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Tag Archives: Medical-Legal

FDA: Zofran May Be DEADLY

Get ready for a “black box” warning on Zofran. The FDA has just issued a “safety alert” stating that Zofran may now be potentially deadly. The FDA is now recommending ECG monitoring in patients who receive Zofran who have potential “electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.” After all, Zofran has now gone generic like previous anti-nausea medications that have also received black box warnings. The FDA approved Zofran for use in 1991, meaning that Zofran has been on the market for twenty years. Now, through diligent research, the FDA has decided that that Zofran may cause QT prolongation — just like most of the other anti-nausea medications. As a result, GlaxoSmithKline has been ordered to perform studies to determine whether Zofran could prolong QT intervals, and, if so, to what extent. Since the FDA states that it has been performing “ongoing safety studies” … for the past twenty years … why doesn’t the FDA actually publish the results of those safety studies that led to the posting of its alarming “safety notice”? Now we have one less medication in our armamentarium to treat nausea and vomiting.  I suppose we can always give ginger root until that gets a black box warning, too. It’s only been around for a few centuries. Whoa. I think that my heart just skipped a beat. Reading FDA safety notices may have caused me to have QT prolongation. I think that we need to put black box warnings on FDA safety notices and no one should read them without proper EKG monitoring. Who do we get to study that?

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More Florida Medical Follies

Yet another reason to stay away from Florida if you are a physician. The inspectors and health care agencies down there leave quite a bit to be desired. The Florida Agency for Healthcare Administration cited an emergency department’s staff for failing to give “adequate care” to 13 week pregnant patient before she had miscarriage of twins. The timeline of events for the patient was outlined in this article. At 9:45 a.m. the patient came to the emergency department with pelvic pain and vaginal bleeding. At 10:30 a.m., the patient was diagnosed with pain and bleeding, a urinalysis and a battery of blood tests ordered, but there was no test ordered that would have revealed her glucose level. There was also no discussion of whether to discontinue or maintain the patient’s insulin pump. Ultrasound tests were ordered, then changed, which “caused a delay.” At 11:45 a.m., the patient was bleeding heavily and was “in obvious labor” according to state inspectors. The ultrasound scan showed both fetuses had normal heart rates. The state inspectors stated that the emergency physician “failed to initiate any immediate response to the ultrasound report, the patient’s continued labor pains and the profuse bleeding.” At 12:25 p.m., the physician performed a pelvic exam and suctioned some large blood clots from the vaginal canal. The patient then “spontaneously aborted one of the fetuses.” Inspectors noted that the patient was not informed of any risks of performing a pelvic exam, nor did she give informed consent for the pelvic exam. A second ultrasound was ordered. By 2 p.m., the second ultrasound showed a normal heartbeat in the remaining fetus. At that point “the doctor took no steps to stop labor or maintain the second pregnancy.” Additionally, the emergency physician’s report showed that the second fetus had no heartbeat, which conflicted with the radiologist’s report. At 4 p.m., the patient’s blood-sugar level was measured and found to be “critically low.” She then received orange juice and IV dextrose. At 5:30 p.m., an obstetrician arrived and performed a pelvic exam. He ordered no additional procedures or medications. At 6:15 p.m., the woman passed the second fetus. The inspectors stated that the physician failed to monitor blood sugar levels, failed to respond to the patient’s bleeding and pain, and failed to intervene to stop her labor. In eight of ten other cases that inspectors reviewed, the hospital was cited for failing to document the amount of the patient’s blood loss, failing to record vital signs, and failing to record other case information. We need more information about the other cases, but even without extra information, I’m still calling out the inspector and the Florida Agency for Healthcare Administration. Many of these citations are uninformed and inappropriate. #1 No discussion documented about whether to continue or discontinue the patient’s insulin pump. Such discussions are rarely held in the emergency department. Should the patient’s blood glucose have been checked sooner? Probably. However, if a patient is not having symptoms suggestive of low blood glucose, how often should the glucose level be checked — especially with an unrelated complaint? Should hospitals be cited when glucose levels aren’t checked in a diabetic patient with an ankle sprain or laceration? #2 The emergency physician “failed to initiate any immediate response to the ultrasound report, the patient’s continued labor pains and the profuse bleeding.” How much bleeding was there? What were the patient’s vital signs? Notice how the report is vague about the findings? Also notice how the report doesn’t state what the emergency physician should have done, and only made vague accusations about what the emergency physician didn’t ...

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Where Are Force Fields When You Need Them?

When I first heard about the lawsuit in which Louisiana attorneys sued a hospital system because it didn’t prepare well enough for Hurricane Katrina, I thought they were kidding. Really? Hospitals have to be built to withstand hurricanes and flooding from one of the deadliest and costliest storms in American history? Now I see the absolute futility in trying to use logic to defend against lawsuits. Tenet Healthcare has decided to settle the class action lawsuit against it for $25 million. When the nation’s resources couldn’t even rescue many hurricane survivors, the hospital corporation was sued because of “insufficiencies in [its] backup electrical system” and because it did not have sufficient “plans for patient care and evacuation” during one of the worst hurricanes in the country’s history. The failed levees and the government’s lackluster response are not at issue, though. Plaintiff attorneys called those factors “irrelevant” to the responsibility that the hospital had in the face of the hurricane. That leaves me wondering. What is a hospital’s duty to patients in the face of a disaster? I’d ask the lawyers, but I’m sure that no one would answer. And the legal community apparently didn’t set the bar very high for itself during the same disaster. After all, courthouses and law offices in New Orleans were closed after Hurricane Katrina. For heck’s sake, the MAIL wasn’t even being delivered. The problem is that the civil legal system works retrospectively, saying that “if only you took these measures, the injury would not have occurred” or “if only you hadn’t done this, the injury wouldn’t have occurred.” Of course, it is easy to determine what should or should not be done after the fact. Law is the ultimate Monday Morning Quarterback. I have never seen an attorney issue a press release stating that liability should never ensue if a person or corporation takes or avoids certain measures. So what can we do prospectively to prevent similar lawsuits against hospitals in the future? Not defensive medicine … defensive corporate action plans, of course. I’ve come to the conclusion that everyone really needs to pay hospitals a lot more for providing health care. After all, in the event of an invasion from outer space, it’s going to cost a heck of a lot of money to have laser canons mounted on top of every hospital in the United States to defend patients from aliens who are hell bent on sucking out the brains of infirm humans with extra-terrestrial soda straws.

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King v. St. Barnabas

Walter Olson at Overlawyered.com forwarded me a case to comment upon. The opinion was King v. St. Barnabas Hospital. The facts of the case are that a 38 year old off-duty prison guard was playing basketball in the prison gym when he collapsed. Seven minutes later, medical clinic staff arrived to find the patient unresponsive and not breathing. CPR was started. A defibrillator was used to check the heart rhythm and the patient’s heart was in asystole, or “flat line.” The patient was defibrillated once – after one first responder thought the patient may have had episodes of ventricular fibrillation. The patient remained in asystole. No IV line was started and the patient was not intubated, even though the first responders had the equipment available. Six minutes later, a doctor arrived and inserted an IV. Epinephrine was given, but the patient remained in asystole and was pronounced dead. The plaintiff’s expert – unnamed in the appellate opinion – testified that to a reasonable degree of medical certainty that defibrillating someone in asystole “eliminate[s] any chance of recovery for the patient” and that “securing the patient’s airway and administering oxygen is ‘vital’ to avoid hypoxemia.” The failure to provide IV medications “contributed to [the patient’s] failed resuscitation and death and diminished his chances of survival.” The trial court threw the case out, noting that the expert failed to show any studies showing survival rates of patients in asystole or whether medications given post-arrest improves a patient’s chances of survival. The appellate court reversed the decision of the trial court, stating that the patient was “found in a life-threatening, nonresponsive state” and that ACLS protocols wouldn’t exist if there wasn’t evidence that the protocols improve survival. I have so many issues with the case and the testimony that I don’t know where to begin. Let’s start with the appellate court opinion. Dear justices: This patient wasn’t in a “life-threatening” state. He was dead … for seven minutes. Asystole without respirations equals death. If the medical personnel are able to revive a patient, they have brought the patient back from death. Failure to snatch someone out of the Grim Reaper’s hands should not be a compensable harm. The expert’s opinions also bother me. Yes, technically defibrillation causes “damage” to heart muscle. There is no evidence that defibrillation decreases survival or recovery for patients in asystole. While it wasn’t known at the time the incident occurred, Dr. Gordon Ewy showed that delaying resuscitation for intubation actually decreases survival as well. Failure to provide IV medications similarly has little effect on survival. Epinephrine doesn’t improve immediate survival or hospital discharge in cardiac arrest when AHA guidelines are followed. This paper (.pdf) shows that epinephrine actually tends to cause a trend toward less survival in cardiac arrest. UPDATE: I forgot to check David Neuman, Graham Walker et al’s incredibly useful site “The Number Needed to Treat” regarding the utility of ACLS medications in cardiac arrest. Evidence-based opinion: 100% of patients receiving the medications “saw no benefit.” A plethora of case law requires that expert opinions have some basis in fact. There was no basis for causation and there was little if any basis for the expert’s other opinions. A plaintiff should not be able to proceed with a case based on an unsubstantiated expert’s opinion about standards of care and causation. The circuit court was right to throw out the case. If the expert had some studies supporting his theories, he needed to put up or shut up. I also thought it was … interesting … that the appellate court’s opinion identified the defense expert by ...

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The Case of the Crazy Rabid Squirrel

Who (if anyone) is to blame? Man and squirrel fight it out in man’s driveway. Squirrel scratches him twice, man runs inside grabs BB gun and plugs squirrel ala Elmer J Fudd. Man then calls health department for advice about what to do. Health department tells him to go to ED for rabies shots. After waiting for 2 hours the following day in the ED, the patient is told that squirrels don’t carry rabies in the United States and he doesn’t need the rabies shots. Later he is billed $692 for the emergency department visit and doesn’t want to pay the $382 deductible. The patient stated that “the health department and the hospital should get together and straighten it out.” Should a hospital and physician be responsible for getting payment from third parties when patients don’t like the medical advice they have received? Isn’t that kind of like someone in a restaurant telling the owner to get payment from the noodle maker because the patron didn’t like the spaghetti?

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Dr. Perfect

I occasionally get asked to review charts from other emergency departments in order to determine whether the care provided was appropriate. One of the cases from a visit to a competitor emergency department is below. A patient with a longstanding history of migraine headaches comes to the hospital for another one of her typical migraine headaches. Light aversion, noise aversion, nausea – all her usual symptoms. She ran out of her Imitrex and when she called her doctor for a refill, she was told to go to the emergency department instead. Her exam showed no physical abnormalities. She got a shot of Imitrex and a shot of morphine. Her headache improved and she was discharged home with her usual headache medications. Two days later, her headache returned. She happened to be visiting family in a large city and went to the emergency department in a hospital where we often refer patients. This time she was having visual changes. The emergency department physician there gave her more Imitrex and morphine and called neurology to come see the patient. The neurologist evaluated the patient and discovered papilledema on her funduscopic exam. A lumbar puncture confirmed the diagnosis of pseudotumor cerebri. Fine. The diagnosis may or not have been missed on the first visit. Assume it was. I got asked to review the chart because the patient complained to the hospital administration. The patient was upset because two of the doctors at the tertiary care hospital told the patient words to the effect of “You’re lucky. If we hadn’t have caught this, you’d be blind in a couple of days.” Are their self worth that low that they have to make inflammatory statements like this in an effort to aggrandize themselves? You didn’t call the docs involved. I checked. You didn’t request a copy of the chart from her emergency department visit. I checked that, too. Statements like this, even if they are true, serve little purpose. The patient didn’t lose her vision. Her vision was normal. Woo hoo. You saved her. Don’t dislocate your shoulder patting yourself on the back. Actually, statements like that do serve one purpose. They make it a pretty good bet that none of the doctors in our department will ever refer another patient to you or your your hospital. And if a patient tells any of our docs about any of your screw ups, chances are pretty good that the rest of us will hear about it. Chances are also pretty good that our docs will let any other patients who might need your services in the future know about your mistakes and how you aren’t perfect, either. Good work. picture credit here

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