How Many Times Must the Question Be Answered? the Application of the Learned Intermediary Doctrine in the Norplant Contraceptive
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Golden Gate University Law Review Volume 30 Article 5 Issue 2 Women's Law Forum January 2000 How Many Times Must the Question Be Answered? The Application of the Learned Intermediary Doctrine in the Norplant Contraceptive Products Liability Litigation Stacey Leffler Ravetta Follow this and additional works at: http://digitalcommons.law.ggu.edu/ggulrev Part of the Torts Commons Recommended Citation Stacey Leffler Ravetta, How Many Times Must the Question Be Answered? The Application of the Learned Intermediary Doctrine in the Norplant Contraceptive Products Liability Litigation, 30 Golden Gate U. L. Rev. (2000). http://digitalcommons.law.ggu.edu/ggulrev/vol30/iss2/5 This Note is brought to you for free and open access by the Academic Journals at GGU Law Digital Commons. It has been accepted for inclusion in Golden Gate University Law Review by an authorized administrator of GGU Law Digital Commons. For more information, please contact [email protected]. Ravetta: Learned Intermediary Doctrine NOTE HOW MANY TIMES MUST THE QUESTION BE ANSWERED? THE APPLICATION OF THE LEARNED INTERMEDIARY DOCTRINE IN THE NORPLANTCONTRACEPTIVE PRODUCTS LIABILITY LITIGATION I. INTRODUCTION The Norplant Contraceptive Products Liability Litigation1 ("Norplant Litigation") was lengthy and complex multidistrict litigation involving the prescription Norplant Contraceptive Device ("Norplant,,).2 Since the introduction of the first oral contraceptives in the late 1960s, the first Intrauterine Devices ("IUDs") in the 1970s, and Norplant in the 1990s, women expe rienced various adverse side effects when using any of these methods to prevent pregnancy.3 Many women who suffered negative reactions brought lawsuits against the pharmaceuti- 1 See In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374 (5th Cir. 1999) [hereinafter "Norplant Litigation 11"]. 2 See In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700 (E.D. Tex. 1997) [hereinafter "Norplant Litigation 1]. See also Norplant Litigation II, 165 F.3d at 374. 3 . See generally MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass. 1985); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287 (E.D. Mich. 1991); In re AH. Robins Co. Inc., "Dalkon Shield" IUD Products Liability Litigation, 505 F. Supp. 221 (J.P.M.L. 1981); Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. Sup. Ct. 1999). 331 Published by GGU Law Digital Commons, 2000 1 Golden Gate University Law Review, Vol. 30, Iss. 2 [2000], Art. 5 332 GOLDEN GATE UNIVERSITY LAW REVIEW [Vol. 30:2 cal companies under products liability theories.4 The results of the lawsuits varied depending on the jurisdictions in which the they were filed and the types of injuries the women sustained.6 Similarly, in the Norplant Litigation, the plaintiffs alleged various side effects and claimed that the defendant did not provide adequate warnings of the potential risks.6 The com plaints against Norplant's manufacturer, Wyeth Laboratories, and its parent company, American Home Products (collectively "AHP") focused on twenty-six adverse reactions common to the majority of the plaintiffs. 7 The primary issue presented in the Norplant Litigation was the federal district court's decision to apply the learned inter mediary doctrine to the plaintiffs' failure to warn claims against AHP.B Since Norplant was a relatively new method of contraception at the time of the litigation, the court had lim ited binding precedent to apply to the facts of the plaintiffs' case. 9 Therefore, the court looked to similar cases involving prescription drugs and concluded that it should apply the learned intermediary doctrine to all of the plaintiffs' claims. 10 As a result of this determination, the court held that the de- 4 See generally MacDonald, 475 N.E.2d 65; Reaves, 765 F. Supp. 1287; Dalkon Shield, 505 F. Supp. 221; Perez, 734 A.2d 1245. 6 See generally MacDonald, 475 N.E.2d 65; Reaves, 765 F. Supp. 1287; Dalkon Shield, 505 F. Supp. 221; Perez, 734 A.2d 1245. 6 See Norplant Litigation I, 955 F. Supp. at 702. 7 See Defendant's No.2 Memorandum in Support of Motion For Partial Summary Judgment He Adequacy of the Norplant Labeling at 2, Norplant Contraceptive Prod ucts Liability Litigation, 955 F. Supp. 700 (E.D. Tex. 1997) (MDL 1038). 8 See Norplant Litigation I, 955 F. Supp. at 702. The plaintiffs claimed that the de- fendant's failure to adequately warn of Norplant's side effects gave rise to liability under numerous theories including: strict liability, negligence, misrepresentation, breach of implied warranty of merchantability, and under the Texas Deceptive Trade Practices Act ("DTPA"). See id. at 703. 9 See id. at 703. Since the federal district court's jurisdiction over the Norplant Litigation was based on diversity of citizenship, the court applied Texas law to the case. See id. 10 See id. at 704. The court looked to Texas court decisions ~nvolving prescription drugs and the decisions of other states regarding the treatment of failure-to-warn claims specifically involving prescription contraceptives since the Texas courts had ruled on that issue See id. at n.18. http://digitalcommons.law.ggu.edu/ggulrev/vol30/iss2/5 2 Ravetta: Learned Intermediary Doctrine 2000] LEARNED INTERMEDIARY DOCTRINE 333 fendant was insulated from liability to the plaintiffs for the adverse reactions they experienced as a result of using N or plant.l1 Subsequently, the court granted summary judgment in AHP's favor. 12 On appeal, the United States Court of Ap peals for the Fifth Circuit affirmed the lower court's ruling.13 Part II of this Note begins with a general discussion of fail ure to warn causes of action and the application of the learned intermediary doctrine thereto. Further, Part II discusses cases essential to understanding the background of the Norplant Litigation. Next, Parts III and IV explain the facts and proce dural history underlying the Norplant Litigation. Part V first examines the federal district court's analysis of the case. It then discusses the Fifth Circuit's analysis of the federal dis trict court's summary judgment ruling in AHP's favor. Part VI examines the federal district c\:mrt's pivotal decision to apply the learned intermediary doctrine to the plaintiffs' claims against AHP, and the Fifth Circuit's decision to affirm this ruling, thereby effectively ending the litigation. Further, Part VI also notes that direct-to-consumer advertising creates a new and unprecedented issue in failure to warn product liability cases involving prescription drugs. II. BACKGROUND Norplant is comprised of synthetic hormones that prevent pregnancy. 14 These hormones potentially cause adverse side effects. 15 The Norplant Litigation began when women experi encing side effects sought to certify a nationwide class of per sons who suffered or may suffer injury as a result of using Norplant against the device's manufacturer, Wyeth Laborato- 11 See id. at 701. 12 See id. 13 See Norplant Litigation II, 165 F.3d at 375. 14 See In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374, 376 (5th Cir. 1999) [hereinafter "Norplant Litigation 11"]. 15 See In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 702 CE.D. Tex. 1997) [hereinafter "Norplant ~itigation rJ. Published by GGU Law Digital Commons, 2000 3 Golden Gate University Law Review, Vol. 30, Iss. 2 [2000], Art. 5 334 GOLDEN GATE UNIVERSITY LAW REVIEW [Vol. 30:2 ries, Inc., and its parent company, American Home Products (collectively "AHP,,).16 The plaintiffs claimed that AHP was liable for failing to adequately warn them of the risks inherent 17 in Norplant use. Both the federal district court and the Fifth Circuit applied the learned intermediary doctrine to the plain tiffs' claims, thereby insulating AHP from liability for failing to warn the ultimate consumer. IS An examination of the author ity relied on by both courts in the Norplant Litigation illus trates the complexity and longevity of the central legal issue presented in this litigation: the application of the learned in termediary doctrine and its continuing impact on a pharma ceutical manufacturer's liability for failing to directly warn 19 consumers of the risks associated with its products. A. THE NORPLANT CONTRACEPTIVE DEVICE In 1991, AHP introduced Norplant to the birth control mar 20 ket after more than two decades of development and testing. Norplant consists of six thin, match-stick size, silicone-coated, capsules of synthetic progesterone, called levonorgestrel, in 21 serted just below the skin of a woman's upper arm. Norplant may remain in place for up to five years, and while implanted, constantly releases a small, continuous dose of levonorgestrel 16 . See ,d. 17 See id. IS See Norplant Litigation I, 955 F. Supp. at 701. See also Norplant Litigation II, 165 F.3d at 375. 19 See Norplant Litigati~n I, 955 F. Supp. at 704-705 (citing MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass. 1985); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287 (E.D. Mich. 1991); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974)). 20 See Perez v. Wyeth Laboratories, Inc., 713 A.2d 588, 589 (N.J. Law Div. 1997). The Population Council, a non-profit organization committed to the advancement of reproductive health developed Norplant. The Population Council began development of Norplant in 1966 and tested it on over 55,000 women in forty-four cou~tries over the following two decades. The Population Council granted Wyeth Laboratories, Inc. the exclusive right to market Norplant in the United States. See id. n .. See Planned Parenthood FederatIon of AmerIca, Inc., Fact Sheet: Norplant and You (1997). Levonorgestal is the term for synthetic progesterone hormone. See id. http://digitalcommons.law.ggu.edu/ggulrev/vol30/iss2/5 4 Ravetta: Learned Intermediary Doctrine 2000] LEARNED INTERMEDIARY DOCTRINE 335 22 into the blood stream.