April 5th, 2011

Malpractice Lawsuits and Cardiology: Searching for a Safe Harbor

Several Cardiology Fellows who are attending ACC.11 this week are blogging together on CardioExchange. The Fellows include Sandeep Mangalmurti, Hansie Mathelier, John Ryan (moderating and providing an outsider’s view from Chicago), Amit Shah, and Justin Vader. See the previous post in this series, and check back often to learn about the biggest buzz in New Orleans.

Both New Orleans and ACC.11 continue to remain a feast for the mind and the palate, as we continue through Day 3 of the summit. Too many presentations and too little time…a week would still not be enough.

I made a point of attending a symposium on Professional Liability Claims today, both due to intellectual interest and personal self-preservation; like most physicians, I expect to be sued someday. The lessons imparted are worthy of dissemination, I think. The moderator and discussant (Dr. William Oetgen, MD, MBA and Dr. Frank Flannery, MD, JD) took us through actual case studies where cardiologists had been sued for medical malpractice, and then discussed the key teaching points.

Some of the lessons should already be familiar to cardiologists: follow up on test results, keep patients informed of abnormalities, document extensively and accurately. Basic professionalism goes a long way in managing malpractice risk, and physicians who fail to meet these fundamental standards should be held to account.

A more vexing dilemma is how to deal with liability risk in clinically ambiguous situations where decisions require a balancing of risks and benefits.  Here is an actual malpractice case for your review: The patient is a 27-year-old male with a history of obesity and hypertension who presents to his primary care doctor with complaints of 10 days of dizziness, weakness, and near syncope. He is generally a quite active outdoorsman, whose hobbies include rock climbing and scuba diving. His family history is significant only for hypertension and MI. He is noted to be bradycardic to <50 bpm, and serial EKGs show significant conduction abnormalities, including an intermittent LBBB and RBBB, as well as eventual 2:1 AV Block. He remains very symptomatic in the ER, and is immediately transferred to the ICU for monitoring, with a STAT cardiology consult. This cardiologist diagnoses possible complete heart block, and consults a cardiac surgeon for possible pacemaker placement. A DDD device is placed without complication, and the patient is eventually discharged from the hospital to resume his life.

The patient eventually moves out of the area and follows up with a new cardiologist for continued management of his pacemaker.  Interrogation shows that the patient no longer requires pacing; his new cardiologist wonders whether his previous heart block might be due to Lyme disease, given the patients’ history of outdoor activity. Lyme titers are ordered, and are positive.

The patient files a lawsuit against the ER physician, the original consulting cardiologist, and the cardiac surgeon, arguing that they were negligent in failing to test for Lyme disease and failed to meet standard of care by placing a permanent instead of a temporary pacemaker. He further alleges that by not fully informing him of the possibility of Lyme disease as a reversible cause of his condition, informed consent was never obtained. The defendant physicians maintain that routinely checking for Lyme disease is not the standard of care, especially given the absence of history of tick bites or rashes; they resolve to take it to a jury.

One of the most important issues in this case is identifying the appropriate standard of care; specifically, is it standard of care to routinely check Lyme titers in this clinical situation? Sometimes this question degenerates into a battle of experts, with each side marshalling its own witnesses to define the standard in a manner most advantageous to their client. The consequences of ambiguous and shifting standards of care are clearly undesirable. If they don’t know the standard of care, providers may defensively order unnecessary tests and procedures. The actual cost of defensive medicine remains controversial, with estimates ranging in the tens of billions annually. One need only consider the policy consequences of the aforementioned case to appreciate how quickly the costs can add up. If failure to test for Lyme disease is a breach of standard of care, does everyone require this test prior to pacemaker placement? Or does there need to be a “reasonable” clinical suspicion, and if so, what is it? Will busy cardiologists even care what is “reasonable”? Are they likely to just order the test on everyone just to be safe?

In an attempt to add some more consistency and predictability to the system, both providers and policymakers have considered using professional guidelines as a surrogate for standard of care. Adherence to clinical guidelines would serve as a “safe harbor” against liability. These “safe-harbor” statutes were previously attempted in Maine, and have been considered at the national level. In another version of this policy proposal, adherence to guidelines would not automatically shield against liability, but failure to adhere would be powerful evidence of malpractice. (For an excellent discussion of this topic, see Mello M. Of swords and shields: the use of clinical practice guidelines in medical malpractice litigation. Univ Penn Law Rev 2001;149:645-710.)

So do the ACC guidelines help us define standard of care in this case? Somewhat…per the guidelines: Permanent pacemaker implantation is not indicated for AV block that is expected to resolve and is unlikely to recur (e.g., drug toxicity, Lyme disease, or transient increases in vagal tone or during hypoxia in sleep apnea syndrome in the absence of symptoms). However, this is only a Class III recommendation, so it is hardly dispositive, and may not be extraordinarily helpful either to cardiologists or juries. In the absence of formal safe harbors, we are still forced to use guidelines as just one piece of evidence presented to juries, to be given whatever weight they see fit.

In this case, the jury found that standard of care was violated, and Lyme titers should have been drawn prior to placement of either a temporary or permanent pacemaker. However, only $50,000 was awarded, suggesting that the jury did not find the plaintiff had been injured significantly. In the end, one suspects that both defendants and plaintiffs walked away from this case feeling injured.

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

4 Responses to “Malpractice Lawsuits and Cardiology: Searching for a Safe Harbor”

  1. At least in some States of the Union the range of Lyme Disease has been enlarging since at least 25 years ago; even considering this, a large area of the USA is free of this problem and being a pediatrician, faced with this person in the ICU, being far away from an endemic area, even if Lyme Disease is associated with the issue that possibly has the person there, I might not be jumping to check for Borrelia ab, The same that I will not think of checking for Chagas Disease in the case that a person in the USA with cardiomegaly that is not from or has not traveled to an endemic area. I don’t know if this will help with a jury stirred by the plaintiff’s lawyer, but for sure I will mention this circumstance to my attorney if face with this issue in court.

    Competing interests pertaining specifically to this post, comment, or both:

  2. I don’t think testing for Lyme disease would be the standard of care in most places.

  3. Robin Motz, M.D., Ph.D. says:

    The only cure for the malpractice crisis is to make all such cases no-fault/workmen’s comp cases, as is done in no-fault automobile insurance.

  4. William J Oetgen, MD, MBA says:

    Thanks to Dr. Mangalmurti for highlighting our session on Medical Professional Liability. The Lyme case is indeed an interesting one. A point that has not been raised is the issue of false negative serologies in Lyme disease. There is, of course, no guarantee that in the acute phase of the disease, this patient’s serology would have been positive.

    With respect to Dr. Motz suggestion that a no-fault system would be the solution, I think that one problem with that suggestion is that it would be enormously more expensive than the current system. Patricia Danzon suggested in 1985, that only 10% of negligently injured patients file a claim.