United States Court of Appeals
`For the Eighth Circuit
`___________________________
`
`No. 19-1361
`___________________________
`
`Stephanie Ideus
`
` Plaintiff - Appellant
`
`v.
`
`Teva Pharmaceuticals USA, Inc.
`
` Defendant - Appellee
`
`Teva Branded Pharmaceuticals Products R&D, Inc.
`
` Defendant
`
`Teva Women’s Health, Inc.
`
` Defendant - Appellee
`____________
`
`Appeal from United States District Court
`for the District of Nebraska - Lincoln
`____________
`
`Submitted: September 23, 2020
` Filed: February 8, 2021
`____________
`
`
`Before KELLY, WOLLMAN, and STRAS, Circuit Judges.
`____________
`
`
`STRAS, Circuit Judge.
`
`
`

`

`After suffering complications from the implantation of an intrauterine device,
`
`Stephanie Ideus sued the product’s manufacturer. The central question was whether
`it had to warn Ideus directly about the potential risks of using the device. We agree
`with the district court1 that, under Nebraska tort law, it did not.
`
`
`I.
`
`
`Teva Pharmaceuticals USA, Inc. and Teva Women’s Health, Inc. manufacture
`
`and sell a device called ParaGard T 380A Intrauterine Copper Contraceptive. This
`T-shaped device, which is placed in the uterus, can prevent pregnancies for up to ten
`years. Accompanying the product are two inserts—one for the prescribing physician
`and another for the patient—with warnings and instructions. Before implanting the
`device, physicians are supposed to give patients time to read the latter insert, discuss
`it with them, and answer any questions.
`
`After going through this process with her physician, Ideus decided to have the
`
`device implanted. When she later tried to have it removed, however, her physicians
`discovered that it had broken apart and a piece had become embedded in her uterus.
`Removing it required surgery.
`
`
`
`Ideus sued Teva in federal district court for, as relevant here, breach of its duty
`to warn her of the potential risks. In granting summary judgment to Teva, the court
`applied the learned-intermediary doctrine, which as a general rule allows
`manufacturers of certain types of medical products to discharge their duty by
`warning “medical profession[als]” of the risks rather than the patients themselves.
`Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841–42 (Neb. 2000). Ideus’s
`position, both before the district court and on appeal, is that the Nebraska Supreme
`Court would not apply it to contraceptive devices like ParaGard.
`
`
`
`1The Honorable John M. Gerrard, Chief Judge, United States District Court
`
`for the District of Nebraska.
`
`
`
`-2-
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`

`

`II.
`
`
`Despite disagreeing throughout about the application of the learned-
`
`intermediary doctrine, the parties now agree on three basic points. First, Nebraska
`law applies. See Menard, Inc. v. Dial-Columbus, LLC, 781 F.3d 993, 997 (8th Cir.
`2015). Second, Teva provided adequate warnings to Ideus’s physician. Third, with
`no dispute about the adequacy of those warnings, the sole issue on appeal is whether
`Teva had an obligation to warn Ideus too, which raises a legal question that we
`review de novo. Carson v. Simon, 978 F.3d 1051, 1059 (8th Cir. 2020).
`
`Like most states, Nebraska requires manufacturers to warn consumers directly
`
`about any “risk[s] or hazard[s] inherent in the way a product is designed.” Freeman,
`618 N.W.2d at 841 (quotation marks omitted). But there is an exception, known as
`the learned-intermediary doctrine, for prescription drugs. Id. at 841–42. So far, the
`Nebraska Supreme Court has not said whether it would apply the learned-
`intermediary doctrine to other products like IUDs. So our task is to predict what it
`would do, which requires us to look at what it has said. See Menard, Inc., 781 F.3d
`at 997.
`
`The key discussion is in Freeman. In that case, a patient developed serious
`
`health problems from the use of Accutane, a prescription acne medication. See
`Freeman, 618 N.W.2d at 832. One of her claims was that the manufacturer had
`misled her about the potential risks. Id. The Nebraska Supreme Court, in the course
`of considering the claim, “adopt[ed] § 6(d) of the Third Restatement” of Torts, the
`provision covering the learned-intermediary doctrine. Id. at 841–42; see also
`Restatement (Third) of Torts: Products Liability § 6(d) (Am. L. Inst. 1997). It says
`that
`
`
`[a] prescription drug or medical device is not reasonably safe due to
`inadequate instructions or warnings if reasonable instructions or
`warnings regarding foreseeable risks of harm are not provided to:
`
`
`
`
`-3-
`
`

`

`(1) prescribing and other health-care providers who are in a position to
`reduce the risks of harm in accordance with the instructions or
`warnings; or
`
`(2) the patient when the manufacturer knows or has reason to know that
`health-care providers will not be in a position to reduce the risks of
`harm in accordance with the instructions or warnings.
`
`
`Restatement (Third) of Torts: Products Liability § 6(d) (emphasis added). What this
`provision does is insulate a manufacturer of “prescription drug[s] or medical
`device[s]” from duty-to-warn liability if it “adequate[ly]” communicates the risks to
`“health-care providers,” id. § 6(d) & cmt. e, unless “special facts require a direct
`warning to the consumer,” Freeman, 618 N.W.2d at 842. The rationale is that
`medical professionals are typically “in the best position to” analyze the potential
`risks and decide “whether the patient should use the product.” Id. at 841–42
`(quotation marks omitted).
`
`Although Freeman involved a “prescription drug,” the Restatement treats
`
`“medical device[s]” no differently, which suggests that the Nebraska Supreme Court
`would, if faced with the question, apply the learned-intermediary doctrine to devices
`like ParaGard. See id. at 842 (quoting Restatement (Third) of Torts: Products
`Liability § 6(d)). Indeed, just like Accutane, it is prescribed by physicians, so it fits
`within the rationale for the rule: they will be “in the best position to” advise their
`patients about the risks of using it. Id. at 841–42 (quotation marks omitted).
`
`Nevertheless, Ideus argues that the Nebraska Supreme Court would recognize
`
`an exception to the learned-intermediary doctrine for prescription contraceptives.
`She points to three cases, one from Massachusetts and two from federal district
`courts in Michigan, that require direct warnings to consumers for those types of
`products. See Restatement (Third) of Torts: Products Liability § 6 cmt. e
`(“leav[ing]” open the possibility for other “exceptions” in “developing case law”).
`
`
`
`
`-4-
`
`

`

`There is no question that Massachusetts has adopted a prescription-
`
`contraceptives exception, MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 70
`(Mass. 1985), but the law in Michigan “is less than clear,” Spychala v. G.D. Searle
`& Co., 705 F. Supp. 1024, 1032 n.5 (D.N.J. 1988). Some courts have suggested that
`Michigan would follow Massachusetts’s lead, see Odgers v. Ortho Pharm. Corp.,
`609 F. Supp. 867, 879 (E.D. Mich. 1985); Stephens v. G.D. Searle & Co., 602 F.
`Supp. 379, 381 (E.D. Mich. 1985), although others have reached the opposite
`conclusion, see Beyette v. Ortho Pharm. Corp., 823 F.2d 990, 992–93 (6th Cir. 1987)
`(applying the learned-intermediary doctrine to an IUD under Michigan law); Reaves
`v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1291 (E.D. Mich. 1991) (predicting that
`“the learned[-]intermediary doctrine does apply to oral contraceptives under
`Michigan law”). The bottom line is that Massachusetts stands alone in
`unequivocally adopting it.
`
`On the other side of the ledger are a number of states that have rejected it.
`
`Among them are Arkansas, Colorado, Delaware, Florida, Illinois, Indiana, Kansas,
`Louisiana, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, and
`Washington.2 Numerous federal courts have done so too, including for IUDs. See,
`e.g., Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992); Gonzalez v.
`Bayer Healthcare Pharms., Inc., 930 F. Supp. 2d 808, 820–21 (S.D. Tex. 2013);
`
`2West v. Searle & Co., 806 S.W.2d 608, 614 (Ark. 1991); Hamilton v. Hardy,
`
`549 P.2d 1099, 1110 (Colo. App. 1976), overruled on other grounds by State Bd. of
`Med. Exam’rs v. McCroskey, 880 P.2d 1188 (Colo. 1994); Lacy v. G.D. Searle &
`Co., 567 A.2d 398, 400 (Del. 1989); Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683
`(Fla. 1990); Martin by Martin v. Ortho Pharm. Corp., 661 N.E.2d 352, 356–57 (Ill.
`1996); Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 548–49 (Ind. Ct. App.
`1979); Humes v. Clinton, 792 P.2d 1032, 1041 (Kan. 1990); Cobb v. Syntex Lab’ys,
`Inc., 444 So. 2d 203, 205 (La. Ct. App. 1983); Hoffman-Rattet v. Ortho Pharm.
`Corp., 516 N.Y.S.2d 856, 859 (Sup. Ct. 1987); Seley v. G. D. Searle & Co., 423
`N.E.2d 831, 839–40 (Ohio 1981); McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982);
`McEwen v. Ortho Pharm. Corp., 528 P.2d 522, 528–30 (Or. 1974); Brecher v.
`Cutler, 578 A.2d 481, 485 (Pa. Super. Ct. 1990); Wyeth-Ayerst Lab’ys Co. v.
`Medrano, 28 S.W.3d 87, 92 (Tex. App. 2000); Terhune v. A. H. Robins Co., 577
`P.2d 975, 978 (Wash. 1978) (en banc).
`
`
`
`-5-
`
`

`

`Amore v. G.D. Searle & Co., 748 F. Supp. 845, 849–50 (S.D. Fla. 1990). One
`consistent theme in their analysis is that contraceptives are no different from other
`prescription drugs and medical devices, at least in terms of the level of “guidance,”
`“knowledge,” and “skill” required of physicians. Terhune, 577 P.2d at 978.
`
`Every indication is that the Nebraska Supreme Court would follow what has
`
`become an “overwhelming majority” rule. Spychala, 705 F. Supp. at 1032; see also
`In re Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 704 n.18 (E.D.
`Tex. 1997) (collecting cases), aff’d, 165 F.3d 374 (5th Cir. 1999). After all, by
`adopting the Restatement and noting that the learned-intermediary doctrine has been
`widely adopted, it has already signaled its hesitance to become an outlier. Freeman,
`618 N.W.2d at 842.
`
`It is true, as Ideus points out, that this case is not our first foray into the area.
`
`Over 30 years ago, in Hill v. Searle Laboratories, a Division of Searle
`Pharmaceuticals, Inc., we concluded that the learned-intermediary doctrine does not
`apply to IUDs. 884 F.2d 1064, 1070–71 (8th Cir. 1989). Still, for at least three
`reasons, Hill does not tie our hands here. First, Hill arose under Arkansas law, not
`Nebraska law. See id. Second, we were writing on a blank slate in Hill, see id.,
`whereas here the Nebraska Supreme Court has already embraced the learned-
`intermediary doctrine and defined its contours by adopting the Restatement,
`Freeman, 618 N.W.2d at 842. Third, more courts have weighed in over the past
`three decades, so the legal landscape looks different now than it did then.3 See In
`re Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. at 704 n.18.
`
`
`
`3As for the dissent’s suggestion that we should certify the question to the
`
`Nebraska Supreme Court, neither party has requested it, we did not certify in Hill,
`884 F.2d at 1070–71, and we had even less to go on there. In this case, Freeman
`already provides an extensive analysis of the learned-intermediary doctrine, 618
`N.W.2d at 841–42, and no one disputes that it has been more than 35 years since the
`last state appellate court adopted a prescription-contraceptives exception.
`-6-
`
`
`
`

`

`For these reasons, we agree with the district court that Teva was entitled to
`
`summary judgment.4 All it was required to do under Nebraska law was warn
`medical professionals like Ideus’s physician about ParaGard’s potential risks.
`
`
`III.
`
`We accordingly affirm the judgment of the district court.
`
`
`
`
`KELLY, Circuit Judge, dissenting.
`
`Because I believe we lack sufficient guidance from the Nebraska courts as to
`
`whether Nebraska would apply the learned-intermediary doctrine to intrauterine
`devices and other contraceptives, I would certify the question to the Nebraska
`Supreme Court before deciding the merits of this appeal.
`
`The Nebraska Supreme Court’s decision in Freeman v. Hoffman-La Roche,
`
`Inc., 618 N.W.2d 827 (Neb. 2000), tells us little more than that Nebraska applies the
`learned-intermediary doctrine to prescription acne medication. The court today
`emphasizes that Freeman “adopt[ed] § 6(d) of the Third Restatement,” 618 N.W.2d
`at 842. But it is unclear why adopting this provision means that Nebraska would
`refuse to recognize exceptions to the learned-intermediary doctrine. Indeed, the very
`text of § 6(d) recognizes an exception for direct-to-consumer warnings. Specifically,
`it provides that “[a] prescription drug or medical device is not reasonably safe due
`to inadequate instructions or warnings if reasonable instructions or warnings
`regarding foreseeable risks of harm are not provided to” either:
`
`
`4Ideus separately argues that the Nebraska Supreme Court would adopt a
`
`direct-to-consumer-advertising exception. See Perez v. Wyeth Lab’ys Inc., 734 A.2d
`1245, 1257 (N.J. 1999) (holding “that the learned[-]intermediary doctrine does not
`apply to the direct marketing of drugs to consumers”). Even assuming that Nebraska
`would follow New Jersey’s lead, this case does not involve direct-to-consumer
`advertising. The patient insert does not qualify, see id., nor does a magazine
`advertisement postdating the implantation of her device by over six years.
`-7-
`
`
`
`

`

`
`
`(1) prescribing and other health-care providers who are in a position to
`reduce the risks of harm in accordance with the instructions or
`warnings; or
`
`(2) the patient when the manufacturer knows or has reason to know that
`health-care providers will not be in a position to reduce the risks of
`harm in accordance with the instructions or warnings.
`
`
`Restatement (Third) of Torts: Products Liability § 6(d) (Am. L. Inst. 1997)
`(emphasis added).
`
`In fact, in acknowledging that the “[learned-intermediary] doctrine as stated
`
`in the Third Restatement has . . . been adopted in other jurisdictions,” the Nebraska
`Supreme Court in Freeman cited as an example a New Jersey decision declining to
`apply the doctrine where the manufacturer advertised directly to consumers (one of
`the very exceptions sought by Ideus in this case). 618 N.W.2d at 842 (citing Perez
`v. Wyeth Lab’ys, Inc., 734 A.2d 1245 (N.J. 1999)). The court also explained that
`the learned-intermediary doctrine “is followed in virtually all jurisdictions that have
`considered whether to adopt it,” including some which recognize “exceptions for
`instances where special facts require a direct warning to the consumer.” Id. But the
`Nebraska Supreme Court did not elaborate as to whether it would follow suit and
`recognize such exceptions. And it didn’t need to. The facts in Freeman did not
`trigger that analysis, and the court’s brief discussion of the doctrine simply does not
`tell us one way or another what Nebraska would do in future cases. In the absence
`of guidance from Nebraska courts, I find insufficient support for the court’s
`conclusion that Nebraska would follow the “majority” rule.
`
`Where, as here, “we find no state law precedent on point and where the public
`
`policy aims are conflicting the case may properly be certified to the state court.”
`Hatfield, by Hatfield v. Bishop Clarkson Mem’l Hosp., 701 F.2d 1266, 1267 (8th
`Cir. 1983) (en banc). The question of whether to carve out a contraceptives
`exception
`to
`the
`learned-intermediary doctrine—and
`thus,
`to
`impose on
`
`
`
`-8-
`
`

`

`contraceptives manufacturers a duty to warn consumers directly—depends in large
`part on whether a state views the prescribing of contraceptives as different than that
`of other drugs or medical devices. See, e.g., MacDonald v. Ortho Pharm. Corp., 475
`N.E.2d 65, 68-69 (Mass. 1985). A decision in either direction, and in “so uncertain
`an area of tort law,” involves a value judgment that we need not—and should not—
`venture into “without first seeking guidance” from the Nebraska Supreme Court.
`McKesson v. Doe, 141 S. Ct. 48, 51 (2020) (per curiam) (holding that federal court
`should have certified question of Louisiana tort law where inquiry involved
`considering “moral, social, and economic factors,” including “the fairness of
`imposing liability” (cleaned up)); see also Danler v. Rosen Auto Leasing, Inc., 609
`N.W.2d 27, 32 (Neb. 2000) (explaining that Nebraska employs “a risk-utility
`balancing test” to determine whether to impose a legal duty, considering factors such
`as “the magnitude of the risk” and “the policy interest in the proposed solution”); cf.
`West v. Searle Co., 806 S.W.2d 608, 614 (Ark. 1991) (citing public policy reasons
`to apply the learned-intermediary doctrine to oral contraceptives despite the Eighth
`Circuit’s recent decision in Hill v. Searle Lab’ys, a Div. of Searle Pharm., Inc., 884
`F.2d 1064, 1070-71 (8th Cir. 1989), that—under Arkansas law—the learned-
`intermediary doctrine did not apply to IUDs and other forms of birth control).
`
`In this case, “certification would not deprive th[e] court of jurisdiction, nor
`
`would it force the parties into state court, but rather would afford the parties a state
`forum for a state law question which process may obviate further extensive
`consideration by this court.” Hatfield, 701 F.2d at 1268; see also id. at 1269 (“The
`fact that the district court did not certify this question does not bar this court from
`utilizing the certification procedure.”); Neb. Rev. Stat. § 24-219 (permitting
`Nebraska Supreme Court to answer certified questions when the federal proceeding
`involves a question of state law that “may be determinative of the [pending] cause”
`and the certifying court believes “there is no controlling precedent”). Though a
`federal court sitting in diversity generally has a duty to resolve state-law issues
`properly before it, in my view, this case presents one of the unusual circumstances
`where certification is necessary.
`
`
`
`
`-9-
`
`

`

`For these reasons, I respectfully dissent.
`______________________________
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`-10-
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