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UNDERSTANDING CARDIOLOGY MEDICAL MALPRACTICE CLAIMS

Posted by Kathleen on July 6th, 2017


boat1It costs about $80,000 to defend a cardiologist in a medical malpractice claim resulting in payment—nearly four times the cost in ophthalmology, the least expensive specialty to defend. That is a great deal of money, and it likely heightens cardiologists’ motivation to do everything possible to avoid liability lawsuits, while still doing what is best for the patient. All future lawsuits cannot be avoided, but understanding the clinical circumstances of previous suits may help minimize their prevalence and impact, while still allowing cardiologists to provide excellent healthcare.

A recent examination of closed claim data from The Doctors Company, the nation’s largest physician-owned medical malpractice insurer, helps identify steps cardiologists can take before, during, and after patient interactions that meet the twin goals of optimizing patient care and protecting themselves legally, particularly in the face of inevitable complications and other poor clinical outcomes.

Cardiology may hold a unique place in the medical malpractice landscape because of its diverse set of physician-patient interactions. Not only do they diagnose conditions that are often life-threatening, they also perform invasive procedures on some of the very sickest patients. The wide diversity of these cases may make this specialty a particularly good model upon which to extrapolate conclusions about the liability pitfalls facing all clinicians. Analysis of the details of 429 closed claims occurring in cardiology between 2007 and 2013 offers insight to all physicians about the types of clinical scenarios that create the largest potential liability risks.

Topping malpractice claims is failure of diagnosis, which was alleged in 25% of closed cases. While myocardial infarctions are sometimes misdiagnosed in cardiology—and even more frequently among physicians without specialized cardiac training—the new data show cardiologists are more likely to overlook non-cardiac diagnoses that present similarly to a cardiac ailment, such as pulmonary embolism, aortic dissection, or even cancer.

Lawsuits stemming from procedural or surgical complications are the next most prevalent, which is both unsurprising and frustrating to surgeons. Even the most skilled and experienced proceduralist will have complications; in an ideal world, expected complications should not, in and of themselves, trigger a lawsuit. Unfortunately, they often do.

For interventional cardiologists, lawsuits stemming from vascular access complications—retroperitoneal bleeding, in particular—represented the primary source of liability danger, with a close second being other vascular complications such as embolism or coronary artery damage.

Among electrophysiologists, three complications represented the bulk of malpractice suits: 1) arterial laceration during a pacemaker implantation or electrophysiology study, 2) atrioventricular node damage during ablation that required pacemaker placement, and 3) pulmonary vein stenosis after ablation. Transesophageal echocardiography, though not an invasive vascular procedure, had two primary liability risks—first, lawsuits after esophageal perforation, and second, neurological damage caused by neck flexion in patients with undiagnosed epidural abscess.

The data also shows that prescribing certain medications should set off “liability alarm bells,” since improper medication management accounts for the fifth most common allegation. For example, the significant lung and liver side effects from amiodarone can be a fertile ground for lawsuits from patients who may blame the physician years after the drug was first prescribed. Similarly, the use of Coumadin and Heparin often places cardiologists between a rock and a hard place. The drug’s narrow therapeutic window can create liability problems for physicians who need to decrease a patient’s stroke risk, but may end up causing severe bleeding.

Cardiologists should become more aware of the most prevalent types of diagnosis or procedural errors and engage in meticulous informed consent. That same meticulous attention must be paid to documentation, workup, and follow up after a complication occurs. Failing to act expeditiously—by not ordering a CT scan to evaluate a possible retroperitoneal bleed, for instance—may turn a routine complication into a lawsuit. Rigorous documentation is always needed, but it’s particularly needed when physicians choose a high-risk, liability-prone medication. Prescribing the drug is perfectly acceptable, of course; it’s simply important to inform the patient about its inherent risks and vigilantly monitor for side effects. Lastly, non-cardiac issues need to be carefully watched, particularly when following up on a possible cancer diagnosis or when prescribing non-cardiac medications.

It’s notable that the top reasons for cardiology lawsuits diverge so widely, encompassing both diagnosis and procedure allegations. This suggests there is no single aspect of the practice of cardiology that is particularly liability-prone. Different types of cardiologists, both proceduralists and non-proceduralists, face different types of dangers, and need to be recognized.

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is an honored medical expert and lifetime clinical scholar valued immeasurably by her plaintiff and defense attorney-clients as a time/cost-efficient asset to medical malpractice, personal injury and product liability claims. Kathleen provides flawless investigative navigation of meritorious complexities, meticulous comprehensive medical record reviews, locates trusted preeminent experts, is a recognized medical researcher and lifetime standard of care clinical consultant. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

HEPARIN OVERDOSE & PHYSICIAN LIABILITY

Posted by Kathleen on June 15th, 2017


When Will Hospitals Learn How To Use Heparin?

boat1Heparin is one of the most basic medicines commonly used worldwide. It is the primary anticoagulant used by hospitals and is part of the World Health Organization’s List of Essential Medicines. Anticoagulants carry extreme volatility that make a patient 10 times more likely to develop intracerebral hemorrhage, thus — Heparin (unfractionated heparin UFH) and Coumadin (Warfarin) — must be used with the utmost caution in accordance with standard of care.

Medical negligence unfortunately is still quite common with administration of heparin related to the measuring and following of PTT levels after the initial bolus is administered to insure therapeutic levels.

The amount of heparin given is typically based upon a nomogram in which the patient’s initial heparin dose is calculated on weight. But that’s just to start the heparin. The  cardiovascular system is dynamic and constantly changing in response to medical conditions such as surgery and reactions to medication. The American College of Chest Physicians state that because anticoagulant response to heparin varies among patients, it is standard of care to monitor heparin and to adjust the dose based on the results of coagulation testing. PTT and INR are the most common lab values used, although antifactor Xa is also now used by hospitals nationwide.

Once on heparin, the patient must be continually monitored to ensure levels remain safely therapeutic – too low, heparin is ineffective while too high increases bleeding risks to patients. PTT should be measured 6 hours after the loading bolus dose of heparin, and the continuous IV dose should be adjusted according to the result, and PTT and INR need to be meticulously monitored thereafter.

High Risk Patients

Patients experiencing or at risk of deep vein thrombosis, pulmonary embolism, atrial fibrillation or other conditions may be given blood thinners to prevent blood clots that could lead to heart attack or stroke. Anticlotting drugs are also given to patients who have already had a heart attack or stroke to reduce the risk of further damage or recurrence. Others are used during certain medical procedures or treatments to prevent clotting in the medical equipment tubing, such as during bypass surgery or kidney dialysis.

While intended to treat or prevent potentially life-threatening health problems, anticoagulants themselves can be very dangerous. Many blood thinners have very narrow margins of error—even the slightest error in strength or dosage can have devastating consequences.

Some populations are particularly susceptible to overdose and must be treated with extreme caution and monitored carefully when on anticoagulants; these populations include the elderly, infants, and patients with certain health conditions or those on specific medications.

Patient Overdose

In the vast majority of overdose cases, practitioner error is the cause. Sometimes, the cause of the overdose is tragically omission. Often, a nurse or doctor misreads the medication label and administers a higher or lower strength dose of the blood thinner and overdoses or under-doses the patient.

In other instances, the practitioner may fail to properly inform the patient that certain medications, supplements, or dietary choices may exacerbate the effects of the anticoagulant, thereby leading to an overdose even when the strength and dosage would have otherwise been appropriate. In all of these instances, the harm could have been avoided were it not for the practitioner’s failure to meet the standard of care in administering these medications which are well known to be lethal if not dispensed and managed with extreme caution.

Failure to Monitor Malpractice Claims

In other instances, the practitioner may fail to properly inform the patient that certain medications, supplements, or dietary choices may exacerbate the effects of the anticoagulant, thereby leading to an overdose even when the strength and dosage would have otherwise been appropriate. In all of these instances, the harm could have been avoided were it not for the practitioner’s failure to meet the standard of care in administering these medications which are well known to be lethal if not dispensed and managed with extreme caution.

Failure to Monitor Malpractice Claims

In many cases, negligence occurs in the practitioner’s failure to monitor the patient for signs and symptoms of an adverse reaction or overdose. Depending upon the type of blood thinner employed and the patient’s health, it may be necessary to obtain certain blood tests at regular intervals to ensure the patient’s clotting level is still within a safe and therapeutic range.

With or without follow-up blood tests, patients must be informed they can experience an overdose that is clinically manifested by outward symptoms of increased or abnormal bruising; excessive bleeding from even minor cuts and scrapes; nose bleeds; or blood in the stool, urine or vomit. Patients may also report a headache, chest pain, stomach pain, dizziness or sudden weakness among other symptoms. Serious injury or death may be avoided with prompt recognition of signs of an overdose and rapid, adequate treatment; however, when left unchecked, patients may suffer severe consequences including gastrointestinal bleeding, hemorrhagic stroke or death.

BRIDGING THERAPY

Patients taking anticoagulants in a clinical setting of a surgical procedure walk a fine line – You don’t want to bleed too much… or too little. Doctors have to walk this fine line by making reasonable judgments.

Generally, the standard of care requires surgical patients to be taken off of Coumadin before surgery to let the INR fall in the therapeutic range of 2.0-3.0 for atrial fibrillation or 2.5-3.5 for prosthetic heart valves to <1.5.

For those patients at greatest risk of developing a thromboembolism, bridging therapy with an anticoagulant may be required. Treatment resumes as soon as prudent after the surgical procedure and continued until the INR reaches the desired therapeutic level. In patients whose risk is only moderate, it is generally safe to stop Coumadin and let the INR sink to a level <1.5 without bridging therapy.

The New England Journal of Medicine addresses “Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation”.

PHYSICIAN LIABILITY

Studies by the American College of Cardiology support that prescribing certain medications such as anticoagulants set off liability alarm bells since improper medication management accounts for the fifth most common allegation. The use of warfarin often places cardiologists between a rock and a hard place. Anticoagulant’s narrow therapeutic window can create liability problems for physicians who need to decrease a patient’s stroke risk, but may end up causing severe bleeding.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is an honored medical expert and lifetime clinical scholar valued immeasurably by her plaintiff and defense attorney-clients as a time/cost-efficient asset to medical malpractice, personal injury and product liability claims. Kathleen provides flawless investigative navigation of meritorious complexities, meticulous comprehensive medical record reviews, locates trusted preeminent experts, is a recognized medical researcher and lifetime standard of care clinical consultant. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

ABDOMINAL AORTIC ANEURYSM MISDIAGNOSIS│MEDICAL MALPRACTICE

Posted by Kathleen on May 29th, 2017


boat1Abdominal Aortic Aneurysm (AAA) is an outpouching at the area of the weakness in the abdominal aorta involving all three layers of the artery wall. An aneurysm is defined as an increase of greater than 50% from the vessel’s original sizefor an abdominal aortic aneurysm, this equates to a diameter of approximately 3 cm. The larger the aneurysm, the greater the risk of rupture. AAAs are commonly diagnosed either incidentally or when they become symptomatic or rupture. Whereas morbidity and mortality are low for elective treatment of an AAA, outcome for a ruptured AAA (rAAA) remains poor even when prompt treatment is provided.

Case Study: A 67-year-old man who is a long-term smoker arrives in the emergency department (ED) via ambulance with complaints of severe back and abdominal pain. He reports that the pain is tearing in nature and constant. Upon arrival in the ED, the patient’s heart rate is 130, blood pressure is 70/40, and respiratory rate is 20. Glasgow Coma Scale (GCS) score is 15, and he is able to hold a conversation. Electrocardiography (ECG) shows sinus tachycardia with no ST-segment changes. Examination of the abdomen reveals a tender pulsatile mass. There is a high clinical index of suspicion for a symptomatic or rAAA.

DIAGNOSIS

In this particular case study, the appropriate diagnostic approach is ultrasound (US) which is an easy imaging study that most emergency physicians can perform effectively. In an emergency, aortic evaluation is often done as an extension of FAST (focused assessment with sonography in trauma), whereby the diameter of the abdominal aorta can be assessed for the presence of an aneurysm. The presence of free fluid, the visualization of an AAA, and the clinical correlation usually are strongly indicative of a symptomatic or rAAA. In an elective or clinical situation, US provides an inexpensive and effective method of screening for an AAA that may require treatment or ongoing surveillance. Studies show that aneurysm-related mortality can be reduced by employing ultrasound-based screening of at-risk population groups, capturing patients with previously undetected AAAs, and proceeding to appropriate treatment on the basis of the rupture risk.

In this case study, computed tomography angiography (CTA) is not appropriate, because of the patient’s hemodynamic instability, especially if abdominal US visualizes an AAA. Attempts to perform CTA will only delay the necessary surgical treatment. Nevertheless, CTA remains the gold standard for diagnosing rAAAs and may still be indicated if the patient is hemodynamically stable enough and if endovascular aneurysm repair (EVAR) for an rAAA (rEVAR) is being considered as an option. It may also reveal alternative pathologic conditions, such as ruptured viscera or aneurysms of arteries other than the abdominal aorta.

RISK OF RUPTURE

The presence of an aneurysm that is at least 3 cm in its largest dimension implies some degree of rupture risk. As might be expected, a larger aneurysm carries a higher risk of rupture and ensuing morbidity and mortality even when treated promptly. A smaller aneurysm still carries a risk of rupture, but the risk is so small that elective repair is not indicated, despite the low incidence of complications from such treatment.

Clinical trials support aneurysms smaller than 5.5 cm do not benefit from early intervention as compared with those larger than 5.5 cm. It has been suggested, however, that this threshold should be lowered to 5 cm for female patients, who are at greater risk for rupture with AAAs larger than 5 cm.

Ongoing surveillance is recommended for patients with aneurysms smaller than 5.5 cm; as a rule, surveillance should be more frequent in those with aneurysms larger than 4 cm. These patients should be on best medical therapy for optimization of cardiovascular risk status. Antiplatelet agents, statins, and smoking cessation have all been shown to decrease cardiovascular risks.

CLINICAL MANAGEMENT

Large-bore access in the cubital fossa is mandated, but fluid resuscitation is not required in this particular case study because BP is sufficient to maintain cerebral and cardiac perfusion. Permissive hypotension prevents further blood loss from the rupture and improves the outcome of an rAAA. Attempting to elevate BP to the normal range might precipitate further intra-abdominal blood loss. Obviously, rAAA patients may present with a wide spectrum of shock, from the patient with a stable contained rupture to the patient who is essentially moribund.

CLINICAL AND SURGICAL INDICATIONS

Studies predicting outcomes in rAAA patients are derived from retrospective analysis of characteristics predictive of poor outcome. A Glasgow Aneurysm Score (GAS) higher than 85 is predictive of mortality. Similarly, a Hardman index score of 2 predicts a mortality of 80%. Nevertheless, such scores should not be used as the sole basis of the clinician’s decision whether to opt for operative management.

Clinical indications for surgical repair of noninfective aneurysms are: An aneurysm size in excess of 5.5 cm; rAAA; A tender or symptomatic aneurysm or an aneurysm that is growing rapidly (>10% annually). A tender aneurysm is an indicator of impending rupture; the rapid growth in size stretches the retroperitoneal tissue and causes pain. Because larger aneurysms can cause discomfort during examination, the examiner may be uncertain whether the pain a patient feels is due to the large size of the aneurysm or to true tenderness signaling impending rupture. In some cases, stranding in the periaortic tissue may be observed on CTA in a tender but nonruptured aneurysm. Similarly, rapidly growing aneurysms are thought to be associated with a higher risk of rupture because of their potential to grow substantially between surveillance scans. In these scenarios, it may be safer for the patient to undergo elective repair even if the aneurysm is smaller than 5.5 cm.

SURGICAL OPTIONS & TECHNIQUES

In a situation where the AAA has not ruptured, once the decision has been made to intervene, options are as follows: Open AAA repair and EVAR. Currently, with the advent of EVAR, elective open AAA repair is being performed less frequently; it is more commonly used in younger patients or in patients whose anatomy is not suitable for EVAR. As a general rule, the patient must have adequate cardiovascular and respiratory fitness and a life expectancy of at least 2 years. Open AAA repair can be carried out via either a transperitoneal or a left retroperitoneal approach, each of which has advantages and disadvantages. The transperitoneal approach affords good access to all vessels, including the common and external iliac vessels on both sides, and allows inspection of abdominal organs; however, it can be cumbersome and increases the risk of bowel injury in the setting of a previous laparotomy. The left retroperitoneal approach avoids bowel adhesions while accessing the aorta, especially the juxtarenal and suprarenal aorta; however, it affords only limited access to the right iliac vessels, making bifurcated repair difficult. Systemic heparin is frequently given in the elective setting but is generally avoided in cases of rAAA.

An aortic crossclamp is usually placed in the infrarenal position, but suprarenal clamps may sometimes be required until the sac is opened and depressurized and an infrarenal clamp can be placed. In some rAAA cases, supraceliac clamps may be required to gain control. A bifurcated graft may be required if the aneurysm involves the iliac vessels. Usually, the graft is sewn in as an inlay, but occasionally, the aorta may be transected and the graft sewn on in an end-to-end fashion. The inferior mesenteric artery typically is not replanted unless it is of a large caliber. The aneurysm sac is usually closed over the graft, with special attention to covering the upper anastomosis. It has been suggested that this may decrease the incidence of aortoduodenal fistulas.

For EVAR, various off-the-shelf devices are commonly available. However, there are some conditions that must be met to ensure success. The anatomy of the aneurysm is by far the most important factor dictating whether an endograft is a suitable choice for a given patient.  – – – First, to ensure good proximal sealing of the endograft, an adequate “neck” is required; this is usually defined as 15 mm between the lowest renal artery to be preserved and the start of the aneurysm, though some devices only require 10 mm. This boundary is being challenged by the ongoing development of newer devices. For juxtarenal or pararenal aneurysms without an adequate neck, an alternative endovascular technique would be required, such as the use of an endograft plus chimney stents or the use of a custom-made fenestrated or branched device. – – – Second, because access to the aorta is commonly obtained via a transfemoral approach, adequate-sized access vessels must be available. Severely diseased, calcified, or tortuous iliac vessels or a stenosed aortic bifurcation may prevent passage of the endograft to the desired destination. Adjunctive procedures (eg, angioplasty, stenting, or placement of surgical conduits) may be performed to facilitate delivery of the endograft. Other anatomic factors (eg, neck angulation, thrombus in the neck, or tortuous anatomy) may persuade the surgeon to use one device in preference to others. Patient factors (eg, renal function) may also dictate whether EVAR is the best option.

MORTALITY

The perioperative mortality associated with elective EVAR is approximately 1.5% in most major studies, which is significantly better than that associated with open aneurysm repair (~ 4.5%) in other trials. Long-term outcomes of EVAR have been widely studied; the annual rate of reintervention for stent-graft–related problems is approximately 5%, and the annual risk of rupture after implantation is approximately 1%.

SURGICAL COMPLICATIONS

Aneurysm- and graft-related complications include the following:

  • Endoleak
  • Graft occlusion
  • Renal artery occlusion
  • Infection

Endoleaks are divided into four types:

  • Type I – Lack of seal at proximal or distal sealing zones, resulting in arterial pressurization of the aneurysm sac
  • Type II – Backbleeding from patent lumbar vessels or the inferior mesenteric artery
  • Type III – Graft dissociation or tear through the graft material
  • Type IV – Graft porosity

Type I and III endoleaks require urgent treatment because the aneurysm sac remains pressurized and continues to be at risk for rupture. Type II endoleaks generally do not require treatment unless there is ongoing sac expansion.

SURGICAL OUTCOMES & SURVIVAL

  • Perioperative mortality for EVAR ranged from 0.5% to 1.7%, whereas open repair was in the range of 3-5%.
  • The combined rate of operative mortality and severe complications was 4.7% and 9.8% for open repair.

EVAR is undoubtedly associated with lower perioperative morbidity and mortality, but the survival benefit seems to be lost over the longer term.

At 2 years after intervention, the overall survival benefit of EVAR is lost. The similarity in overall mortality was due to an increased proportion of cardiovascular-related deaths in EVAR patients. At 6-year follow-up, EVAR again conferred no survival advantage in clinical trials, and the rates of aneurysm-related deaths were similar in studies and this finding was repeated at 15-year follow-up.

Studies have suggested that more repeat interventions are required for patients treated with EVAR:

  • The 2-year reintervention rate was 30% for EVAR and 19.1% for open repair (a statistically significant difference).
  • The annual risk of reintervention in EVAR patients was 5%.

SURGICAL PREFERENCE

In the case study (above), more vascular surgeons would probably opt for open repair. Given the long history of open AAA repair, most vascular surgeons and the institutions where they work should be comfortable dealing with AAAs both in the elective setting and in the context of rupture. Generally, surgeons, anesthesia personnel, and nursing staff members will all be well aware of the steps and equipment required for open rAAA repair.

In contrast, treatment of an anatomically suitable rAAA by means of EVAR (ie, rEVAR) is a relatively new concept that often cannot be implemented, whether because the surgeons lack the necessary experience, because the available infrastructure is inadequate, or both. To perform rEVAR, the surgeon must have rapid access to the angiography suite or an angiography-capable hybrid operating room, must have a wide range of stent grafts readily available, and must have the assistance of nurses skilled in the smooth handling of angiography wires and devices. To date, only specialized medical centers have been set up to perform rEVAR.

As of April 2017, trials supported an EVAR-first approach to rAAA management offered no significant survival benefit at 1 year but was associated with shorter hospital stays, afforded patients better quality of life, and was cost-effective.

MEDICAL MALPRACTICE  – AAA MISDIAGNOSIS

Only one-third of patients with AAA clinically present with the classic triad of abdominal pain, shock, and a pulsatile abdominal mass. Because these typical features are frequently absent, misdiagnosis is a common problem. As a result, emergency physicians must be aware that leaking or ruptured AAA may present with atypical signs and symptoms frequently leading to such erroneous diagnosis as renal colic, diverticulitis, or gastrointestinal bleeding. Any patient with or without hypotension, who presents with abdominal pain, flank pain, or back pain must be evaluated for a symptomatic AAA.

The signs and symptoms of an AAA are easily confused with such disease entities as renal colic diverticulitis, GI bleed, musculoskeletal pain, etc. Failure to diagnosis an AAA may result in a disaster both for the patient and the ED physician. The physician’s duty to the patient mandates practicing with a high clinical index of suspicion for AAA when evaluating any patient with risk factors who presents with abdominal, back, or flank pain, with or without associated hypotension. Patients may present with the additional confounding findings of an unexplained drop in hemoglobin, hematuria, a left lower quadrant tender mass, or syncope. The evaluation for an AAA must be aggressively pursued in such patients with ultrasound (standard of care is CTA if the patient is hemodynamically stable) in order to avoid the failure to diagnosis this condition. If the diagnosis is made and surgery undertaken while the patient’s blood pressure is stable, the mortality rate is low. However, if the diagnosis and surgical therapy is delayed, and the hematoma no longer is contained, the blood pressure will fall, and with it the chance for a successful outcome. The reasonable and prudent ED physician must include AAAs in the differential diagnosis whenever evaluating patients with these clinical presentations. Listening to the patient is paramount as the history alone in many cases of AAAs drives the workup and makes the diagnosis.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is an honored medical expert and lifetime clinical scholar valued immeasurably by her plaintiff and defense attorney-clients as a time/cost-efficient asset to medical malpractice, personal injury and product liability claims. Kathleen provides flawless investigative navigation of meritorious complexities, meticulous comprehensive medical record reviews, locates trusted preeminent experts, is a recognized medical researcher and lifetime standard of care clinical consultant. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

MEDICAL MALPRACTICE │ FAILURE TO DIAGNOSE PULMONARY EMBOLI – Plaintiff vs. Defense

Posted by Kathleen on May 9th, 2017


boat1A 15 year old patient, who was one week post-arthroscopic knee surgery, went to the ED with complaints of left chest pain. The pain was worse when he laid flat. He had no fever or dyspnea and denied other complaints. In the ED, the patient had normal vital signs and pulse oximetry. The physician performed a physical exam and ordered an EKG and a chest x-ray, both interpreted as normal. The patient’s pain resolved after receiving Toradol and was sent home with a diagnosis of pleurisy and Rx for Naprosyn. Two weeks later, the patient again developed chest pain and dyspnea. He was transported by ambulance back to the ED where he died from bilateral pulmonary emboli.

A medical malpractice lawsuit was filed against the treating emergency physician and the emergency physician’s group. Plaintiff experts testified: The EKG showed Q3T3 abnormalities and the chest x-ray demonstrated cardiomegaly – which were allegedly both suggestive of a pulmonary embolism; Symptoms presented a classic case of pulmonary embolism and the diagnostic measures that the emergency physician took in response to those symptoms did nothing to prove or disprove the presence of a pulmonary embolism. The treating physician testified that relief of pain from a pulmonary embolism would not occur with administration of Toradol – experts called that reasoning ridiculous. Plaintiff experts concluded that the standard of care required the treating physician to obtain a CT scan in order to rule out a postoperative pulmonary embolism, and failure to do so was grossly improper, egregious, and contrary to fundamental medical principles.

 

STANDARD OF CARE ARGUMENTS

PLAINTIFF

  • Failure of duty to the patient was in failing to practice with a high clinical index of suspicion for postoperative Pulmonary Emboli.
  • The omission of not ordering a CT scan as a PERC (pulmonary emboli rule-out criteria) was a breach in standard of care and the core of the medical malpractice suit.
  • Given the patient’s history of new onset of post-operative pleuritic chest pain, it was the duty of the ED physician to consider PE as a differential diagnosis and ruling it out with CT scan would have been safe practice. Unsafe practice led to a bad outcome.
  • A suggestive clinical presentation of acute postoperative pleuritic chest pain, a suggestive EKG, and the duty to rule out a life-threatening emergency, should have prompted a thorough PE rule-out that included a CT scan.
  • [D-dimer was clinically mandated – if low, it would have supported no CT scan. D-Dimer is a rule-out blood test for DVT & PE as it suggests presence of a blood clot.
  • [PERC, definitively yes, given the patient’s recent surgery. Ordering a d-dimer practice would have been safe practice & the omission is below standard of care.
  • A normal chest X-ray does not support a diagnosis of pleurisy.
  • None of the tests ordered were reliable to rule-out PE. Defense is not based on number of tests ordered, but what tests were appropriate.
  • The clinical presentation without tachypnea or tachycardia may suggest an early onset of PE, that of a younger patient with intact compensatory mechanisms of which early intervention would have been lifesaving.
  • Cardiomegaly is an abnormal clinical presentation/clinical indicator especially in a 15 y/o. Q3T3 can be a common EKG finding & a normal variant, however an EKG with a new S1Q3T3 indicates right heart strain and PE– Cardiomegaly supports heart strain.
  • Ultrasound (lung and venous) would have been a safe noninvasive diagnostic process for PE that can yield improved sensitivity and specificity obviating the need for pulmonary CT scan in many cases according to the March 2017 issue of Academic Emergency Medicine
  • Blindly treating symptoms without knowing the cause supports gross failure to protect the patient from the worst possible outcome.
  • Failure to order medical follow-up post-ED discharge (for at least 2 weeks) was failure of duty to the patient.
  • The patient was in the subpediatric population of an adolescent (12-21), not pediatric (2-12).
  • Regardless of age, any postoperative patient can form a clot and embolize it.

DEFENSE

  • Arthroscopic knee surgery is not a long bone and patients ambulate immediately post-op thus not at high risk for DVT and PE.
  • Patient’s vital signs and oxygenation were normal, clinical exam was normal, the alleged abnormalities found on x-ray and EKG were not predictive of pulmonary embolism, and the patient had a low pre-test probability for pulmonary embolism. Reasonable standard of care was provided.
  • [Practice with a low clinical index of suspicion for PE: Pediatric PE are exceedingly rare 1 in 100,000 (50% related to indwelling CVP’s) & two thirds of pediatric PE originate in the UE, not LE.
  • [Generally speaking, 15 year olds have a very low risk of thromboembolic disorder.
  • [Risk is so low in the pediatric population that PE diagnosis would have been unlikely.
  • The diagnosis of PE was not known until 2 weeks post-ED discharge – the chest pain may have been from post-operative crutch-walking, thus the PE hypothetically may not have been present at the time of the initial ED exam.
  • CT scanning all pleuritic patients is not good practice.
  • Chest pain is less associated with PE than is dyspnea.
  • D-dimer would have been positive secondary to recent surgery.
  • The utilization of d-dimer has not been well-studied in children.
  • The risk of harm from CT scan (radiation & contrast) was greater than the risk of the diagnosis. (Whatever the percentage risk the patient is 100% dead).
  • Often, the thought process of the physician is entirely absent from the record, despite the fact it was subtle, deep & considered.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is an honored medical expert and lifetime clinical scholar valued immeasurably by her plaintiff and defense attorney-clients as a time/cost-efficient asset to medical malpractice, personal injury and product liability claims. Kathleen provides flawless investigative navigation of meritorious complexities, meticulous comprehensive medical record reviews, locates trusted preeminent experts, is a recognized medical researcher and lifetime standard of care clinical consultant. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

PANCREATIC CANCER MISDIAGNOSIS & MEDICAL MALPRACTICE

Posted by Kathleen on April 20th, 2017


boat1What Is Considered Medical Malpractice?

Pancreatic cancer is a very difficult disease to diagnose. Many times, symptoms do not present themselves until the advanced stages. Because of this, it is very difficult to determine whether medical malpractice was a factor in the delay of diagnosis. There are many factors that enter into the decision of medical malpractice. All patients have a right to reasonable standard of care in the diagnosis and treatment of any disease or illness.

In the case of pancreatic cancer, there are some definite factors that should have been addressed for the care to have followed a reasonable standard of care. Risk factors, symptoms, a more thorough exam and diagnostic tests are all part of the minimal care that every patient should receive.

It is extremely important that the physician takes an extensive medical history. If a patient suffers from some these risks factors, some additional testing may be warranted for pancreatic cancer.

During litigation, plaintiff will argue that a delay in diagnosis and treatment of pancreatic cancer results in a premature and preventable death while the defense will contend that any delay would have no effect on the outcome because the prognosis for pancreatic cancer, regardless of when it is diagnosed, is very poor.

What Are The Symptoms?

Even though the symptoms of pancreatic cancer are also the same as many other illnesses, these symptoms as well as risk factors may be enough reason to take some additional tests to rule out pancreatic cancer. Some of those symptoms included.

    • Smoking is the most important risk factor. Smokers have twice as much of a chance to contract the disease as a non-smoker.
    • Overweight or obese individuals are 20% more likely to get the disease.
    • Exposure to certain chemicals in the workplace such as a metal refinery can increase the incidence of the disease.
    • Age becomes a factor – 71 is the average age of someone diagnosed with pancreatic cancer.
    • Men are 30% more likely to present than women.
    • Family history is imperative as this form of cancer does run in the family.
    • People with diabetes have a higher incidence of pancreatic cancer.

If risk factors and symptoms are present, a more thorough exam should be completed. An extensive exam of the abdominal region should be done looking for masses or fluid buildup in the region. There could also be an enlarged gallbladder or liver. Even though these may be symptoms of other diseases as well, pancreatic cancer cannot be ruled out without further testing. This type of cancer may also spread to the lymph nodes so they should be examined as well.

Most importantly, there are newly developed blood tests that can lead to early diagnosis and treatment of pancreatic cancer. Other critical diagnostics include CT scan which is considered the gold standard to detect pancreatic cancer. Other diagnostics include MRI and ultrasound.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is a time-honored medical expert who assists plaintiff and defense attorneys in navigating meritorious complexities for medical-legal claims. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

 

PANCREATIC CANCER MEDICAL MALPRACTICE – Early Diagnosis of Deadly Pancreatic Cancer Now Possible With Blood Test

Posted by Kathleen on April 19th, 2017


boat1Early Diagnosis of Deadly Pancreatic Cancer Now Possible With Blood Test

Doctors might be able to diagnose pancreatic cancer sooner by looking at what your cells are ejecting. Pancreatic cancer is so deadly in part because it is hard to find early enough for treatment to be effective. Studies now support scientists can look for a certain protein in what are called extracellular vesicles to detect the disease.

The protein, EphA2, is considered a biomarker of pancreatic cancer because of its role in tumor growth, the study says. Those extracellular vesicles are also active in how cancer progresses and spreads, as they carry signals around your body. Looking for EphA2 in those cell-emitted bubbles, the researchers were able to use blood samples to distinguish between patients with pancreatic cancer, patients with the inflammatory illness pancreatitis and healthy controls.

Research supports having a biomarker that can detect early-stage pancreatic cancer is crucial in order to give doctors an opportunity to remove cancerous tissue from the pancreas before the disease spreads.

It is difficult to capture an early diagnostic signal when there are no symptoms – It is not like breast cancer, where you may feel pain and you can easily check for an abnormal growth.

Studies support this new method for detecting pancreatic cancer could also be used to track treatment and how well patients are responding to it.

The discovery may help more than just pancreatic cancer patients. The EphA2 protein, while mostly absent from the discharge of healthy cells, is abundant not only in the presence of pancreatic tumors but also in the early stages of other cancers like colon cancer, suggesting its potential as a target for early cancer detection.

During litigation, plaintiff will argue that a delay in diagnosis and treatment of pancreatic cancer results in a premature and preventable death while the defense will contend that any delay would have no effect on the outcome because the prognosis for pancreatic cancer, regardless of when it is diagnosed, is very poor.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is a time-honored medical expert who assists plaintiff and defense attorneys in navigating meritorious complexities for medical-legal claims. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

 

CARDIAC ABLATION

Posted by Kathleen on January 12th, 2017


boat1Cardiac ablation is a procedure that can correct heart rhythm problems (arrhythmias).

Cardiac ablation works by scarring or destroying tissue in your heart that triggers or sustains an abnormal heart rhythm. In some cases, cardiac ablation prevents abnormal electrical signals from entering your heart and, thus, stops the arrhythmia.

Cardiac ablation usually uses long, flexible tubes (catheters) inserted through a vein or artery in your groin and threaded to your heart to deliver energy in the form of heat or extreme cold to modify the tissues in your heart that cause an arrhythmia.

RISKS – Collateral Damage – Avoidable Complications:

  • Cardiac perforation
  • Cardiac Tamponade: Acute (intraoperative);  Early onset, late onset (postoperative)
  • Exsanguinating hemorrhage
  • Bleeding or infection at the site where your catheter was inserted
  • Damage to your blood vessels where the catheter may have scraped as it traveled to your heart
  • Inferior vena cava laceration
  • Damage to your heart valves
  • Damage to your heart’s electrical system, which could worsen your arrhythmia and require a pacemaker to correct
  • Blood clots in your legs or lungs (venous thromboembolism)
  • Stroke or heart attack
  • Narrowing of the veins that carry blood between your lungs and heart (pulmonary vein stenosis)
  • Atrioesophageal fistula
  • Esophageal injury (erosion, ulceration, perforation)
  • Gastric motility/pyloric spasm
  • Deep sternal wound infection (mediastinitis)
  • Serious adverse device effect
  • Damage to your kidneys from dye used during the procedure
  • Phrenic Nerve Injury (diaphragm paralysis – avoidable complication)
  • Permanent injury
  • Death

EXPERT CONSENSUS GUIDELINES

Expert Consensus Statement on Catheter Ablation.

INFORMED CONSENT

Conservative non-invasive alternative treatment; Risks and benefits; Why specifically cardiac ablation procedure is recommended as a first-line intervention; Pre-existing conditions that may impact positive outcome; Outline procedure; Safety; Efficacy; Post-operative quality of life; Surgical technical competence.

MEDICAL MALPRACTICE – Mitigating liability risk

It costs ~ $80,000 to defend a cardiologist in a medical malpractice claim resulting in payment—nearly four times the cost in ophthalmology, the least expensive specialty to defend. Among electrophysiologists, three complications represent the bulk of malpractice suits:

1) arterial laceration during a pacemaker implantation or electrophysiology study,

2) atrioventricular node damage during ablation that required pacemaker placement,

3) pulmonary vein stenosis after ablation.

Also, transesophageal echocardiography, though not an invasive vascular procedure, has two primary liability risks—first, lawsuits after esophageal perforation, and second, neurological damage caused by neck flexion in patients with undiagnosed epidural abscess.

Cardiologists and electrophysiologists must be aware of the most prevalent types of diagnosis or procedural errors and engage in meticulous informed consent. That same meticulous attention must be paid to documentation, workup, and follow up after a complication occurs – suspected or realized. Failing to act expeditiously—for example, by not ordering a CT scan to evaluate for possible cardiac tamponade, may turn a rare complication into a lawsuit. In addition, high-risk, liability-prone use of warfarin often places cardiologists between a rock and a hard place – The drug’s narrow therapeutic window can create liability problems for physicians who need to decrease a patient’s stroke risk, but may end up causing severe bleeding.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is a time-honored medical expert who assists attorneys in navigating meritorious complexities for medical-related claims. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

 

STANDARD OF CARE RESOURCES

Posted by Kathleen on January 3rd, 2017


boat1Standard of Care is the foundation for every medical malpractice case. Three primary categories of standards are pivotal to developing a comprehensive medical malpractice case:

Legal Resources:

  • Practice Acts – State Practice Acts can be obtained where the incident occurred and for each discipline involved. The practice act creates the framework of practice for the healthcare professional.

Regulatory Resources:

  • Accreditation Organizations – The Joint Commission and DNV accredit hospitals, laboratories and a variety of outpatient and diagnostic facilities. NCQA accredits managed care organizations.

Authoritative Resources:

  • Professional Associations – Professional association standards are persuasive in court and provide specific information relevant to the case issues. Standards are available for nursing, medical and ancillary care associations.
  • Scientific Literature – Textbooks, journal articles or research are credible resources for standard of care. These sources often provide the most in-depth information relevant to standards.
  • Healthcare Facility Resources – These resources pertain to the facility’s policy and procedures, standards and practice guidelines. Meticulously assess facility sources for accuracy and consistency with the standard of care.

 

Kathleen A. Mary, RNC, Legal Nurse Consultant Certified is a time-honored medical expert who assists attorneys in navigating meritorious complexities for medical-related claims. For over 25 years, 100% of Kathleen’s cases (hundreds) have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

Best Hospitals 2016-17

Posted by Kathleen on November 27th, 2016


boat1U.S. News & World Report announced its 27th annual Best Hospitals rankings to help patients make more informed health care decisions. U.S. News compared nearly 5,000 medical centers nationwide in 25 specialties, procedures and conditions.

2016–17 Best Hospitals Honor Roll

  1. Mayo Clinic, Rochester, Minn.
  2. Cleveland Clinic
  3. Massachusetts General Hospital, Boston
  4. Johns Hopkins Hospital, Baltimore
  5. UCLA Medical Center
  6. New York-Presbyterian University Hospital of Columbia and Cornell
  7. UCSF Medical Center, San Francisco
  8. Northwestern Memorial Hospital, Chicago
  9. Hospitals of the University of Pennsylvania-Penn Presbyterian, Philadelphia
  10. NYU Langone Medical Center
  11. Barnes-Jewish Hospital/Washington University, St. Louis
  12. UPMC Presbyterian Shadyside, Pittsburgh
  13. Brigham and Women’s Hospital, Boston
  14. Stanford Health Care-Stanford Hospital, Stanford, Calif.
  15. Mount Sinai Hospital, New York
  16. Duke University Hospital, Durham, N.C.
  17. Cedars-Sinai Medical Center, Los Angeles
  18. University of Michigan Hospitals and Health Centers, Ann Arbor
  19. Houston Methodist Hospital
  20. University of Colorado Hospital, Aurora

 

Top Five Best Hospitals in Selected Specialties

Top 5: Cancer
  1. University of Texas MD Anderson Cancer Center, Houston
  2. Memorial Sloan Kettering Cancer Center, New York
  3. Mayo Clinic, Rochester, Minn.
  4. Dana-Farber/Brigham and Women’s Cancer Center, Boston
  5. UCLA Medical Center
Top 5: Cardiology & Heart Surgery
  1. Cleveland Clinic
  2. Mayo Clinic, Rochester, Minn.
  3. New York-Presbyterian University Hospital of Columbia and Cornell
  4. Massachusetts General Hospital, Boston
  5. Duke University Hospital, Durham, N.C.
Top 5: Orthopedics
  1. Hospital for Special Surgery, New York
  2. Mayo Clinic, Rochester, Minn.
  3. Cleveland Clinic
  4. Rush University Medical Center, Chicago
  5. Hospital for Joint Diseases, NYU Langone Medical Center, New York

 

Kathleen A. Mary, RN, Legal Nurse Consultant Certified is an honored medical expert who assists attorneys in navigating meritorious complexities of any medical negligence claim. For over 25 years, 100% of Kathleen Mary’s hundreds of cases have been positively settled without trial. Please contact Kathleen for your next medical-legal case.  

 

Surgical Errors Increase Hospital Profits

Posted by Kathleen on June 22nd, 2013


Hospitals can make much more money when surgery goes wrong and leads to complications that need correcting.

And that presents a problem for patients. The financial incentives do not favor better care.

The current payment system rewards hospitals for bad care – below Standard of Care, and fails to provide incentives that would benefit patient safety.

“The magnitude of the numbers was eye-popping,” says Atul Gawande, a professor of surgery at Harvard Medical School, and an author of the study, which was just published in JAMA, the Journal of the American Medical Association. “It was much larger than we expected.”

The study underscores how ludicrous the incentives are in the American health care system, generally paying doctors for each medical service they provide, even if some of that care is the result of a surgery gone wrong.

If a patient with private insurance had complications after surgery, hospitals made $39,017 more profit than if all had gone well. That’s compared to an additional profit of $1,749 for a Medicare patient with complications after surgery.

“That’s an indication of the level of perversity here,” Gawande says. “Having a complication was profitable, and fighting complications was highly unprofitable.”

It’s not surprising that health care costs are higher when there are complications, since patients need more care to get better. And it’s not surprising that hospitals bill private insurers at a much higher rate than Medicare.

There was no profit with Medicare patients. The paper used “contribution margin,” which is revenues minus variable costs. In other words, the expense of items used directly for a patient’s care, not overhead or other fixed costs.

The much higher margin on cases involving mistakes is enough to make a patient think that hospitals aren’t highly motivated to reduce medical negligent errors. In fact, one reason that Gawande and his colleagues embarked on the study is that many hospitals have been slow to adopt safe practices proven to improve the quality of care and save money.

“We have never seen hospitals that are actively trying to cause complications to make a profit,” Gawande told Shots. “But we’ve seen a lot of hospitals where you say, “Why aren’t you investing in reducing risk, the way other industries do?’ “

The researchers looked at 34,000 surgeries at 12 hospitals in the Texas Health Resources system in 2010. About 5 percent of people experienced complications. That included surgical site infection, sepsis, pulmonary embolism, stroke, heart attack, pneumonia and other infections.

The study was part of a larger effort to improve quality in the system.

“It’s just more evidence that payment reform is key to health care reform,” says Mark Lester, executive vice president of Texas Health Resources, and a co-author of the paper. “We’ve unmasked some hidden perverse incentives that are just part of our system.”

Efforts are underway to reduce financial incentives for providing more care, including bundled payments for Medicare that pay the same amount for a procedure, with or without complications.

Wonder how your hospital is doing? “Ninety percent of the country is still functioning in the world we describe in the paper,” Gawande says.

Kathleen A. Mary, RN, Legal Nurse Consultant Certified, is a medical expert proven to be invaluable in helping attorneys meticulously navigate meritorious complexities of any medical negligence claim. Please contact Kathleen for your next medical-legal case – 100% of her cases have been won and positively settled without trial.