Pharmacists Medical Malpractice Case Study with Risk Management Strategies
Presented by HPSO and CNA
Note: This case involves the death of a 63-year-old male patient with multiple, serious health conditions that resulted in medical disability, leaving him unable to work for 5 years and limited his capacity for physical activity to very light housework. The patient had a 30-year pack-per-day smoking habit, and he was taking more than 20 medications for COPD, diabetes, hypertension and pain associated with long-standing lower back and hip joint problems.
The patient had been a patron of the owner-pharmacist for more than 20 years at the time of his death, which was due to cardiac arrest. However, his spouse obtained prescription medications when necessary from another pharmacy and was not acquainted with the defendant.
During the two weeks prior to his death, the patient requested and received more than 20 medication orders from the defendant pharmacist. Refill medications included the calcium channel blocker Calan (verapamil), which he had taken for many years, as well as Celexa (citalopram) for generalized anxiety disorder. He also received a new prescription for Flomax (tamsulosin) for urinary hesitancy.
Several days after receiving his medications, the patient collapsed at home. His spouse found him unresponsive and called 911 for emergency services. Emergency medical personnel did their best to stabilize the patient and transported him to a local hospital emergency department (ED). Efforts to resuscitate the patient in the ED were not successful.
Eighteen months after his passing, the patient’s spouse filed a wrongful death lawsuit, alleging that the patient suffered myocardial infarction due to a failure to counsel the patient about a potential drug interaction. After being served and reviewing the Complaint, the pharmacist contacted his insurer and met with defense counsel to discuss the matter. The Complaint asserted that the addition of tamsulosin to the patient’s medication regimen, primarily verapamil and citalopram, created a significant risk and led to the patient’s death.
The pharmacist informed his attorney that, in his opinion, the allegations were without merit. He described the pharmacy’s procedures for filling prescription orders, including the process for confirming that medication counseling is offered, provided (or declined) and documented. Moreover, he informed his attorney that he performed a review prior to dispensing and found no clinically significant drug-drug interactions that would support the plaintiff’s allegation of wrongful death.
The attorney and pharmacist agreed that a more plausible explanation for the patient’s death involved his complex medical history and cardiovascular risk factors, including obesity, hypertension and diabetes. The attorney believed that these baseless allegations may have represented an attempt by the plaintiff and/or plaintiff counsel to obtain a pre-trial settlement, or to force a trial and place the decision in the hands of a sympathetic jury. Because the patient’s spouse was not a patron of the pharmacy, she may not have been aware of the procedures established and implemented to educate patients and prevent adverse outcomes, such as drug-drug interactions. Based upon the pharmacist’s procedures and thorough documentation, the defense planned to obtain expert review and schedule depositions to develop a robust defense, in the event that the jury trial that was demanded in the Complaint would become necessary.
Depositions proceeded, providing additional support for the defense’s case. The pharmacologist defense expert supported the pharmacist’s actions and testified that, in his opinion, the standard of care had been met. The expert stated that the dispensed medications were not likely to be the cause of the patient’s cardiac event. The pharmacist was also an excellent witness on his own behalf. The pharmacy records included documentation that medication counseling had been offered and provided to the patient. Counseling did not include a patient warning about a drug-drug interaction, consistent with the defense’s position that this allegation was baseless.
The patient’s spouse testified that she pursued the lawsuit based upon medical test results before her husband’s death. His complaint of chest pain was investigated by a cardiologist a few months prior to his death, and coronary artery catheterization findings were negative. Plaintiff counsel identified a medical expert who testified at deposition that the patient’s medications may have contributed to his collapse and subsequent death related to drug metabolism. However, the expert was unable to provide convincing support for a clinically significant drug interaction.
Following completion of the depositions, the defense team agreed that if the suit was not withdrawn, they were prepared to move for summary judgment. If the summary judgment motion was denied, the defense planned to proceed to trial with a high degree of confidence for a favorable outcome.
Risk Management Comments
Although it is challenging to accurately predict the outcome of any legal proceeding, in this case, the defense was able to build a strong case with a high probability of success. Important factors included:
- An experienced healthcare provider with a commitment to quality care, as evidenced by excellent pharmacist-patient communications and medication counseling procedures; careful and thorough prescription review and dispensing activities; and recordkeeping practices that met or exceeded the standard of care.
- Rapid communication and full engagement of the insured pharmacist with claim professionals and legal counsel.
- Identification and qualification of appropriate experts to strengthen the defense, as well as the ability to identify gaps and weaknesses in the defense plan and in the plaintiff’s case.
The case resulted in a successful defense of the insured pharmacist. Defense counsel submitted a Motion for Summary Judgment, and the plaintiff decided to voluntarily dismiss the action prior to the Court’s decision on the Motion.
Total Incurred Legal Expenses: $75,000
Risk Management Recommendations
This case study illustrates the value of implementing and complying with procedures to:
- Identify relevant drug interactions and contraindications.
- Offer/provide medication counseling and document the process.
- Provide required patient information leaflets and written instructions.
Although these and other risk management activities are integral to the ability to help claims and lawsuits, actions taken by a healthcare professional once a claim is asserted or a lawsuit is filed are critical to a successful defense:
- Do not attempt to resolve professional liability or professional license investigation matters independently, without appropriate guidance and legal counsel.
- Immediately notify the professional liability insure of a claim, lawsuit or professional licensing board investigation. If employed, follow established internal notification procedures.
These are illustrations of actual claims that were managed by the CNA insurance companies. However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information
- Cooperate fully with your defense attorney in order to comprehensively prepare for the deposition. For cases that proceed to this point, understand that a “deposition” is a statement under oath that is recorded verbatim and may be videotaped. The importance of preparing for and providing a sound deposition cannot be over-emphasized. Conducting and videotaping practice or mock deposition sessions for review represent an effective approach to preparation.