Longtin v. Organon USA, Inc.

363 F. Supp. 3d 186
CourtDistrict Court, District of Columbia
DecidedNovember 27, 2018
DocketCivil Action No. 15-30014-MGM
StatusPublished
Cited by2 cases

This text of 363 F. Supp. 3d 186 (Longtin v. Organon USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Longtin v. Organon USA, Inc., 363 F. Supp. 3d 186 (D.D.C. 2018).

Opinion

MASTROIANNI, U.S.D.J.

I. INTRODUCTION

Cali Longtin ("Plaintiff") brings this action against Organon USA, Inc., N.V. Organon, Schering Corp., Merck & Co., Inc., and Merck Sharp & Dohme ("Defendants"), for claims related to a stroke she suffered in New Jersey following her use of NuvaRing, a prescription contraceptive.1 Presently before the court is Defendants' motion for summary judgment as to all counts. (Dkt. No. 90.) For the following reasons, the court will grant Defendants' motion.

II. BACKGROUND AND PROCEDURAL HISTORY

The following facts, which are construed in a light most favorable to Plaintiff, are not disputed, except as otherwise noted. In 2008, while living in Massachusetts, Plaintiff began using NuvaRing following an appointment with Mary Casartello, a certified nurse midwife at Riverbend Medical Group. (Dkt. No. 98, Pl's Resp. to Def's Statement of Material Facts ("Pl's Resp. to Def's SOF") ¶ 33; Dkt. No. 104, Def's Resp. to Pl's Statement of Additional Material *189Facts ("Def's Resp. to Pl's SOF") ¶¶ 10-11.) NuvaRing is a combination hormonal contraceptive ("CHC") containing the hormones estrogen and progestin. (Pl's Resp. to Def's SOF ¶ 1.) Unlike oral contraceptives, NuvaRing is a flexible ring that is inserted in a woman's vagina once every 28 days and is removed after day 21 for a seven-day ring-free interval, after which a new NuvaRing is inserted and the 28-day process begins again. (Id. ¶ 5.) Between 2008 and 2010, while living in Massachusetts, Plaintiff used NuvaRing as prescribed and did not use any other form of hormonal contraceptive. (Def's Resp. to Pl's SOF ¶ 15.)

In October of 2010, Plaintiff moved to New Jersey for a new job, where she continued using NuvaRing. (Id. ¶¶ 17-19.)2 On September 27, 2013, Plaintiff saw Dr. Kimberlee Austin, an obstetrician/gynecologist in New Jersey, for an appointment. (Id. ¶ 22.) At that appointment, Dr. Austin prescribed Plaintiff NuvaRing, recognizing Plaintiff was using the medication, and provided samples. (Id. ¶¶ 23-24; Pl's Resp. to Def's SOF ¶ 39.) From September 27, 2013 to January 16, 2014, Plaintiff used the NuvaRing samples Dr. Austin provided, as instructed. (Def's Resp. to Pl's SOF ¶ 27.)

On January 16, 2014, Plaintiff suffered a left middle cerebral artery stroke, resulting in cognitive and physical deficits. (Id. ¶ 28.) In May of 2014, Plaintiff moved back to Massachusetts to live with her parents. (Dkt. No. 90-19 at 66, 96.) Plaintiff has since remained in Massachusetts, but moved to her own apartment in June of 2016. (Id. at 65-66.)

Organon had submitted a New Drug Application ("NDA") for NuvaRing on December 28, 1999, seeking the approval of the Federal Drug Administration ("FDA") to market the product in the United States. (Id. ¶ 9.) The NDA included proposed language for the labels addressed to both doctors and patients warning of the risk of stroke, among other complications. (Id. ¶¶ 12, 14.) Following some minor changes to the proposed stroke warning labels requested by the FDA and accepted by Organon, those warnings ultimately provided as follows. The label addressed to doctors stated, in relevant part:

NuvaRing ® (etonogestrel /ethinyl estradiol ring) and other contraceptives that contain both an estrogen and a progestin are called combination hormonal contraceptives. There is no epidemiologic data available to determine whether safety and efficacy with the vaginal route of administration of combination hormonal contraceptives would be different than the oral route. Practitioners prescribing NuvaRing ® should be familiar with the following information relating to these risks.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in *190healthy women without underlying risk factors....
1. THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS
* * * *
c. Cerebrovascular diseases
Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes ), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke.... In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25 for users with severe hypertension. The attributable risk is also greater in older women.

(Dkt. No. 90-2 at 15-16, 18-19.) The label addressed to patients stated, in relevant part:

NuvaRing ® contains a combination of a progestin and estrogen, two kinds of female hormones....
Contraceptives that contain both an estrogen and a progestin are called combination hormonal contraceptives. Most studies on combination contraceptives have used oral (taken by mouth) contraceptives. NuvaRing ® may have the same risks that have been found for combination oral contraceptives. This leaflet will tell you about risks of taking combination oral contraceptives that may also apply to NuvaRing ® users.
* * * *
What are the possible risks and side effects of NuvaRing ®?
* * * *
Heart attacks and strokes
Hormonal contraceptives may increase your risk of strokes (blockage of blood flow to the brain) or heart attacks (blockage of blood flow to the heart). Any of these conditions can cause death or serious disability....

(Id. at 37, 46.) The FDA approved NuvaRing and its doctor and patient labels on October 10, 2001. (Id. at 2.)3

Plaintiff commenced this action on January 29, 2015. (Dkt. No. 1.) On March 2, 2015, the United States Judicial Panel on Multidistrict Litigation ("JPML") issued a Conditional Transfer Order transferring this action to MDL No. 1964 in the Eastern District of Missouri for consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407. (Dkt. Nos. 6-7.) On November 1, 2016, the JPML remanded this action from the MDL to this court for case-specific discovery and further proceedings. (Dkt. Nos. 9-10.) Defendants filed a motion for *191summary judgment on July 9, 2018, Plaintiff filed an opposition on August 16, 2018, and Defendants filed a reply on August 30, 2018. (Dkt. Nos.

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