Admissibility of Medical Protocol in Medical Malpractice Actions

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Written by Christopher Glass

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In medical malpractice action, the admission of medical guidelines or protocol can be advantageous, either to demonstrate that such guidelines were followed, or to show they were ignored.  Such guidelines or protocol are common in the medical profession.  However, when seeking to admit written protocol or guidelines, you must first overcome the hearsay problem.  The hearsay problem is rooted in the concern that the author of written protocol is not subject to cross-examination, in the way that a testifying expert would be.  The Court of Appeals in Spensieri v. Lasky, 94 NY2d 231 (1999) rejected on hearsay grounds the plaintiff’s attempt to introduce Physicians’ Desk Reference (PDR) protocols and recommendations regarding a drug prescribed to plaintiff by the defendant doctor.  PDR is basically an encyclopedia of information about various drugs that drug manufacturers provide to the FDA.  Plaintiff sought to introduce written portions of the PDR regarding proper uses of the drug as stand alone proof of the standard of care.  Plaintiff’s expert testified that the PDR was a standard of care for physicians and when plaintiff attempted to introduce relevant portions of the PDR, defendant’s objection on hearsay grounds were sustained.  The Court of Appeals notes in upholding the lower court’s determination that, “Generally, the standard of care for a physician is one established by the profession itself (internal citations omitted)… in our view the information contained in the PDR can only be analyzed in the context of the medical condition of the patient.  The testimony of an expert is necessary to interpret whether the drug in question presented an unacceptable risk for the patient… Thus, plaintiff was not prohibited from offering testimony concerning her expert’s professional evaluation of defendant’s conduct based, in part, on reliance on the PDR.  Plaintiff was barred only from offering the contents of the PDR as stand alone proof of the standard of care.”  Id.  Thus, it was held that although the plaintiff’s expert could rely in part on the PDR in evaluating what the standard of care is, plaintiff could not admit the actual written portions of the PDR for the truth of the matter they asserted.

However, the scope of Spensieri is limited by Hinlicky v. Dreyfuss, 6 NY3d 636 (2006).  In Hinlicky, the defendant doctor indicated he followed a set of clinical guidelines regarding when to do a cardiac screening for non-cardiac procedures, published by the American Heart Association.  He further testified that he incorporated the guidelines into his practice shortly after they were published.  A flow diagram that he used and continued to use to evaluate patients was testified to, and defendant noted that this helped him in his treatment decision.  Over objection, the actual diagram was admitted on the basis that the document was being used not to establish the truth of the matter it asserted, but only to explain the evaluation procedure, as merely one link in the chain which the doctor relied upon to reach his treatment conclusion.  The Court of Appeals held that the defendant was prohibited from offering the diagram and AHA guidelines as “stand alone proof” of the standard of care, but that here the diagram and guidelines were admitted not as stand-alone proof of the standard of care, but rather as “one link in the chain” of the defendant’s evaluation process.  The court did note, however, that once admitted for demonstrative rather than substantive purposes, plaintiff was entitled to a limiting instruction.

Therefore, defendant doctors may introduce actual written guidelines or protocols regarding treatment, but only for the purpose of demonstrating their process of evaluating what treatment options to follow.  In similar vein, a plaintiff’s expert, under the holdings in Spensieri and Hinlicky, should be able to testify that the standard of care, under the whatever the particular circumstances may be, required the defendant to consult applicable guidelines or standards, and that failure to consult such standards constituted a deviation from the standard of care.  The written protocol or guideline at this point could then be admitted for demonstrative purposes, rather than as stand alone proof of the standard of care.

Regardless of which party seeks to introduce written guidelines or protocols for demonstrative purposes, such admission will be subject to a limiting instruction.  The First Department spoke on this issue in Halls v. Kiyici, 104 A.D.3d 502, 503, 960 N.Y.S.2d 423, 424 (1st Dep’t 2013).  In Halls, plaintiff alleged that defendant gastroenterologist failed to recommend and perform a timely colonoscopy.  Defendant performed a 2004 colonoscopy on plaintiff revealing polyps that had developed into a tubular adenoma, and he recommended a three-year follow up.  This timeframe was consistent with American Gastroenterological Association clinical guidelines.  “At trial, defendant requested that the court allow him to introduce the Guidelines into evidence, arguing that they would support the methodology he used in treating plaintiff.  Plaintiff’s counsel objected to the Guidelines’ admission, and requested a limiting instruction reminding the jury that the Guidelines did not set forth standards of care with regard to the diagnosis and treatment of plaintiff’s colon cancer.  The court agreed to give a limiting instruction, and informed the jury that the Guidelines ‘are being admitted as [they] relate to [defendant’s] position.  Ultimately, the determination as to whether [defendant] followed the accepted standards of care … is a fact that you will have to determine, all the evidence and the facts of the case as you determine them.’”  Id. at 503-04, 960 N.Y.S.2d 423, 424 (2013).  On Appeal, the First Department found reversible error in the limiting instruction, stating,  “The court erred in failing to give the instruction that plaintiff requested.  Although the trial court’s instruction informed the jury that it was to make its determination based on ‘all the evidence,’ this instruction was not sufficient to guide the jury on how to apply the Guidelines to the facts before it. The court’s instruction as rendered failed to make clear to the jury that the Guidelines were simply recommendations regarding treatment, and thus, that compliance with the Guidelines did not, in and of itself, constitute good and accepted medical practice.” Id.

Whether you are plaintiff or defense counsel, when the opposing party seeks to introduce medical guidelines or protocol for the purpose of demonstrating the physician’s evaluation process, it is imperative that a limiting instruction be demanded.  Furthermore, hearsay objections must be made if the guideline or protocol is being introduced for the truth of the matter it asserts, namely, where the guideline is introduced as stand-alone proof of the standard of care.