695 NYS2d 259 | N.Y. Sup. Ct. | 1999
Motion (No. 847) of defendant Lederle Laboratories, Division of American Cyanamid Company (Lederle) and the cross motion (No. 2631) of the plaintiff for summary judgment are both denied.
Plaintiffs complaint
“A characteristic of live Sabin polio vaccines such as Orimune is that not only is the vaccine’s recipient immunized from polio, but unimmunized persons who come into close contact with the recipient also are immunized through a shed virus which spreads from the recipient to the ‘contact.’
“A risk-free alternative to inoculation with the live Sabin vaccine is the Salk vaccine in which the virus is killed so that the recipient cannot contract polio nor can the recipient shed a live virus to unimmunized contacts.”
Plaintiff is the father of Diana, born on December 16, 1978. Diana’s pediatrician was the codefendant doctor, Leroy L. Schwartz (now deceased). Dr. Schwartz administered three doses of Orimune to Diana: one in March 1979, a second in May 1979, and the third in July 1979. Plaintiff was diagnosed
Defendant Lederle has moved for summary judgment claiming it is not liable for plaintiffs condition because Lederle provided adequate warnings on its package insert at the time in question (Martin v Hacker, 83 NY2d 1 [1993]). Plaintiff cross-moves for summary judgment, seeking a court determination that the insert provided by Lederle was inadequate.
The 1975 package insert for Orimune, under the heading “Adverse Reactions”, reads:
“Expert opinion is in agreement that the administration of live oral polio virus vaccines is generally an effective and safe method of protecting populations against the natural disease. Paralytic disease following the ingestion of live polio virus vaccines has been reported in individuals receiving the vaccine, and in some instances, in persons who were in close contact with subjects who had been given live oral polio virus vaccine.
“The rare occurrence of ‘vaccine related cases’ were considered ‘compatible’ with vaccine induced disease where certain epidemiological criteria including certain incubation, clinical and laboratory values, could be judged compatible with vaccine as a cause. It has been estimated that the risk of vaccine induced paralytic poliomyelitis is about one chance per million doses.
“The estimated risk of vaccine-induced paralytic disease occurring in vaccines or those in close contact with vaccines is extremely low. However, the ‘risk’ should be considered by the physician and such information should be conveyed to the parent(s) at the time of vaccination. Those parents of a vaccíneo who have not had previous polio vaccination should probably be considered among those adults as subject to increased risk of exposure and in this special situation, in the judgment of the physician responsible, protection may be needed for these intimate contacts.”
This case has a lengthy history in the courts. In 1992, codefendant Schwartz was granted summary judgment dismissing plaintiffs’ complaint as against him. This decision was affirmed by the Appellate Division (Tenuto v Lederle Labs., 207 AD2d 541) and thereafter reversed by the Court of Appeals (90 NY2d 606, 614) which found that the “[p]laintiffs f[e] 11 within a determinate and identified class — immediate family members— whose relationships to the person acted upon [plaintiffs’ infant
Schwartz also sought summary judgment against Lederle on its cross claim against him for indemnity and contribution. This motion was denied by the Supreme Court but reversed by the Appellate Division (Tenuto v Lederle Labs., 234 AD2d 284, 285-286) which dismissed Lederle’s cross claims, holding: “The learned intermediar/ doctrine provides that a manufacturer’s duty is to warn the physician of risks posed by its products. The physician, in turn, has a duty ‘to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects’ (Martin v Hacker, 83 NY2d 1, 9). Contrary to the defendant Lederle’s contention, the ‘learned intermediary’ doctrine did not impose a duty on the physician to inform these plaintiffs, who were not his patients, of the warnings contained in the package insert provided by Lederle (see, Wolfgruber v Upjohn, 72 AD2d 59, affd 52 NY2d 768; Eiser v Feldman, 123 AD2d 583). Accordingly, Lederle’s cross claim against the defendant Schwartz is without merit as a matter of law.”
As noted above, plaintiff’s claim against Schwartz was reinstated by the Court of Appeals; however, Lederle never appealed the dismissal of its cross claim against Schwartz (Tenuto v Lederle Labs., 90 NY2d 606, 609, supra).
New York generally follows the guidelines set forth in the Restatement with respect to products liability (see, e.g., Eiser v Feldman, supra; McFadden v Haritatos, 86 AD2d 761; Farina v Niagara Mohawk Power Corp., 81 AD2d 700; Wolfgruber v Upjohn Co., supra; Baker v St. Agnes Hosp., 70 AD2d 400). The new Restatement (Third) of Torts — Products Liability sets forth a separate section specifying the standard of liability for prescription drugs such as the one at issue here. Section 6 provides that
“[flor purposes of liability * * * a prescription drug * * * is defective if at the time of sale or other distribution the drug * * *
“is not reasonably safe due to inadequate instructions or warnings”. (Restatement [Third] of Torts — Products Liability §6 [b] [3].)
Regarding this new section 6, an article by the Food and Drug Institute provides: “As a practical matter under this standard, manufacturers should be able to present all the facts and circumstances surrounding the selection or omission of each particular warning. The test turns on whether the defendant acted as a reasonably prudent manufacturer would have acted in similar circumstances. Moreover, the new test plainly provides that no liability results for unknown and unknowable risks — the standard already followed by many jurisdictions.” (Wagner and Peterson, The New Restatement [Third] of Torts— Shelter From the Product Liability Storm for Pharmaceutical Companies and Device Manufacturers?, 53 Food & Drug LJ 225, 234-235.) The Food and Drug Institute’s article cites to case law of various jurisdictions, including New York’s Martin v Hacker (83 NY2d 1, supra), which clarified New York law with respect to warnings for prescription drugs. Martin v Hacker (supra, at 8, 10) states that “[t]he manufacturer’s duty is to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist”, and that such warnings “may be held adequate as a matter of law.” However, except in cases where the most unusual circumstances exist, the adequacy of drug warnings is a question of fact (see, Ramirez v Wyeth Labs., 179 Misc 2d 764 [Sup Ct, NY County, Sklar, J.], citing Morrow v Mackler Prods., 240 AD2d 175, 176).
In Martin v Hacker (supra, at 10) the Court of Appeals set forth the factors to be used in analyzing the adequacy of drug warnings. The Court said: ‘Whether a given warning is legally adequate or presents a factual question for resolution by a jury requires a careful analysis of the warning’s language. The court must examine not only the meaning and informational content of the language but also its form and manner of expression. Always bearing in mind that the warning is to be read and understood by physicians, not laypersons”.
According to the Court of Appeals this analysis should start with ascertaining the seriousness of the involved risk, which depends on the consequences of the side effects. After establish
As a general rule, courts agree that the duty of a drug producer or drug seller to warn of a particular risk only attaches at the time that such party knew, or should have known, of the risk in question (see, Prosser and Keeton, Torts § 96, at 688 [5th ed], citing, inter alia, Reyes v Wyeth Labs., 498 F2d 1264, supra). In any given case, whether the drug producer or drug seller provides “updated information as to all of the drug’s known side effects” (Martin v Hacker, supra, at 11) within an acceptable time frame is an issue that must be determined. In Baker v St. Agnes Hosp. (70 AD2d 400, 402, supra) the Court spoke of the availability of such information “at the time the instant cause of action arose.” Other cases also speak of the information available at the time that the drug was used (see, e.g., Donigi v American Cyanamid Co., 57 AD2d 760 [“whether in 1958 (the time of use) the defendant knew or should have known that its product caused permanent teeth staining in children”]; Ezagui v Dow Chem. Corp., 598 F2d 727, 733 [2d Cir 1979] [“(t)he knowledge of risk available to (the defendant) in 1960 (the time of use)”]). One commentator noted: “A time continuum is emphasized in duty to warn cases. Courts attempt to determine at what point sufficient knowledge was present, thereby creating the duty.” (Note, The Liability of Pharmaceutical Manufacturers for Unforeseen Adverse Drug Reactions, 48 Fordham L Rev 735, 749, n 101 [1980], citing, inter alia, Basko v Sterling Drug, 416 F2d 417 [2d Cir 1969].) The Basko court (supra, at 426) stated: “Dates are thus vitally important, since the duty to warn depends on when the risk became apparent.” Thus, two dates are critical here — the date the vaccine was administered, and the date that certain risks associated with the vaccine became apparent. Here, the date the vaccine was administered, March, May and July of 1979, is not at issue. What is at issue is the date or time period that the risks associated with the vaccine became apparent and whether the information provided with the vaccine plaintiffs daughter received adequately warned of those known risks.
In determining that date or time period, a brief review of some past polio cases is in order. In 1972 a Florida mother
In 1975 a Kansas father contracted polio after his infant daughter had been administered Orimune (Johnson v American Cyanamid Co., 239 Kan 279, 718 P2d 1318). Johnson’s deposition testimony indicated that he had assisted in the administration of the oral polio vaccine. Johnson steadied the infant by placing his hand under her jaw. Some of the vaccine ran out of the infant’s mouth onto an open cut on Johnson’s hand which, he believed, occurred earlier in the morning while he was fixing a barbed wire fence on his farm.
The Supreme Court of Kansas concluded that the trial court had erred in denying the defendant’s motion for a directed verdict. The dissenting Judge, however, emphasized “that the warning [the same 1975 insert warning at issue here] * * * did not in any way convey to [the doctor] the fact that there was a reasonably available alternative product and the reasonable risks posed by such alternative product.” (Johnson v Amer
In 1974 a Michigan mother developed polio after her infant daughter was administered the Sabin oral polio vaccine manufactured by Lederle (Dunn v Lederle Labs., 121 Mich App 73, 328 NW2d 576, 578). “Lederle admitted at trial that it knew of contact polio as early as 1966” but the Michigan Court of Appeals found that Lederle had no duty to warn how to avoid the dangers of contact polio. (Supra, 121 Mich App, at 76, 328 NW2d, at 578.) The Dunn court stated (supra, 121 Mich App, at 81, 328 NW2d, at 580) that “[a] danger is often avoided simply by refusing to use the dangerous product” but that “this option was not available to the plaintiff, her daughter, or her doctor” (apparently Michigan law mandated vaccination with the Sabin oral vaccine). The Dunn court held: “Considering the slight risk of contact polio[
The October 7, 1977 Centers for Disease Control’s Morbidity and Mortality Weekly Report noted: “Although the risk of vaccine-associated paralysis is extremely small for vaccines and their susceptible family and other close personal contacts, they should be informed of this risk. When the attenuated vaccine strains are to be introduced into a household with adults who have never been vaccinated, some physicians may choose to give these adults at least 2 doses of IPV a month apart, if not the full primary series, before the children receive TOPV (Trivalent Oral Polio Vaccine).”
In 1993, the New York Court of Appeals in Martin v Hacker (83 NY2d, supra, at 11) reinforced prior holdings that a drug warning “must convey updated information” and cited, with approval, Baker v St. Agnes Hosp. (70 AD2d, supra, at 406)
From October of 1977, when Lederle knew of the Federal Government’s recommendations regarding vaccination of adults who may be in close contact of children receiving Orimune, until the 1979 Orimune package insert, there is no indication that Lederle took any steps “to bring that knowledge to the attention of the medical profession.” (Baker v St. Agnes Hosp., supra, at 406.) Plaintiff also points to other documentary evidence (see, e.g., Nightingale, Recommendations for a National Policy on Poliomyelitis Vaccination, 297 [No. 5] New Eng J Med 249 [Aug. 4, 1977]) which highlights the risk of close contacts contracting paralytic polio; yet defendant did not promptly revise its package insert or take other steps to indicate that IPV should be offered to close contacts to reduce the risk of contracting contact polio. Clearly this information was available at the time plaintiffs daughter was vaccinated.
According to Martin v Hacker (supra, at 9), prescription drug warnings are intended for the physician having “the least knowledge and experience with the drug” who is going to use these warnings to “balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects.” Under the circumstances of this case, this court finds that Lederle’s failure to include the available information about IPV precautions with respect to the steps a physician could take to avoid the risk of contact polio raises issue of fact as to whether Lederle provided reasonable
“instructions or warnings * * * to * * *
Moreover, plaintiff raises an issue of fact as to whether the warning Lederle did provide in the 1975 package insert met the standard of “accuracy, clarity and relative consistency” set out in Martin v Hacker (supra, at 11). Plaintiff notes, for example, Lederle’s use of quotation marks around the word “risk” in the package insert at issue, which arguably “dilutes the intensity of [the] caveat” (Martin v Hacker, supra, at 11).
In order to obtain summary judgment, a movant must establish its defense or cause of action sufficiently to warrant a court’s directing judgment in its favor as a matter of law (see, e.g., Zuckerman v City of New York, 49 NY2d 557, 562; Friends of Animals v Associated Fur Mfrs., 46 NY2d 1065, 1067-1068). There are issues of fact as to the adequacy of the 1975 package insert for Orimune which cannot be resolved upon the papers now before the court. The existence of such factual issues precludes summary judgment (see, e.g., Vigio v New York Hosp., 228 AD2d 278; Mendolia v Saad, 201 AD2d 710). The focus of the court on a summary judgment motion is issue finding, not issue determination (see, e.g., Amatulli v Dehli Constr. Corp., 77 NY2d 525, 532).
Accordingly, it is ordered that the defendant’s motion (No. 847) and the plaintiffs cross motion (No. 2631) for summary judgment are both denied.
. The complaint originally contained a loss of consortium claim on behalf of plaintiffs then wife which was discontinued pursuant to a January 7, 1998 stipulation which was “So Ordered” by this court.
. An attenuated polio virus is one which laboratory processes have rendered incapable of producing disease (to the extent of attenuation), but which retains sufficient strength to cause the production of antibodies to resist and destroy an attacking wild or virulent polio virus in the vaccinee’s alimentary tract. (See, Reyes v Wyeth Labs., supra, at 1296, appendix B.)
. Testimony at trial indicated that the incidence of contact polio was between one in five million (the rate for all vaccine-related polio cases) and one in 10 million.
. Looking to California law, the Second Circuit determined that in the absence of any applicable California precedent on the issue, “the California Supreme Court would not expand a manufacturer’s duty and require that specified precautions be stated, especially where the warnings are being directed to a ‘learned intermediary’ such as a doctor. In short, judgment notwithstanding the verdict should have been directed since there is no duty under California law to specify precautions in the prescription drug context.” (Plummer v Lederle Labs., supra, at 358.)