In re Norplant Contraceptive Products Liability Litigation

Citation955 F.Supp. 700
Decision Date04 March 1997
Docket NumberNo. 1:95-CV-5229.,No. 1:95-CV-5360.,No. 1:95-CV-5243.,No. 1:95-CV-5178.,1:95-CV-5360.,1:95-CV-5178.,1:95-CV-5243.,1:95-CV-5229.
PartiesIn re NORPLANT CONTRACEPTIVE PRODUCTS LIABILITY LITIGATION. Jennifer BURTON v. AMERICAN HOME PRODUCTS CORPORATION, a Delaware Corporation d/b/a Wyeth-Ayerst Laboratories, and Wyeth Laboratories, Inc. Theresa GOINS (Harrison) and Andrea Elaine Haught v. AMERICAN HOME PRODUCTS CORPORATION, a Delaware Corporation d/b/a Wyeth-Ayerst Laboratories, and Wyeth Laboratories, Inc. Beverly McDANIEL v. AMERICAN HOME PRODUCTS CORPORATION, a Delaware Corporation d/b/a Wyeth-Ayerst Laboratories, and Wyeth Laboratories, Inc. Kristy YOUNGBLOOD v. AMERICAN HOME PRODUCTS CORPORATION, a Delaware Corporation d/b/a Wyeth-Ayerst Laboratories, and Wyeth Laboratories, Inc.
CourtUnited States District Courts. 5th Circuit. United States District Court of Eastern District Texas

Chris Parks of Parker and Parks, Port Arthur, TX, Roger Brosnahan of Brosnahan, Joseph & Suggs, Minneapolis, MN, Turner Branch, Branch Law Firm, Alberquerque, NM, for Plaintiffs.

John W. Vardaman, F. Lane Heard III, Steve Farina of Williams & Connolly, Washington, DC, Paul W. Gertz, Larry Germer, Tonya Connell Adams of Germer & Gertz Beaumont, TX, for Defendants.

MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

SCHELL, Chief Judge.

This matter is before the court on Defendants' Motion for Summary Judgment filed on January 28, 1997. Plaintiffs filed a response on February 11, 1997. Defendants filed a reply on February 14, 1997. The court issued its Preliminary Order on Application of the Learned Intermediary Doctrine as it Pertains to Defendants' Motion for Summary Judgment ("Order") on February 20, 1997. In the Order, the court advised counsel of the court's decision to apply the learned intermediary doctrine in analyzing Plaintiffs' failure to warn claims so that counsel could prepare for oral argument on Defendants' Motion for Summary Judgment to be held on February 24, 1997.1 Pursuant to the court's request, the parties submitted supplemental memoranda in support of their respective positions, focusing particularly on the issues of causation and whether the learned intermediary doctrine applies to each of Plaintiffs' theories of liability. On February 24, 1997, after consideration of the parties' submissions and applicable law and after hearing oral argument, the court announced its decision to grant Defendants' Motion for Summary Judgment. This written opinion and order sets forth more fully the court's reasons for granting the motion.

INTRODUCTION

On August 5, 1996, the court denied Plaintiffs' Motion for Class Certification, which sought to certify a nationwide class of "all persons ... who have suffered or may suffer injury as a result of using Norplant designed, manufactured, supplied, distributed, sold and/or placed in the stream of interstate commerce by Defendants."2 In the court's Memorandum Opinion and Order Denying Plaintiffs' Motion for Class Certification and Dismissing Class Complaint, the court decided that class certification was premature and that bellwether trials were necessary to aid the court in determining the appropriateness of issue certification under Federal Rule of Civil Procedure 23(c)(4) for a nationwide class of Norplant plaintiffs.3 This action is the first of three bellwether trials in MDL 1038 and involves five plaintiffs.4 The five plaintiffs are Jennifer Burton, Theresa Goins, Andrea Haught, Beverly McDaniel, and Kristy Youngblood (hereinafter "Plaintiffs").

Plaintiffs contend that American Home Products Corporation ("AHP") and its subsidiary Wyeth Laboratories Inc. ("Wyeth") (collectively "Defendants") failed to adequately warn both the consumers and the prescribing physicians of the side effects associated with the use of Norplant.5 Plaintiffs complain that Norplant caused multiple side effects, including prolonged menstrual bleeding, headaches, mood changes, depression, weight gain, hair loss, arm pain, dizziness, and nausea.6 Plaintiffs contend that Defendants' failure to adequately warn of these side effects gives rise to liability under theories of strict liability, negligence, misrepresentation, breach of implied warranty of merchantability, and under the Texas Deceptive Trade Practices Act ("DTPA").7

APPLICABLE LAW

Because jurisdiction over these cases is based on diversity of citizenship, Texas law governs the determination of the substantive issues.8 The United States Supreme Court in Erie held that federal courts must follow the substantive law decisions of the state's highest court.9 Texas appellate courts have adopted and applied the learned intermediary doctrine in cases involving a drug manufacturer's duty to warn about the potential hazards of prescription drugs. These decisions have been cited with approval by the Texas Supreme Court.10 However, neither the Texas Supreme Court nor any other Texas appellate court has dealt with a failure-to-warn claim involving a prescription contraceptive.11 Where the issues involved are ones upon which the state supreme court has not yet ruled, federal courts must attempt to predict how the state supreme court, if presented with the question, would decide the issue. Therefore, this court must make an Erie-guess. To aid in the court's decision, the court looks to existing Texas caselaw involving prescription drugs and the treatment of failure-to-warn claims involving prescription contraceptives in other jurisdictions.12

I. TEXAS FAILURE-TO-WARN CASES INVOLVING PRESCRIPTION DRUGS

"In a failure to warn case, the plaintiff must show that the warning was defective and that this failure to warn was the producing cause of the plaintiff's injury."13 "For cases involving a drug manufacturer's duty to warn, Texas courts apply the `learned intermediary' doctrine."14 Under the learned intermediary doctrine, "when a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the ultimate consumer."15 "[O]nce the physician is warned, the choice of which drugs to use and the duty to explain the risks become that of the physician."16 "However, ... when the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user" as a result of the defective warning.17 While Texas cases applying the learned intermediary doctrine do not involve prescription contraceptives, an exception to the doctrine for contraceptives such as Norplant is not warranted according to the overwhelming weight of authority from other jurisdictions.

II. FAILURE-TO-WARN CASES INVOLVING PRESCRIPTION CONTRACEPTIVES

Though the court was unable to locate any cases dealing with the issue of applying the learned intermediary doctrine in cases involving the Norplant contraceptive in particular, courts outside Texas have repeatedly rejected arguments by plaintiffs that oral contraceptives and IUDs should be excepted from the doctrine.18 Only a single jurisdiction, Massachusetts, recognizes an exception to the doctrine for prescription contraceptives.19 Plaintiffs argue that Michigan and Arkansas also created an exception to the learned intermediary doctrine for prescription contraceptives,20 but this argument is somewhat misguided. Although two federal district court decisions from Michigan created an exception to the doctrine for oral contraceptives,21 a third, more recent decision by another district court held that this is an incorrect statement of Michigan law and that the learned intermediary doctrine applies.22 Similarly, the prediction of the United States Court of Appeals for the Eighth Circuit that Arkansas would adopt an exception for contraceptives23 has been repudiated by the supreme court of that state.24 Despite the overwhelming majority of jurisdictions that have refused to create an exception to the learned intermediary doctrine for prescription contraceptives, Plaintiffs argue that the court should create an exception for Norplant under Texas law.

III. CREATING AN EXCEPTION TO THE LEARNED INTERMEDIARY DOCTRINE FOR NORPLANT?

Plaintiffs contend that the court should create an exception to the learned intermediary doctrine for Norplant because: (1) Defendants' actions effectively displaced the physician, thereby making application of the learned intermediary doctrine improper; and (2) prescription contraceptives, as opposed to other prescription drugs, are an exception to the learned intermediary doctrine.25 For the following reasons, the court finds Plaintiffs' contentions to be without merit and determines that the Texas Supreme Court, if presented with the question, would apply the learned intermediary doctrine in these cases.

A. Defendants' Conduct Did Not Result in the Displacement of the Prescribing Physician

Plaintiffs cite Reyes v. Wyeth Laboratories26 for the proposition that when the physician's role is abrogated, the learned intermediary doctrine no longer applies.27 In Reyes, however, no physician played any role in the decision to prescribe and dispense to the plaintiffs' child an oral polio vaccine, or in counseling with the parents as to possible side effects, or in administering the drug.28 Unlike the circumstances in Reyes, physicians are involved in prescribing and implanting Norplant. Furthermore, those prescribing physicians have a duty to discuss the risks and benefits of Norplant with each patient. Clearly, Norplant is administered in the context of a physician-patient relationship.29

In addition, Plaintiffs argue that this court should extend the Reyes holding to these cases because the physician assumes a passive role in that "the [Norplant prescribing] physicians essentially became conduits for passing on Wyeth materials"30 and that Wyeth was guilty of "consciously removing the physician from the...

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78 cases
  • In re Norplant Contraceptive Products Liab. Lit.
    • United States
    • U.S. District Court — Eastern District of Texas
    • 14 Agosto 2002
    ...that their allegedly inadequate physician warnings were the producing cause of Plaintiffs' injuries. In re Norplant Contraceptive Prod. Liab. Litig., 955 F.Supp. 700, 702-03 (E.D.Tex.1997), aff'd, 165 F.3d 374 (5th Cir.1999). The court found that the learned intermediary doctrine did indeed......
  • Polt v. Sandoz, Inc.
    • United States
    • U.S. District Court — Eastern District of Pennsylvania
    • 26 Mayo 2020
    ...medical providers will not be in a position to play the role of the learned intermediary.").11 See In re Norplant Contraceptive Prod. Liab. Litig., 955 F. Supp. 700, 704 (E.D. Tex. 1997), aff'd, 165 F.3d 374 (5th Cir. 1999) ("Only a single jurisdiction, Massachusetts, recognizes an exceptio......
  • Larkin v. Pfizer, Inc., No. 2002-SC-0746-CL.
    • United States
    • United States State Supreme Court — District of Kentucky
    • 17 Junio 2004
    ...other jurisdiction that has addressed the issue has rejected an exception for oral contraceptives. See In re Norplant Contraceptive Liab. Litig., 955 F.Supp. 700, 704-05 (E.D.Tex.1997), and cases cited therein. A third exception, recognized only by New Jersey, is for direct-to-consumer adve......
  • Nowell v. Medtronic Inc.
    • United States
    • U.S. District Court — District of New Mexico
    • 29 Marzo 2019
    ...physician not to prescribe the product for the plaintiff.")(internal quotation marks omitted); In re Norplant Contraceptive Prods. Liab. Litig., 955 F.Supp. 700, 710 (E.D. Tex. 1997) (stating that the plaintiffs have the burden of proving that a different warning would have changed the deci......
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1 firm's commentaries
  • Confident Learned Intermediaries Defeat Warning Causation
    • United States
    • LexBlog United States
    • 6 Junio 2022
    ...performing . . . surgeries employing [the] devices”) (footnote omitted); In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 710-11 (E.D. Tex. 1997) (no causation where “all five of the prescribing physicians testified unequivocally that none of the information sho......
3 books & journal articles
  • CHAPTER § 9.03 The Learned-Intermediary Doctrine
    • United States
    • Full Court Press Regulation of Pharmaceutical Manufacturers Title CHAPTER 9 Product Liability
    • Invalid date
    ...Med. Inc., 179 F.3d 154, 162-63 (4th Cir. 1999) (applying Virginia law). Fifth Circuit: In re Norplant Contraceptive Prod. Liab. Litig., 955 F. Supp. 700, 709 (E.D. Tex. 1997) (applying Texas law). Eleventh Circuit: Bodie v. Purdue Pharma Co., 236 F. App'x 511, 522-24 (11th Cir. 2007) (reco......
  • CHAPTER § 10.04 State and Federal Causes of Action and Defenses
    • United States
    • Full Court Press Regulation of Pharmaceutical Manufacturers Title CHAPTER 10 Third-Party Payors as Plaintiffs
    • Invalid date
    ...2008), cert. granted, judgment vacated on other grounds, 556 U.S. 1101 (2009); see In re Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 709 (E.D. Tex. 1997) ("The gravamen of all of Plaintiffs' causes of action, including misrepresentation and violation of the [Texas Deceptiv......
  • The learned intermediary doctrine in Florida: courts wrestle with claimed exceptions to the doctrine in drug and device litigation.
    • United States
    • Florida Bar Journal Vol. 82 No. 11, December 2008
    • 1 Diciembre 2008
    ...Doe v. Solvay, 350 F. Supp. 2d 257 (D. Maine 2004) (applying LID to deceptive and unfair trade practices act and fraud); In re Norplant, 955 F. Supp. 700 (E.D. Tex. (44) Id. at 1373,quoting In re Norplant, 955 F. Supp at 709. (45) Id. at 1373. (46) Id. at 1375. (47) Id. at 1375-76, citing C......

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