Arnold v. Lee, No. 6-154/05-0651 (Iowa App. 5/24/2006)
| Decision Date | 24 May 2006 |
| Docket Number | No. 6-154/05-0651,6-154/05-0651 |
| Parties | MARY ARNOLD and KENNETH ARNOLD, Plaintiff-Appellants, v. LARRY LEE, Defendant-Appellee. |
| Court | Iowa Court of Appeals |
Appeal from the Iowa District Court for Boone County, William Pattinson, Judge.
Mary Arnold appeals the district court's ruling denying her motion for a new trial. AFFIRMED.
Marc S. Harding, Des Moines, for appellant.
Sara J. Gayer, Constance Alt, and Tricia Hoffman-Simanek of Shuttleworth & Ingersoll, P.L.C. Cedar Rapids, for appellee.
Heard by Mahan, P.J., and Hecht and Eisenhauer, JJ.
Mary Arnold appeals the district court's ruling denying her motion for a new trial. She argues the district court erred when it refused to admit into evidence a packaging insert from a medical device used during her surgery. We affirm.
Arnold underwent laparotomy (stomach) surgery in October 2001. The surgery required general anesthesia. Larry Lee, a certified registered nurse anesthetist (CRNA), used an endotracheal tube to administer the anesthesia. An endotracheal tube is a tube that is inserted through the mouth and into the trachea. The tube is held in place by an inflated cuff, a small balloon on the exterior of the tube that is filled with air.
Arnold brought a medical malpractice suit against Lee alleging excessive pressure in the tube's cuff caused damage to her trachea. At trial, she sought to enter into evidence an insert from the tube's packaging. The insert is written by the tube's manufacturer. It contains various information and cautions about the tube and its use. The district court, however, refused to admit the insert. It concluded the written statement was hearsay.
At trial, several witnesses testified as to the use of the tube. The jury ultimately found for Lee. Arnold filed a motion for new trial, arguing the district court erred in not admitting the insert. Without a hearing, the district court denied her motion. Arnold appeals.
Generally, we review the district court's rulings on the admission of evidence for abuse of discretion. State v. Dullard, 668 N.W.2d 585, 589 (Iowa 2003). We review hearsay rulings, however, for errors at law.1 Id. Our supreme court has identified three reasons for the different treatment of hearsay evidence. First, hearsay evidence must be excluded unless it can be classified as an exception or exclusion under the hearsay rule or some other provision. Id. "Subject to the requirement of relevance, the district court has no discretion to deny the admission of hearsay if it falls within an exception, or to admit it in the absence of a provision providing for admission." State v. Newell, 710 N.W.2d 6, 18 (Iowa 2006). Second, whether a statement is hearsay is a legal question. Dullard, 668 N.W.2d at 589. Finally, hearsay evidence is presumed to be prejudicial. McElroy v. State, 637 N.W.2d 488, 493 (Iowa 2001).
However, "when the basis for admission of hearsay evidence is the expert opinion rule, which provides no hard and fast rule regarding admissibility, we will employ an abuse of discretion standard." Kurth v. Iowa Dep't. of Transp., 628 N.W.2d 1, 5 (Iowa 2001) (evaluating rules 5.703 and 5.705).
Arnold argues the district court erred when it refused to admit the manufacturer's packaging insert. We note from the outset that (1) Arnold concedes the insert is hearsay; (2) she could not establish an author or a publication date for the insert; and (3) she could not establish that a copy of the same insert came with the tube used in her surgery. Nonetheless, Arnold argues the insert is admissible under the learned treatise, residual, and expert exceptions to hearsay. See Iowa Rs. Evid. 5.703, 5.803(18), (24). She also argues the insert is admissible as evidence probative on Lee's standard of care. We review each of her claims below.
According to rule 5.803(18), a statement that qualifies as a learned treatise is considered an exception to the hearsay rule. Rule 5.803(18) reads as follows:
To the extent called to the attention of an expert witness upon cross-examination or relied upon by that witness in direct examination, statements contained in published treatises, periodicals, or pamphlets on a subject of history, medicine, or other science or art, established as a reliable authority by the testimony or admission of the witness or by other expert testimony or by judicial notice. If admitted, the statements may be read into evidence but may not be received as exhibits.
Under rule 5.803(18), a learned treatise may be admitted into evidence as long as it is shown to be reliable authority. The party may show the treatise is reliable through its own witness, on cross-examination of another party's witness, or through judicial notice. See Iowa R. Evid. 5.803 advisory committee notes. The treatise itself, however, may not be received into evidence. Instead, statements from the treatise may be read into the record. Ward v. Loomis Bros., Inc., 532 N.W.2d 807, 812 (Iowa Ct. App. 1995).
Arnold attempted to establish the requisite foundation through Lee and both parties' expert witnesses. Lee did not testify specifically about package inserts, but said that he read information from pharmaceutical and medical device manufacturing companies. He testified that he used their warnings and recommendations as guidelines. Dr. Mitchell Sosis, an anesthesiologist called by Arnold, testified on direct examination that the package inserts constitute a reliable, accurate authority. On cross-examination, however, he admitted that he could not find a publishing date and did not know the author of the particular insert used at trial. Further, when asked if he relied on the insert in his practice of anesthesia medicine, he testified,
A. Well, let me explain. Rely is not necessarily a word that I would use. I think it's a word with legal connotations probably you understand better than I do. I would say read it, find it interesting and useful, and I apply it to my practice.
Q. As a guideline? A. You might say that.
William Miller, a CNRA called by Lee, testified that he did not and would not rely on information that comes from a manufacturer. Finally, Dr. Mark Kline, an anesthesiologist called by Lee, testified about his use of information from manufacturers as follows:
Q. Would you consider the literature or the information put out by the company to be authoritative and reliable? A. I would hope it would not be unreliable, but to say that it's authoritative, it depends on who wrote it, how it was written, how it was reviewed. It may represent the company's own bias on how to use something, but not actually how it's used in the clinical practice.
Q. And in fact, isn't it oftentimes true that physicians, and for that matter, maybe CRNAs take things and use them in a way that's off-label or different than what it's been approved for use as. Have you heard of off-label usage? A. Yes. That is primarily applied for medication; the approval basis for it is completely different for medication. We, of course, use medications off-label all the time.
Q. Would you feel that it would be important to go ahead and use it as the manufacturer intended that these tubes be used? A. Well, I mean, we often have to modify the way we use something to meet the clinical situation. The manufacturer may give you some basic guidelines, but it doesn't really apply if you have a sick patient. So I don't think you can make that generalization.
Arnold also argues the insert is reliable and authoritative because the information it contains was approved by the Federal Drug Administration (FDA).
Iowa case law gives us little guidance in interpreting this rule of evidence. In reviewing other jurisdictions' case law regarding this particular question, we find that a slight majority do not allow the insert for the truth of the matters asserted within. See Garvey v. O'Donoghue, 530 A.2d 1141, 1144-46 (D.C. 1987) (); Zweig v. E.R. Squibb & Sons, Inc., 536 A.2d 1280, 1282 ( (); Whisenhunt v. Zammit, 358 S.E.2d 114, 428-29 (N.C. Ct. App. 1987) (); Spensieri v. Lasky, 723 N.E.2d 544, 547 (N.Y. 1999) (). But see Morlino v. Med. Ctr. Of Ocean Cty., 706 A.2d 721, 729-30 (N.J. 1998) (); Brambley v. McGrath, 788 A.2d 861, 864-67 (N.J. Super. Ct. App. Div. 2002) (same). Given the facts of this particular case, we find the rationale against admitting the insert under rule 5.803(18) to be most persuasive.
First, no expert at trial could say that he relied upon the package insert as an authoritative instruction in using the tube. Instead, Lee and two of the experts testified they would use the insert for its guidelines. Essentially, we understand their testimony to mean they would take the warnings and information contained in the insert into account when evaluating a patient, but that they might deviate from the manufacturer's recommendations if needed. Thus, we do not think any of the experts considered the information in the insert to be "authoritative" in the manner required by rule 5.803(18).
Second, we find Dr. Kline's testimony as to off-label use to be particularly persuasive. If we were to allow the package insert into evidence under rule 5.803(18), the jury would be allowed to consider the statements in the insert for the truth of what they assert: that there is only one way to use the tube. In an age where drugs are frequently used for purposes not approved by the FDA, we decline to set such a precedent. Therefore, we understand package inserts for pharmaceuticals and...
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