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A Fall During Physical Therapy Following Knee Surgery, Too Soon to Weight Bear?

The patient, a gentleman now in his mid 70's, underwent bilateral total knee replacement in 1988. The patient is moderately overweight (his BMI may put him in the "obese" category, but he is not "morbidly obese") and diabetic. In 2004, the patient developed a severe ulcer on his left foot. The ulcer becomes chronic (multiple debridements, etc.). In 2005, the patient began to have problems (pain, swelling) with his right knee. In 2006, with the left foot ulcer still not healed, the patient undergoes revision of the right knee.

Post-operatively, the patient engaged in physical therapy/rehabilitation. He could not bear weight on his left foot because of the ulcer so, with the aid of a walker, he "hopped" on the right leg. Approximately one year following the revision surgery, the patient developed pain and swelling of the right knee. 3-phase imaging showed that the screws were backing out the right femur.

Is there a claim here? Did the orthopaedic surgeon err in revising the right knee with the left foot ulcer still not healed? Did the surgeon (or the physical therapy/rehabilitation staff) err in having the patient engage in active, as opposed to passive, physical therapy/rehabilitation following the revision surgery?

Patient ultimately required a re-revision of the right knee. That surgery and the post-operative course were uncomplicated.

***


Following knee revision surgery, the standard of care requires that the patient begin weight bearing on the knee in question as soon as possible. In the absence of any other contra-indications for weight bearing, it is my opinion that the ulcerative left foot alone would not be sufficient reason to forgo weight bearing physical therapy and I would note that "hopping" is quite common in acute care facilities.

It is also unlikely that the hopping had anything to do with the subequent issues that developed with the screws. It may be worthwhile to focus on the adequacy of the first surgery, but, it is highly unlikely that the PT caused any harm.

- Celeste Dolan, MSPT

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Drug Study, Informed Consent & Regulatory Issues

Age 83, ex-fireman. About age 81 was doing almost daily patient volunteer work at local hospital and in reasonably good health, except for some minor kidney problems, and a prior bypass at age 71.

2005 has a stent put in. A month later, another stent is scheduled, but there's a curve in his artery and the doctor can't do it so sends him to big hospital. Sees Dr. there for the stent. In preparation for it, doctor tells him he is going to put in dye that may affect kidneys, but there's a drug out there being investigated, and that it will protect his weak kidneys from the bad effects of the dye during the angioplasty.

Patient is asked to and does sign a contract to participate in this study of a drug, which appears to be fraudulent on its face. It states that the DRUG will help protect his weak kidneys. They infuse this drug, thru a catheter, directly into his kidneys. In fact, the drug warning essentially says the drug is ONLY to be used for patients presenting to a hospital with acute decompensating congestive heart failure who have shortness of breath, nothing else. The letter to doctors in 7/05, about 4 mos before this contract, says it is NOT to be used for outpatient infusion, repetitive use, to improve renal function or to enhance diuresis. In fact, the letter says use of the DRUG is associated with dose-dependent increases in creatinine, and that the biggest increases occurred days after its use was discontinued. It says studies should be done on this kidney situation.

So here we have a guy with weak kidneys, who does NOT fit the profile of someone needing the drug (no CHF and acute SOB), and a drug that is not recommended to help kidneys, in fact it is shown to hurt kidneys but needs more kidney studies, being told in a contract that the drug will protect his kidneys and help him.

He gets the DRUG directly infused into his kidneys for several hours, and has the angioplasty done (balloons, since couldn't fit stent in curve), and heart is now good. But, just like the data shows, several (5-6) days after this several hour infusion of the DRUG directly into his kidneys, he has kidney failure, cardiac shock and is admitted for several days into another hospital. He does recover, but is not nearly the same health-wise at all– too weak to walk much, heart still ok. Can only sit around now.

***

This case is rife with regulatory issues. The two central facts to establish are the IND (investigational new drug) status of the study in question and the wording of the Institutional Review Board (IRB) protocol relating to the study in question.

Let me begin by explaining that "IND" is a somewhat, no, quite, unfortunate acronym that has been galvanized over the years. While the noun of the phrase is indeed "Drug", it actually refers to a study! The first time a drug is ever shipped across state lines for its very first national study of any kind, the drug gets its first IND. At that point, the drug and the study are more or less synonymous, so there's not much confusion. In fact, it was probably called IND (instead of INS) because someone didn't think ahead to the 2nd study that a drug might be in.

The confusion comes later, when the drug has been approved for one indication, and the sponsor (or an investigator, less commonly) is seeking an additional indication for the drug. The new study needs its own IND, even though the drug could be ten years old and used routinely in the clinic. The study's IND allows the drug to be shipped for use in the new experimental context.

From the case description, it sounds like the study has at least gotten an IND from the FDA in order to use the drug in the context described. If it has not, and if the drug has been approved for some other indication, then the physician would have to argue that he was using the drug off-label according to his discretion in the practice of medicine. But if that's the case, there shouldn't have been any discussion of a study in the first place, so let's assume that the IND is in order. The first issue to resolve is whether the IND was "investigator-initiated" or "sponsor-initiated" (sponsor=pharmaceutical company). In general, the initiator of the IND is more liable.

Next, the wording of the informed-consent contract that the patient signed in order to participate in the study is critical. This document is regulated by the IRB. If the drug is being investigated as to whether it will protect the kidneys from dye-related complications, the informed consent document cannot state that the drug will protect the kidneys (FDA 21 CFR 50.20). If it does state that, the independent IRB or the investigators (or both) can be held liable for a violation of 21 CFR 312.7. This is such a fundamental rule of informed consent, it is difficult for a responsible researcher to even imagine this mistake being made by either the IRB or the investigators. If this did occur, the plaintiff's case is extremely strong, and there isn't very much more to talk about here.

To make this hypothetical case a little murkier, let's say that the informed consent document states, as it should, that there is to be no expected benefit from participating in the study. It is still possible that the investigator verbally informed the patient otherwise. This of course would be difficult to prove, but could be argued. Another possibility is that the drug has already been approved for kidney protection in certain situations (indications), but that this new IND is trying to get a broader indication.

Another potential loophole to be aware of is the "Treatment IND" (see FDA 21 CFR 312.34, 312.35, and 312.36). This provides a mechanism for providing eligible subjects with investigational drugs for the treatment of serious, life-threatening, or emergency conditions for which there are no satisfactory alternative treatments. As described it seems unlikely that the physician's side would be able to argue this convincingly, but nonetheless it is an avenue which could be explored.

We would want to see the informed consent document in order to advise on this case.

-- Brett Mensh, MD, PhD

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A Fall in the Doctor's Office?

June 20, 2007: Sally, age 63, had a doctor’s appointment with Dr. OBGYN at 1:30 for a growth on her lower private area, which turned out to be a cyst. Sally and daughter arrived at 1:30 and waited 1 ½ hours in the waiting room before being called back. Sally was called back and the nurse took her weight, blood pressure, etc. Daughter went to the examining room with her and once again, it was an hour wait in the examining room.

Daughter decided to leave the room for Sally’s examination for this was very personal and felt Sally would be more comfortable if daughter left the room. Dr. OBGYN and nurse finally came into the room and examined Sally, determining she had a cyst that needed to be removed. Daughter told the nurse that Sally fell easily. They both left the room to get whatever they needed to remove her cyst. Once again, Sally was left for a long period of time. Sally had to use the bathroom, so she tried to get off the table by herself. There was no help button and Sally was wearing only a gown and her socks.

Daughter was in the waiting room and heard a boom that sounded as if someone threw a chair into the wall. Next, daughter heard Sally screaming and took off running into the examination room. Daughter arrived approximately the same time as the nurse and another doctor. Sally was lying on the floor with her head against the door crying in pain. She seemed very disoriented for a few minutes. The nurse got Dr. OBGYN and she came in to examine the situation.

Sally could not walk and expressed severe pain. It took Dr. OBGYN, the nurse and daughter to lift Sally back on the table. Sally was unable to walk or put pressure on her left hip. Dr. OBGYN looked at her leg and told Sally and daughter she didn’t think anything was broken or she wouldn’t be able to move it. Dr. OBGYN asked Sally if she wanted to proceed with the cyst removal and Sally said ok since she was already there.

Procedure done, once again, it took the doctor, nurse and daughter to get Sally off the table. She could not walk. They brought in a wheelchair and on the way out, the nurse said not to worry about the bill. Of course Sally was sent one anyway. Daughter loaded Sally up into her SUV while Sally was crying in pain. Daughter took her home and Sally’s husband and daughter took Sally to a clinic and it was determined that she broke her hip. Daughter expressed over and over again that from the sounds of her fall and how disoriented she was that Sally took a good blow to the head. Clinic doctor asked if Sally was completely knocked unconscious and daughter said no, but that she did appear to be out of it for a minute or two. Sally was sent to the hospital by ambulance.

Sally had surgery on the 22nd of June. Sally was on high doses of blood thinners. Following the surgery, the family noticed it was taking days for Sally to come out of her anesthesia, at one point being called to the hospital to try and wake her up. Sally was in such a deep sleep and so lethargic, she was forgetting to breathe.

In the meantime, hospital started her blood thinner giving her shots in the abdomen. Hospital lowered her pain medication to help Sally stay awake and eventually admitted her to the rehabilitation floor. Daughter stayed with Sally everyday and would wheel her to therapy and she would be so lethargic she couldn’t hold her head up and would fall asleep sitting in her wheelchair. At this pint, hospital is still pumping blood thinners in Sally. The following days the family started noticing that she couldn’t feed herself, was unable to move her hands, she all of a sudden was like a severe stroke patient. Finally, daughter approached hospital doctor and asked if Sally could have a head injury. Every day daughter would arrive and Sally was getting worse. A CAT scan revealed that Sally had a subdural hematoma. They immediately took her off blood thinners and gave vitamin K to help thicken her blood.

Sally spent ten days on the therapy floor and after being taken off blood thinners, did seem to improve a bit. She could feed herself a little better. She has been receiving physical and occupational therapy at home. She did have a speech therapy for a while for speech and swallowing problems.

In summary: Sally, although weak, walked into a doctor’s office as a functioning adult. Yes, she had health problems, but she was able to drive, walk, take care of herself and her husband, maintained her house and finances. She left unable to do anything for herself and still cannot. The family has to provide twenty-four hour care for Sally. She is still unable to walk, due to balance problems or use her hands properly. She cannot dress herself, take herself to the restroom, etc. This has had a major impact on her life and on the family’s life. Sally will never be the same that daughter can see.


***


There seem to be a number of issues here:

The clinic has a responsibility to the patient to provide a safe environment. If the patient was felt to be at risk for falling, it would be negligent in my view to leave her on an examination table, unattended, while the Doctor and Nurse went to prepare for her office surgery. Either Sally's daughter should have been summoned to watch after her or a staff member assigned to her. It is our practice not to have patients wait on the elevated examination table, but rather in a normal chair if no one is in the room with them, just for that reason.

Secondly, the physician(s) was probably negligent in failing to carefully examine her injuries after the fall, especially in a patient who could not weight bear. Appropriate examination at that time would certainly have revealed the hip fracture; whether it would have shown evidence of the subdural hematoma is questionable. It would not be expected of a OB-GYN physician to FULLY evaluate a trauma of this nature, I believe, but any physician would likely recognize that this was a significant trauma which required investigation. The most proper disposition would be to transfer Sally to an Emergency Department, by ambulance, if necessary. Had this been done, her hip fracture would have been quickly diagnosed and treated. Whether or not a Head CT would have been ordered on that occasion or if ordered would have shown the subdural hematoma is not completely clear. However, from the history given in the case, I think a Head CT probably would have and should have been ordered.

The clinic doctor who diagnosed Sally's fracture appropriately sent her to the hospital by ambulance. Probably he did not have the facility in the clinic to perform a head CT, which certainly could have been done in the hospital.

It is reasonable to think that the standard of care required that a head CT be done upon her admission to the hospital if there was evidence of a significant head injury. Whether a CT at that time would have shown a subdural hematoma or brain injury, I do not know. Certainly, evidence of an intracranial injury would be a contraindication to any anticoagulation after the hip surgery.

Certainly, if Sally had significant deterioration in her mental status while on the rehabilitation floor, it would be negligent for the nurses and physicians caring for her to fail to recognize that this might be due to her original head injury and order appropriate evaluation (ie CT scanning)

The original injuries from her fall in the Doctor's office were certainly causative of her fractured hip and subdural hematoma. Whether the delay in diagnoses of the hip fracture and head injury by the OB-GYN doctor or the failure to diagnose her intracranial injury (and the use of anticoagulants) by the other physicians and staff attending to her were causative of further injury to her is not completely clear from the information provided, but does seem likely to me, at least as far as the head injury is concerned.

Did Sally require brain surgery for the subdural hematoma, or simply just correction of the anticoagulation?

Finally, age 63 is a bit young for developing a fractured hip and a subdural hematoma from a ground-level fall. This suggests that her original injury must have been very severe, indeed, as her daughter recalls.

--Frank Brodkey, M.D.


Editor’s Note: Needless to say, this is a nightmare case for everyone involved. The Ob-Gyn, while not expected to be a traumatologist should not have discharged a patient who walked in and was unable to walk out. I agree with Dr. Brodkey that the next appropriate steps were either transfer to the nearest emergency department or direct admission to the hospital with consultation by specialists to address both the orthopedic issue and Sally’s altered mental status.

Given the history of head trauma and persistent altered mental status, it is irrelevant whether Sally lost consciousness or not. She needs a CT scan. She certainly needs a CT scan prior to anticoagulation (blood thinners) given her trauma. Delaying hip surgery to address acute medical issues is not uncommon. One does not take a patient to the operating room for a not imminently limb threatening injury until all relevant medical issues have been addressed. Since it is standard to put hip surgery patients on anticoagulation (in this case what sounds to be a low-molecular weight heparin formulation), a CT scan was warranted.

Failures of physician-to-physician communication, failure to suspect a serious or semi-serious head injury and most importantly, failure to listen to the patient’s daughter are the most egregious errors of judgment. Nevertheless, I cannot help but wonder if Sally didn't already have a chronic subdural hematoma or normal pressure hydrocephalus before any of this happened. This makes it all the more striking that she was cleared for orthopedic surgery.

To summarize, based on the information provided:

1. The Ob/Gyn should not have discharged a patient unable to weight bear and/or with altered mental status if that is not the condition which she arrived for outpatient surgery and, especially, if she had trauma in the office. The next appropriate step would have been transfer to the ER or direct admission to the hospital.

2. If Sally had persistently altered mental status or persistent headaches after head trauma, she should not have been cleared for surgery.

3. Sally's daughter reports that her mother was prone to falling prior to the visit to the Ob/Gyn. This makes me wonder if she didn't already have a chronic subdural hematoma or normal pressure hydrocephalus before any of these events occurred.

--Matthew R. Lewin, M.D., Ph.D.

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Drug Overdose of Dilaudid & Morphine?

A 70-year-old woman is transported to the emergency department by EMS after falling and fracturing her left hip. (Height 5'3, Weight 195 lbs.) While en route to the hospital, the EMS technician administered 2 mg Morphine by IV (at 7:09 p.m.), and 4 mg Zofran by IV (at 7:10 p.m.).

The woman was admitted to the emergency department at 7:22 p.m. An ER physician examined the woman in the emergency department. She was given a total of 4 mg more Morphine from arrival until 7:50 p.m. She was then given a total of 6 mg Dilaudid between 8:15 p.m. and 10:40 p.m., and 2 mg Ativan at 11:10 p.m.

See chart:

Time/Medication
7:09 p.m.2 mg Morphine (in ambulance)
7:10 p.m.4 mg Zofran (in ambulance)
7:30 p.m.2 mg Morphine
7:50 p.m.2 mg Morphine
7:50 p.m.4 mg Zofran
8:15 p.m.2 mg Dilaudid
10:20 p.m.2 mg Dilaudid
10:40 p.m.2 mg Dilaudid
11:10 p.m.2 mg Ativan


At 11:30 p.m., the woman left the emergency department by ambulance stretcher for transfer to a hospital with specialized orthopaedic care. At that time, she was noted to be asleep, her color was pink and her blood pressure was 113/91. A few minutes later (while in the ambulance), the EMT noted that she was pale and did not have a blood pressure. She was returned to the emergency department and CPR was performed. The ER physician reported that she had an episode of emesis and aspiration. The woman was resuscitated and admitted to the ICU on a ventilator. She remained comatose. Pulmonary embolism was ruled out with CT. She developed multi-organ failure. She was taken off life support and died two days later. Her death summary lists aspiration pneumonia, cardiac arrest and shock as reasons for death.

From an ER perspective, are the dosages of pain medicine administered concerning for severe complaints of pain? Did the administration of this medicine cause a cardiac or respiratory arrest?

***


The main issues involved here include the possibility of narcosis from the doses of narcotics given and the combination of narcotics and zofran/ativan resulting in excess sedation.

Most references list the IV conversion of dilaudid to morphine as 1 to 5 or 6.. Therefore the switch in the narcotic from 2mg of morphine to 2mg of dilaudid represented a 5 or 6 fold increase in narcotic effect, and led to the equivalent of 30-36mg of morphine being administered over a period of 2.5 hours and 20-24mg administered over a period of 20 minutes or so. The addition of the 2 doses of Zofran, I believe, is safe, however the addition of 2mg of Ativan to the high doses of narcotic given likely led to additional respiratory depression, which, in turn, led to the patient's respiratory and cardiac arrest.

The major deviation from standard of care probably results from an unfamiliarity with the pharmacokinetics of dilaudid. The hypothetical does not state for certain if the inter-hospital transfer was performed via ACLS ambulance. Certainly, standard of care would require such a transfer in this patient who had received multiple narcotics and sedation in the transferring hospital.

---Frank Brodkey, M.D.


Editor’s Note: I agree with Dr. Brodkey’s analysis about the astonishingly improper dosing of opioid analgesics alone or, in combination, with ativan. What is potentially more astonishing in the hypothetical is the apparent lack of attention to the standard emergency treatment of the patient with acute altered mental status: the checking of blood glucose preceded, or followed, by naloxone (e.g. Narcan), a standard opioid overdose reversal agent. This is the undisputed standard of care in the management of the acutely altered patient, especially one who is known to have been given opioids such as morphine or dilaudid. Thus, aside from the opioid overdose, the other elephant in the room is the apparent failure to use an instantaneous and effective antidote to opioid overdose—naloxone.

If either the paramedics or the emergency physicians failed to use this antidote, that would be a highly significant breach of the standard of care. Rapid recognition and utilization of naloxone might have rendered the original medication error irrelevant. If administered, it is likely the patient would have been admitted to the hospital, treated with a naloxone drip and transferred to the orthopedics service once stabilized. An expert reviewer should be giving the same or more attention to the mode of resuscitation whether or not the error was recognized at the time of resuscitation.

--Matthew R. Lewin, M.D., Ph.D.

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Your hypothetical here.


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Questions of Discharge, Vaccination and Neonatal Pneumonia

A 27 week premie is delivered by c-section due to mom's placenta prevaria. The baby spends 2 months in NICU primarily for RDS with some apnea which by history was resolved with caffeine. No episodes of apnea within 9 days of discharge from NICU to home. The only immunizations given in the hospital are a 1 st dose of HBV at 36 weeks (3 days before discharge from the hospital) with no adverse reaction and a 1st dose of synagis at 36 weeks (3 days before discharge from the hospital) with no adverse reaction.

The baby is discharged from the NICU by the neonatologist and is stable with resolving anemia as her only recorded and diagnosed remaining condition at 36 weeks. Within 5 days of this discharge, the baby presents to her pediatrician for a "well visit" and receives the following immunizations: DTAP, Hepb-1p, Hib, pneumonia conjugate and rotovirus. The Pediatrician's records show everything is normal both prior to and following the vaccinations although the mother believes that her baby was very lethargic and listless at the time of the presentation. She contends that when she alerted the nurses to this fact she was told that the bay was perfectly healthy and was just sleeping. This was a fourth child and child number 3 was also a 27 week premie and is perfectly healthy today but remained in the NICU far longer than for two month's after he was delivered.

3 hours after leaving the pediatrician's office the baby is taken to the local community emergency room listless, unresponsive to tactile stimuli and "hardly breathing" where she is found to have chest "retractions" and is diagnosed on chest CT with pneumonia. She is intubated and is transferred to the NICU at a University Hospital (that hospital's records are pending); however we know that the baby was placed on a ventilator at that hospital as she could not breathe on her own, We understand that 1.5 months later she was eventually stabilized and discharged. Her current sequalae are not totally known (we are awaiting these records and input from various specialists that have seen her) but no apparent encephalopathy has been found to date.

Was the baby discharged from the original NICU too soon? Were the appropriate vaccinations given and at the appropriate times; particularly the pneumonia conjugate? Should the above vaccinations have been administered if the baby was listless and lethargic previous as mom contends? Were the symptoms at presentation to the ER an adverse reaction to the vaccinations administered within 3 hours of the "event" and is this "event" the type of "event" associated with an adverse reaction to the vaccinations such that the claim is subject to the National Vaccine Injury Act, or, are these symptoms more likely associated with other factors?




Dr. Lewin:

The Emergency Department appears to have acted promptly to evaluate and stabilize the patient's respiratory insufficiency. She was noted to be in respiratory distress, intubated and transferred to the NICU. With regard to the pediatrician's office and question of "premature" discharge from the NICU. The patient was home for 5 days without any apparent need for medical attention--suggesting discharge from the NICU was reasonable. What happened at the pediatrician's office is a question mark: Mom says the child was already lethargic, but the pediatrician's notes suggest otherwise. Is Mom's recollection a post hoc reconstruction of events? Based on what followed (ER visit and admission ot the ICU) it seems as if the mother's assessment was correct.

The diagnosis of pneumonia does not support the hypothesis of an adverse reaction to the vaccines. That the vaccines were administered in a child that may have been ill is certainly questionable, but I don't see how this changed the outcome--if the infant had pneumonia, she would have declared herself anyway. It is possible that the stress of the vaccines was sufficient to cause the child to declare her illness sooner, but again, I am not at all convinced there is any intrinsic relationship between the vaccines and subsequent events.

My questions:

1. what were the child's vital signs at the time of the pediatrician's office visit and by what method were they taken (e.g. rectal vs. axillary temperature)?
2. is there a record of Mom's concerns in the pediatrician's notes?
3. if there was evidence of illness at the pediatrician's office, did failure to recognize this change the outcome of the case?

My suspicion is that the answer is "No."

For one thing, Mom contends the child was already ill at the time of the visit to the pediatrician, suggesting she was on her way to declaring disease. With regard to premature discharge from the NICU and the appropriateness of the vaccines--she tolerated the first set and was apparently doing okay at home for the better part of a week. Based on the data provided me, it is hard to fault anyone or the vaccines. The patient has pneumonia.


Dr. Brodkey: I have not been in a neonatal ICU in many years. However, it seems that the baby was in the NICU for about nine weeks and from the description of the situation, it wouldn't seem to me to be likely that the child was sent out of the NICU prematurely.

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Cerebral Hemorrhage Following Treatment for DVT

A 68 year old African-American lady with a history of normal pressure hydrocephalus developed a deep vein thrombophlebitis in the left leg. After starting lovenox treatment, she suffered a crippling, left cerebral hemorrhage.

She had undergone exchange of a ventriculoperitoneal shunt on 9/12/07. She was referred for rehabilitation and on 9/20/07 developed pain and swelling in the left leg, which on doppler examination showed extensive deep vein thrombophlebitis. With the patient on the rehabilitation floor, lovenox in a dose of 1mg/kg/day was started, whereupon her leg started to improve. On 9/22/07, however, the patient had sudden onset of garbled speech and weakness of the right arm and leg. CT scanning demonstrated an acute, left-sided, cerebral hemorrhage in the deep portion of the brain, near the tract of the shunt insertion. The patient has shown some improvement subsequently with therapy but remains dysphasic and weak on the right side.



The literature regarding anti-coagulation after neurosurgery is somewhat variable. Most references, however, suggest waiting at least two weeks to a month for full dose anticoagulation in a post-operative brain surgery patient. Prophylactic doses of heparin or lovenox(eg 40mg/daily) are considered to be safe and effective.

I think it is reasonable to conclude that her cerebral hemorrhage was most likely caused by the inappropriate full-dose anticoagulation of this patient within just a few days of her brain surgery. The standard of care in that situation would involve placement of an inferior vena cava umbrella, perhaps with antithrombotic doses of heparin or lovenox. Review of the rest of the patient's past medical history (for hypertension, strokes, etc., ) and the relevant CT scan may help to define further the patient's situation.

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Informed Consent for Surgical Anesthesia

A 50-year-old man arrived at the hospital for an elective total knee replacement. Based on preoperative discussions, the patient expected to receive spinal anesthesia. The patient reportedly signed an anesthesia permit required by this hospital that stated that any change in the anesthesia plan must occur in writing. For unclear reasons, the patient ultimately received general anesthesia and suffered the adverse outcome of permanent unilateral hearing loss with tinnitus, an unusual complication. The anesthesia records failed to note or explain any change in the anesthesia plan.

The patient was understandably upset about his hearing deficit and also angry about the unexpected change in his anesthesia plans.

"Consent" is fundamental to the process of shared decision making between doctors and patients, allowing the former to relay information about treatment, and the latter to decide what can be physically done to them in the course of treatment.

Although national and international jurisdictions emphasize the legal necessity of consent to varying degrees, the process remains much more than simply a legalistic requirement for a patient to sign a form. Consent may be legally valid when obtained verbally or even non-verbally, such as when a patient holds out his or her arm for intravenous cannulation. Documentation merely acts as evidence that a discussion took place; it does not absolve the clinician or the hospital from potential liability if a complication occurs. Local and national guidelines pertaining to consent are just that -- guidelines, not law. However, they may help to interpret relevant law and inform the standard of care provided by the doctor.

In this case and based on the discussion above, the anesthetist ought to inform the patient that the procedure will involve a series of steps. For example, "you will be taken to operating theatre awake, you will have an intravenous cannula (or two) inserted, you will be attached to standard monitoring equipment, you will be given an anesthetic, you will have the operation, and you will recover in a special area after the operation and before being sent back to the ward." Regarding the specific type of anesthesia, the anesthetist should also inform the patient that several options exist and fall into three broad categories -- regional, general, or a combination of both. The discussion should state that it may be necessary in an emergency to change from one to another of these approaches. More specific information (possibly in written form) concerning risks and complications should be provided about general anesthesia, spinal/epidural anesthesia, sedation, urinary catheterization, further analgesia, and blood transfusion. Operator-specific risks could be quoted if they are available. Consideration should be given to providing patient-specific risks, according to coexistent pathology. Patients may ultimately require a period of reflection, either alone or in conversation with their families, before arriving at a decision. Standard written information, provided at preassessment clinics or prior to surgery, could be given to patients to help inform their decision.

It should be reiterated that it is the operator's responsibility to check consent: the anesthetist must check what anesthetic or procedures the patient has given consent for. This is particularly relevant if hospital policy requires that consent be obtained in advance of the procedure, and by a third party who may not actually be involved in the procedure itself. The time period between obtaining consent and the procedure occurring is irrelevant. Good "practice" allows sufficient time for a patient to make an informed decision and also allows an opportunity to recheck consent verbally if considerable time has elapsed since consent was originally given.

Informed consent is rarely an issue in anesthetic practice. Nevertheless, patients have successfully sued for damages in cases in which the doctor had not done what the patient had asked. In addition, a duty remains for the doctor to inform the patient and repeat a consent discussion if he or she intends to embark on a course of treatment that differs from the original agreement. In this case, the patient received a treatment to which he appeared not to have consented, although it is unclear exactly what happened (e.g., a failure to seek consent? a failure to understand what the patient had previously consented to?), or if an error actually occurred. Documentary evidence, in the form of a "full-disclosure" style consent form would not be a sufficient defense to a legal suit in battery in most jurisdictions. Without evidence of either general anesthesia being emergently required for the patient, or general anesthesia having been discussed as a treatment option at the outset, the anesthetist may be liable in the civil or criminal laws of battery or negligence.

It is unusual to quote the risk of unilateral hearing loss after anesthesia during a consent discussion. Ironically, the hearing loss that occurred is apparently less prevalent following general anesthesia (approximately 1:10,000) than after intrathecal anesthesia (approximately 1:7). A clever lawyer might argue that the alteration in anesthetic management actually reduced the risk to the patient-although the litigant's lawyer would also point out that his client was not informed of the risk during the consent process.

*Excerpted from the Agency of Healthcare Research and Quality.

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Cancer from Kidney Transplant Mystery

Early 30's male who died of ovarian cancer that he contracted from a cadaveric kidney transplant. The donor was a late 50's female whose history included a hysterectomy. The reason for the hysterectomy is not explicitly stated in the records of the recipient transplant center. The kidney was received through an organ procurement organization member of UNOS.

With regard to procurement organization: The main issues in this case is whether the patient was properly screened by the organ procurement agency and were there signs of malignancy (either gross or on histology) at the time of harvesting.

A long and detailed series of questions was presented to the deceased donor's husband. Among the sets of questions asked were two potentially and directly related to the tragic death of the patient. These addressed the nature and indication of donor's hysterectomy (fibroids, excessive uterine bleeding) and if she had any known history of actual or suspected cancer ("yes", a breast mass which was determined to be benign. Otherwise, "No".). The husband did not indicate if the ovaries were removed.

The donor kidney was subsequently harvested and a wedge biopsy performed looking at a frozen section, which is typical of an intraoperative biopsy because of the time limits imposed by the surgical procedure (i.e. specialized fixation and staining require much much more time than is practical given the urgency of the organ donation and O.R. time). Please also note that a wedge biopsy covers a much larger tissue area than a needle biopsy, though neither is perfect. Procurement organization explicitly states that no evidence of neoplasm was found.

One can only conclude that a very reasonable degree of diligence was made on the part of the procurement organization and the physicians involved in the organ procurement concerning the potential for donor-related malignancy. That being said, there are a few, small stones remaining unturned. These are:

1. the pathology report is a summary of the pathology report and not the actual pathologist's report.

2. there is a small, but finite chance that obvious histologic evidence of cancer cells was missed and a second opinion about the pathology specimens might be warranted. I do think the likelihood of this is small. Nevertheless, if your clients can gain peace of mind or some form of closure from this it might be worthwhile.

My overall view of the matter is that your patient got incredibly unlucky and that no-one is likely to be at fault save Fate.

*Opined on by Dr. Lewin

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