Chapter 15 Utilization of Industry Standards in New York Products Liability Litigation

• Jurisdiction: New York

CHAPTER FIFTEEN UTILIZATION OF INDUSTRY STANDARDS IN NEW YORK PRODUCTS LIABILITY LITIGATION E. Stewart Jones, Jr., Esq.
Joseph C. LaValley III, Esq.*

I. SCOPE OF “INDUSTRY STANDARDS”

Products liability cases involve a manufacturer or seller of an item, or one of its component parts, defending an action brought by a buyer, user or bystander under a negligence, strict liability or breach-of-warranty cause of action, or some combination of same. Identifying the industry standards relevant to the product that is the subject of the action is a practical problem in any products liability case. Industry standards are developed by the United States or state agencies (i.e., “government standards”); private sources such as scientific and professional societies (e.g., American Society of Mechanical Engineers (ASME), whose standards are processed through the American National Standards Institute (ANSI)); trade associations (e.g., Association of Home Appliance Manufacturers); and standards developing and testing organizations (SDOS) such as the American Society for Testing and Materials (ASTM) or Underwriters Laboratories (UL)

Experts with industry, academic and/or government backgrounds are likely to know the sources of standards for the manufacture of the product or component part at issue. An attorney familiar with computer and manual research may supplement his or her expert’s efforts to locate applicable standards. Standards for products produced outside the United States may be available from international organizations and/or sources within the country(ies) where the products or component parts at issue are produced ²⁸³⁷

II. PUTTING STANDARDS INTO EVIDENCE

A. Admissibility (Hearsay and Judicial Notice)

Applicable standards in products liability cases are usually not authored by witnesses. Therefore, as out-of-court statements offered to prove the truth of the matter asserted therein, the introduction of standards can be challenged as inadmissible hearsay. Nevertheless, standards can usually be introduced into evidence under one of the exceptions of the hearsay rule

Judicial notice of common law, federal and state statutes, municipal and county codes, rules and regulations is authorized by the N.Y. Civil Practice Law and Rules 4511 (CPLR) and Federal Rules of Evidence 201 (FRE). Judicial notice allows the principle, statute, regulation or fact to be included in a judge’s findings or as part of the judge’s jury instructions. In addition to statutes, regulations and treatises, federal district courts can judicially notice facts that are widely and generally known ²⁸³⁸

New York trial and appellate courts have sua sponte taken judicial notice of safety standards in municipal administrative codes. In Howard Stores Corp. v. Pope ²⁸³⁹ the Court of Appeals took judicial notice of provisions in the New York City Administrative Code, which required that warning labels be put on every container of combustible materials sold in New York City. Although the complaint did not contain any reference to the Administrative Code provisions, the appellants’ brief to the Court of Appeals did. In finding that the complaint of tenant and owners of a building damaged in a fire should not have been dismissed upon a motion by the vendor of the dangerous and unlabeled floor-finishing material, the Court of Appeals held that it could take judicial notice of the Administrative Code labeling requirements for combustible materials “as a public statute although it is not alleged in the complaint.” ²⁸⁴⁰

In Rothstein v. City University of New York, ²⁸⁴¹ the Second Department took judicial notice of the New York City Building Code (part of the Administrative Code), which requires that each step in an aisle in a place of assembly be clearly marked with a permanent contrasting color stripe and a step light. Here, the City University was the defendant in a damages suit for injuries suffered by a person who fell down the steps while attending a performance at the Walt Whitman Theater at Brooklyn College.

The Rothstein plaintiffs did not mention any statute, ordinance, rule or regulation in their claim or bill of particulars, although they reserved the right to do so. The trial court took judicial notice of the tape and light requirement in the N.Y.C. Building Code and found the defendant 80 percent at fault for not following that standard. The Second Department found that the trial court had acted properly in taking judicial notice of the tape and light requirement, which “created an additional theory of liability in the case” but added “no new facts” and, therefore, “did not significantly prejudice the defendant by denying it a full and fair opportunity to defend.” The Second Department held that CPLR 4511(b) expressly authorizes the court, in its discretion, to take judicial notice of a regulation. ²⁸⁴²

In addition to the judicial notice provision in CPLR 4511, other CPLR sections authorize the introduction of standards into evidence, notwithstanding their hearsay nature: the business records exception in CPLR 4518; certification of the lack of a public record, covered in CPLR 4521; and a public officer’s certificate of a fact ascertained or an act performed by him, set forth in CPLR 4520. Section 4515 of the CPLR authorizes an expert to give an opinion without being asked a hypothetical question and to state “reasons [for the opinion] without first specifying the data upon which it is based.” If a standard is the basis for the expert’s opinion, it would be admissible under CPLR 4515; if the standard is part of an official United States or state record, it is admissible under CPLR 4540.

Federal statutes providing for certification of official records kept within the United States or any state, district, commonwealth or territory, such as Federal Rules of Civil Procedure 44 (FRCP), can be used to qualify standards for admission into evidence. Rule 901(b)(7) of the FRE, which provides for self-authentication of domestic federal and state public documents, can also be used to qualify a standard for admission.

Federal exceptions to the hearsay rule are FRE 803(6)–(8), covering records of regularly conducted activity and public records and documents; FRE 803(18), authorizing the reading into evidence of a treatise, periodical or pamphlet “on a subject of history, medicine, or other science or art” recognized by an expert as reliable authority; and FRE 702–704, allowing expert testimony on facts and data that are not admissible in evidence, provided such facts or data are information of the type upon which experts rely. Rules 702 through 704 may also allow the introduction of industry standards into evidence, notwithstanding the hearsay rule.

Rule 803(18) of the FRE allows safety codes and standards to be introduced into evidence if they are (1) prepared by an organization formed for the chief purpose of promoting safety or (2) published by the government, even if they do not have the force and effect of law. ²⁸⁴³ Under Apicella v. McNeil Laboratories, Inc., ²⁸⁴⁴ material admitted under FRE 803(18) can be utilized as evidence-in-chief, and not just for impeachment purposes.

Federal statutes such as 28 U.S.C. § 1732, which authorizes admission of routine records by governmental agencies, and 28 U.S.C. § 1773, which authorizes admission of a certified copy of a public record, may also provide authority for admission of a standard into evidence.

The hearsay rule and the court’s view of the reasons pharmaceutical companies publish drug product information in the Physician’s Desk Reference (PDR) prevented a plaintiff from introducing the PDR, by itself, into evidence to establish the standard of care for a doctor in prescribing and monitoring a drug. In Spensieri v. Lasky, ²⁸⁴⁵ the plaintiff, a 29-year-old female, suffered a severe stroke rendering her quadriplegic and unable to speak following her taking estrogen prescribed by a physician to control her irregular menstrual bleeding. She sought to use drug information excerpts from the PDR to prove that a physician’s standard of care requires not prescribing an oral contraceptive with a higher estrogen content which may increase the risk of thromboembolic disease. The Court of Appeals affirmed the Appellate Division’s affirmance of a jury verdict for the defendant and the trial court’s denial of a new trial.

In so doing, the Court of Appeals rejected the “Mulder rule,” established by the Minnesota Supreme Court in Mulder v. Parke Davis & Co., ²⁸⁴⁶ which states that the PDR is prima facie evidence of a physician’s standard of care. Although the Mulder rule was adopted by the Second Department in Gatto v. Cooper ²⁸⁴⁷ and Paul v. Boschenstein, ²⁸⁴⁸ and by the Third Department in Armstrong v. State, ²⁸⁴⁹ the Court of Appeals expressly declined to adopt that rule in Spensieri. The Court reasoned that the PDR warnings are hearsay statements published by pharmaceutical companies to comport with federal Food & Drug Administration (FDA) regulations, to serve advertising needs, to provide necessary information to doctors and to limit the companies’ liability, whereas, the standard of care for a physician is established by the medical profession itself. The testimony of an expert is necessary to interpret whether the drug in question presented an unacceptable risk for the patient in either its administration or the monitoring of its use.

The holding in Spensieri is significant as it established for the first time under New York law that the PDR, by itself, is hearsay and, therefore, insufficient to establish a standard of care. ²⁸⁵⁰ Although Spensieri is a medical malpractice case rather than a product liability case, its analysis concerning the admissibility of standards adopted by a product manufacturer as evidence of a standard of care, to be applied in a litigated matter, is relevant in product liability cases

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