breast cancer. So, last June, Janelle Trenchfield underwent surgery to remove lymph nodes and a lump in her breast.  A few days after the surgery, Trenchfield was told that she didn't have cancer after all.  Her biopsy had been confused with another patient's at Winthrop-University Hospital in Mineola, NY.  It appears that a label with her name on it had been inadvertently placed on another woman's biopsy. 

Now, Janelle Trenchfield is left with physical and emotional scars.  Her breast is severely scarred from the surgery and she is more susceptible to disease after having lymph nodes removed.  In addition, she has had to deal with the anguish and trauma of thinking she had cancer.  As a result of her suffering, Trenchfield has filed a medical malpractice lawsuit in state Supreme Court.

Wrong-site surgeries have highlighted the news recently, and we've discussed them, especially the wrong-site surgeries at Rhode Island Hospital, in previous blog posts.  However, there are many more instances in which surgeries may constitute harmful medical malpractice and negligence on behalf of doctors and healthcare workers.  Surgical errors include operations performed on the wrong person, surgical instruments such as sponges, needles, and instruments left inside the patient, and patients catching fire during cauterization procedures.  In other cases, there have been reports of patient deaths caused by the use of contaminated surgical instruments, contaminated drugs administered to the patient, and blood transfusions of the wrong blood type.

These are all serious, potentially fatal medical errors that constitute negligence and medical malpractice.  As a patient or patient advocate, it's important to take proper precautions prior to any surgery.  Make sure to discuss the procedure and any concerns with the surgeon and theanesthesiologist.

The Joint Commission, the group that is responsible for accrediting hospitals, has established a "Universal Protocol" for surgeons and surgical procedures.  The protocols include:  the use of check lists and "time outs" to ensure the right patient and correct body part.  These protocols were specifically developed to protect patients and reduce medical errors.

After its 5th wrong-site surgery since 2007, Rhode Island Hospital has been fined $150,000 and ordered to install video cameras in all operating rooms.  In addition, the hospital will be required to have a clinical employee monitor all surgeries for a year and have a surgeon involved in the marketing of the hospital's surgical site.

The last wrong-site surgery involved surgery on a patient's two fingers. Rather than mark the fingers prior to surgery, surgical employees marked the patient's wrist.  The state health department also noted that the surgical team failed to take a "time out" in order to verify the patient's identity as well as the type and site of the surgery.  This failure occurred once again prior to the second surgery.

Rhode Island Hospital had previously been fined $50,000 in 2007 after surgeons operated on the wrong areas of three patients' brains.

A Rhode Island hospital has been cited for its fifth wrong-site surgery since 2007.  A surgeon at the Rhode Island hospital operated on the wrong part of a patient's hand.  In 2007, surgeons at the same hospital operated on the wrong sides of patient's heads in three separate brain surgeries.  At that time, the hospital was fined $50,000 for the errors.  The surgical errors occurred at Rhode Island Hospital, the state's largest hospital and the main teaching hospital for Brown University.

According to Dr. Mark R. Chassin, president of the Joint Commission, a private entity that inspects and accredits health-care organizations, wrong-site surgeries happen frequently and medical protocols have done little to prevent them. 

These are events that should never happen.  The unfortunate truth is that no hospital today in the U.S. or around the world ... can guarantee that they will never happen. We do not know how to perfect our processes to ensure these [errors] never happen.” 

According to Chassin's organization, approximately 40 wrong-site surgeries occur across the country every week.

While the debate about healthcare reform continues in Congress, there is little discussion among legislators about including patient safety measures in either House or Senate versions of healthcare legislation.  An analysis by Hearst newspapers has shown relatively little interest in preventative measures in hospitals that could potentially save thousands of lives. 

Medical errors including hospital infections, misdiagnoses, failures to diagnose, and wrong site surgeries contribute to thousands of lives lost each year.  These are avoidable medical malpractice errors that could be addressed by patient safety measures.

However, there is some good news to report concerning patient safety.  Last week, New Jersey became the sixth state in the country to provide consumers with hospital-specific error reports.  The other states that provide such a service to consumers are Colorado, Indiana, Massachusetts, Minnesota, and Washington.  I am pleased to say that our own state of New Hampshire will soon be added to this list of reporting states.

The FDA is investigating Cedars-Sinai Hospital for radiation errors concerning a CT scan that transmitted higher than normal levels of radiation.  The problem appears to have been occurring since February 2008 when a CT scan's radiation levels were set too high. 

The FDA noted, “The magnitude of these overdoses and their impact on the affected patients were significant,” the federal agency said, warning that undetected overdoses put “patients at increased risk for long-term radiation effects.”

The patients who received the CT scans received 8 times the regular dosage of radiation for a normal CT scan. 

It is noteworthy and perhaps significant that the FDA issued a nationwide alert and did not specifically name Cedars-Sinai Hospital in their alert.  It is quite possible this overdosage in radiation is not an isolated incident.

In this week's New England Journal of Medicine, two physicians discuss the status of medical errors in healthcare in the context of the 10th anniversary of To Err is Human, the Institute of Medicine's report concerning patient safety.  The authors, Robert M. Wachter, M.D. and Peter J. Pronovost, M.D., Ph.D. both extol the progress made in patient safety, both physicians acknowledge that medical errors remain a significant concern.

Interestingly, both physicians make a strong case for increased physician accountability in resolving and avoiding medical errors that cause an estimated 100,000 preventable deaths in the US each year.  Pronovost argues,“But despite making systems safer and counseling staff on best practices, mistakes continue to happen, so it’s time to add some accountability and enforcement policies to address and stop unsafe practices,” he says.

The authors cite such examples of unsafe practices as healthcare workers' failure to properly wash their hands before entering a patient's room as well as failure to avoid wrong site surgeries, which are estimated at 4,000 each year.

Accountability and transparency are important factors in avoiding medical errors and malpractice as well as ensuring patient safety.  The article's recognition that the "no blame" approach in dealing with medical errors and patient safety is not a panacea for good medical practice or patient safety.

La Compañia Farmacéutica Bayer Healthcare se enfrenta a pleitos o casos civiles federales con relación a sus populares píldoras anticonceptivas Yaz y Yasmin. Los pleitos siguen una carta de advertencia de FDA emitida a Bayer afirmando que la empresa farmacéutica no cumple con advertir a pacientes  sobre los riesgos de las píldoras y  a la misma vez sobre-estima los beneficios de las drogas. El año pasado, Bayer ejecutó una campaña de mercadeo correctivo por 20 millones de dólares como parte de su acuerdo con la FDA para corregir sus anuncios agresivos y engañosos.  Las píldoras Yaz y Yasmin han sido asociadas con un mayor riesgo de coágulos de sangre, embolia pulmonar, ataques cardíacos y derrame cerebral. Actualmente, se ha presentado una moción con el Grupo Judicial de expertos de Estados Unidos sobre litigios de Multidistritos para consolidar y centralizar los 132 casos pendientes contra Bayer, el fabricante de las drogas. Todos los casos en su mayoria  contienen denuncias similares sobre la incapacidad de Bayer en advertir a los consumidores sobre la posible amenaza de muerte y  efectos secundarios asociados con Yaz y Yasmin, asi como el riesgo de hipertensión arterial, derrame cerebral, coágulos, enfermedad de la vesícula biliar, trombosis venosa profunda, embolia pulmonar y  muerte repentina. La moción pide que estos casos se consoliden ante el Juez James G. Carr  del Distrito Tribunal de  Estados Unidos y el Distrito Norte de Ohio, en Toledo. Tanto Yaz y Yasmin son anticonceptivos orales que contienen etinilestradiol y  drospirenone de progestin las mismas que no se encuentran en cualquier otro anticonceptivo con excepción del producto genérico Oscella. Si se concede la moción y se forma un MDL (litigios multidistritales), los casos legales en contra de Yaz y Yasmin seguirían siendo  casos individuales y no parte del "class action suit" de Yaz y Yasmin. Se espera que una audiencia sobre la moción MDL sea ventilada en septiembre del 2009.

 

Because New Hampshire has no mandatory medical error reporting system, there is no way to determine the extent of medical errors in the state.  We do know that many victims of medical errors come to us for legal advice.  The issues may range from failures to diagnose heart attacks, failures to diagnose cancer, surgical errors, medical errors that cause birth defects such as Erb's palsy, and emergency room mistakes. 

The lack of any reporting system in NH means that there's no accurate way to measure the damage caused by these medical errors.  Perhaps more importantly, there's no way to correct these errors or hold people accountable for such medical mistakes.  Until such a system is in place, those who need medical attention are at risk for preventable errors.  This should be part of the current healthcare debate.  It's an issue that affects us all and leads to an inevitable rise in healthcare costs.

Anesthesia errors are a risk in any surgical procedure. When a patient undergoes an operation, anesthesia is administered in order to sedate the patient.  The anesthesiologists are supposed to monitor vital signs such as heart rate, respiration, and blood pressure. 

The most common anesthesia problems we've encountered involved inexperienced anesthesia personnel such as CRNA's or anesthesia technicians who fail in their duty to recognize problems such as a sudden drop in blood pressure, respiration or heart rate.  These errors may be caused by inattention or a failure to properly monitor a surgical patient's vital signs.  Such errors can result in catastrophic injuries to the patient including permanent brain damage or coma.

Other anesthesia errors include mistakes concerning the dosage of anesthesia, intubation errors, and turning off the alarm on the pulse oximeter.  The last error is perhaps more a mistake in procedure than an error.  The pulse oximeter is designed to measure a patient's blood oxygen level.  Turning off the alarm deprives healthcare workers of a necessary and critical medical warning device that's designed to alert doctors and nurses of patient distress.

We've been successful in handling anesthesia malpractice cases because we have the expertise to properly evaluate the claims.

Alli, a popular over-the-counter diet drug and its prescription counterpart Xenical have drawn FDA scrutiny after more than 2 dozen adverse event reports linked the drugs to liver injury.

According to the FDA press release, "Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain."

Alli contains half the dose of orlistat of Xenical.  Both diet drugs are designed to block the absorption of fat in the intestines.

While the FDA's release noted that the investigation is ongoing and in its early stages, anyone who has taken either drug and experience symptoms associated with liver injury such as weakness, fatigue, jaundice, or discolored urine should contact their doctor as soon as possible.

On May 1, 2009 another dietary drug supplement, Hydroxycut, was pulled from the market after adverse event reports linked the supplement to liver injury.

Patient safety and healthcare industry accountability have been pushed to the side in the midst of the clamor over the public option debate in the latest battle concerning healthcare reform.  This is a mistake that has grave public safety ramifications.  It's estimated that 200,000 Americans die from common medical errors that lead to failures to diagnose, misdiagnoses, brain injuries, botched births, and wrong side surgeries.  These statistics are alarming and could be addressed with mandatory reporting of medical errors and a system that responds in a corrective way to these medical errors.  

The Dead by Mistake (http://www.chron.com/deadbymistake) website notes that certain procedures could be mandated to avoid such errors.  "For example, there could be regulations for marking a surgical site or a checklist for inserting a catheter. Both are known practices for avoiding medical errors -- wrong site surgery and hospital-acquired infections -- but their use is not widespread."  

In spite of the errors, mandatory medical error reporting has been blocked by doctors and medical associations who fear medical malpractice lawsuits and have a general distaste for oversight. 

The journalists at Dead by Mistake recommend that the public engage in this important issue.  On their website, they've listed some things the general public can do to raise awareness of this important issue:

- Ask AHRQ to publish hospital-specific information on safety, (301) 427-1364, hcup@ahrq.gov.

- Ask your state health officials to release hospital-specific information on errors and infections.

- Find out if your hospital is accredited: Joint Commission, www.QualityCheck.org; and Health Facilities Accreditation Program, www.hfap.org

- Ask your local hospital if it participates in Leapfrog Group's hospital survey and if not, ask why, www.LeapfrogGroup.org

- Ask your hospital to voluntarily release its error and infection rates.

- Ask your hospital if it has adopted the National Quality Forum's policy on full and immediate disclosure of errors to patients and their families.

- Demand that medical professional societies take responsibility for errors that occur in their profession and address them systematically.

- Join Consumer Union's "Safe Patient" campaign, www.SafePatientProject.org.

- Report medical errors that affect your family to your state health department and the Joint Commission, (800) 994-6610, complaint@jointcommission.org.

New Hampshire is in the process of establishing an adverse event reporting system.  The system is supposed to ensure that New Hampshire hospitals report at least 28 measures set by a national healthcare quality organization. 

If you walk into any hospital in New Hampshire and visit a floor where patients are being treated, you’re bound to see one of two things: 1) a doctor furiously scribbling a prescription; and 2) a nurse dispensing medication to a patient. They’re routine until something goes wrong- a pharmacist misreads the doctor’s handwritten prescription order or a nurse gives the wrong drugs to a patient. The sad fact is that both errors are avoidable. Specific technology has been designed, developed and implemented for doctors to enter prescription orders electronically and for nurses to cross reference the drugs to be dispensed with the patient’s wrist band. When the doctor enters an order or a prescription electronically, the risk of error is significantly reduced. The same holds true for a nurse dispensing drugs. Under this system, the drugs have a specific bar code which matches the bar code on the patient’s wristband. Once both are scanned, the risk of error is negligible. The technology is called computerized provider order entry, or CPOE. Unfortunately, few hospitals take advantage of the technology. A recent survey of hospitals nationwide found that fewer than 17% use the electronic prescription pad and even fewer hospitals use the bar coding system. This failure to adapt is astounding considering that using these simple programs saves lives. Hospital administrators who oppose such measures cite the cost of implementing the new technology as well as reluctance among some healthcare professionals to adapt to new routines and procedures. The recent federal stimulus package has addressed some of the cost concerns by approving federal dollars to assist hospitals with the purchase of new equipment including the purchase of electronic health information systems. If an electronic information system helps save lives and reduces medical errors, isn’t that worth the additional cost?

Former New England Patriots defensive back Tebucky Jones has filed a lawsuit against Patriots team physicians Dr. Thomas J. Gill IV and Dr. Dr. Bertram Zarins . Dr. Jeffrey Brody, the Rhode Island Hospital physician who interpreted the results of Jones’ third MRI, and Shields MRI of Rhode Island are also named in the lawsuit. Jones suffered the career ending knee injury in a 2006 pre-season game against the Washington Redskins. The lawsuit filed in Suffolk County Superior Court alleges that the “failure to diagnose his injuries led to his wrongful release by the New England Patriots and consequential loss of income.” After Jones was assisted off the field during the 2006 pre-season game, he was taken the following day to Shields MRI in Rhode Island. The results of that MRI showed a chronic ACL tear as well as a hamstring injury. According to Jones, Drs. Gill and Zarins told the football player that he suffered a hamstring injury. They instructed him to ice the hamstring and recommended strengthening exercises. Jones insists neither doctor mentioned the torn ACL in spite of the MRI results. The pain persisted so Jones went back to Gill and Zarins who ordered another MRI at Shields in Rhode Island. Once again, the MRI showed a chronic ACL tear coupled with a hamstring injury. Yet, the star defensive back was not informed of the torn ACL. In December 2006, Jones underwent a third MRI. This MRI noted no ACL tear. Jones’ lawyer has stated that the third MRI was performed with a machine called an open MRI. According to Jones’ lawyer, open MRIs can produce low resolution results that are not as accurate as closed MRI machines. In October 2007, Jones finally learned the severity of his knee injury. During a tryout with the Oakland Raiders, Jones underwent another medical exam which revealed the torn ACL. The injury was so severe the Raiders refused to sign him to a contract. According to the Boston Herald, Dr. Gill has been sued before. “Gill has been sued at least one other time in the last 10 years. In 2005, the medical malpractice insurance company representing Gill made a payment to a woman who sued him claiming he failed to diagnose a tumor, according to Suffolk Superior Court records and the Massachusetts Board of Registration in Medicine. Prior to the case’s dismissal, a medical tribunal ruled in favor of the patient.”

Nosotros sabemos que a veces es muy difícil vivir y trabajar en un país que no es necesariamente el nuestro. Nosotros comprendemos que a veces es difícil también comunicarnos en nuestro propio lenguaje. En la oficina de abogados de Abramson, Brown y Dugan estamos dispuestos a ayudarlo. Si usted o un familiar tiene un caso de mala práctica médica con fundamentos básicos para probarlo, nosotros podemos ayudarlos a obtener una compensación legal. Usted tiene derecho a obtener compensación si un doctor o proveedor de cuidados de salud no provee los cuidados adecuados a los que Ud. tiene derecho. Si usted o un familiar es víctima de negligencia médica es necesario contratar un abogado que lo ayude a reclamar la compensación adecuada por el daňo o muerte. En algunos casos médicos y proveedores de cuidados de salud cometen errors que pueden causar daῆos irreparables o muerte en algunos casos. No dude en llamarnos para una consulta legal.

Nearly 14 million Americans have experienced a heart attack. According to the Centers for Disease Control and Prevention, coronary disease remains the leading cause of death in the United States. Yet, one in 50 heart attack victims are misdiagnosed by emergency room physicians and sent home. Failure to diagnose a heart attack may occur even though the patient describes the known warning signs of a heart attack: shortness of breath, chest pain, tightness in the chest, blurred vision, or an irregular heart beat. Failure to diagnose and promptly treat often results in death or severe disability. Once it is determined a patient is suffering a heart attack, prompt medical action is required to prevent further damage or death. Such medical actions may include giving oxygen to the patient, administering clot busting drugs such as tPA, emergency angioplasty or coronary artery bypass surgery. Failure to diagnose a heart attack or failure to intervene medically may lead to irreversible heart damage, stroke, or death. In my years as a medical malpractice attorney, I've represented clients whose treating physicians failed to properly diagnose a heart attack as well as those who were not treated promptly.

Deborah Jean Howard, 42 was killed when her 2009 Honda was rear-ended on Interstate 93 and struck a tree. She was pronounced dead at the scene of the crash. While law enforcement officials don't believe alcohol played a factor in the fatal car accident, inclement weather and speed appear to have played a part in the crash. The accident occurred in New Hampton between Exits 23 and 22. Howard was crowned Miss New Hampshire in 1991 and had remained active in the program by participating in and judging events.

The Wall St. Journal published an interesting article today on the controversial but growing trend of doctors performing outpatient surgeries in their offices. These offices are often unregulated and the rising number of adverse incidents has led some states to examine the practice and legislate regulation for the facilities. It is estimated that between 35,000 to 40,000 doctors perform surgical procedures in their own offices. Only a small fraction of these offices is accredited and regulated by independent health review agencies. The Journal article estimates that 45% of outpatient surgical procedures are performed in hospital outpatient departments, which are highly regulated and normally in close proximity to a hospital if something goes awry during the procedure. Another 38% of these outpatient services takes place in ambulatory surgery centers, which are also regulated and accredited. That leaves 17% of outpatient procedures that are performed in unregulated and unaccredited facilities. In these situations, the surgeries are performed under the medical license of the practitioner. As one might imagine, this had led to problems including surgical errors, anesthesia errors, catastrophic injuries and death. It's also led to some lawsuits against the doctors who've performed such procedures in questionable settings. If you're scheduled to have an outpatient procedure, please make sure the facility is regulated and accredited by an independent health agency or the state. Your life may depend on it.

I am pleased to welcome you to our firm's blog.  In this forum, we will discuss all aspects of medical malpractice including New Hampshire law concerning medical malpractice, client stories, our trial work, the various types of medical malpractice as well as a variety of related subjects such as defective medical devices and harmful drugs. 

The lawyers at Abramson, Brown, and Dugan are experienced trial lawyers who are recognized experts in the field of medical malpractice and plaintiff personal injury.  We are an award winning firm whose partners are "AV" rated by their peers in the profession.  We take pride in the fact that many of our cases come from attorney referrals.  Our work on behalf of our clients has earned us the reputation of being New Hampshire's premier medical malpractice law firm.