Medical Malpractice Bulletin – November, 2015

Perspective: Why is a thoracic aortic dissection so often missed?
By Charles A. Pilcher MD FACEP

What are the first things an emergency physician should think of when confronted with a patient complaining of new onset chest pain? Heart attack? Sure. But given how common heart attacks are and how attuned to that diagnosis most physicians are (or should be), how often does a physician actually fail to consider an acute MI as the cause?

Not very, I contend.

Those things that should first be thought of are those conditions that can kill a patient if an ED doc does not consider them in his/her differential and rule them out – either with a well-documented history and exam or with appropriate testing. The top 3 are:

  • Pulmonary embolus
  • Acute coronary syndrome without MI
  • Aortic dissection

Lawsuits for a missed aortic dissection are nearly 200 times more likely than lawsuits for a missed MI. Find out why here ->

Antibiotics sufficient for treatment of appendicitis – sometimes.
An example of a “non-inferiority trial”

We frequently find examples of “non-inferiority trials” in studies of pharmaceuticals. Companies actually get studies published that show that their new “blockbuster drug” is just enough different from an older drug to gain market share not just because it is new, but because it is at least as good as the current best option, i.e., not worse. No wonder the cost of medical care is so high! However, in the past year Salminen et al. showed that carefully selected patients with appendicitis could be treated with antibiotics, and that antibiotic treatment alone is no less effective than standard appendectomy. This time the proposed treatment is not only “new” but actually cheaper, so that the “not less inferior” approach has merit. Patient selection is crucial. Those with perforations, abscesses, appendicoliths, etc., are excluded. A JAMA editorial by Kaji and Lewis goes into great detail about non-inferiority trials and concludes that “A noninferiority trial does not distinguish between a new treatment that is noninferior and one that is truly superior and cannot demonstrate equivalence.” A second editorial by Livingston & Vons concludes that “The time has come to consider abandoning routine appendectomy for patients with uncomplicated appendicitis.”

EMRs can be costly in malpractice suits
Several recent million dollar plaintiff verdicts have hinged directly on the documentation or lack thereof in the EMR according to Dr. Keith Klein of UCLA, who presented his data in Chicago this spring to the Health Information and Management Systems Society. Dr. Klein gave several examples of cases where “good, honorable, caring physicians” were “victimized by the EMR.” In one case a physician missed an abnormal UA, and the plaintiff was awarded nearly $2 million for renal damage when the judge noted that “the EMR doesn’t seem to track this well.” No one could figure out who was responsible to take action. When a witness in another case said that the EMR allows data to be massaged t0 “create flow charts and graphs,” the judge asked “You mean to tell me you alter [the medical record] as you see fit?” In a third case the judge dismissed the EMR as unreliable, saying that it was “plagiarism, which you euphemistically categorized as ‘cut-and-paste.'” In another case the judge called the hospital’s EMR “abominable,” Klein reported. Providers must be responsible for their documentation and cannot be the handmaiden of the EMR, its templates or its design. Thus, it is incumbent upon physicians, hospitals, insurers and defense attorneys to educate their users on the proper use of any EMR, for when something goes wrong, one can be certain that it will be gone through with a fine-tooth comb by the plaintiff attorney. For more on the EMR, with emphasis on “metadata” and “audit trail,” see “Electronic Medical Records: Metadata as Evidence in Litigation” by Meyers et al.

Did “haste” trump “safe” for Boehringer’s dabigatran (Pradaxa)?
Pradaxa (dabigatran, cost $3000/yr) has been touted as the anticoagulant alternative to warfarin (Coumadin, cost $200/yr) because “no monitoring of clotting function is needed.” However, problems with the drug have cropped up since its release. The biggest of these is that there is no reversal agent for patients who experience a brain hemorrhage as a result of stroke or trauma. While vitamin K and other agents will reverse warfarin and protamine and other agents will reverse heparin, only hemodialysis has been able to reverse dagigatran.  Thus, the drug appears not to be as safe as alleged. A BMJ article by Deborah Cohen points out that not all patients respond to the “one size fits all” dosing” touted by manufacturer Boehringer Ingelheim (BI) and routine testing may still be indicated. But wait! That was last year! Just last month the FDA granted BI “accelerated approval” of the reversal agent idarucizumab (Praxbind). The drug works within 4 hours but costs “thousands of dollars.” [Editor’s Note: BI makes a useful but expensive and dangerous drug. They then make another useful and expensive drug to reduce the dangers of the first drug. They may now make more money selling both drugs than on either drug alone. “I nearly killed you with my expensive drug, but if you buy my other expensive drug, I may be able to save you.” I think I now know the meaning of “chutzpah.” / CP] 


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