DC Medical Malpractice & Patient Safety Blog

Propofol is a surgical anesthetic safely used only in a hospital operating room or a comparably equipped medical facility with continuous monitoring of the patient's heart rate and breathing. The idea of using propofol as a sleep aid in a private home, with a doctor occasionally looking in? Unthinkable, before Michael Jackson's death.

Now Dr. Conrad Murray has been convicted of manslaughter for his role in Jackson's death. Murray was supposed to be Jackson's personal doctor, a unique physician with only one patient, who was paid $150,000 a month by Jackson's concert agency to keep the singer healthy.

Medical malpractice occurs when a doctor violates basic patient safety rules and causes harm to a patient. But this was much worse. Dr. Murray was guilty not just of breaking rules, but of a fundamental conflict of interest. Apparently seduced by his large monthly salary, he threw his medical judgment out the window and let Michael Jackson wheedle him into dangerous and ultimately fatal behavior with powerful prescription drugs. If he had "just said no," like any ethical, responsible physician would have done, Jackson presumably would have shopped for some other doctor to supply him drugs. But then Jackson's death would have been on some other hands, and Murray would not be facing prison and loss of his medical license.

While this is a particularly egregious example, conflicts of interest are common in medicine, from unnecessary surgery to advocating drugs, surgical devices and other treatments based on the doctor's relationship with the drug or device manufacturer.

No surgical patient wants to experience, or remember, the details of their operation, and the drugs given to put patients to sleep generally work nicely to create a blank slate in the mind for anything that happened after the anesthesiologist told the patient to start counting backward. But not always.

As many as 1 in 100 patients reports afterward that he or she was awake during the surgery, and can recount details of what was heard that make it clear it wasn't a dream. The psychic injury is worse because the paralysis that accompanies anesthesia usually means that aware patients can do nothing to signal to the doctor that they can hear what is going on.

Sometimes these patients are psychologically traumatized enough (with post-traumatic stress disorder) that they end up in the office of a malpractice lawyer like me, asking if they have a legitimate claim against the anesthesiologist or the surgeon.

The answer to that question is "Probably not," according to the latest research.

The problem is that while anesthesiologists have a rough idea of which patients are at high risk, nobody knows how to guarantee, or even improve the odds, that "intra-operative awareness" will not occur.

A study published this week in the New England Journal of Medicine assessed two possible ways of cutting the risk of intra-op awareness. One involved monitoring brain waves. The other involved measuring the concentration of anesthetic gases being exhaled by the patient. The study found that neither clearly worked, although there were fewer reports of intra-op awareness in the patients whose anesthetic gas levels were monitored.

You would think that if someone is awake by mistake during surgery, it means they weren't given enough anesthesia. But you would be wrong, according to the experts. Despite decades of research, we don't know that much about consciousness and memory, and their relationship to general anesthesia. And the ability to figure out during surgery who might still be awake when they look asleep is surprisingly rudimentary.

Here's the conclusion of an editorial on the subject that was also published in the NEJM, written by Gregory Crosby, M.D., an anesthesiologist at Brigham & Women's Hospital in Boston:

Monitors are meant to supplement, not supplant, clinical decision making, and depth-of-anesthesia monitors that reduce complex neurobiology to simple numbers are no exception. It is unreasonable to expect any such monitor to unfailingly detect conscious awareness — a specific and still mysterious property of the brain and mind — and neither patients nor physicians should think otherwise. Notwithstanding this and other weaknesses of current devices, a window into the anesthetized brain, albeit a foggy one, may still be useful, in conjunction with information from other monitors ... as a generic, all-purpose index of the brain's response to powerfully sedating drugs. Whether these devices add value in this way remains to be seen, but when minding the mind during sedation and general anesthesia, a little insight into how the brain is reacting is apt to be better than none, especially if it challenges historical ways of gauging anesthetic depth and catalyzes the search for something better.

Article first published as Awake by Mistake During Surgery: A Patient's Nightmare on Technorati.

It was supposed to be a routine hernia operation. But then the surgeon ordered the anesthesiologist to give the patient a blood-thinning drug. The anesthesiologist, who wasn't familiar with the drug, injected the drug directly into the patient's i.v. line, as soon as the surgeon ordered it. That was a double mistake, and it started a cascade of consequences for the patient, who later became our law firm's client.

The legal issue in the medical malpractice lawsuit we filed was: Who was responsible for the misuse of the drug? Just the anesthesiologist, who should have known better than to inject the drug intravenously, and so soon? Or the surgeon too?

That issue was finally resolved this week in our client's favor. Here is what happened.

The too-quick use of the drug Lovenox, which was intended to prevent blood clots in the legs after the surgery, caused bleeding in the spinal cord, with permanent nerve damage for our client. The use of the drug was against the "black box warning" on the drug's official labeling, which said doctors should wait after a spinal anesthetic at least several hours, and also against the official policy of the Washington, DC hospital where the surgery happened.

The anesthesiologist settled out of court on the eve of trial and turned over to the injured patient the anesthesiologist's cross-claim for "contribution" against the surgeon.

The trial court then ruled, after a hard-fought trial, that the surgeon was jointly responsible with the anesthesiologist for the injury.

After a long battle, the District of Columbia Court of Appeals affirmed the trial court's ruling in all respects. You can read the decision on our firm's website here.

A wrongful death and medical malpractice lawsuit has been filed against a Vancouver, Wa., pain clinic by four plaintiffs who allege the clinic prescribed excessive amounts of pain medications, causing overdose deaths and addictions.

The estates of two patients who died of opiate overdoses are suing Vancouver Payette Clinic in Clark County, Wa., circuit court, along with two other plantiffs who allege the clinic prescribed them "grossly excessive" amounts of controlled substances that caused physical and mental injuries.

"Payette Clinic practitioners knew or had reason to know that the massive quantities of controlled substances they were prescribing were either being diverted by patients and sold in the illegal drug market, or being taken by their patients at great risk to the patient's own health," the suit says.

The clinic was previously been linked to the Dec. 9, 2008 overdose death of an 18-year-old girl.

The lawsuit contends that between January and November 2007, five people prescribed opiates by the clinic died from prescription overdoses, ranging from methadone to morphine intoxication.

The suit contends the clinic failed to do pill counts or give its patients random drug tests to control the massive amount of pills prescribed. It said a man died from a drug overdose Sept. 29, 2009 after a nurse practitioner prescribed him over 5,000 morphine sulfate tablets, in addition to other drugs, between June 2007 and July 2008. At the time of his death, he had over 2000 200-mg morphine sulfate tablets in his possession.

The Payette Clinic was raided by federal narcotics agents in March 2009. By December 2009, the advanced nurse practitioners at the clinic forfeited for 2 years (until December 2011) their licenses to prescribe Class II opiates, including oxycodone, Oxycontin, methadone or morphine.

Source: The Oregonian

A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers.

They were developed using Failure Mode and Effect Analysis (FMEA), a scientific methodology that identifies where problems occur in the use of pain medications and the underlying causes of those problems. The FMEA research identified 79 areas where problems occur in the use of opioidsand 290 potential causes of those failures.

Tools now available include clinical materials and risk assessments for physicians, safe-use guides for patients and general education for all groups. The organization also plans to develop additional tools based on the research.

Jeffrey Gudin, MD, a pain management and addition specialist at the Englewood Hospital and Medical Center in Englewood, N.J., says that healthcare professionals need to do a better job of assessing our patients' pain medication needs and of communicating the risks of the medications they prescribe.

"Through the resources of the C.A.R.E.S. Alliance, patients, caregivers and health professionals will have access to information, tools and resources to help them better understand these risks and better ensure that the medications are used properly by only those for whom they are prescribed," he says.

The alliance, which is sponsored by Covidien, the largest producer of prescription pain medications in the U.S., also will work to ensure that patients suffering from chronic pain have access to necessary medications.

Source: Medical News Today
You can obtain tools and other resources here.

Nurse anesthetists have been proven to deliver about as safe and high quality care as physician anesthesiologists, but there's still a key question every patient should ask before being put to sleep by a nurse anesthetist.

"Is there a doctor anesthesiologist nearby in case there's an emergency during my surgery?"

That's the question you need to get answered. In most hospitals and many free-standing surgery centers, the answer will be, "Of course, we wouldn't dream of putting patients to sleep without an anesthesiologist supervising the anesthetists." But in other facilities, particularly same-day surgery centers, the answer will be, "No, we don't think it's necessary."

And that "no" should give you pause.

Anesthesiologists have MD degrees and broad training in medicine. They also spend a lot more years learning anesthesia than nurses who come up through a "CRNA" program (Certified Registered Nurse Anesthetist). It costs about six times as much to train an anesthesiologist as an anesthetist, and the anesthesiologists are paid about double what nurse anesthetists get paid.

If something goes terribly wrong during surgery -- and luckily that's a rare event nowadays, thanks to improvements in anesthesia technology over the last thirty years -- I know who I want nearby. That's an anesthesiologist.

You can read more about this in a series of letters to the editor in the New York Times debating the merits of state governments passing laws that opt their state out of the Medicare requirement that surgery centers have an anesthesiologist supervisor.

I discuss anesthesia and other issues about safe surgery in my book, "The Life You Save."

Healthcare providers need to know more about the efficacy and potency of hydromorphone, a pain killer frequently used as a morphine substitute in post-operative patients, to avoid medication errors and adverse drug reactions (ADR), says an advisory from the Pennsylvania Patient Safety Authority (PPSA).

Researchers hired by PPSA reviewed 1,694 medication error and 937 adverse event reports involving hydromorphone from January 2008 to October 2009. They identified lack of knowledge about hydromorphone potency and the difference in potency between morphine and hydromorphone as the most significant factors causing serious medication errors, particularly when a patient is switched from morphine to hydromorphone.

Hydromorphone is administered in doses that range from 0.4 mg to 2 mg, whereas patients may receive as much as 7-10 mg of morphine. Incorrect dosing may occur when prescribing, dispensing or administering hydromorphone when a physician, pharmacist or nurse confuses hydromorphone and morphine. Other medical errors noted in the study were giving patients the wrong drug and not noting a documented allergy.

Some adverse drug reactions to hydromorphone also may be preventable. The study found that of the 447 reported ADRs involving central nervous system or respiratory effects, 292 (65%) were preventable, and, of these, 205 (70%) resulted from dosing errors.

To reduce the number of medical errors and ADRs involving hydromorphone, the study recommended implementing risk reduction strategies such as constraints and standardization, which focus on system improvement. It also recommended writing hydromorphone with the first five letters capitalized (i.e. HYDROmorphone) to further distinguish it from morphine.

Source: Pennsylvania Patient Safety Authority
You can view the report here.

The news from Colorado that a drug-addicted surgery technician had exposed thousands of patients to the Hepatitis-C virus raises questions about the institutions' procedures for protecting patients.

According to news accounts, the surgery tech, Kristen Parker, swapped her dirty syringes, filled with saline, for clean ones filled with Fentanyl, in operating rooms at Rose Medical Center in Denver and Audubon Ambulatory Surgery Center in Colorado Springs. That way she could steal Fentanyl, a powerful morphine-based drug that is used for surgical anesthesia, and inject it into herself to feed her drug habit. Ms. Parker has just been charged in a federal criminal complaint.

The institutions are sending certified letters to 4,700 patients at Rose and 1,000 at Audubon advising them to get tested for Hepatitis-C. That's because Ms. Parker tested positive for Hepatitis-C, and several patients already have tested positive.

Hepatitis-C is a virus that causes chronic liver infection in about 75 to 85 of every 100 persons who get an acute infection. A few of those who get chronic infection go on to develop cirrhosis or liver cancer. There is no known cure for Hepatitis-C infection.

The Colorado Springs Gazette reports:

Parker worked at Rose from October 21, 2008 until April 2009. She resigned on April 20 from Rose, but the hospital refused to accept her resignation and instead fired her.
She went to work for Audubon shortly after being fired from Rose. She worked there from May 4 until Monday, said Dr. J. Michael Hall, Audubon's medical director.
Hall said certified letters are being sent to all patients who had outpatient surgery at the center's Circle Drive and Union Boulevard location May 4-July 1 advising them they may have been exposed and with instructions on what to do.

Surgical technicians are not licensed health care providers. Yet because their job involves preparing operating rooms for surgery, they have access to powerful drugs, so it's foreseeable the job can attract addicts. A similar incident occurred in Washington, D.C., a few years ago, where a tech at a major hospital was caught swapping out syringes filled with powerful pain reliever drugs for plain salt water so that he could inject himself with the narcotic drugs.

According to the Gazette:

Prior to being hired at Rose, she [Ms. Parker] submitted to a pre-employment blood test which tested positive for hepatitis C. She was allowed to start work but hospital officials counseled her about the disease and exposure possibilities.
Rose placed her on administrative leave following an incident in which a co-worker was pricked by a needle in Parker's pocket on March 23, 2009.
According to the affidavit, Parker quickly disposed of the needle and denied any use of narcotics. She was allowed to return to work after a drug screening test came back negative.
The hospital placed her on administrative leave again after a co-worker reported seeing Parker in an operating room to which she was not assigned. She was tested again for drugs and this time the results were positive for Fentanyl.

The questions yet to be answered include:

1. Why hire someone positive for a contagious disease like Hepatitis-C and give them access to needles which can spread the disease?
2. Why not fire her the first time she was found with a needle?
3. Why did the second institution hire her so quickly after she was fired by the first? Were references checked? Shouldn't she have been required to advise the surgery center who her most recent employer had been?
4. Should there be a central data bank so that health care employers can find out about fired or disciplined employees, so they cannot easily travel from job to job? There is such a data bank for licensed health care workers, but perhaps it should apply to unlicensed ones as well.