Drug Misadventures: Medical-Legal Cases and Caveats for the Emergency Physician
By John F. Luerssen, BA, Indiana University, and Gregory P. Moore, MD, JD, Emergency Medicine Residency, Madigan Army Medical Center, Tacoma, WA.
In the emergency department (ED), a central component of a physician's daily care and job performance is to administer or prescribe drugs. The improper use of these drugs, however, can lead to a multitude of harmful outcomes if attention is not paid to detail. This can place the ED physician in a position of liability. This paper will share actual recent legal cases and the pitfalls that may occur when dispensing medications.
Narcotics
Narcotics are a frequent source of respiratory arrest and are often at the center of successful malpractice claims. In Trustee for Decedent's Heir v. Medical Provider, Hospital and Doctor, the case highlights the importance of knowing the proper dosages and the necessity to monitor the patient once drugs have been given. A patient was brought into the ED complaining of severe abdominal pain after having spent the day drinking alcohol. After the patient stated that his pain level was a 10 out of 10, the physician directed that he be given 1-2 mg of hydromorphone (Dilaudid) every 20 minutes. It was later revealed in court that the physician did not know about the patient's high blood alcohol level and had assumed that the nurses would monitor the response of the patient to the drug. Records showed that, over the course of an hour, 6 mg of hydromorphone was administered. Two hours after arrival in the ED, the patient was found to be in cardiopulmonary arrest, and resuscitation efforts failed. The defendant claimed that the patient was given an appropriate dosage due to the fact that the patient was obese, in severe pain, and, thus, didn't require monitoring. The defendant also claimed that the death was caused by severe hemorrhagic pancreatitis. A settlement of $500,000 was reached.1
It's important to note that hydromorphone (Dilaudid) is a narcotic that is roughly 10 times as potent as morphine. The initial dosage for IV administration is 0.2-0.6 mg every 2-3 hours as needed. There have been a multitude of recent cases successfully litigated due to respiratory arrest from this drug.
A second case, Renee Hurtado, Jose Hurtado, deceased, et al. v. County of Los Angeles, Harbor-UCLA Medical Center, involved a patient who was seen in the ED following a paragliding accident. The patient arrived in the ED suspected of having a broken pelvis and internal bleeding. He was conscious, breathing, and complained of severe pain, which prompted the use of fentanyl. An hour and a half later, the patient experienced respiratory depression and died soon after a failed intubation. The plaintiff contended that a fentanyl overdose was the cause of death and that the drug's administration was not monitored. The case was settled for $305,000.2
In contrast to hydromorphone potency, fentanyl is estimated to be up to 100 times as potent as morphine. The recommended dosage for intravenous administration is 1-2 mcg/kg, and the effect usually lasts 30-60 minutes.
These two cases are but a few of the many cases that involve excessive narcotic administration, inadequate monitoring, and respiratory arrest. Multiple actions could have been done differently that could have resulted in better outcomes. When a narcotic is initially given, it should be given slowly. If the patient doesn't obtain optimal response, then more can be given. Secondly, monitoring a patient after narcotics have been delivered is highly recommended, as any possible problems will be discovered sooner rather than later. In both cases, signs consistent with an overdose were discovered after 90 minutes, at the earliest. Had the patients been monitored, then their condition could have been reversed. Providers need to be aware of, and respect, the potency of both hydromorphone (Dilaudid) and fentanyl compared to morphine. Hydromorphone is currently a very popular and commonly administered drug in the ED. As noted earlier, hydromorphone is about 10 times as potent as morphine, whereas fentanyl is about 100 times as potent. Lastly, if the provider is unsure of the dosage, then he or she should review the indications, contraindications, and the proper dosage prior to administration. These suggestions will go a long way toward alleviating the type of poor outcome illustrated by these cases.
In Beatty v. Oro Valley Hospital, a man was seen in the ED complaining of vomiting, bloody urine, and abdominal pain and was diagnosed as having kidney stones. The patient was given 4 mg of IV morphine as well as ketorolac (Toradol) and was discharged two hours later. His wife was on the way back to pick up her husband after he was discharged. However, the patient, believing he saw his wife outside the hospital, attempted to cross an elevated road with a lane divider to get to her vehicle. He ended up falling about 30 feet and, as a result, became a paraplegic. The plaintiff brought suit for negligence, asserting he was still under the influence of the pain medications when discharged before his transportation had arrived. The defendant argued that the morphine had already been metabolized and that the physician's only responsibility was to have a discharge plan, not the actual compliance of the said plan. A verdict was reached in favor of the plaintiff.3
In this case, the correct treatment was given for this particular patient; however, the hospital failed to ensure a safe discharge after narcotics were given. The physician or nursing staff need to note that a patient has a safe discharge when given narcotics or other sedating drugs. Most often, the staff and/or hospital are liable for this action. A physician can minimize his or her personal liability by documenting on the chart "patient with safe ride home" or writing an order stating "discharge to a safe ride home."
Drug Allergies
The proper use of antibiotics, whether given after diagnosis or for prophylaxis, can effectively treat or prevent infections in patients. However, when antibiotics are given without diligently noting a patient's past history, the risk of future litigation increases. Two recent cases follow.
In Fisher v. Desai, an 18-month-old was seen in the ED, found to have otitis media, and was given amoxicillin/clavulanic acid (Augmentin). The following day in the ED, she was given azithromycin (Zithromax) and diphenhydramine (Benadryl) after she developed an allergic reaction causing both of her eyes to become swollen. The next day, the patient arrived in the ED again, this time with only one eye still swollen shut. The physician made the diagnosis of orbital cellulitis and prescribed IV ceftriaxone (Rocephin). Despite a known penicillin allergy documented in the patient's records, the nurses gave the ceftriaxone. The patient, a few minutes later, became apneic, cyanotic, and unresponsive, and the ensuing resuscitation efforts failed. It was later discovered that the ED physician who had prescribed the ceftriaxone had not reviewed the patient's medical records. The plaintiff argued that a cephalosporin should not have been given to a patient with a known penicillin allergy. The case was settled for $3 million.4
An additional case involving a known antibiotic allergy occurred with a 79-year-old man who was planning to have knee replacement surgery. In George Martin, deceased, and Dorothy Martin v. John W. Zimmer, MD, and Coastal Orthopedics Associates, the defendant, Dr. John Zimmer, suggested that vancomycin and oxacillin be given prophylactically prior to the surgery. The plaintiff stated that he had been given vancomycin before and had almost died from the reaction. The plaintiff also noted that the reaction could be found in his medical records. However, Dr. Zimmer believed that the reaction was simply a common one and proceeded with the administration of the antibiotic. The resulting reaction caused the patient to spend a majority of the year in the ICU on a ventilator, suffering from multi-organ system failure. In court, the plaintiff asserted that the use of vancomycin was negligent and also unnecessary, as he did not have an infection at the time of surgery. Had there been an infection, then the surgery would not have taken place. The defendant maintained that the original reaction was due to the oxacillin and not the vancomycin and that there was insufficient evidence to tie the first reaction to the use of those antibiotics. The judgment against the defendant totaled $1.6 million.5
Some have claimed that among patients who report having a penicillin allergy, 0.17% to 8.4 % will have an allergic reaction if given a cephalosporin. These reports often include prior preparations of cephalosporins that contained trace amounts of actual penicillin. Thus, naturally, if a cephalosporin containing penicillin is administered, an allergic reaction might ensue.6-10 Also, the study doesn't acknowledge the severity of the reaction. In contrast to those who report a penicillin reaction, a study was done showing that those with confirmed reactions are only expected to react negatively to cephalosporins 2% of the time. There is less risk of reaction with newer generation of cephalosporins.
In light of the low statistical chance of having a reaction to a cephalosporin with a known penicillin allergy, had the physicians in these two cases explored the past history better, they could have opted to use alternative antibiotics. In the vancomycin case, it appears as if only a cursory review was performed on the patient's records. In the first case, it wasn't done at all. It is important to ask whether or not the use of an antibiotic that has the potential to induce a reaction is even necessary at all, especially prophylactically. Safer alternatives, if they're available, could alleviate any potential complications.
Anticipating Side Effects/Contraindications
The next two cases illustrate how a physician can treat the primary presenting symptoms correctly but overlook other side effects of certain drugs. Take, for example, Anonymous Patient v. Anonymous Hospital and Physicians, a case in which a 52-year-old man was brought into the ED after having syncope (during which he suffered a head injury). It was revealed by an EKG that the patient was in the midst of a myocardial infarction. He was moved to the catheterization lab and given anticoagulants. Afterward, the patient experienced an intraparenchymal hemorrhage. The plaintiff claimed he had informed the physician of the head injury and, thus, a CT scan should have been ordered. Additionally, he claimed that his brain hemorrhage was a result of being over-prescribed anticoagulants. The defendant contended that treatment of the myocardial infarction took precedence and there was not enough time to have a CT performed. The case was settled for $1,540,000.11
It is important when administering any potentially harmful medication that contraindications have been reviewed and don't exist.
Another case, Campbell v. DeAngelis, again highlights the failure to anticipate a drug's side effects. Upon arrival at the ED, the patient, who was a known diabetic, had a blood sugar level of 74, which rose to 118 three hours after being given glucagon and glucopaste. Seeing no further reason for the patient to stay in the hospital, the physician discharged the man, who went home and fell asleep. The next morning, he was found unresponsive after having suffered brain damage caused by metabolic encephalopathy. The plaintiff believed that he should have been admitted to the hospital after he had come into the ED two days earlier with severe hypoglycemia. Admittance would have been needed to further determine the cause of multiple and frequent bouts of hypoglycemia. The plaintiff also claimed that he was taking Lantus (insulin glargine), which is a long-acting insulin. The defendant explained that the patient had a history of depression, schizophrenia, and alcohol abuse and had been seen in the ED 11 times in the past five years for blood sugar issues. The defendant alleged that the patient's noncompliance made care difficult. It was decided that 90% of the fault lay with the defendant and 10% with the plaintiff. A $21.4 million verdict was returned.12
Cases in which side effects are overlooked are not uncommon. In the first case, the physician should have assessed the head trauma associated with a syncopal episode. The saying "be on guard" is certainly pertinent here. The physician could have simply ordered a CT scan to rule out any intracranial hemorrhage on the way to the catheterization lab and most likely avoided a lawsuit in the process. The physicians who treated the diabetic patient should have recognized first that the number of repeated visits to the ED was a sign of poor patient compliance. Secondly, the physician should have considered the dangers of long-acting sugar medications and presumed that the patient would go to sleep and, thus, not be able to recognize the recurrence of hypoglycemic symptoms.
When a patient is discharged, a physician should feel certain that critical medications will be administered properly and also that the patient understands the pharmacologic actions and length of effects.
Mixed Meds Beware
In some instances, a combination drug is prescribed where one of the substituent drug's effects is desired and the other drug's effects may be overlooked or even contraindicated for the specific treatment. In the case Anonymous Woman v. Anonymous Optometrist, a patient was diagnosed with a corneal ulcer by her optometrist and prescribed Tobradex eye drops, which contain the antibiotic tobramycin and dexamethasone, a steroid. Her condition continued to deteriorate and she was then seen by an ophthalmologist, who discontinued the Tobradex due to the fact that steroids are contraindicated in the treatment of a corneal ulcer. Although the patient's ulcer resolved, she ended up with 20/400 vision in the affected eye, which was later corrected surgically to 20/30 vision with glasses. She also suffered from an enlarged iris and ptosis. The plaintiff was awarded an $825,000 settlement against the optometrist.13
In Bryn v. Kaiser & Blau, the plaintiff was given acetaminophen and hydrocodone (Vicodin) for 16 years for pain stemming from an orthopedic surgery that required the patient to wear a prosthesis. The plaintiff presented to the Kaiser facility to have his prescription refilled frequently enough to warrant the pharmacist to tell him that they couldn't refill it that often. As a result, the plaintiff proceeded to go to an outside pharmacy for the medication. Thus, the patient was receiving Vicodin from both the Kaiser pharmacy and an outside one at the same time. The plaintiff eventually developed liver failure and underwent a liver transplant, which was due to excessive use of the acetaminophen component. This was estimated to be an astounding 10,000 pills per year. In arbitration, the defendant stated that the plaintiff had refused their recommended pain management therapy and had also been told by both the Kaiser pharmacist and an outside pharmacist of the dangers of overusing the drug. An award of $1,425,000 was given in arbitration.14
The lesson to take away from both of these cases is that the providers focused only on one of the active ingredients of the combination drugs. When the optometrist prescribed the tobramycin/dexamethasone combination, he or she presumably was thinking about the antibiotic quality and not the steroid component. The same holds true for the man who was given hydrocodone/acetominophen for 16 years. The focus was on the pain-relieving aspect of the hydrocodone, while the toxicity of acetaminophen was overlooked.
Uncommonly Used Medications
Occasionally in the ED, patients require a drug that is not frequently given and, thus, unfamiliar to the providers. Anonymous 21-Year-Old Woman v. Anonymous Emergency Room Physician, Anonymous Pharmacist is a case in which that unfamiliarity led to a disastrous outcome for the patient and a $15.5 million settlement against the physician and pharmacist. A 21-year-old female was seen in the ED after she took too much acetaminophen (Tylenol) trying to mitigate menstrual pain. The physician gave her IV acetylcysteine (NAC), a drug that the physician had never administered and the pharmacist had never dispensed before. When the pharmacist wrote the prescription, he or she wrote that the drug should be given in three stages, with the second stage given "times" four hours and the final stage "times" 16 hours. What the pharmacist meant, however, was that it should be given over the course of four hours and 16 hours. Unfortunately, the physician didn't review the drug dosing and administered it as directed by the pharmacist. This led to the second stage being overdosed by four and a staggering dosage 16 times what is required for the final stage. After the infusion, lab results showed that the acetaminophen toxicity had been corrected. However, after the original order had expired, another physician, who was also unfamiliar with this drug, directed that NAC continue to be given at 16 times the normal rate. The patient then became agitated, sluggish, and even pulled out her IV. The nurse called the physician on duty, who, without actually evaluating the patient, instructed them to give her haloperidol (Haldol), an antipsychotic. Five minutes later, she was seizing and transferred to the ICU. It was five hours before a physician physically checked on the patient, despite the frequent seizing. The ICU physician, who also was unfamiliar with NAC, again ordered that she receive the IV acetylcysteine at 16 times the normal dose. The patient suffered brain herniation, with a resultant persistant vegetative state. The plaintiff brought suit, claiming the patient received 180,000 milligrams of NAC despite the maximum dosage being 14,600 milligrams. On top of the exorbitant amount of drug given, approximately 6,000 milliliters of fluid was infused (proper volume of the medication should have been 160 mL). As noted earlier, a $15.5 million settlement was reached.15
The easiest way to avoid such a disastrous chain of events would be to simply look up the dosing information for a drug if one is not familiar with it. Had one physician double checked the dose, then the patient might not have suffered. Unfortunately, it's easy and common to give either too much or too little medication. A simple movement of a decimal point when calculating doses, rates, and concentrations can be disastrous. This can occur when using medication that is uncommon or with other medications that are given via drip administration (pressors) or via protocols (heparin).
Summary
Improper use of medication can lead to significant exposure and liability of the ED physician. There are frequent successful court cases that can easily be avoided with basic and diligent prescribing practices. Common sources of litigation include allergic reactions, anticipated side effects, dosing errors, and failing to recognize severity/potency of medications.
Attention to past medical history, recent events, and appropriate monitoring can also be invaluable.
References
1. Trustee for Decedent's Heirs v. Medical Provider, Hospital and Doctor, Medical Malpractice Verdicts, Settlements, & Experts: 2010;26:10.
2. Renee Hurtado, Jose Hurtado, deceased, et al v. County of Los Angeles, Harbor-UCLA Medical Center, Los Angeles County (CA) Superior Court, Case No. TC-021-716. Beatty v. Oro Valley Hospital LLC, Pima County (AZ) Superior Court, Case No. CV 2009-6246.
3. Fisher v. Desai, Medical Malpractice Verdicts, Settlements, & Experts: 2009;25:17.
4. George Martin, deceased, and Dorothy Martin v. John W Zimmer, MD, and Coastal Orthopedics Associates, Essex County (MA) Superior Court, Case No. ESCV2003-01021.
5. Petz LD. Immunologic cross-reactivity between penicillins and cephalosporins: A review. J Infect Dis. 1978;137:S74.
6. Dash CH. Penicillin allergy and the cephalosporins. J Anitmicrob Chemother. 1975;1:107.
7. Daulut S, Solensky R, Earl HS, et al. Safety of cephalosporin administration to patients with histories of penicillin allergy. J Allergy Clin Immunol. 2004;113:1220.
8. Goodman EJ, Morgan, MJ, Johnson PA, et al. Cephalosporins can be given to penicillin-allergic patients who do not exhibit an anaphylactic response. J Clin Anesth. 2001;13:561.
9. Fonacier L, Hirschberg R, Gerson S. Adverse drug reactions to a cephalosporin in hospitalized patients with a history of penicillin allergy. Allergy Asthma Proc. 2005;26:135.
10. Anonymous v. Anonymous Hospital and Physicians, Medical Malpractice Verdicts, Settlements, & Experts: 2010;26:13.
11. Campbell v. DeAngelis, Philadelphia (PA) Common Pleas Court, Case No. 090200546
12. Anonymous Woman v. Anonymous Optometrist, Medical Malpractice Verdicts, Settlements, & Experts: 2011;27:34.
13. Bryn v. Kaiser & Blau, (Unfiled Kaiser Arbitration). Medical Malpractice Verdicts, Settlements, & Experts: 2009;25:20.
14. Anonymous 21-Year-Old Woman v. Anonymous Emergency Room Physician, Anonymous Pharmacist, Medical Malpractice Verdicts, Settlements, & Experts: 2011;27:9.
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