Monday, June 1, 2009

Malpractice or Criminal?

The Cleveland Plain Dealer reports on the story of Eric Cropp, a local ex-pharmacist, who was recently convicted of involuntary manslaughter in the tragic death of a 2 year old girl under his care. The child, Emily Jerry, was being treated for cancer at Cleveland's Rainbow Babies and Children's Hospital. A pharmacy technician had mistakenly prepared Emily's chemotherapy medicine in a hypertonic solution of saline. Eric Cropp, the supervising pharmacist on duty that day, had signed off on the preparation. Emily Jarry slipped into a coma and subsequently died.

As a result of the incident, the Ohio legislature passed what is now known as "Emily's Law", which provided quality control guidelines for pharmacy technicians. Prior to the law, people could obtain employment in a pharmacy lab with barely a high school diploma. Reassuring, no? The pharmacy technician in this case, Katie Dudash, was granted immunity in return for testifying against her boss, Eric Cropp. Mr. Cropp now faces sentencing (maximum 5 years in prison) on July 17th.

A case like this is obviously tragic and unnecessary. This Cropp character was undeniably negligent and unprofessional to the extent that he was the one ultimately responsible for making sure that that little girl got the correct medicine. But I have to admit, I was initially taken aback when I read that he was being prosecuted as a criminal. He wasn't drunk or impaired. He wasn't even the one who prepared the mixture. He was inattentive and lazy and careless, and now he faces the real possibility of serving jailtime as a consequence. He's a pharmacist, not a doctor, but the implication and precedent is clear-- health care professionals are not immune to the prospect of a criminal trial .

Generally, medical malpractice is litigated as a civil tort. In civil cases, as opposed to criminal suits, the alleged victim brings the lawsuit for the purpose of remedying perceived damages sustained via monetary compensation. In criminal cases, the State is the plaintiff. The core elements of a successful medical malpractice suit include: an owed duty (physician/patient relationship), breach of duty (the act of malpractice), injury sustained (the negligence leads to a complication), and damages suffered. The plaintiff must prove all four elements in order to win the case. For example, let's say your surgeon nicks your bile duct during a routine lap chole, but is able to successfully identify and repair it at the same operation. That's a lawsuit you won't win because you've only really proven 1 of the 4 elements (injury sustained). The sole purpose of medical malpractice (as trial lawyers will gladly tell you) is to reimburse an injured patient for negligence and to encourage health care professionals (via the negative feedback mechanism of a million dollar lawsuit) to better govern themselves, i.e physicians who have been successfully sued multiple times for medical malpractice presumably will then show up on the radar of the state licensing boards and face loss of practice privileges.

Doctors face potential criminal charges more commonly for procedural violations such as medicare fraud and selling narcotics prescriptions. Criminal prosecution for medical malpractice, on the other hand, is extremely rare in the United States, but maybe that's starting to change; more than half of the criminal cases since 1809 have been filed since 1984. When we talk about criminal conduct, there are two main components: actus reus (guilty act) and mens rea (guilty mind). Mens rea deals with the perpetrator's state of mind, specifically his intent. Criminal prosecution of medical malpractice includes mens rea as the fifth component that must be proven.

In California in 1996, Wolfgang Schug MD saw an 11 month old child in the ER, diagnosed an advanced inner ear infection and recommended that the parents drive the kid to a larger hospital 55 miles away. The child ended up dying of overwhelming sepsis. Five months later Dr Schug was handcuffed in his ER by detectives and brought to the County jail. He was charged with second degree murder. At trial, the judge listened to the prosecutor's presentation and threw out the case before Dr. Schug's attorneys could present any counter-evidence.

The frightening thing is that the decision to make a medical malpractice event a criminal case is entirely up to the discretion of the prosecutor. Vague, non-specific terms like "wanton disregard of patient well-being" and "willful recklessness" are used to guide the decision making process but ultimately it becomes an arbitrary judgment call. We can all imagine scenarios where a doctor could be justifiably criminally prosecuted. The recalcitrant drunk surgeon who skips out of town before formal disciplinary measures can be implemented and finally really hurts someone while impaired at some rural, unsuspecting hospital in another state. The depraved OB/Gyn who repeatedly refuses to follow standard of care guidelines such as fetal monitoring because he "knows what's best". The quack who forges a medical degree after losing his license in one state and ends up clear across the country in a doc-in-the-box where he kills someone by writing the wrong prescription. But rarely is the real world so incontrovertible. We will always have bad outcomes secondary to questionable decision making in medicine. We have safeguards in place (hospital QA committees, state licensing boards, national malpractice databases) to help ensure that "bad physicians" are identified and either reformed or removed from practice. But is it enough? Eric Cropp lost his license after a professional inquiry. He hasn't been able to find work since. He disgraced himself as a pharmacist. But now he will also go through the rest of his life stigmatized as a convicted felon who has done time in the clink. He's basically ruined. The tragic death of a toddler notwithstanding, I find such a predicament rather harsh.

Something is off in a case like this. Criminal prosecution of doctors will never be common, number one, because who the hell would ever go to medical school if there was a possibility you could not only get sued, but have to go to jail for an unintentional error (and btw defending a criminal lawsuit is NOT covered by malpractice insurance), and number two, the trial lawyers would never allow it (remember, in a criminal suit the State is the plaintiff and the purpose is punishment rather than compensation of the victim/trial lawyer). But a case like this one sets an ominous precedent for future emotionally charged situations where there are bad outcomes (like when a child dies). Can you imagine losing your child because some idiot technician mixed up the wrong medicine and the lazy-ass pharmacist didn't bother to properly inspect it? You'd want justice right? And exactly how does a $12 million or whatever malpractice judgment in your favor propitiate your rage when you've just buried your kid? You'd want those responsible punished somehow, beyond financial decimation, beyond professional disbarment, but truly, irrevocably punished. You'd give all that settlement money just to see them led off to jail in handcuffs. I understand that kind of pain. But let's make sure the full force of the law is reserved for those rare cases of "wanton negligence" and "willful neglect"....


Anonymous said...

Your Paper's really called "The Plain Dealer"??? There was a Navy Heart Surgeon Court Martialed for Manslaughter back in the 80's, convicted, was doin hard time till his case was overturned on appeal. From the evidence, didn't sound like he was a very competent surgeon, but clearly didn't meet the requirements for manslaughter. The Prosecution made a big deal that he was "Legally Blind WITHOUT his glasses" a meaningless statement since "Legally Blind" is defined as20/400 or worse WITH correction. Navy had to give him back pay, and a discharge for PR reasons, still ruined the guy's life. Google "Dr. Billig" if you want more...


rlbates said...

As tragic as it is that the child died due to Cropp's "inattentive and lazy and careless"; I agree with you that the real fear (for me) comes in the prosecutor's "arbitrary judgment call" in deciding whether it is a malpractice or criminal case. This should scare all medical providers.

Joseph Sucher, MD FACS said...

I agree with you on all points. This is scary stuff.

I do have one note to make. You commented on "injury sustained" and possibly alluded (or I inferred) that this correlates one-to-one with negligence. In you example the injury sustained is not necessarily negligence. By definition:

NEGLIGENCE - The failure to use reasonable care. The doing of something which a reasonably prudent person would not do, or the failure to do something which a reasonably prudent person would do under like circumstances. A departure from what an ordinary reasonable member of the community would do in the same community.Bile duct injury certainly can be caused by negligence, but I suspect that often times it is not. I probably read too much into your good example... but I wanted to make this point of clarification.

Finally.. I enjoyed this post because it dove tails a bit with Dr. Wachter's post yesterday about Hospital Peer ReviewJFS

Anonymous said...

I'm uneasy with the concept of criminalizing what essentially amounts to carelessness/negligence.

But it does happen in other arenas, and quite frequently. It's not at all unusual for someone to be criminally prosecuted for careless or reckless behavior that leads to someone else's death. You've probably heard of involuntary manslaughter.

Except in the most wanton and egregious cases (which admittedly are very rare), health care professionals have always gotten a free pass. You can't really say this for any other group in our society. Is this really fair? Is it fair to the victims? Heck, the health care industry has a long and ugly tradition of covering up its errors and being less than honest with patients and families. Maybe it's time to level the playing field.

Anonymous said...

i thought the four dreaded d's are

direct (as in your lack of diligence directly caused the damage)

Chris said...

The pharmacy association aren't sitting back on this. Both the Ohio pharmacy association and other groups are planning to push for an FAA-like immunity system that would encourage pharmacists to report errors (they do a poor job now) in exchange for immunity from prosecution.

I wrote about reaction to the Eric Cropp case here.

Anonymous said...

I have to go with criminal negligence here. It seems to my, admittedly untrained, eye to be a classic example. Not unlike a parent's lack of supervision for a teenager's party at his home ending in a drunk driving death or injury from one of the partygoers.

Pharmacists and physicians benefit financially by having lower level care providers under their supervision. In exchange they are expected to actually supervise and check on the work of these individuals. To not do so is gross negligence and in this tragic example ended in death. Too often there is a cursory (and often not even that) review of a lower or mid-level's work. This is completely inappropriate.

I agree, however, that some sort of reporting system of errors with immunity from criminal prosecution (but still allowing for compensation for the victim) is a prudent course to pursue. Shining the light of day on error has the amazing ability to reduce it.

If the general population is expected to trust healthcare then healthcare must prove itself trustworthy. The time has passed when blanket trust can or should be expected.

Trust has been lost and it is incumbent upon healthcare to earn it back. Admitting mistakes is a beginning. It allows the system that permitted the error to be adjusted to assist in preventing its recurrence.

SarahW said...

The death of the child was preventable, the pharmacist's negligence caused the death.
But that's not the whole of it. The prosecutor felt his conduct rose to the level of CRIMINAL negligence, which would imply there was more than mere mistake, or falling short of standards of care.

In this case a key fact was probably the testimony that that the pharmacist was actively INFORMED by his underling that there was something wrong with the chemotherapy preparation.

In spite of being * informed*that the solution was improperly prepared, he was indifferent to the consequences to human life, despite the fact that his expert knowlege, and his special duty to recipients of medication, would have informed him of potentially fatal risks and required him not to release a potentially deadly solution for use by patients.

In other words, he knew the bad solution might injure directly (by causing harm) or indirectly (by not being the proper therapeutic dose, leaving the patient's underlying condition improperly treated)

Now, that may not be the case here, but it would form a reasonable basis to presume a callous disrequard for human life resulting in death, that is, a criminally negligent homicide.

A pattern of similar mistakes in the past or other troubles might make a prosecutor take a hard line regarding this fatal incident - I don't know the whole context. But this situation can be distinguished from mere malpractice, for instance, he failed to check the solution, relying on the competence of his underling, but was never informed of any problem.... or he prepared the solution himself and made a mistake because of illegible handwriting or confusing labeling of products, or made a dosing error of his own but was unaware of it before sending it out.

Here he was informed the solution was defective.
The conseguences were fatal. He was an expert with not only a duty to ensure the correct solution was provided, but with full knowlege of the potential consequences of a defective batch - conscious that death or injury might result from the error he was TOLD was made. He took his chances. That chance he took may rise to the level of criminal neglignence.

Nick Dupree said...

Back in the early 90s, before 19-year-old girl "pharmacy technicians" were the norm, and most medications were prepared by actual licensed pharmacists, we had a serious mixup with a medicine involving my younger brother.

He was still a baby then, about six years old, and was taking antibiotics (in liquid form). Just in time, we realized the label was papering over the REAL label, which identified it as a powerful anti-seizure sedative that likely would have killed my brother.

Mislabeling kills people. My mom went down to the pharmacy and hit the roof.

Turns out that pharmacist was crazy overworked for weeks and fatigued to the max. Why? the pharmacist shortage, the one that would soon force them to delegate much of the work to 19-year-old girls.

That pharmacist was put on forced leave for several weeks.

Anonymous said...

Anybody who doesn't see this as a terrible forecast of potential things to come needs to get out of the profession.

Criminal act? Are you kidding? He made a mistake. We all do....everyday.

Human error within a system which has process hiccups....absolutely.

The judge is terribly ignorant. Shame on him.

But the Ohio Board of Pharmacy knows all too well about JCAHO, system processes, error prevention, system improvement, etc. SHAME ON THEM for revoking his license.