Yates v. Ortho-McNeil Pharm., Inc.

• Decision Date: 05 January 2015
• Docket Number: Case No. 3:09 oe 40023.
• Citation: 76 F.Supp.3d 680
• Parties: Stephanie YATES, Plaintiff, v. ORTHO–McNEIL PHARMACEUTICAL, INC., et al., Defendant.
• Court: U.S. District Court — Northern District of Ohio

76 F.Supp.3d 680

Stephanie YATES, Plaintiff

v.ORTHO–McNEIL PHARMACEUTICAL, INC., et al., Defendant.

Case No. 3:09 oe 40023.

United States District Court, N.D. Ohio, Western Division.

Signed Jan. 5, 2015.

Daniel G. Tronolone, Tronolone & Surgalla, Lawlor F. Quinlan, III, Terrence M. Connors, Connors & Vilardo, Buffalo, NY, Gerard A. Strauss, Hamburg, NY, Janet G. Abaray, Burg Simpson Eldredge Hersh Jardine, Cincinnati, OH, Michael S. Burg, Burg Simpson Eldredge Hersh Jardine, Englewood, CO, for Plaintiff.

John D. Winter, Patterson, Belknap, Webb & Tyler, New York, NY, Julie A. Callsen, Robert C. Tucker, Tucker Ellis, Cleveland, OH, Susan M. Sharko, Jennifer L. La Mont, Florham Park, NJ, for Defendant.

MEMORANDUM OPINION

KATZ, District Judge.

Stephanie Yates, who is a New York resident, sued Ortho–McNeil Pharmaceutical, Inc. (now know as Janssen Pharmaceuticals, Inc.), Alza Corporation, Johnson & Johnson Pharmaceutical Research and Development, LLC (now known as Janssen Research & Development, LLC), and Johnson & Johnson in the Erie County (New York) Supreme Court. Ms. Yates alleged that she had been prescribed the Ortho Evra ® birth control patch which allegedly caused her to have a stroke. The Defendants moved for summary judgment. (Doc. No. 48). Ms. Yates filed a response (Doc. No. 57), and the Defendants filed a reply. (Doc. No. 65). Both parties also filed sur-replies. (Doc. Nos. 85, 86).

On April 7, 2014, 2014 WL 1369466, the Court granted Defendants' motion for summary judgment on Ms. Yates's failure to warn claim. Defendants' motion to dismiss Ms. Yates's manufacturing defect, negligence, breach of implied warranty, and breach of express warranty claims for failing to state a claim for relief was denied. The Court also denied Ms. Yates's motion to amend her complaint. (Doc. Nos. 88, 89).

Defendants have now moved for summary judgment on Ms. Yates's manufacturing defect, negligence, breach of implied warranty, and breach of express warranty claims. (Doc. No. 90). Ms. Yates has filed a response (Doc. No. 94), the Defendants have filed a reply (Doc. No. 95), and Ms. Yates has filed a sur-reply. (Doc. No. 100).

On October 15, 2014, the Court heard oral argument on the pending motion for summary judgment. (Doc. No. 112). Thirty-nine minutes into the oral argument, former co-lead counsel Michael S. Burg and Janet G. Abaray for the Ortho Evra® Multidistrict Litigation (MDL) Plaintiffs, along with Michael A. London, former liaison counsel for the MDL Plaintiffs, moved to intervene pursuant to Federal Rule of Civil Procedure 24(b). (Doc. No. 105). The Defendants filed a response opposing the motion to intervene. (Doc. No. 106). The proposed intervenors have filed a reply. (Doc. No. 109). The proposed intervenors filed a motion for leave to file an amici curiae brief requesting the Court to deny the motion for summary judgment. (Doc. No. 113).

Following oral argument, the Court granted the parties leave to file supplemental briefing on the question of whether federal law preempts Ms. Yates's state law design defect claim. The Defendants filed their initial brief (Doc. No. 111), Ms. Yates filed a response (Doc. No. 114), and the Defendants filed a reply. (Doc. No. 116). The Defendants have also filed a brief opposing the request to file the amici curiae brief. (Doc. No. 115). The proposed intervenors have filed a reply in support of their motion to file an amici curiae brief. (Doc. No. 117).

I. Facts

On September 4, 2008, Ms. Yates sued the Defendants asserting that after she had been prescribed the Ortho Evra ® birth control patch, she suffered a stroke on April 24, 2005. Ms. Yates alleged the following causes of action: 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.

The Defendants removed the case to the United States District Court for the Western District of New York. Following removal, the case was transferred to the undersigned as related to the Ortho Evra ® litigation by the Judicial Panel on Multidistrict Litigation. In re Ortho Evra Prods. Liab. Litig., 1:06 cv 40000 MDL 1742 (N.D.Ohio).

Ms. Yates first received counseling concerning different birth control options, including the Ortho Evra ® patch, on November 3, 2004. Before then, Ms. Yates was unaware of the Ortho Evra ® patch either from advertisements or from personal contacts. Ms. Yates admittedly had never heard of the Ortho Evra ® patch until she met with OB/GYN Associates of Western New York in November 2004.

Jennifer Anne Smith is a licensed physician's assistant and, since 2001, specialized in obstetrics and gynecology at OB/GYN Associates. Her job included seeing, examining, diagnosing, and treating women for both routine gynecology examinations and gynecological problems. Ms. Smith also prescribes medicines, including hormonal contraceptives. Her knowledge and expertise concerning contraceptives comes from multiple sources, including her medical training, published literature in professional journals, professional conferences, continuing medical education classes, the Physicians' Desk Reference, office handouts, and product information provided by company sales representatives.

According to her deposition, Ms. Smith decides on what medications to prescribe based upon her clinical experience, knowledge of product, and patient assessment. With regards to birth control, Ms. Smith considers not only the medication, but also the circumstances of the particular patient, including the patient's health, physical condition, personal and family medical history, and potential contraindications. Ms. Smith weighs the risks and benefits of the medicine for the particular patient. Ms. Smith prescribes a birth control product based upon her independent medical judgment and her conclusion that the medicine will be safe and effective for the particular patient. Ms. Smith admittedly recognizes that all medicines have potential risks and only prescribes medications if she is satisfied that “the patient is more likely to be helped than hurt by the product.”

Over the years, Ms. Smith has prescribed many different hormonal birth control products, which she concedes have risks, including an increased risk of blood clots, deep vein thrombosis, heart attack, and stroke. She also acknowledges that warnings about those risks have been included in the package inserts for healthcare professionals and patients for many years, long before she prescribed the Ortho Evra ® patch to Ms. Yates in 2005. Ms. Smith stated she has counseled patients concerning these risks for many years.

Ms. Smith was and still is familiar with the risks and benefits of the Ortho Evra ® patch. This knowledge existed even before she prescribed the Ortho Evra ® patch to Ms. Yates. Based upon her experience, Ms. Smith believes that the Ortho Evra ® patch is easy to use and has a high compliance rate. Ms. Smith was familiar with the risks and contraindications set forth in the Ortho Evra ® package insert, including the Detailed Patient Labeling, when she prescribed the Ortho Evra ® patch to Ms. Yates. Based upon her clinical judgment, Ms. Smith feels that Ortho Evra ® is a reasonable, safe, and effective birth control method for some patients, and continues to prescribe the product.

On November 3, 2004, Ms. Yates was seventeen years old. She went to OB/GYN Associates in order to be placed on birth control because of “[s]evere menstrual cramps ” and because she was sexually active. Ms. Yates's mother, Judy Yates, did not accompany her daughter to this meeting.

On that date, Ms. Smith counseled Ms. Yates concerning the options, risks, and benefits of the various birth control products on the market. Ms. Smith's office notes state she discussed the risks, benefits, and side effects of various contraceptive options. Ms. Smith's habit and custom was to discuss the risks involved, including headaches, nausea, breast tenderness, moodiness, blood clots, and stroke. She also discussed the benefits of preventing an unplanned pregnancy and the relief from menstrual cramping. Ms. Yates concedes she was counseled concerning the risk of a stroke and clotting associated with the Ortho Evra ® patch.

Ms. Yates selected Depo–Provera because the injections were only required at three-month intervals. Ms. Yates received her first Depo–Provera injection on November 26, 2004. She never returned for the second shot, and on March 3, 2005, she told nurse Christine Palbo that she decided to discontinue Depo–Provera due to weight gain. Ms. Yates stated she wanted to try the Ortho Evra ® patch. Ms. Yates complained of heavy or irregular bleeding, which was a recognized side effect of the Depo–Provera injection, and was a common complaint by Depo–Provera users. Nurse Palbo consulted Ms. Smith concerning Ms. Yates's request to change her birth control method. Ms. Smith approved the change to the Ortho Evra ® patch, starting March 6, 2005. However, due to continuous bleeding and a possible pregnancy, Ms. Yates did not begin using the Ortho Evra ® patch until April 17, 2005.

Ms. Smith stated in her deposition that when a patient decides to change her birth control method, it is her standard practice to re-counsel the patient concerning the risks of the product, including the risk of a stroke. On April 15, 2005, two days before Ms. Yates started using the patch, Ms. Smith advised Ms. Yates that the Ortho Evra ® patch might be less effective due to her weight. Ms. Smith, per her routine, again reminded Ms. Yates concerning the potential risks and side effects associated with the use of the Ortho Evra ® patch. Ms. Yates failed to perform any research regarding the Ortho Evra ® patch because she trusted the medical advice she was given. Ms. Yates admitted in her deposition that she would still have used the Ortho Evra ® patch if she read the warning in the Detailed Patient Labeling, including the warnings about the risk of stroke.

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