Ideus v. Teva Pharm. United States, Inc.

• Decision Date: 19 February 2019
• Docket Number: 4:16-CV-3086
• Citation: 361 F.Supp.3d 938
• Parties: Stephanie IDEUS, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. and Teva Women's Health, Inc., Defendants.
• Court: U.S. District Court — District of Nebraska

361 F.Supp.3d 938

Stephanie IDEUS, Plaintiff,

v.TEVA PHARMACEUTICALS USA, INC. and Teva Women's Health, Inc., Defendants.

4:16-CV-3086

United States District Court, D. Nebraska.

Signed February 19, 2019

Douglas W. Peters, Kutak, Rock Law Firm, Omaha, NE, Vincent J. Moccio, Bennerotte & Associates, Eagan, MN, for Plaintiff

Frederick M. Erny, Jeffrey F. Peck, Mary L. Tate, Ulmer, Berne Law Firm, Cincinnati, OH, Patrick R. Turner, Dvorak Law Group, Omaha, NE, for Defendants

MEMORANDUM AND ORDER

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.

Ideus 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 instructions 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.

The learned intermediary doctrine is an exception to the general rule that a manufacturer or seller 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 or reasonably foreseeable uses that may be made of the products it sells. Freeman , 618 N.W.2d at 841. In essence, the doctrine provides that when prescription drugs are involved, a manufacturers' duty to warn is discharged so long as the manufacturer provided adequate warnings to a patient's prescribing health-care provider. Id.

But not all courts agree that the learned intermediary doctrine applies to prescription contraceptives. Some courts distinguish contraceptives from other prescription drugs and decline to apply the learned intermediary doctrine. MacDonald v. Ortho Pharm. Corp , 394 Mass. 131, 475 N.E.2d 65 (1985) ; Stephens v. G.D. Searle , 602 F.Supp. 379 (E.D. Mich. 1985). In those jurisdictions, the manufacturer has a duty to directly warn a consumer about the risks of the product. Other courts, however, do not treat contraceptives differently. See West v. Searle Co. , 305 Ark. 33, 806 S.W.2d 608, 614 (1991) ; Cobb v. Syntex Laboratories , 444 So.2d 203 (La. App. 1983) ; McKee v. Moore , 648 P.2d 21 (Okla. 1982) ; Seley v. Searle & Co. , 67 Ohio St.2d 192, 423 N.E.2d 831 (1981) ; Ortho Pharmaceutical Corp. v. Chapman , 180 Ind.App. 33, 388 N.E.2d 541 (1979) ; Terhune v. A. H. Robins Co. , 577 P.2d 975, 978 (1978) ; McEwen v. Ortho Pharm. Corp. , 270 Or. 375, 528 P.2d 522 (1974) ; Leibowitz v. Ortho Pharm. Corp. , 224 Pa.Super. 418, 307 A.2d 449 (1973). And in those jurisdictions, the learned intermediary doctrine applies to all prescription drugs or devices—including contraceptives.

Although the Nebraska Supreme Court has adopted the learned intermediary doctrine, Freeman , 260 Neb. at 571, 618 N.W.2d 827, it has yet to address whether it would recognize an exception to the learned intermediary doctrine for prescription contraceptives. So, this Court is tasked with predicting whether the Nebraska Supreme Court would apply the learned intermediary doctrine to contraceptives.

According to Teva, the Nebraska Supreme Court would apply the learned intermediary doctrine. In support of that argument, Teva points to the rationale behind the learned intermediary doctrine:

"the physician, as the prescriber of a drug, is in the best position to give a highly individualized warning to a patient based on the physician's knowledge of the patient and the inherent risks of the drug." Kociemba v. G.D. Searle & Co. , 680 F.Supp. 1293, 1305 (D. Minn. 1988). And because contraceptives are prescribed by physicians, Teva argues that the doctrine necessarily applies. See filing 81 at 27-18. Ideus, however, claims that the Nebraska Supreme Court would distinguish between contraceptives and other prescription drugs. This is true, Ideus argues, because contraceptives are, by their very nature, distinguishable from average prescription drugs. See filing 90 at 13-15.

This Court agrees with Teva. It is true that Ideus' view is consistent with courts in Massachusetts and Michigan, see MacDonald , 475 N.E.2d at 66 ; Stephens , 602 F.Supp. at 380. And Ideus view is also consistent with the Eighth Circuit's decision predicting Arkansas law in Hill v. Searle Labs., a Div. of Searle Pharm., Inc. —a decision Ideus relies on extensively to support why, in her view, Nebraska would create an exception to the learned intermediary doctrine for contraceptives. 884 F.2d 1064, 1070 (8th Cir. 1989). But after Hill was decided, the Arkansas Supreme Court determined to the contrary that the learned intermediary doctrine does apply to contraceptives. West v. Searle Co. , 305 Ark. 33, 806 S.W.2d 608, 614 (1991). And just as important, the factors articulated in Hill for a modified approach to the learned intermediary doctrine, if applied in this case, counsel in favor of applying the doctrine.

In Hill , the plaintiff sued the manufacturer of her copper IUD after the product perforated her uterus and partially imbedded itself in her uterine wall. Id. The district court determined that ...