Legal Review & Commentary: Adverse drug reaction leads to death and an $830,000 verdict in Kentucky 

By Jan Gorrie, Esq.
Buchanan Ingersoll Professional Group
Tampa, FL

News: A 59-year-old man was admitted to the hospital for elective angioplasty. Ten hours after surgery, he experienced a severe adverse reaction to anti-clotting medication and suffered intracranial bleeding. He had a seizure, went into a coma, and died one week later. The patient’s estate brought suit against the cardiologist and the hospital for negligence. While the doctor was exonerated, the hospital was found liable, and the jury awarded the plaintiff $830,000 in damages, which included $100,000 for the widow’s loss-of-consortium claim.

Background: The 59-year-old patient had a family and personal history of cardiac disease. Shortly after being re-elected to a second term as sheriff, he underwent elective angioplastic surgery. The procedure began in the early evening and concluded, with some minor complications, around midnight. Following surgery, the cardiologist ordered the drug ReoPro, a blood thinner for preventing post-surgical blood clots, for the patient. In a very small percent of patients, ReoPro causes a potentially fatal reaction called thrombocytopenia, an extreme decrease in blood platelets. To avoid this, the ReoPro package insert indicates that within two to four hours after receiving the medication, patients should be tested to monitor their platelet count.

In this case, it was five hours after ReoPro was administered that the hospital ran a routine blood test. By the time test assay results were completed and posted, it was around 8 a.m. Over the course of eight hours post-surgery, the patient’s blood platelet count had dropped to 12,000 when the normal and expected level ranges from 150,000 to 390,000. The lab reported the results to the patient’s nursing station and labeled the results "panic level." The data was not appreciated as an emergency and staff did not mobilize a response. It was not until another hour and 45 minutes had passed, at 9:45 a.m., that the lab result was finally recorded by the medical staff, but the results still were not acknowledged as a crisis situation. Coincidentally, also at around 9:45 a.m., the sheriff experienced a seizure related to post-surgical, intracranial bleeding. He went into a coma and died one week later.

The plaintiff’s estate brought suit against the cardiologist and hospital. The plaintiff claimed the doctor should not have initiated the surgery so late in the evening, when the full complement of support staff was not available. The plaintiff also claimed the cardiologist was negligent in not issuing a STAT or timed order to test the patient’s blood platelet level in conjunction with prescribing ReoPro, as recommended in the prescription drug’s package insert. The plaintiff claimed that if the blood test had been performed in a timelier manner, the condition would have been discovered hours sooner and the resulting intracranial bleeding and subsequent seizure, coma, and death could have been averted.

As to the hospital, the plaintiff alleged that staff committed an unwarranted delay in testing the blood platelet level in direct violation of a policy issued just months before the incident. According to the hospital’s standard order, once ReoPro was administered, staff should have tested the patient’s blood platelets in keeping with the prevailing medical literature’s recommendations and cautions. The plaintiff also alleged that once the testing was complete, the hospital failed to appropriately transmit the results to the nurse’s station.

The plaintiff maintained that the decedent could have been effectively treated until 6 a.m. Had the patient’s blood had been drawn in a timely manner, the plaintiff alleged, four hours after the ReoPro was administered and tested after five hours, by 5 a.m., the life-threatening problem identified by the lab could have been recognized and properly addressed by the nursing staff and physician.

In the providers’ defense, affirmative proof was introduced showing that proper staffing and adequate procedures were available to deal with the patient’s complications the evening of the surgery as well as on the patient’s unit the morning after. The defense argued that the etiology of the intracranial bleeding was complex and not related solely to the adverse reaction to ReoPro. Evidence presented by the hospital indicated that the intracranial hemorrhage was apparent prior to the patient’s seizure. There was further defense proof that the patient’s multicentric bleeding was extremely rare. The defense minimized the impact of the delay in testing the patient’s blood platelets, noting that if the platelet count had been the only complication, it could have been successfully handled despite the delay. The defense also emphasized the decedent’s underlying multisystem physiological problems leading up to the need for surgery, including other neurological and cardiac problems, as well as natural aging patterns.

The jury returned a defense verdict in favor of the cardiologist, but assessed $830,000 against the hospital. Damages included $100,000 to the sheriff’s widow on her claim for the loss of consortium.

What this means to you: While not all medication errors result in patient death or harm, the higher the number of errors, the higher probability of harm. Some hospitals and health care providers are implementing electronic prescription order-entry systems to address the human and financial tolls that medical errors can cause. Computerized systems have been shown to prevent medication errors and improve medical outcomes. Not only can the systems eliminate paper orders, which are often written illegibly, they can also check physician orders for problems such as incompatible medication and patients’ drug allergies as well as highlight potential adverse reactions. If the hospital in this case employed such a system, it probably would not have precluded the patient from receiving the prescribed medication, but it might have further re-enforced the need for more stringent patient monitoring.

This case presents one such case where a medication incident, which resulted in a potentially treatable adverse reaction, ultimately contributed to the death of a patient. Given the likelihood of this facility being accredited by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), this case probably resulted in a sentinel event report.

"Hopefully, this type of event does not occur on a routine or regular basis; and in light of the outcome — even if not required to be reported as a sentinel event to JCAHO (if the facility was not an accredited hospital) or state agency — risk management should do an analysis of the incident and determine what went wrong, why it happened, and what processes or systems need to be changed so that it will not happen again," says Stephen Trosty, JD, MHA, CPHRM, director of risk management consulting at APAssurance Corp. of East Lansing, MI. "While it is never possible to prevent all complications, incremental improvements can prevent errors and save lives. The risk manager’s assessment should involve all persons involved in the care (or lack thereof) of the patient from the physicians to pharmacists."

Although the cardiologist thought that his day had ended after performing successful angioplastic surgery, his duties are not complete until the patient has been discharged. Though the physician was not found liable by the jury, "in this particular case, the physician should have noted in the chart the need for a blood test in two to four hours after administration of the drug ReoPro," Trosty says. "Because this drug is known for causing a potentially fatal reaction in some patients, the noted physician’s order should have been written as STAT or timed. As a further precaution, he also should have mentioned to the nursing staff the importance of timely testing of the patient’s blood and looking at the results as soon as received as a backup reminder to be sure it was done. Extra care could have been taken by the physician in ordering the testing and in stressing the importance of an immediate review of results, considering the potential for a very serious negative outcome."

As for the action and reactions of the hospital’s nursing and laboratory staff, "it would have potentially changed the outcome (for both the patient and hospital) if the hospital personnel would have followed their own existing standard order and policy," Trosty says. "The standard order called for timely blood platelet monitoring in compliance with the drug package insert, but this order was ignored. An assessment of why the standard order was not followed should be conducted in order to prevent future occurrences of noncompliance. Further, all staff should be trained in existing policies, procedures, and standing orders and have ready access to them. If this training had not occurred, steps should to taken to assess why it had not taken place; for it is extremely difficult to defend against not following one’s own standing orders/policies particularly in light of the outcome.

"By way of example, this particular case demonstrates the need for hospitals to be sure they have policies for using ReoPro and to assure that the policies follow the drug insert. Just as there should be policies on all high-risk drugs relative to giving the drug, testing a patient after the drug is given, and reviewing lab test results in a timely manner, the same should be true for this drug. In addition, the pharmacy should be able to put a colored label or notation on high-risk drugs or drugs requiring special attention and/or testing. The use of colored labels by the pharmacy should be accompanied with training and educating of nursing and other affected departments as to what the different colors mean. With proper implementation, even labeling can make it easier and quicker for staff to know that certain drugs require special care or attention. Even without a color-coded system, it is important to be sure that all nursing units, lab, pharmacy, and other relevant patient care departments have a list of high-risk drugs used in the hospital, including drugs requiring special monitoring or testing; list(s) should be updated regularly, should be checked to be sure they are the same for all departments, and should be related to existing formularies. Unfortunately, in this instance, despite the lab’s appropriate panic-level’ labeling, the notice was not acknowledged once the results were delivered to the nurses caring for this patient," notes Trosty.

"Further, the lab should have a policy for prioritizing the testing of orders for high-risk drugs even if no STAT order accompanies the blood specimen. This can help the lab know that certain tests need to be run before others and the results returned to the floor or unit ASAP and flagged as emergent, if so determined by the testing processes. It can also indicate which drugs should have a follow-up call to the floor after test results are sent up. There should also be a policy on how quickly all lab test results are to be reviewed and recorded after received on floor/unit. Optimally, this policy should apply to standard testing, STAT testing and time-ordered testing, with appropriate times for review and recording of results for each type of test. In this case, once the blood sample was drawn, it took three hours for the tests to be run and posted, and so it is unlikely that it was recognized as urgent," adds Trosty.

Once high-risk medications are delivered and administered, monitoring, follow-up reporting, and communication become essential.

"The lab should have a mechanism to emphasize or stress panic level on a report. There should be a way to place panic level or other warning messages in bold print or large letters or even use a special color sheet for these lab results. This type of highlighting can help alert nursing or clerical staff to the fact that this result has to be reviewed and acted on immediately. The facility may also want to consider implementing a call-back system whereby lab personnel would call the floor or unit with panic levels lab results to be sure that these results are seen and responded to in a timely manner. Hospitals should try to have as many backup/safeguard systems in place as possible in an effort to prevent or avoid error. This will enhance your patient safety program. Policies should cover appropriate response to test results with panic levels and the need to immediately check all returned test results to determine if panic levels exist for a given patient. This should be standard operating procedure on all floors and units and for all nursing, clerical, and physician staff. The one hour-and-45-minute delay in acknowledging critical lab results, as occurred in this case, should be recognized as too long for any type of abnormal test results returned to the floor," states Trosty.

In addition to developing appropriate policies and procedures for handling high-risk medications, "risk management should also look at orientation and inservice programs for nursing (including clerical staff), lab, pharmacy, physicians, and other related departments to be sure that they include information about high-risk drugs, STAT lab orders, returning and receiving lab results with panic levels, and labeling of high-risk drugs. Orientation and inservicing should address what the proper actions are in all of these instances. Inservice training can also be used to review identified problem and high-risk areas or areas in which existing policies are not being adhered to," says Trosty.

Policies and procedures are useless if not followed, and so "to ensure that existing policies are appropriate and are adhered to, the hospital can also conduct a root-cause analysis of this occurrence. This will enable them to review the systems and processes involved in the event and to identify any needed revisions. There should also be a quality improvement and/or peer review process for nursing, pharmacy, laboratory, medical staff, and all other clinical/patient care departments. Particular emphasis should be placed on addressing high-risk patients, high-risk drugs/meds, and high-risk procedures. Quality improvement/peer review can also help to identify actual or potential problems and allow for interventions to prevent the problems from occurring or reoccurring. The process should review systems and processes that are involved in the interaction between multiple departments or units, and should encourage analysis of issues/occurrences that cross or involve multiple departments or units," adds Trosty.

"To the extent possible, evaluations should be made in a nonpunitive and nonthreatening manner and should encourage involved personnel to determine what might be improved rather than cause them to defend their particular action department. The importance of establishing a culture that does not consist of trying to place blame if an adverse event occurs should not be underestimated; for the ultimate goal should be to develop a patient safety culture in which systems or processes that require improvement or revisions can be identified and addressed. A culture which tries to find the guilty party responsible for the adverse occurrence and then punish that person does not foster the atmosphere needed to get people to complete occurrence reports accurately and completely, or to honestly and fully participate in root-cause analysis or other efforts that examine systems and processes for required improvements or revisions," concludes Trosty.

Reference

Riley vs. Jewish Hospital and Raible, Jefferson County, (KT) Circuit Court. Case No. 99 CI 5198.