Defeating the eight-hour rule in anesthesia cases.

The defense jumped from the pages of the medical records. It was a simple, direct, and potentially effective explanation of the anesthesiologist's actions. Indeed, any juror who recalled the movie The Verdict would remember this defense.

In that film, Paul Newman plays a plaintiff attorney who represents a woman in a medical negligence action based on gastric aspiration during general anesthesia. As a result, she suffers catastrophic brain damage. From the witness stand, the defendant repeats a simple refrain: "General anesthesia is appropriate when the patient has had nothing by mouth for more than eight hours."

In my real-life case, my client's husband, David, fell within the eight-hour rule. He had had nothing by mouth since midnight, and anesthesia had begun at 8:15 a.m. The defense would argue that the anesthesiologist had acted properly. In effect, the defense would say David's gastric aspiration during induction of anesthesia and his death were unfortunate but not preventable. This type of defense--the straightforward "we followed the rules" strategy--can be difficult to counter, but it is one plaintiff attorneys must be prepared to fight.

Gastric aspiration occurs when the contents of a patient's stomach pass through the esophagus and into the pharynx. There, some of the vomit overcomes the body's natural protective reflexes and enters the trachea. This material then passes into the bronchial tree.

The stomach contents are primarily acidic due to the normal secretions in the stomach, but the administration of antacids before anesthesia can lessen this acidity. If the stomach contents are sufficiently acidic, a chemical burn of the lung tissue occurs. Lung damage from acidic vomit occurs rapidly, like a flash burn. It can take only 12 to 18 seconds.

As I read the medical records in my case, I could predict the anesthesiologist's answers to my questions years before her deposition. Her response would become a mind-numbing mantra: "More than eight hours had passed with the patient having nothing by mouth." Although this was true, what occurred was medical negligence. There must be exceptions to the eight-hour rule, as there are for every rule of medicine. And when these exceptions apply, the anesthesiologist must prepare for and prevent gastric aspiration.

Our case would depend on identifying the factors that trigger an exception to the rule. As always, the case began with the medical records.

On September 15, 1994, David, age 31, was hit by a car while driving his motorcycle. He suffered multiple injuries, including fractures of his right wrist and his left femur, tibia, and elbow. Not surprisingly, he complained of a great deal of pain and received morphine sulfate--a powerful narcotic--by injection.

That evening, David underwent surgery for his leg fractures and casting of his right wrist. The anesthesiologist in this surgery recognized that several factors put David at increased risk for gastric aspiration during anesthesia. Because he was a trauma patient, it was assumed that he had eaten before the accident and so had a full stomach. He had been in shock, and had undergone multiple trauma. Also, since he was in pain, he was receiving narcotics.

The anesthesiologist successfully prevented gastric aspiration by performing a rapid sequence induction of anesthesia with cricoid pressure. The technique of rapid sequence induction is designed to minimize the time during which the airway is unprotected and to allow time to insert a cuffed endotracheal tube quickly.

The standard approach is intravenous administration of thiopental followed by succinylocholine. At the same time, a scrub nurse, anesthesia assistant, or the assistant surgeon will apply manual pressure to the cricoid cartilage at the level of the C-6 vertebrae. By using the thumb and forefinger, the cricoid pressure will effectively close the esophagus until the cuffed endotracheal tube is established in the patient's airway.

David tolerated the procedure well and returned to the intensive care unit. The next day, he complained of more severe pain. He was started on an 1V drip of morphine sulfate. Despite this, he continued to have pain, and on September 17, the dosage was increased.

The nursing staff in the intensive care unit kept detailed notes of September 17. During the day, the staff noted that David had decreased bowel sounds. He had had no bowel movements since his admission to the hospital. He tried to eat his dinner but could not finish the meal and vomited two hours later. The nurses recorded this development in the notes and reported it to the ICU physician.

The orthopedic surgeon scheduled a second surgery for September 18. The procedure was to be done under general anesthesia. He ordered that David receive nothing by mouth after midnight.

At 7:55 a.m. on September 18, the defendant anesthesiologist saw David for the first time. Her pre-anesthesia evaluation noted stable vital signs and no prior reaction to anesthesia, and she concluded that he was fit for general anesthesia. She reviewed the medications listed on his chart and noted that he had received Carafate, Docusate Sodium, and Zantac. However, she was not aware of the morphine sulfate drip.

The anesthesiologist began premedication with Versed, followed by Reglan and Robinul. The latter two agents were to prevent vomiting after the surgery. At this point, the contents of David's stomach regurgitated into his oral cavity. The anesthesiologist responded appropriately by turning his head to the side and lowering it on the table in an attempt to move the vomitus to the front of his mouth. She then suctioned the mouth. Certainly, some portions of gastic contents reached his lungs.

With the orthopedic surgeon's consent, the surgery continued. During surgery, David's oxygen saturation continued to decline despite aggressive ventilation. After the operation, the tube that had been inserted to help him breathe was removed, but when his oxygen saturation fell to 51, the tube was inserted again. Medicines were given to cause sedation and paralysis at the time of reintubation. The physicians wanted David paralyzed and totally sedated because of the potential for a long period of mechanical ventilation.

The first postoperative chest X-ray showed diffuse, fluffy infiltrates bilaterally. X-rays over the next several days revealed increased amounts of infiltrates in David's lungs. In laypeople's terms, his lung fields resembled a snow-covered field. The trauma surgeon performed a bronchoscopy to wash out any particulate matter from the lung field.

Steroids were also given to lessen the inflammation from the aspiration. The anesthesiologist gave David Decadron, and the trauma surgeon then administered Solucortef. Steroids were discontinued on the fifth postoperative day because his condition did not improve.

The trauma surgeons took cultures every day. On the second day after surgery, a sputum culture revealed a fungal infection. Two days later, a blood culture also revealed this infection. From that point, multiple antibiotics could not control the condition.

On September 24, David went into kidney failure. There was also evidence of other organs failing. The next day, he died of cardiac arrest.

Aspiration process

To understand the need to prevent or lessen the likelihood of gastric aspiration, an understanding of the aspiration process is necessary. Fluid and liquid content enter the stomach through the esophagus, which contains an opening at the top and another at the bottom. The lower opening--the gastroesophageal sphincter--plays the primary role in preventing gastric reflux.

Anesthesiolgists rely on the following rule of thumb: After eight hours without food or liquids, the patient's stomach will be empty. But pain and recent trauma will slow the process. Also, narcotics will lessen the motility of the gastrointestinal tract, which will, in turn, reduce the flow of Food into the intestines.

Narcotics also decrease the tone of the gastroesophageal sphincter, which increases the likelihood of gastric reflux. In addition, the administration of muscle relaxants during anesthesia will lessen or defeat the body's natural protective reflexes and allow vomitus to enter the trachea.

With this information, we can look at how the eight-hour defense failed this anesthesiologist. At the anesthesiologist's deposition, I first established the exact events that occurred at the hospital. Once those facts were clear, I discredited her defense that it had been more than eight hours since the patient had had anything by mouth.

My goal was to show that the exceptions overcame the rule.

Delayed gastric emptying

My first goal was to establish that the passage of eight hours did not immunize the defendant from liability because several factors should have alerted the physician that the mere passage of a certain amount of time was not enough to prevent gastric aspiration. These included the trauma that David had endured, the administration of morphine, the decreased bowel sounds, the vomiting episode the night before surgery, and the use of medications for bowel obstruction.

The following questions were important in making this argument:

Q: Were you aware of any gastrointestinal complaints prior to the pre-anesthesia evaluation?

A: No.

Q: Were you ever told that David had gastrointestinal complaints within 18 hours before this surgery?

A: No.

Q: Were you aware of any vomiting or emesis that he had prior to the induction of the anesthesia?

A: No.

Q: Were you told that he vomited approximately 700 ccs of coffee-ground material the previous night?

A: No.

Q: So at the time that you started this anesthesia that morning, you were not aware of that vomiting history?

A: Yes.

Q: Could the vomiting be a sign of gastrointestinal disturbance or a lack of gastric motility, which may continue until the time of surgery?

A: Probably.

These answers demonstrate several things. First, David had an upset stomach causing vomit. Second, the anesthesiologist did not carefully review the previous day's medical records. Third, the gastrointestinal difficulty probably existed when she induced anesthesia.

Q: Were there any signs in this patient of delayed gastric emptying?

A: No.

Q: Is delayed gastric emptying an important consideration before administering anesthesia?

A: Yes.

Q: With delayed gastric emptying, would there be an increased risk of aspiration of gastric contents?

A: Yes.

Q: Because of the buildup of the gastric contents?

A: Yes.

Q: Was it known to anesthesiologists in 1994 that a patient following a trauma has dilation of the stomach?

A: Yes.

Q: Does that increase the chance of delayed gastric emptying when the stomach dilates or opens up?

A: Yes.

Q: Will the presence of pain and administration of morphine to the patient delay the emptying of the stomach?

A: Yes.

Q: If this patient had continual complaints of pain, and morphine was administered to him, will that decrease the gastric emptying?

A: Yes.

Q: And those two facts will then increase the chance of aspiration?

A: Yes.

Again, these questions show the potential for delayed gastric emptying and aspiration in this patient.

Q: Did you examine the nursing records to find out if he had decreased bowel sounds?

A: No.

Q: When you saw the patient, you did not check for the bowel sounds yourself?

A: No.

Q: Was there any sign that this patient had a gastrointestinal obstruction preventing the emptying of the gastric contents into the intestines?

A: No.

Q: Would decreased bowel sounds and a lack of bowel movement for the last two days be of any importance to you in evaluating his risk for anesthesia?

A: No.

The second surgery was performed only 56 hours after the first. In his deposition, the attending trauma surgeon conceded that the potential for postoperative bowel obstruction was a recognized complication for all postsurgical patients. Nonetheless, this anesthesiologist was unaware of this history.

Pre-anesthesia evaluation

In her pre-anesthesia evaluation, the anesthesiologist noted that the patient was receiving Zantac, Carafate, and Docusate Sodium. The following series of questions was asked during the anesthesiologist's deposition:

Q: And the Zantac is what, Doctor?

A: It's an antacid.

Q: OK. So David got Carafate and Zantac given as an antacid?

A: Yes.

Q: And he got Docusate Sodium for bowel movements or lack of bowel movements, correct?

A: Yes.

Q: Based on his medications, was this a patient who had some type of gastrointestinal difficulty?

A: Yes.

Lower-gastroesophageal sphincter tone

Having shown a substantial basis for delayed gastric emptying, the deposition turned to the topic of how the lower opening to the esophagus was overcome.

Q: Will pain decrease the lower esophageal sphincter function?

A: I don't recall.

Q: Will pain stimulate the sympathetic nerve system, causing a decrease in the lower esophageal sphincter tone?

A: Probably.

Q: Was this patient in continuous pain or did he complain of pain from the time of his first surgery until the morning of September 18?

A: I believe so.

Q: With that pain he may have had a decreased lower esophageal sphincter tone?

A: Probably.

Q: Will medications affect this?

A: Yes.

Q: Doctor, won't opiates decrease the lower esophageal sphincter tone?

A: Yes.

Q: Isn't morphine one of the opiates?

A: Yes.

Q: Wouldn't a continuous drip of morphine into the patient lower the esophageal sphincter tone?

A: I don't remember if the patient was on a continuous morphine sulfate drip.

Q: If a patient is receiving morphine on a continuous basis until surgery, will that decrease the lower esophageal sphincter tone and reflex?

A: Probably.

Q: Would that increase the risk of reflux of the gastric contents into the upper esophagus and pharynx?

A: Yes.

Administration of steroids

As noted above, the anesthesiologist began administering Decadron after the aspiration. The trauma surgeon then used Solucortef. But, by 1994, a consensus existed that steroids increased the risk of superimposed infections.

The following questions illustrated this point:

Q: You gave Decadron 10 milligrams IV, is that correct?

A: Yes.

Q: And what was the purpose for giving that?

A: The purpose is for early start of any aspiration. They claim that it can help if you give it early enough.

Q: By 1994, was there a consensus in the medical literature that steroids given for aspiration during anesthesia are not effective in changing the ultimate course of the patient?

A: Yes.

Q: Do steroids also increase the risk that the patient will develop infections?

A: Yes.

Q: Because they suppress the patient's immune system?

A: Yes.

The testimony of the plaintiff's anesthesiology expert and the infectious disease physician established that David became vulnerable to infection after the aspiration and administration of steroids. The development of the fungal infections was the final blow.

The anesthesiologist's deposition was crucial to David's case. These excerpts show that the eight-hour rule defense was crumbling. The deposition questions also covered several other topics, including the use of antacids preoperatively to lower the acidic content of the stomach and the proximate cause of the aspiration leading to David's death.

Appreciation of the underlying medicine, careful preparation, and strong guidance by a qualified anesthesiologist were crucial to the ultimate resolution of the case. After the anesthesiologist's deposition, defense counsel requested a settlement conference and the case settled.

The defense had relied on a general rule of thumb: The passing of eight hours since a person eats anything eliminates the possibility of gastric aspiration. By recognizing the complexity of the subject and understanding the exceptions to the rule, the plaintiff was able to overcome that defense. Sometimes, the simple and direct defense is not enough.

Gastric aspiration cases

Here are a few reported verdicts and settlements in cases involving gastric aspirations:

* Makeny v. Parisian, No. L 153897 (Va., Fairfax County Cir. Ct. July 1998). An anesthesiologist failed to perform rapid sequence induction when the decedent was at high risk for aspiration due to pre-existing gastric reflux and excessive weight. The trial resulted in a verdict for the plaintiff.

* Doe v. Roe, confidential docket no. (Cal. Super. Ct. Nov. 5, 1994). A patient aspirated into the lungs during bowel obstruction surgery after a scrub nurse released cricoid pressure to retrieve a fallen suction device. The parties reached a settlement.

* L.P. v. B. W., No. 33-C2-93-000666 (Minn., Kanabe County Dist. Ct. 1994). A 64-year-old woman undergoing exploratory abdominal surgery suffered pulmonary aspiration, resulting in adult respiratory syndrome and death. Interestingly, the reported defense was that the patient had multiple underlying medical problems, was noncompliant, and had a limited life expectancy. The parties reached a settlement.

* Plauche v. Louisiana Patients' Compensation Fund, No. 88-1215 (La. Commissioner of Insurance 1990). A 69-year-old woman undergoing surgery to repair a femoral hernia suffered aspiration and died. The parties reached a settlement.

* Doe v. Roe, confidential docket no. (Va., Richmond County Cir. Ct. 1997). A patient who underwent a laparoscopic procedure that perforated the bowel became septic and was returned for surgery. The patient aspirated and ultimately died. The plaintiff alleged that the failure to apply cricoid pressure allowed regurgitation to occur. The parties reached a settlement.

* Watkins v. Anesthesia Associates of Dayton, PC., No. 94-1976 (Ohio, Montgomery County C.P. 1996). The plaintiff's decedent aspirated during exploratory surgery for advanced cancer. The plaintiff alleged the failure to use a nasogastric tube to drain the patient's stomach before surgery and to apply cricoid pressure was negligent and allowed aspiration to occur. The trial resulted in a verdict for the plaintiff.

Kevin G. Burke practices with Corboy & Demetrio in Chicago.