Ideus v. Teva Pharm. USA, Inc.

• Decision Date: 08 February 2021
• Docket Number: No. 19-1361,19-1361
• Citation: 986 F.3d 1098
• Parties: 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
• Court: U.S. Court of Appeals — Eighth Circuit

986 F.3d 1098

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

No. 19-1361

United States Court of Appeals, Eighth Circuit.

Submitted: September 23, 2020

Filed: February 8, 2021

Rehearing and Rehearing En Banc Denied March 15, 2021

Vincent J. Moccio, Bennerotte & Associates, Eagan, MN, Douglas Peters, Kutak & Rock, Omaha, NE, for Plaintiff-Appellant.

Frederick M. Erny, Linda E. Maichl, Jeffrey Francis Peck, Mary L. Tate, Ulmer & Berne, Cincinnati, OH, Patrick R. Turner, Turner Legal Group, LLC, Omaha, NE, for Defendants-Appellees.

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. , 260 Neb. 552, 618 N.W.2d 827, 841–42 (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.

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:

(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").

There is no question that Massachusetts has adopted a prescription-contraceptives exception, MacDonald v. Ortho Pharm. Corp. , 394 Mass. 131, 475 N.E.2d 65, 70 (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) ; 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.

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...