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Woman, Discharged Prematurely, Dies of Overdose From Pain Pump Refill


A woman had scoliosis and developed chronic pain related to her scoliosis. At first, she tried to control the pain with oral medications and patches, but she disliked them because she felt they impaired her function. After consulting at a hospital's pain clinic, she elected to have surgery to implant an intrathecal pain pump.

 

The woman’s pain pump was battery powered and had a center reservoir that held 20 milliliters. The pump could be programmed to deliver medication from the reservoir to the spine at a specific rate. A doctor could also use a device to read the “telemetry” from the pump. The device identified the patient, how much medication was left, and when the pump had to be refilled. From the date the pain pump was implanted to the incident at issue in this case, the woman had six refills and adjustments to the pump.

 

After an initial period using morphine, the woman’s pain pump was filled with 1 milligram per milliliter of Dilaudid. Dilaudid—also known as Hydromorphone—is a semi-synthetic opioid similar to morphine, but stronger.

 

The woman was happy with the pump because she did not feel the medication provided by the pump impaired her function like she did with the oral medications. She was scheduled to have a refill of the pump at the hospital's pain clinic.

 

At the hospital’s pain clinic, a physician assistant (PA) attempted to refill the woman’s pump using a refill kit. He had the woman lie down and took the pump’s telemetry, which verified the woman’s name and told him there were 13 milliliters of medicine in the pump. After sterilizing and draping the patient, he took the template from the refill kit and felt the skin to make sure that the template fit over the pump. If the template fit properly a teardrop part on the template matched a teardrop part on the pump. However, the PA could not match the template to the pump.

 

A new pain clinic physician helped the PA. She oriented the template, which she was confident was properly oriented over the pump to access the center port. She then watched as the PA inserted the needle and aspirated 11.5 milliliters of fluid from the pump. After discarding the aspirated medicine, she saw the PA refill the reservoir with 20 milliliters of the new medicine.

 

When the PA removed the needle the PA and the pain clinic physician saw some fluid come out from the injection site. The PA palpitated the area around the injection site and more fluid came out. Within one minute, the woman complained of feeling dizzy. She became unable to breathe for herself, her pupils became pinpoint, and she became somnolent, at which point the PA and physician got a crash cart.

 

They immediately placed the woman on oxygen and started an I.V. to administer Narcan, a medication used to reverse the effects of opioids. The new pain clinic physician retrieved another pain clinic physician, who obtained a new refill kit and immediately aspirated the pump. He withdrew about 19 milliliters of medicine. She called the emergency room and informed them that they were bringing the woman down because she had some medicine that had gotten under her skin and she had clinical signs of an overdose. She was taken to the emergency room, intubated, placed on a ventilator, and given a Narcan drip. She was then transferred to the critical care unit.

 

The Narcan drip was discontinued about two days later. Within a couple hours, her condition deteriorated. She could not carry on a conversation or stay awake. The pain clinic physician got the critical care unit to restart the Narcan drip, which helped. The woman was on the Narcan drip the following day and appeared much improved. At some point before the morning of the fourth day after the overdose, she was taken off mechanical life support and had been weaned off Narcan. The critical care physician that took over her care on the fourth day found that the woman appeared to be showing clear improvement and had resolution of her illness. She no longer needed ventilation or Narcan and had even been taken off oxygen. Even though her husband testified that the critical care physician who discharged the woman never examined her, the critical are physician claimed the woman was also fully alert, knew where she was, and had normal vital signs. From this, he concluded that the Dilaudid's toxicity had worn off. Accordingly, he discharged her from the hospital on that same morning.

 

After her discharge from the hospital, the woman’s cough became worse and she became progressively more tired. She was not given supplemental oxygen for use at home, but was merely told to schedule an appointment with the pain clinic in two weeks. She was too tired to move from the couch. Two days after her discharge, she called to schedule an appointment with her doctor, but he could not see her until five days after her discharge.

 

Four days after her discharge, her husband left the house for just over an hour. When he got home, he found her on the sofa totally unresponsive. He called 911. Emergency personnel arrived but could not revive her. She died shortly thereafter.

 

The woman’s estate sued the new pain clinic physician, the critical care physician who discharged the woman, and the hospital. The complaint alleged that the hospital's staff negligently refilled her pain pump and caused an overdose of Dilaudid. It further alleged that the hospital's staff negligently discharged her before the effects of her overdose had been resolved and that she ultimately died from that overdose.

 

The case proceeded to trial. Before trial, the parties stipulated that the pain pump was working properly. At trial the defense argued that only a small portion of Dilaudid had been injected into a pocket outside the pump.

 

The estate presented evidence that the PA injected the Dilaudid into the pain pump's catheter access port. The estate’s expert in anesthesiology and pain medicine testified that the pain pump had two ports: a center port used to refill the pump's reservoir and a catheter access port that allowed direct access to the catheter. He stated that it was dangerous to inject medicine into the catheter access port because the medicine would go directly to the patient's spine. In order to prevent such occurrences, the company that manufactures the pump has two separate access kits. The estate’s expert noted that after the PA injected the Dilaudid into what the PA and new pain clinic physician stated was the pain pump's reservoir, the woman immediately and quickly stopped breathing and became unresponsive. The fact that she responded to the injection immediately indicated that the injection went directly to her intrathecal space—into her spinal column—which could only have occurred if the PA injected the Dilaudid into the catheter access port. If only a small portion of Dilaudid had been injected into a pocket outside the pump, as claimed by the defense, it would have taken much longer for her to feel the effects. Even if the injection missed the pump and hit an artery, she would not have suffered such an immediate reaction.

 

The estate’s expert also found it noteworthy that the woman had to be on Narcan for four days after her overdose. She had to be on Narcan because when the physicians tried to wean her off the Narcan she again stopped breathing. The estate’s expert concluded that if the Dilaudid had not been injected directly into her intrathecal space, the effect would not have been immediate and it would not last more than four days.

 

The estate’s expert in critical care medicine opined that the critical care physician violated the standard of care when he discharged the woman because he should have kept her for a prolonged period of observation after stopping the Narcan and should have performed further tests to ensure that she was ventilating properly. The medical records showed that the woman had a drop in blood pressure on the day of the overdose and then again in the intensive care unit the day before she was discharged and on the morning of her discharge. She was also on Narcan for a prolonged period of time. According to the estate’s expert, this evidence should have caused the critical care physician to realize that this was not a normal overdose. If this had been a normal overdose, the Dilaudid should have cleared from her system within 12 hours.

 

The estate sought the admission of the other pain clinic physician's deposition testimony at trial and the trial court allowed select pages to be read to the jury. In the parts that were read, the other pain clinic physician expressed his opinion that the pain pump could not be overfilled. He also stated that the only thing that accounted for the facts was that somehow this drug got pushed through the pump and into the intrathecal space. The other pain clinic physician explained that an intramural or intravenous injection could not have caused the kind of respiratory depression the woman experienced.

 

The jury found that the new pain clinic physician was professionally negligent in the placement of the template or instruction on the injection site or supervision. It also found that the critical care physician was professionally negligent in the discharge of the woman from the hospital. Finally, it found that the new pain clinic physician and the critical care physician's negligence proximately caused the woman’s death.

 

The trial court entered judgment against the new pain clinic physician, the critical care physician who discharged the woman, and the hospital. The total amount of the judgment with costs and sanctions was $1,014,097.40. The new pain clinic physician, the critical care physician who discharged the woman, and the hospital moved for judgment notwithstanding the verdict or a new trial. The trial court denied the motion.

 

The Court of Appeals of Michigan affirmed. The court held that the estate did not have to prove the exact path by which the Dilaudid entered the woman’s body, the estate presented sufficient evidence to permit a reasonable jury to find that the PA injected the Dilaudid into the pain pump's catheter access port, there was evidence from which a reasonable jury could find that the critical care physician breached the applicable standard of care by discharging the woman without adequate observation or testing, the estate presented sufficient evidence from which a reasonable jury could find that the new pain clinic physician and the critical care physician breaches of the standards of care applicable to them caused the woman’s death, the defendants’ contention that the opinion of the estate’s expert in anesthesiology and pain medicine was unreliable because it was not founded on evidence was without merit, and the trial court did not err in allowing parts of the other pain clinic physician’s deposition testimony to be read to the jury.

 

The estate did not have to prove the exact path by which the Dilaudid entered the woman’s body. The new pain clinic physician had a duty to ensure that the refill procedure was done appropriately and correctly, which included using the proper template and ensuring that the medicine was not injected into the pump's catheter access port. Even if the new pain clinic physician did not breach the standard of care by causing or allowing the PA to inject the medicine into the side port, it still would be malpractice to cause or allow the injection of a lethal dose of Dilaudid into a person outside the pump. The court concluded that because there was no defect in the pain pump and the pain pump could not be overfilled, the introduction of the Dilaudid into the woman's system had to have been caused either by a direct injection into her body outside the pump or through an injection into the pump through the catheter access port. Either of those events constituted a breach of the new pain clinic physician’s standard of care.

 

Nonetheless, the estate presented sufficient evidence to permit a reasonable jury to find that the PA injected the Dilaudid into the pain pump's catheter access port. The estate’s expert in anesthesiology and pain medicine testimony did not offer a theory that was merely consistent with the known facts; he examined the facts and opined that the woman would not have suffered the immediate and prolonged reaction that she did unless the Dilaudid had been injected directly into her intrathecal space. He further opined that this could only have occurred in one way: the PA must have injected the Dilaudid into the catheter access port. The court reasoned that because the expert’s opinion was deducible from the known facts, it was not mere conjecture. The court concluded that because there was substantial evidence from which the jury could infer that the PA injected the Dilaudid directly into the woman's intrathecal space, it was for the jury to decide the issue.

 

Even though a reasonable jury—examining the critical care physician's testimony along with the documentary evidence—could have found that the woman showed significant signs of improvement that warranted discharging her from the hospital, there was also significant evidence from which a reasonable jury could have found that she had an unusually severe and persistent overdose and was still under the influence of Dilaudid on the day of her discharge and through to the day of her death. The estate’s expert in critical care medicine testified that the peculiar circumstances surrounding her overdose were such that the critical care physician had an obligation to take extra steps to ensure that she was no longer under the influence of Dilaudid before discharging her. Specifically, he should have held her for a longer period of observation and should have checked her blood gas. On the basis of her husband's testimony and the absence of any direct evidence in the medical records, a jury could also have found that the critical care physician did not actually examine the woman and, therefore, was incorrect when he stated that she was fully alert. Accordingly, there was evidence from which a reasonable jury could find that the critical care physician breached the applicable standard of care by discharging the woman without adequate observation or testing.

 

The estate presented sufficient evidence from which a reasonable jury could find that the new pain clinic physician and the critical care physician breaches of the standards of care applicable to them caused the woman’s death. At trial, the new pain clinic physician, critical care physician, and hospital presented evidence that the woman did not die from her overdose of Dilaudid. Their expert said the woman had abnormal cells in her heart and no Dilaudid in her blood, so she probably died of cardiac arrhythmia. The estate presented contrary evidence that many people have abnormal cells in their hearts and the woman showed no signs of having died of a cardiac cause. The estate’s experts explained that there was no Dilaudid in her blood because it was most likely to be found in the brain or epidural tissue. Dilaudid can be in the central nervous system without being in the circulating blood

 

The defendants’ contention that the opinion of the estate’s expert in anesthesiology and pain medicine was unreliable because it was not founded on evidence was without merit. The court noted that the estate’s expert in anesthesiology and pain medicine founded his opinions on the medical records that suggested the woman was still under the influence of the Dilaudid within hours of her discharge, the testimony from her family concerning her condition while at home, and the emergency personnel's reports. Using this evidence, he opined that she was still under the influence of Dilaudid after her discharge and continued to be under its influence through to the day she died. Further, he explained why the blood test performed after she died would not be dispositive as to whether she was still under the influence of Dilaudid on the day she died. The estate’s expert explained that his understanding concerning the length of time that an opioid would persist after an intrathecal injection derived in part from his personal observations in his pain practice—that is, his opinion was informed in part from actual observations that intrathecal injections of lipid soluble opioids will last much longer. In addition, the estate provided the trial court with three peer-reviewed articles that broadly discussed the use of opioids in intrathecal space. All three articles supported the conclusion that the estate’s expert's opinion concerning the lasting effects of opioids such as Dilaudid when injected into the intrathecal space had support in the scientific community. The court also noted that other expert witnesses testified consistently with the estate's expert’s opinion that Dilaudid would persist in a patient's system for a much longer period when injected into intrathecal space or remain in the patient's central nervous system. The court concluded that, on the totality of the record, there was sufficient evidence from which the trial court could reasonable conclude that the opinions of the estate’s expert in anesthesiology and pain medicine were founded on reliable principles and methods and that he reliably applied the principles and methods to the facts of the case.

 

The trial court did not err in allowing parts of the other pain clinic physician’s deposition testimony to be read to the jury. The court reasoned that a fair reading of the testimony showed that the other pain clinic physician’s opinion that there must have been an intrathecal infusion of Dilaudid was not founded on speculation; it was the only conclusion that explained the woman's immediate respiratory distress. To the extent that his opinion involved speculation, he speculated about the mechanism by which the Dilaudid ended up in her intrathecal space. He did not apparently consider it an option that his staff might have injected the Dilaudid into the wrong port. So he opined that it must have been the result of a mechanical failure. Nevertheless, because the other pain clinic physician’s opinion concerning the only explanation for the immediacy of the woman's reaction was not speculation, the trial court did not err when it refused to exclude the testimony on that basis.

 

The Court of Appeals of Michigan affirmed the trial court’s judgment against the new pain clinic physician, the critical care physician who discharged the woman, and the hospital and denial of their motion for judgment notwithstanding the verdict or a new trial.

 

See: Estate of Heisey v. Kafi Yovino, 2014 WL 2619519 (Mich.App., June 12, 2014) (not designated for publication).

 

See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability

 

See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

 

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