Plaintiff has not submitted a single medical finding or opinion that the symptoms she experienced on October 9, 1989 and thereafter were caused by Ecotrin. Indeed she testified in her deposition that no physician has said with a reasonable degree of medical certainty that Ecotrin caused any of her physical ailments. She has evidently not participated in any elimination diet or other procedure to determine the cause of her alleged allergy.
The evidence shows only that plaintiff reported to a doctor that she might have suffered an allergic reaction to Yellow No. 6, or another ingredient in Ecotrin. As stated in Dr. Karol's June 4, 1990 letter "patient experienced an acute allergic reaction that might have been triggered by Ecotrin. . . . The patient was advised to avoid yellow dye, if the latter might have contributed to her acute allergic reaction last October." (emphasis added).
Defendant on the other hand submits credible affidavit evidence that Yellow No. 6 did not cause plaintiff's medical problems.
Defendant's immunology expert, a Dr. Ronald Simon, describes clinical tests he has conducted since 1986 on human sensitivity to Yellow No. 6 and says, "to a reasonable degree of medical certainty there is no medical evidence of any human sensitivity reactions to FD&C Yellow No. 6."
Defendant's toxicology expert, a Dr. Joseph Borzelleca, says that on the basis of his studies, and plaintiff's weight, "to a reasonable degree of medical certainty . . . there would be no adverse effects of ingesting the amount of Yellow No. 6 that would be present in the 12 Ecotrin caplets that plaintiff here consumed over a twelve day period."
Plaintiff has shown no genuine issue of fact as to whether Ecotrin caused plaintiff's medical problems. Absent a showing that Ecotrin caused her injuries, plaintiff cannot recover. See Schimmenti v. Ply Gem Industries, Inc., 156 A.D.2d 658, 549 N.Y.S.2d 152, 154 (2d Dep't 1989).
In any event, even if plaintiff could prove that she experienced an adverse reaction to Ecotrin, she could not recover unless the defendant knew or should have known that "the product contains an ingredient 'to which a substantial number of the population are allergic.'" Kaempfe v. Lehn and Fink Products Corp., 21 A.D.2d 197, 249 N.Y.S.2d 840, 845 (1st Dep't 1964), aff'd, 20 N.Y.2d 818, 284 N.Y.S.2d 708, 231 N.E.2d 294 (1967). See also Young v. United States, 542 F. Supp. 1306, 1311 (S.D.N.Y. 1982) (citing Kaempfe); cf. Holmes v. Grumman Allied Industries, 103 A.D.2d 909, 478 N.Y.S.2d 143, 145 (3d Dep't 1984) (holding Kaempfe inapplicable because defendant with actual or constructive notice "of unreasonable danger to users may [have] a duty of warning"). Plaintiff has made no such showing. Of the number of complaints about Ecotrin, minuscule in relation to the amount of the product sold, none resulted in a lawsuit for injuries. Under the circumstances the defendant had no duty to warn as to the possibility of injuries it could not foresee.
While plaintiff says that Yellow No. 6 is a known allergen and that the Ecotrin she consumed was defective, the evidence does not support this.
Plaintiff submits one medical article describing a physician who conducted blind tests on himself and concluded that Yellow No. 6 caused him severe abdominal cramps. He experienced a reaction after four days of taking two pills per day containing 8 mg. each of the Yellow No. 6 and in a second test after consuming two 8 mg. pills in one day. The subject's prior allergic attacks, which he attributed to Yellow No. 6, cleared after two days on a clear liquid diet.
Defendant's immunology expert Dr. Simon notes that the pills consumed by the subject contained 300 times the amount of Yellow No. 6 contained in each Ecotrin tablet. Dr. Simon also challenges the scientific accuracy of a study conducted by a general practitioner on himself as the sole subject and principal author of the study.
Plaintiff submits a communication from the Swedish Institute that Yellow No. 6 has been banned in Sweden because of its "toxic characteristics . . . [that] can result in allergies and even cancer." Plaintiff also submits a letter from the Norwegian Information Service stating that Norway has banned Yellow No. 6 in pharmaceuticals since 1979. According to Dr. Simon, Norway and Sweden have banned all color additives, not just Yellow No. 6, since 1979.
Plaintiff asserts that Ecotrin was defective for the following reasons: (1) Ecotrin was misbranded under 21 U.S.C. § 352(a), (2) defendant failed to file a New Drug Application for Ecotrin, (3) the lot number of the Ecotrin she consumed was preceded by an "X" indicating it was contaminated, (4) a spectrophotometer at defendant's Philadelphia plant was not calibrated every six-months between 1987 and 1989, as required, and (5) the Yellow Dye Nos. 6 & 10 used in Ecotrin were not certified as required by 21 U.S.C. § 376(a)(1)(B)(1).
A failure to warn may constitute a violation of 21 U.S.C. § 352(a), which states that a product whose "label is false and misleading in any particular" shall be deemed misbranded. Ezagui v. Dow Chemical Corp., 598 F.2d 727 (2d Cir. 1979). But plaintiff has not shown that the description "safety-coated aspirin" on Ecotrin's label constituted an actionable failure to warn. See Kaempfe, 249 N.Y.S.2d at 848 (defendant not negligent in labelling its deodorant "safe for normal skin" absent showing that significant number of consumers experienced allergic reaction).
In response to plaintiff's second, third and fourth assertions of a defect, defendant submits an affidavit from a Charles Muller, its Director of Quality control. He swears to the following. First, that defendant was not required to file a New Drug Application for Ecotrin because it complies with the United States Pharmacopeia, which governs the formulation of over-the-counter drugs. Second, that a spectrophotometer is not used in the production of Ecotrin. Third, that the lot number of the Ecotrin plaintiff consumed contained an "X" because it was batch of "caplets," a relatively new form of Ecotrin. All batches of caplets produced at that time were labelled with "X" lot numbers. Plaintiff submits no evidence to contradict the affidavit.
Defendant has submitted copies of FDA certification of the batch of Yellow No. 6 used in the batch of Ecotrin consumed by plaintiff.
Because there is no genuine issue of material fact, defendant's motion for summary judgment is granted.
Dated: Brooklyn, New York
April 7, 1993
Eugene H. Nickerson, U.S.D.J.
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