Ideus v. Teva Pharm. United States, Inc.

361 F. Supp. 3d 938
CourtDistrict Court, D. Nebraska
DecidedFebruary 19, 2019
Docket4:16-CV-3086
StatusPublished
Cited by5 cases

This text of 361 F. Supp. 3d 938 (Ideus v. Teva Pharm. United States, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Nebraska primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ideus v. Teva Pharm. United States, Inc., 361 F. Supp. 3d 938 (D. Neb. 2019).

Opinion

John M. Gerrard, Chief United States District Judge

This matter is before the Court on the defendants' motion for summary judgment (filing 81). That motion will be granted and the plaintiff's complaint will be dismissed.

BACKGROUND

The facts of this case are set forth in this Court's December 12, 2017 Memorandum and Order. Filing 56. Briefly summarized, the plaintiff, Stephanie Ideus, received the birth control ParaGard T380 Intrauterine Copper Contraceptive. Filing 81 at 6. Four years later, as her physician was removing the ParaGard, a piece of the device broke off and embedded in the myometrium of the plaintiff's uterine wall. Filing 81 at 7. The broken piece was surgically removed in 2016. Filing 81 at 7.

*941Ideus claims she was not adequately warned of the possible risks associated with ParaGard. See filing 96 at 3. To support that contention, Ideus points to an "Information for Patients" brochure she received before the device was implanted, and to the product's package insert, which contains prescribing information for treating physicians. See filing 96 at 3. Both sets of materials, she alleges, lack any warning that the ParaGard "could break during removal," or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded "deep in the uterus[.]" Filing 96 at 6. Ideus has sued the manufacturers of the device, Teva Pharmaceuticals and Teva Women's Health (collectively, Teva), for allegedly failing to provide adequate warnings. See filing 21 at 6-17. Teva moves for summary judgment, and for the reason set forth below, that motion will be granted.

STANDARD OF REVIEW

Summary judgment is proper if the movant shows that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(a). The movant bears the initial responsibility of informing the Court of the basis for the motion, and must identify those portions of the record which the movant believes demonstrate the absence of a genuine issue of material fact. Torgerson v. City of Rochester , 643 F.3d 1031, 1042 (8th Cir. 2011) (en banc). If the movant does so, the nonmovant must respond by submitting evidentiary materials that set out specific facts showing that there is a genuine issue for trial. Id.

On a motion for summary judgment, facts must be viewed in the light most favorable to the nonmoving party only if there is a genuine dispute as to those facts. Id. Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the evidence are jury functions, not those of a judge. Id. But the nonmovant must do more than simply show that there is some metaphysical doubt as to the material facts. Id. In order to show that disputed facts are material, the party opposing summary judgment must cite to the relevant substantive law in identifying facts that might affect the outcome of the suit. Quinn v. St. Louis County , 653 F.3d 745, 751 (8th Cir. 2011). The mere existence of a scintilla of evidence in support of the nonmovant's position will be insufficient; there must be evidence on which the jury could conceivably find for the nonmovant. Barber v. C1 Truck Driver Training, LLC , 656 F.3d 782, 791-92 (8th Cir. 2011). Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial. Torgerson , 643 F.3d at 1042.

DISCUSSION

Ideus' sole remaining claim is that Teva failed to adequately warn her of the risks associated with ParaGard.1 Under Nebraska law, a manufacturer is subject to liability for failing either to warn or adequately to warn about a risk or hazard inherent in the way a product is designed that is related to the intended uses as well as the reasonably foreseeable uses that may be made of the products it sells. Freeman v. Hoffman-La Roche, Inc. , 260 Neb. 552, 618 N.W.2d 827, 841 (2000) ; Rahmig v. Mosley Machinery Co. , 226 Neb. 423, 412 N.W.2d 56 (1987). In other words, a manufacturer's duty to produce a safe product, with appropriate warnings and *942instructions when necessary, is no different from the responsibility each of us bears to exercise due care to avoid unreasonable risks of harm to others. Freeman , 618 N.W.2d at 841.

According to Ideus, Teva breached this duty. More specifically, Ideus claims that neither the warning given to her prescribing physician (i.e. , the package insert), nor the information received directly by Ideus (i.e. , the patient brochure) adequately, if at all, warned of the risk of "embedment or breakage." Filing 57 at 5-6. Teva, on the other hand, argues that the only relevant warning label, the one in the package insert, was adequate as a matter of law. See filing 81 at 5. Alternatively, Teva contends that Ideus' claim is preempted by federal law because it could not unilaterally change ParaGard's warning labels without violating federal regulations. Filing 81 at 17-23.

The Court need not address Teva's latter contention. Even assuming (without deciding) that Ideus' failure-to-warn claim is not preempted, that claim fails nonetheless. But before explaining why that is true, the Court must take a brief detour though the history and applicability of the doctrine underlying much of the parties' dispute: the learned intermediary doctrine.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Jeffrey Thelen v. Somatics, LLC
Eleventh Circuit, 2025
Thelen v. Somatics, LLC
M.D. Florida, 2023
Sharp v. Ethicon, Inc.
W.D. Arkansas, 2020

Cite This Page — Counsel Stack

Bluebook (online)
361 F. Supp. 3d 938, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ideus-v-teva-pharm-united-states-inc-ned-2019.