Dr. L is a successful pathologist who has devoted much of his professional life to the establishment and operation of a diagnostic pathology lab. This facility performed a wide variety of automated testing but did not process Pap smears. When a lab specializing in Pap smears was offered for sale, Dr. L bought it. Over the course of three years, he expanded the business to the point that it served several hundred gynecology practices throughout southern Florida. This success was a direct result of his dedication to satisfying his customers and their patients. He believed that the interpretation and delivery of Pap smear results should be accurate, reliable, and timely. Despite his discipline, he was tripped up by a slide that was incorrectly read before he bought the lab.

The patient was a 42-year-old woman who had undergone a Pap smear as part of a routine gynecologic exam in 1994. The smear was interpreted by an employee and reported to the woman’s gynecologist as “within normal limits.” Almost three years later, the patient returned to the gynecologist’s office, complaining of vaginal bleeding. She was diagnosed with stage 3 carcinoma of the cervix and died 10 months later. A full-time homemaker and a devoted mother, she left behind her husband and six children ranging in age from 2 to 16 years.

Initially, the woman’s husband did not sue. But over time, the financial hardships involved with single-handedly looking after so many children changed his outlook. Four years after the alleged misinterpretation of the Pap smear, he consulted a plaintiff lawyer, who applied for a 90-day extension of the statute of limitations. Once the extension was granted, the lawyer served the lab with the required notice of intent to sue. By the time the state’s mandatory waiting period had expired and the plaintiff lawyer had filed the papers necessary to commence the case, almost five years had passed since the alleged malpractice. Dr. L received the papers in his office three days later. He notified his insurance company, which then sent the papers to its defense lawyer.     

The attorney’s first thought was to try and get the case dismissed through a statute of limitations violation. After several months of initial discovery to establish the dates and the allegations of the plaintiff lawyer, the defense lawyer petitioned to have the case dismissed. At the dismissal hearing, the defense argued that while the Florida statute of limitations on malpractice cases was four years, Dr. L’s case had been filed almost five years after the event. The plaintiff lawyer responded that under state law, the statute of limitations can be extended to seven years if it is shown that “fraud, concealment, or intentional misrepresentation of fact prevented discovery of the injury.” In his brief, the plaintiff lawyer argued that the lab’s failure to advise the patient that her Pap smear was abnormal was in itself evidence of concealment. Furthermore, the slide had not been reviewed by a pathologist. Concealment, the plaintiff lawyer contended, does not need to be intentional. Concealment includes anything that leads to lack of information. By this definition, he argued, there had unquestionably been concealment in this case, and the statute of limitations should be increased to seven years. The defense team replied that the lab staff had no idea that the Pap smear was abnormal, and there was no intentional concealment of the false result. Therefore, the statute of limitations should not be extended. The judge considered the testimony of both parties and dismissed the case.

Legal background

The term “statute of limitations” refers to the time after an alleged wrong within which a case must be filed. This varies from state to state and by the type of lawsuit pursued. The theoretical purpose is to prevent the filing of stale claims in which evidence and witnesses are lost and, to some extent, to reduce congestion in the courts. As this case illustrates, these statutes have been used by state legislatures (at the prompting of state medical societies) to eliminate many malpractice claims in which the damage is not immediately apparent. During the 1980s, the tort reform movement was successful in reducing statutes of limitations in many states to two years. The plaintiff’s bar has been working to reverse that change ever since, with varying degrees of success. In some states, judges have imposed a discovery rule stipulating that the statute of limitations starts running from the time the malpractice is discovered, not when the alleged error actually occurred. In any event, most of the progress made 20 years ago has been negated by effective lobbying activity from the plaintiff’s bar. 

Risk-management principles

It is impossible for mistakes in clinical labs to be eliminated entirely, but the repetitive processing involved in examining thousands of Pap smears lends itself to system improvements through the classic quality-control measures found commonly in manufacturing. Any company operating an assembly line can benefit from having its process assessed by a systems analyst trained to review data collection and process improvement. In this case, there was ambiguity in the appearance of the cells on the Pap smear in question, but the slide was not referred to a senior technician or pathologist for review, which might have been advisable.

Dr. L inherited this lawsuit when he purchased the lab, not realizing he had also bought any malpractice suits dating back to before the sale. He should have made an offer to buy only the assets and the client list rather than the entire company. Alternatively, he could have negotiated a reserve fund withheld from the proceeds of the sale to allow for any future lawsuits.