Lukaszewicz v. Ortho Pharmaceutical Corp.
Citation | 510 F. Supp. 961 |
Decision Date | 28 April 1981 |
Docket Number | Civ. A. No. 79-C-93. |
Parties | Helen Anne LUKASZEWICZ et al., Plaintiffs, v. ORTHO PHARMACEUTICAL CORPORATION et al., Defendants. |
Court | U.S. District Court — Eastern District of Wisconsin |
Charles W. Oppitz, Milwaukee, Wis., for plaintiffs.
Edmund W. Powell, Borgelt, Powell, Peterson & Frauen, S.C., Milwaukee, Wis., for defendants.
DECISION AND ORDER
This is a products liability suit brought pursuant to 28 U.S.C. § 1332.
The plaintiff Helen Anne Lukaszewicz alleges that the defendant manufactured and sold Ortho-Novum, an oral contraceptive, in a defective condition unreasonably dangerous to the plaintiff, and that as a result of her use of the product she suffered a cerebral accident on or about January 20, 1976. Her husband Thomas P. Lukaszewicz seeks damages for loss of society and consortium.
During a status conference held on January 21, 1981, the parties agreed that a threshold legal issue in this action is whether or not the defendant had a duty to warn patients directly of the possible side effects of Ortho-Novum or whether its duty to warn was satisfied by providing warnings to physicians. Plaintiff agreed that if the defendant had no duty to warn her directly, then she has no claim against the defendant and the suit should be dismissed. That issue has now been briefed by the parties and is before the court for decision.
Ortho-Novum is a prescription drug regulated by the federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. § 321 et seq. It has certain known side effects which may be harmful to the user. Plaintiff's claim is that she began to suffer migraine headaches in the summer of 1975 as a result of her use of the drug, and in January 1976 suffered a cerebrovascular accident caused by the migraines and therefore caused, in turn, by the Ortho-Novum.
Section 402A of the Restatement (Second) of Torts, which has been adopted in Wisconsin, Dippel v. Sciano, 37 Wis.2d 443, 155 N.W.2d 55 (1967), imposes liability on the manufacturer of a product which is sold "`in a defective condition unreasonably dangerous to the user or consumer'" regardless of whether the manufacturer "`has exercised all possible care in the preparation and sale of his product.'" Kozlowski v. John E. Smith's Sons Company, 87 Wis.2d 882, 891, 275 N.W.2d 915 (1979), quoting from § 402A. Comment k to the section provides in part:
As a general rule the courts of this country universally hold that in the case of prescription drugs, the provision of proper warnings to a physician will satisfy the manufacturer's duty to warn since the patient cannot obtain the drug except through the physician. See, e. g., Timm v. Upjohn Company, 624 F.2d 536, 538 (5th Cir. 1980); Davis v. Wyeth Laboratories, 399 F.2d 121, 129-130 (9th Cir. 1968); McCue v. Norwich Pharmacal Company, 453 F.2d 1033 (1st Cir. 1972); Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966); Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3d Cir. 1973); Basko v. Sterling Drug, Inc., 416 F.2d 417, 425-426 (2d Cir. 1969).1 This rule has been followed in cases specifically involving the use of oral contraceptives. For example, in Chambers v. G. D. Searle & Co., 441 F.Supp. 377 (D.Md.1975), aff'd 567 F.2d 269 (4th Cir. 1977), the district court stated at page 381:
See also Goodson v. Searle Laboratories, 471 F.Supp. 546, 548 (D.Conn.1978); Lindsay v. Ortho Pharmaceutical Corp., 481 F.Supp. 314, 322, 347, 352 (E.D.N.Y.1979); Dunkin v. Syntex Laboratories, Inc., 443 F.Supp. 121, 123 (W.D.Tenn.1977).
The federal administrative regulations adopted under the federal Food, Drug, and Cosmetic Act do require that in the case of oral contraceptives, warnings in the form of package inserts be given to the patient as well as to the physician. 21 C.F.R. § 310.501 provides in part:2
Several of the courts discussing the duty to warn imposed on a manufacturer of oral contraceptives have obviously been aware of the federal regulations requiring provision of information to the patient, Lindsay v. Ortho Pharmaceutical Corp., supra; Goodson v. Searle Laboratories, supra; Dunkin v. Syntex Laboratories, supra, but without specific discussion none of them have used 21 C.F.R. § 310.501 to impose on a manufacturer of oral contraceptives a duty to warn the patient as well as the doctor, a breach of which would give rise to strict liability in tort to the patient under the applicable state law.
Section 286 of the Restatement (Second) of Torts provides:
The Wisconsin Supreme Court has adopted the principle embodied in that section in the following manner:
"* * * the current Wisconsin approach is `where a statute is designed to protect a class of persons from a particular type of harm, a violation of the statute which results in that type of harm to someone in the protected class constitutes negligence per se.'" Olson v. Ratzel, 89 Wis.2d 227, 239, 278 N.W.2d 238 (Ct.App. 1979), quoting Kalkopf v. Donald Sales and Mfg....
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