Articles on Law, Science, and Engineering

Scientific Misconduct: Part 3 - Standards for Scientific Record Keeping (cont'd)

The Lessons from Medical Malpractice Litigation

The medical record is the basic reference document used in medical malpractice litigation. A well-organized, well-written record is the best defense for the competent health care provider. The poorly written, disorganized record is strong evidence of an incompetent health care provider. The poorly kept record is not, in itself, proof of negligence on the part of the health care provider; but it is proof of substandard care. Because of the importance of lab notes to the conduct of scientific research, an improperly maintained laboratory notebook may actually be proof of research negligence.

Medical malpractice litigation is built around the medical record. The medical record provides the primary objective record of the patient's condition and the care provided. Records are particularly important for a physician's defense. It is the physician's responsibility to keep the medical record. The patient has injuries to show the court; the physician or other health care provider has only the medical records to prove that the injuries were not due to negligence. If the record is incomplete, illegible, or incompetently kept, this is the physician's failure. While courts and juries usually give a physician the benefit of the doubt on ambiguous matters, this does not extend to ambiguities created by incompetent record keeping.

When an injured patient seeks legal advice about filing a medical malpractice lawsuit, the attorney's first task is to review the medical records. The attorney is looking for both specific acts of negligence and at the overall quality of the record. The strongest medical malpractice lawsuits are based on well documented specific acts of negligence. In most cases, however, the negligence is inferred from documented and undocumented events. If the patient's case depends at least partially on assuming that certain events were not recorded, then the attorney must be able to cast doubt on the credibility of the record.

The least credible records are those that are internally inconsistent. An example would be the situation where the physician's progress notes report that the patient was doing well and improving steadily, but the nurses' records indicate that the patient had developed a high fever and appeared to have a major infection. More commonly, the credibility of the records is attacked by demonstrating that it is incomplete. If it is clear that medically important information is missing from the record, then it is easy to convince a jury that the missing information supports the patient's claims.

Editing medical records frequently gets their authors in trouble. Physicians often keep sloppy records because they are pre-occupied with the patient's immediate needs. Many physicians seem to have forgotten that medical records are intended to benefit the patient. They see medical records as a legal formality to avoid medical malpractice litigation. This leads them to "doctor" records to make them look better, unknowingly courting disaster if the record ever is questioned.

A similar danger exists where a scientist edits lab notes after the fact, or even where s/he merely leaves open an opportunity to do so. Every professional who works in a laboratory knows the importance of laboratory notebooks. As with physicians, however, it is easy to ignore the fine points of record keeping when preoccupied with the task at hand. It is a frailty of human nature to concentrate on getting results and let the notebook fall behind. The consequences of such behavior can be disastrous.

Motion pictures and television shape most individuals' notions of trials and legal investigations. These dramatizations involve persuasive witnesses and riveting testimony. They bear little resemblance to the investigation and trial of complex legal disputes. Such legal inquiries are much more like detailed audits. Those who have had to justify deductions to an IRS auditor realize the importance of good records. The Baltimore and Gallo investigations are typical in that the government has built its case by looking for inconsistencies between laboratory records, published articles, and personal testimony.

These investigations illustrate the two key assumptions about written records. First, a contemporary written record is the most credible evidence. Second, if the record has been altered, this is taken as evidence that the record is inaccurate, perhaps implying criminal intent by the author. In a court room, evidence that the medical records have been altered, however slightly, can make an otherwise meritless lawsuit impossible to defend. Similarly, in a research fraud and abuse investigation, evidence of altered laboratory records will probably destroy the career of the person being investigated, irrespective of the truth of the allegations that triggered the investigation.

This presumption against persons who alter records is reasonable. It is the same phenomenon that discredits dishonest politicians who cover up information that, in itself, would not matter to the voters. The problem for scientists and engineers is that, by modifying laboratory records without explaining why at the time, they invite being labeled retrospectively with the most nefarious motive. When the Federal Bureau of Investigation starts analyzing the ink in your notebooks, you must be as pure as Caesar's wife. The best way to do this is to understand how laboratory and other records will be used as evidence in court.

Next -- The Hearsay Rule