6/11/2009

Prosecution of Harmful Errors Decided by Outside Forces

Cheryl A. Thompson

Pharmacist-dominated state boards of pharmacy hold sway over a pharmacist’s license to practice, but prosecuting attorneys and the general public decide when a harmful medication error was a criminal action.

"We happen to be in one of those times where prosecutors seem to be more willing to make decisions that would indicate that something that is a medical malpractice or a pharmacy malpractice case could fit into the criminal law," said former deputy prosecuting attorney Ken Baker, a pharmacist.

Baker is also the former general counsel and senior vice president of Pharmacists Mutual Insurance Company, which provides professional liability coverage. Through the Phoenix law firm Renaud Cook Drury Mesaros, PA, he now runs a consulting practice that focuses on medication-error reduction, risk management, and pharmacy law and regulation.

Earlier Prosecutions

Pharmacist lawyer Ken Baker, in describing what he called a "natural flow" to criminal prosecutions of persons involved in malpractice, recalled two cases from several years ago: the nurses in Colorado and a pharmacist in Ohio.

In 1997, the district attorney for the county encompassing Denver asked a grand jury to evaluate accusations about three hospital nurses’ involvement in the death of a newborn boy. He died after receiving an i.v. injection of penicillin G benzathine suspension. The grand jury indicted the nurses for criminally negligent homicide. Two of the nurses pleaded guilty as part of a plea bargain. The third nurse pleaded not guilty, and the petit jury acquitted her.

In 2001, the prosecutor’s office for the county encompassing Toledo asked a grand jury to evaluate the circumstances in which a hospital outpatient pharmacist dispensed overdoses of two i.v. cancer chemotherapy drugs for a cancer patient, who died. The grand jury indicted the pharmacist for involuntary manslaughter. According to Drug Topics, an employee of the prosecutor’s office admitted that the patient’s daughter had made prosecutors aware of the medication error. Half a year after the indictment, the charge was reduced to a misdemeanor at the prosecutor’s request, Drug Topics reported, and the judge conditionally stayed that charge.

"There’s kind of a natural flow to these things," Baker said. "Once in a while there’s a number of them, and then there’s nothing, and then there’s a few of them again, and then there’s nothing" (see sidebar).

The case of former hospital pharmacist Eric J. Cropp, who awaits sentencing after pleading no contest to involuntary manslaughter in Ohio, is perhaps the most recent example.

Cuyahoga County Prosecutor Bill Mason in 2007 asked a grand jury to evaluate accusations about the involvement of Cropp and pharmacy technician Katherine Dudash in the death of two-year-old Emily Jerry at Rainbow Babies and Children’s Hospital in Cleveland. The toddler died three days after receiving an i.v. cancer treatment that had been prepared in a concentrated sodium chloride solution.

In announcing two indictments against Cropp, the prosecutor’s office said he failed to recognize several errors made by Dudash in preparing the medication dose.

Cropp, Mason’s office stated in a press release, "was required to review and approve the measuring instruments and medicine used by the technician." And by approving the improperly prepared dose for use, Cropp "misbranded" it.

Kim Burns, president-elect of the American Society for Pharmacy Law and an associate professor at LECOM School of Pharmacy in Erie, Pennsylvania, said most crimes involve some level of intent by the perpetrator.

With regard to the case in Cleveland, Burns said she thinks the prosecutor argued in part that the pharmacist should have known, under the circumstances existing that day, that something dangerous could result.

"At what point does intent stop and nonintent start?" she asked rhetorically.

Michigan pharmacist and attorney Christopher Pencak, who has defended health care professionals in criminal cases, called the recent case, in which he was informally consulted, "unique and ominous."

"I’d never seen such a thing" for a negligent pharmacist or physician, he said.

What Cropp did, Pencak said, was not a willful action.

Months before the indictments, the Ohio State Board of Pharmacy had permanently revoked the pharmacist identification card for Cropp after determining that he had violated state codes 14 times in a year.

Timothy Benedict, assistant executive director and compliance administrator for the Ohio State Board of Pharmacy, said it was not common for a license-revocation case related to dispensing errors to proceed to criminal prosecution.

He said the decision was made by the prosecutor’s office.

The Cuyahoga County prosecutor’s office, when asked such general questions as whether it routinely receives information about health care professionals whose licenses have been revoked, declined to comment "because of the pending case."

Pencak said the prosecutor’s office, if determined to pursue Cropp, had two options: file a criminal complaint or present the case to a grand jury.

Grand juries, almost without exception, he said, act as "rubber stamps" for the prosecutor’s office.

Baker said the grand jury process allows a prosecutor to present evidence to a jury of local residents and see whether they believe the facts presented about the situation "meet the criminal statute" and a criminal case should be brought.

The charge to which Cropp pleaded no contest—involuntary manslaughter—in Ohio is a crime of negligence, Baker said. "It is a substantial slip from a standard of care [in] that the person either did not recognize the risk or did not avoid the risk."

But a grand jury, he said, would probably not appreciate the fact that for a pharmacist to totally avoid risk in filling a prescription, he or she must either not make any errors or not fill any prescriptions. "It depends on what kind of information was brought to the jury," he said.

The grand jury declined to indict the pharmacy technician, the prosecutor’s office said in its press release.

As news circulated in latter April that Cropp planned to plead no contest, the Institute for Safe Medication Practices (ISMP) issued a press release decrying criminal prosecution of individuals for harmful medication errors.

Criminal prosecution sends the message, ISMP said, "that clinical perfection is an attainable goal, and that ‘good’ healthcare practitioners never make errors."

ISMP Executive Vice President Allen Vaida partly attributed medication-error-related criminal prosecutions to pressure exerted by the media and victims and their families.

Victims and victims’ families may not be as inhibited as years ago to talk publicly after a medication error, he said.

With some of the harmful medication errors that garner extensive press coverage, Vaida speculated, local prosecutors may feel "under the gun" to show the public that they are doing something.


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