Yates v. Ortho-McNeil-Janssen Pharm., Inc.

808 F.3d 281

Stephanie YATES, Plaintiff–Appellant,

v.ORTHO–McNEIL–JANSSEN PHARMACEUTICALS, INC. ; Alza Corporation; Johnson & Johnson & Pharmaceutical Research & Development, L.L.C.; Johnson & Johnson, Defendants–Appellees.

No. 15–3104.

United States Court of Appeals, Sixth Circuit.

Argued: Oct. 8, 2015.

Decided and Filed: Dec. 11, 2015.

ARGUED:Paul A. Woodard, Connors & Vilardo, LLP, Buffalo, New York, for Appellant. Irene C. Keyse–Walker, Tucker Ellis LLP, Cleveland, Ohio, for Appellees. ON BRIEF:Paul A. Woodard, Terrence M. Connors, Connors & Vilardo, LLP, Buffalo, New York, Daniel G. Tronolone, Tronolone & Surgalla, P.C., Buffalo, New York, for Appellant. Irene C. Keyse–Walker, Robert C. Tucker, Julie A. Callsen, Michael J. Ruttinger, Tucker Ellis LLP, Cleveland, Ohio, Susan M. Sharko, Jennifer La Mont, Drinker Biddle & Reath LLP, Florham Park, New Jersey, for Appellees.

Before: GIBBONS and McKEAGUE, Circuit Judges; ANDERSON, District Judge.^*

OPINION

JULIA SMITH GIBBONS, Circuit Judge.

Stephanie Yates experienced a stroke while using the ORTHO EVRA ® birth control patch, and she now seeks to hold the designers and manufacturers of the patch liable. Yates appeals the district court's award of summary judgment to defendants on all five of her claims. For the reasons set forth in this opinion, we affirm the district court's judgment.

I.

A.

Yates brought suit against Ortho–McNeil–Janssen Pharmaceuticals, Inc., Alza Corporation, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Johnson & Johnson ("defendants") in the New York State Supreme Court for Erie County in September 2008. Defendants then removed the case to the United States District Court for the Western District of New York, pursuant to 28 U.S.C. §§ 1332, 1441, and 1446. Thereafter, the case was transferred to the United States District Court for the Northern District of Ohio, pursuant to 28 U.S.C. § 1407, for consolidated pretrial proceedings in connection with In re: Ortho Evra Products Liability Litigation, MDL No. 1742. Judge David Katz has overseen product liability claims involving ORTHO EVRA ® since March 2006, when the Judicial Panel on Multidistrict Litigation established MDL 1742. See In re Ortho Evra Prods. Liab. Litig., 422 F.Supp.2d 1379, 1381 (J.P.M.L.2006).

In the district court, Yates alleged five causes of action against defendants: (1) strict liability in tort—failure to warn; (2) strict liability in tort—manufacturing defect; (3) negligence; (4) breach of implied warranty; and (5) breach of express warranty. On April 7, 2014, the district court granted summary judgment as to Yates's failure to warn claim. Yates v. Ortho–McNeil–Janssen Pharm., Inc., No. 3:09oe40023, 2014 WL 1369466 (N.D.Ohio Apr. 7, 2014). Thereafter, on January 5, 2015, the district court granted summary judgment as to Yates's remaining claims and entered final judgment dismissing the case. Yates v. Ortho–McNeil Pharm., Inc., 76 F.Supp.3d 680 (N.D.Ohio 2015). Yates timely appealed the district court's dismissal of all five of her causes of action.

B.

Yates first visited OB/GYN Associates of Western New York on May 20, 2004, for her first gynecological appointment. Yates again visited OB/GYN Associates on November 3, 2004, when she was seventeen years old, because she was sexually active and was suffering from severe menstrual cramps. During the November 3, 2004 appointment, a licensed physician assistant—Jennifer Smith—counseled Yates about a variety of contraceptives, as well as the risks and benefits accompanying each product. Smith discussed the risks, benefits, and side effects of several methods of birth control, including oral contraceptives, Depo–Provera, NuvaRing, and ORTHO EVRA ®. Smith testified that it would have been her usual practice to advise Yates that all these methods of birth control carried risks, including breakthrough bleeding, moodiness, headaches, nausea, breast tenderness, blood clots, and stroke, and that the benefits included menstrual relief, and, obviously, birth control. Yates admits that she was counseled concerning the risk of a stroke and clotting associated with ORTHO EVRA ®. At this time, Yates decided to try Depo–Provera, which requires injections at three-month intervals. Before this examination and consultation, Yates admittedly had never heard of ORTHO EVRA ®.

Yates returned to OB/GYN Associates on March 3, 2005, because she wanted to discontinue the use of Depo–Provera due to weight gain. Yates did not want to take an oral contraceptive because she would have trouble remembering to take a pill every day. Yates elected to switch to the ORTHO EVRA ® patch. Smith approved the change to ORTHO EVRA ®, to begin on March 6, 2005. However, Yates was suffering from "constant heavy menses," which is a common side effect of Depo–Provera and which delayed her switch to ORTHO EVRA ®. DE 48–6, Smith Dep., Page ID 286. Yates again visited OB/GYN Associates on March 18, 2005, March 29, 2015, and April 15, 2005. Smith testified that it would have been her custom and practice during the March 18, 2015 visit to again review with Yates the side effects and risks of ORTHO EVRA ®. During the April 15, 2005 visit, Smith again discussed several side effects of ORTHO EVRA ® with Yates. At some time during this visit, Yates was given a sample of ORTHO EVRA ®. Although the sample patches came with a cardboard flyer, which listed a phone number and website associated with ORTHO EVRA ®, Yates never called the number or visited the website. Nor did Yates perform any Internet research on ORTHO EVRA ® prior to using it. Yates further admitted that she would have used ORTHO EVRA ® even if she had read the warnings, which included an increased risk of developing strokes and blood clots.

Yates first used the ORTHO EVRA ® patch on April 17, 2005, and she suffered a stroke on April 24, 2005, while she was still wearing her first weekly patch. One of Yates's expert witnesses, Dr. Mary Elizabeth Roemholdt, a board-certified neurologist and neurophysiologist, opined that Yates's "use of the Ortho–Evra patch was the contributing cause of her stroke." DE 94–8, Roemholdt Aff., Page ID 4697.

Smith began working at OB/GYN Associates in 2001. As a physician assistant, Smith sees patients for routine checkups, gynecological problems, diagnosis, and treatment, and she is authorized to prescribe medications. According to her deposition testimony, Smith prescribes medications based on her knowledge, training, and experience, as well as her assessment of the patient and her own clinical experience. Smith learns about the risks of medications that she prescribes from a variety of sources, including pharmaceutical sales representatives, medical journals, continuing medical education classes, and discussions with other doctors, physician assistants, and nurse practitioners in her office. Smith's custom is to prescribe contraceptives that, in her independent medical judgment, will be safe and effective for the particular patient. With regard to ORTHO EVRA ®, Smith knew that the warnings for the patch included increased risks of thromboembolism and stroke. Smith also acknowledges that she tells her patients that one of the risks of using ORTHO EVRA ® is the risk of developing a blood clot or a thromboembolism. Smith further testified that she still prescribes ORTHO EVRA ® for her patients.

C.

As with other hormonal contraceptives, ORTHO EVRA ® prevents pregnancy by delivering higher and more consistent levels of estrogen and progestin than present in normal menstrual cycles. Strokes are a well-known potential side effect associated with hormonal contraceptives. The ORTHO EVRA ® package insert in use at the time Yates used the patch contained information about the drug for prescribing physicians to review, and included the following warnings:

The use of combination hormonal 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 healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

...

Hormonal 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. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, and smoking interacted to increase the risk of stroke.

In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normal 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 hormonal contraceptives, 2.6 for smokers who did not use hormonal contraceptives, 7.6 for smokers who used hormonal contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women.

DE 48–8, Package Insert, Page ID 326–27.

The FDA requires that patient package inserts accompany each package of an estrogen drug product that the manufacturer or distributor intends to be dispensed to a patient. See 21 C.F.R. § 310.515. Accordingly, the patient package insert for ORTHO EVRA ® included the following warning:

RISKS OF USING HORMONAL CONTRACEPTIVES, INCLUDING ORTHO EVRA ®

...

2. Heart attacks and strokes

Hormonal contraceptives, including ORTHO EVRA ®, may increase the risk of developing strokes (blockage or rupture of blood vessels in the brain ) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability.

Smoking and the use of hormonal contraceptives

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