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Products Liability *Notable Recent Decisions: Clinical Guidelines, Res Ipsa Loquitur* By Michael Hoenig - New York Law Journal - June 13, 2006	Print article

In this column, we survey four recent decisions issued by New York courts. Because of the diversity of topics and space limitations here, we emphasize the pith and substance of the opinions and avoid extensive discussion of each.

Clinical Guidelines

In Hinlicky v. Dreyfuss,¹ a medical malpractice case against an internist, a surgeon and anesthesiologists, the claim focused on whether defendants were negligent in not obtaining a preoperative cardiac evaluation that the 71-year-old patient's heart could tolerate a carotid artery procedure to remove plaque buildup. Twenty-five days after the successful carotid surgery, the patient suffered a fatal heart attack.

The defendant anesthesiologist testified that, in evaluating the patient's need for preoperative cardiac testing, he incorporated into his practice and followed a set of clinical guidelines published in 1996 by the American Heart Association and American College of Cardiology. The witness testified without objection and identified as a proposed exhibit a "flow diagram" or "algorithm," from the guidelines that he and other physicians used to ascertain a patient's need for cardiac evaluation.

When defense counsel asked the witness for background on the guidelines, plaintiff's counsel objected on hearsay grounds to any testimony on what others have stated. But there was no further objection as the witness proceeded to explain how the guidelines were used in his practice. When the algorithm or flowchart was offered into evidence, plaintiff's counsel objected that it was a document taken from another document and constituted hearsay. The trial court allowed the algorithm under the "professional reliability" exception to the rule against hearsay, "as merely one link in the chain of which he relied upon to reach a conclusion."

Thereafter, six out of the seven medical experts presented by both sides clashed over the significance of the algorithm as the standard of care. The trial court mentioned the guidelines in its jury instructions when summarizing the parties' contentions. The Appellate Division affirmed because the algorithm was not admitted for its truth or to establish a per se standard of care. Rather, it was allowed for the nonhearsay purpose of illustrating a physician's decision-making methodology.

The Court of Appeals observed that scientific works generally are excluded as hearsay when offered for their truth. While the algorithm was an extrajudicial statement, it was not "classic" hearsay because it was not offered for its truth but, rather, as "a demonstrative aid for the jury in understanding the process [the anesthesiologist] had followed" in his practice.

Objection Required

Although there was some danger that jurors could draw unsupported inferences from demonstrative evidence excerpted from the guidelines and reproduced as an exhibit, the Court observed that plaintiff never requested a limiting instruction. The Court stressed that once the algorithm was admitted for the limited purpose, "[h]ad plaintiff been concerned that the purpose of admitting the algorithm was changing from demonstrative to substantive evidence, he surely could and should have said so."²

In referring to the "professional reliability exception" to the hearsay rule, readers should note the distinction between admissibility of expert opinion based on otherwise-inadmissible hearsay, as opposed to, admissibility of the out-of-court material (or a portion) itself. Up to now the reliability exception impacts the opinion evidence. It is unclear whether the hearsay itself can come in simply because the expert vouches for its reliability. In Hinlicky, the defendants urged the Court that the algorithm was admissible on "professional reliability exception" grounds.

The Court, however, did not decide the issue of admissibility of the algorithm under the professional reliability exception, as urged by defendants, because the trial court's proper purpose for admitting the algorithm was demonstrative and because plaintiff made no request for clarification or limiting instructions. The Court did note that whether evidence may become admissible "solely because of its use as a basis for expert testimony remains an open question in New York."³ The Court observed that, while some jurisdictions allow otherwise inadmissible materials relied on by an expert witness to reach the jury, in New York, the Court has "acknowledged the need for limits on admitting the basis of an expert's opinion to avoid providing a 'conduit for hearsay.'"⁴

Hinlicky confirms that treatment of hearsay materials relied on by experts is tricky business. Proponents of the hearsay need to navigate the twists and turns of the professional reliability exception. They may need to construct a purpose for the material other than offering it for the truth of the contents. Parties who would be opposed to experts' hearsay need to be vigilant, especially if the out-of-court materials are offered or come in for some purpose other than the truth of the outside information. The jury may give weight to the hearsay for its truth as opposed to the stated purpose for admission. Failure to timely object can poison one's position. Failure to ask for a limiting instruction also can be damaging. Moreover, the quality of the limiting instruction deserves counsel's attention. A short judicial message to jurors in "legalese" often will not do the job.

Res Ipsa

Res ipsa loquitur, an expression most familiar to law students, has current vitality in real-life situations. The doctrine allows an occasional plaintiff to prove defendant's negligence without direct evidence of what actually happened or what the defendant's specific act was. Rather, when applied, res ipsa loquitur allows a jury to consider the circumstantial evidence and infer that defendant was negligent in some unspecified way. The three established criteria required are: (1) the event must be of a kind that ordinarily does not occur in the absence of someone's negligence; (2) it must be caused by an agency or instrumentality within the exclusive control of the defendant; and (3) it must not have been due to voluntary action or contribution on the part of the plaintiff.

Over the years, there has been some ferment over whether the doctrine creates a "presumption" or an "inference" of negligence. Another somewhat unsettled question was whether res ipsa may never be used to justify a summary judgment or directed verdict for the plaintiff. These questions were addressed recently by the New York Court of Appeals in Morejon v. Rais Construction Co.,⁵ a case in which a delivery man was injured when a roll of roofing material fell from the roof of a residence where construction was under way. The Court addressed some of the historical development of res ipsa and set forth the "dazzling array of formulations" that have been used to describe the evidentiary effect. The Court decided to adhere to its jurisprudence which denominates res ipsa loquitur as creating an inference of negligence.

Though it has taken on its own mystique, res ipsa is "nothing more than a brand of circumstantial evidence. Viewed in that light, the summary judgment (or directed verdict) issue may also be properly approached by simply evaluating the circumstantial evidence."⁶ Thus, said the Court, if the evidence presents a question of fact as to defendant's liability, the case should go to trial. If the circumstantial evidence does not reach this level, the defendant will prevail on the law. Alternatively, in the exceptional case, plaintiff should win summary judgment or a directed verdict if it is a case in which no facts are left for determination.

Discovery War

In Mann v. Cooper Tire Co.,⁷ a products liability claim alleging that a defective tire caused a fatal accident in Canada, the Appellate Division, First Department, zealously examined certain trial court discovery rulings. Plaintiff, dissatisfied with defendant's responses to interrogatories, moved to compel disclosure. Defendant cross-moved for a protective order. The trial court ordered the defendant tire manufacturer to provide "more adequate responses." The court further ordered defendant to provide, subject to a protective order, the ingredients of its tire formula (though not the amounts or order in which they were used). Additionally, the trial court limited the scope of disclosure to tires with the "same green tire specifications" and limited the time frame regarding post-manufacture records to the period from the manufacture date of the subject tire until the date of the accident.

Defendant moved to reargue asserting that its tire formula and ingredients were trade secrets not subject to disclosure. The trial court agreed and rescinded its order, holding instead that the tire formula and curing process were trade secrets and thus not discoverable. The court further ordered that the remainder of the disclosure be subject to a confidentiality agreement drafted by the defendant to the extent that the plaintiff sought "technical data, research, materials, and documents that provide insight as to the inner workings of the company." The relevant time frames were reinstated except that pre-manufacture discovery was limited to a period of two years.

On appeal, plaintiff complained that disclosure had been narrowed to an absurdity, that the confidentiality order was crippling and draconian, and that the disclosure was curtailed in a manner allowing defendants to conceal any relevant documents. Armed with records of litigations elsewhere, plaintiff argued that defendant had been criticized by other courts for its disclosure practices. Some of these arguments found a sympathetic ear.

The First Department, reviewing the record, evaluating the competing interests and citing New York's liberal disclosure standards, held that the motion court misapplied the law and exercised its discretion improvidently. First, the Appellate Division tackled the trade secrets issue. The court observed that the discovery order called for production of the ingredients, not the formula itself. Nevertheless, even if the ingredients were deemed a trade secret, the First Department panel found error in the ruling that they were not discoverable. In New York, when trade secrets are sought in discovery, the objectant has the burden to establish that the information sought is a trade secret. When that burden is met, the party seeking disclosure must show that the information appears to be indispensable and cannot be acquired in any other way.⁸

The appellate panel found there is a distinction between the formula and the ingredients. Moreover, said the court, "we are not persuaded that either the ingredients or the formula of the subject tire deserve trade secret protection in this case." Defendant did not meet its burden to show that the ingredients are a trade secret. The court was not persuaded by the conclusory assertions to that effect in an affidavit by defendant's in-house forensic tire expert. Thus, defendant was ordered by the First Department "to make disclosure forthwith" of the requested information and documents. The court also rejected the limitation of disclosure only to tires with the same green tire specification or to a severe limit on the time frame of pre-manufacture disclosure. Finally, the court found the protective order to be "draconian" and specified a slew of topics that were not proper subjects of a protective or confidentiality order.

'Gatekeeping' Experts

In our April 2005 column we reported on the Appellate Division, Second Department's decision in Parker v. Mobil Oil Corp.,⁹ which applied the Frye "gatekeeping" standard to dismiss a complaint alleging a worker contracted a form of leukemia from exposure to benzene as an ingredient found in gasoline.¹⁰ The plaintiff's experts' opinions fell short in Parker because they failed to employ an accepted methodology that incorporated the need to provide the level of plaintiff's exposure to the toxic agent and the dose-response relationship between the benzene and the disease. The Court of Appeals has granted review in Parker but oral argument is not expected until September.

In the meantime, gatekeeping of experts under Frye continues to generate a whirlwind. Hot off the press is the Appellate Division, First Department's decision in Nonnon v. City of New York,¹¹ published on June 6. The panel split 3-2 issuing bristling majority and dissenting opinions. The question in Nonnon concerned plaintiffs who alleged that they were being systematically poisoned by environmental contaminants in and around a now-inactive 81-acre landfill owned by the city and operated by the Sanitation Department for some 16 years until 1979. The city moved to dismiss for, among other things, plaintiffs' failure to allege a viable causal connection between the landfill and 13 plaintiffs' cancers.

The panel majority held that reports and findings by plaintiffs' expert epidemiologists and toxicologists satisfied the Frye standard. To hold otherwise, would deny redress to plaintiffs. The majority reasoned that the deductions of these experts and their methodologies were not the type of "novel science" implicating Frye concerns. The majority also declared Parker's holding inapplicable "because no scientist could make an accurate measurement of the doses of the combined carcinogens to which these plaintiffs were exposed."¹²

A vigorous dissenting opinion systematically discusses how the toxicological and epidemiological experts "failed to use generally accepted scientific methodology" to prove causation as to most of the plaintiffs. The expert opinions lacked a proper foundation and were therefore inadmissible as evidence. The question was not whether toxicology and epidemiology are novel sciences, but whether the opinions as to a causal connection between plaintiffs' exposure to hazardous materials and the diseases alleged were based on generally accepted techniques within their disciplines.

Parker was considered by the dissenters to be a case directly in point. Application here of the accepted methodology recognized in Parker showed that the opinions on causation in Nonnon were "purely speculative" and "fuzzy science at its worst." Clearly, the Court of Appeals' decision in Parker later this year will be a significant gatekeeping development.

Michael Hoenig is a member of Herzfeld & Rubin.

Endnotes:
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[1]. 2006 NY Slip Op 03444 (NY Ct. App. May 2, 2006). For an evaluation as to how the Hinlicky decision affects medical malpractice litigation, see, T.A. Moore and M. Gaier, "Admissibility of Published Standards of Care," New York Law Journal, June 6, 2006, p. 3.
[2]. Id. at p. 8 (Slip Op).
[3]. Id. at p. 9 (Slip Op) (citing People v. Goldstein, 6 NY 3d 119, 126-127 (2005)).
[4]. Id. at p. 9. See M. Hoenig, "'Conduit Hearsay': A Minefield for Lawyers," NYLJ, March 13, 2006, p. 3.
[5]. 2006 NY Slip Op 03619 (NY Ct. App. May 9, 2006).
[6]. Id. at p. 5 (Slip Op).
[7]. 2006 NY Slip Op 04335 (App. Div., 1st Dept., June 1, 2006).
[8]. Id. at p. 6 (Slip Op).
[9]. 16 AD 3d 648 (2d Dept.), leave granted, 6 NY3d 702 (2005).
[10]. M. Hoenig, "'Gatekeeping' Experts: 'Daubert' Boils and 'Frye' Sizzles," NYLJ, April 11, 2005, p. 3.
[11]. 2006 NY Slip Op 04373 (App. Div. 1st Dept., June 6, 2006).
[12]. Id. at p. 12 (Slip Op).