Giffen v. Ortho Mcneil Pharm., Inc.
| Decision Date | 26 September 2014 |
| Docket Number | Case No. 3:12 oe 40001 |
| Parties | RACHEL GIFFEN, Plaintiff, v. ORTHO MCNEIL PHARMACEUTICAL, INC., et al., Defendant. |
| Court | U.S. District Court — Northern District of Ohio |
Plaintiff Rachel Giffen, a Missouri resident, brought this action against Defendants Ortho-McNeil Pharmaceutical, Inc., Alza Corporation, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Johnson & Johnson alleging she had been prescribed the Ortho Evra® birth control patch which caused her to have a stroke. (Doc. No. 1). Defendants filed a motion for judgment on the pleadings or in the alternative, summary judgment. (Doc. No. 16). Plaintiff filed a response (Doc. No. 18) and Defendants replied (Doc. 19). On September 23, 2014, the Court heard oral argument on the pending motion in this case and several other cases concerning the Ortho Evra® birth control patch. The Court has jurisdiction over this matter pursuant to 28 U.S.C. § 1332.
Plaintiff was given a sample of the FDA approved Ortho Evra® birth control patch in March 2008 and used the patch for one month. As a result, Plaintiff alleges she experienced a stroke. Plaintiff commenced this action in the Northern District of Ohio as part of the Ortho Evra® multidistrict litigation (MDL). In doing so, Plaintiff incorporated by reference portions of the MDLMaster Complaint alleging the following causes of action: 1) negligence; 2) negligence per se; 3) strict product liability - failure to warn; 4) breach of express warranty; 5) breach of implied warranties; 6) fraudulent misrepresentation; 7) fraudulent concealment; 8) negligent misrepresentation; 9) fraud and deceit; and 10) gross negligence/malice. (Doc. 1).
From approximately July 2007 to April 2008, Deborah Awoniyi-Obrimah, DNP, RN, WHCNP-BC, worked for Planned Parenthood of Kansas and Mid-Missouri as a licensed nurse practitioner. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 4, 9). She had been working as a nurse or nurse practitioner for approximately fifteen years and was authorized to prescribe hormonal birth control products. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 4). Her knowledge and expertise concerning contraceptives came from multiple sources, including her medical training and education, professional journals, office handouts, and package inserts containing product information about specific medications. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 6, 8).
According to her deposition testimony, Nurse Awoniyi-Obrimah decided what medication to prescribe based on clinical experience, experience with different products, knowledge of products, and patient assessment. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 8-9, 12). After consulting with a patient, Nurse Awoniyi-Obrimah would retrieve the contraceptive from a Planned Parenthood supply room and give it directly to the patient. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 10). She would then counsel the patient about the medicine and encourage them to read the information, or package insert, that came with the specific contraceptive. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 10). As part of this consultation, the patient also received a pamphlet on various birth control methods, which included the risks and benefits associated with hormonal birth control. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 11).
During her employment with Planned Parenthood, Nurse Awoniyi-Obrimah prescribed many different hormonal birth control products, which she concedes have a variety of risks, including clotting events and cerebrovascular events such as strokes. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 11-13). She also acknowledged that warnings about those risks are included in the package inserts, including warnings that smoking increased the risks of adverse events when taking a hormonal birth control. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 12-16, 18).
Nurse Awoniyi-Obrimah was familiar with the risks and benefits associated with the Ortho Evra® patch, including higher estrogen exposure. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 12-16, 18). Nurse Awoniyi-Obrimah confirmed she counseled patients who smoked about the increased risk of a stroke when using the Ortho Evra® birth control patch. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 12-16, 18). She was also familiar with the risks set forth in the Orth Evra® package insert when she prescribed the medication to Plaintiff in March 2008, which included detailed patient labeling containing a warning about increased risk of stroke for smokers. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 12-16, 18). Nurse Awoniyi-Obrimah was also aware the package insert included a specific warning regarding the potential increased risk of venous thromoembolism (VTE) for Ortho Evra® users as compared to the birth control pill. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 16).
In February 2008, Plaintiff met with Nurse Awoniyi-Obrimah at Planned Parenthood for birth control counseling. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 20-21). After consultation, Plaintiff chose the Depo-Provera shot as her preferred method of birth control. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 20-21). In doing so, Plaintiff received the general pamphlet regarding the risks and benefits associated with hormonal birth control. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 21-22).
On March 6, 2008, Plaintiff returned to Planned Parenthood for her scheduled Depo-Provera shot. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 22-23). However, Plaintiff had changed her mind on her preferred birth control method and requested the Orth Evra® birth control patch instead. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 22-23). Nurse Awoniyi-Obrimah prescribed the Orthro Evra® birth control patch and gave Plaintiff a box sample. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 22-23). According to Plaintiff, Nurse Awoniyi-Obrimah instructed her on how to use the patch but did not explain the risks associated with that use. (Giffen Aff., Doc. 18-5, at 122-24). Plaintiff admits she received the package insert with the box sample of Ortho Evra®, which included the detailed patient labeling. (Giffen Aff., Doc. 18-5, at 125-26, 133-34). At that time, Plaintiff smoked one pack of cigarettes per day. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 19-20; Doc. 18-2, at 10).
Plaintiff did not use the Ortho Evra® sample right away. Rather, she became pregnant and returned to Planned Parenthood to terminate the pregnancy at six weeks gestation on June 13, 2008. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 23). Subsequently, Plaintiff began using the Ortho Evra® birth control patch sometime in July 2008 and used it for one month or one cycle (three one-week patches). (Giffen Aff., Doc. 18-5, 123, 129). Plaintiff claims the patch had been "off" for approximately two weeks before she suffered a stroke on September 4, 2008. (Giffen Aff. Doc. 18-5, at 201; Doc. 18-2, at 13).
At her deposition, Nurse Awoniyi-Obrimah testified that before she prescribed Plaintiff the Orth Evra® birth control patch, she considered Plaintiff's personal medical history, family medical history, physical condition based on a physical examination, and desire to obtain birth control. Nurse Awoniyi-Obrimah also took into account all the information she knew about Orth Evra®,including information in the package insert and her knowledge and training as a nurse practitioner, when prescribing Ortho Evra® to Plaintiff. (Awoniyi-Obrimah Aff., Doc. No. 16-3, at 23-24).
In sum, before Plaintiff's stroke, Nurse Awoniyi-Obrimah was aware the Orth Evra® patch could cause a stroke. Nurse Awoniyi-Obrimah was also familiar with the language of the Ortho Evra®'s package insert, including the detailed patient labeling, which warned about the risk of a stroke and increased risks associated with cigarette smoking. Moreover, it was Nurse Awoniyi-Obrimah's custom and practice to discuss with patients the specific risks associated with each hormonal birth control she prescribed. Despite acknowledging the associated risks of hormonal birth control, Nurse Awoniyi-Obrimah confirmed the Ortho Evra® birth control patch was a safe and effective product that she prescribed patients on a regular basis.
Summary judgment is proper where "there is no genuine dispute as to any material fact" and the moving party "is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A party asserting a genuine issue of material fact must support the argument either by "citing to particular parts of materials in the record" or by "showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(1). The Court views the facts in the record and reasonable inferences that can be drawn from those facts in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). The Court does not weigh the evidence or determines the truth of any matter in dispute. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).
The party requesting summary judgment bears an initial burden of demonstrating that no genuine issue of material fact exists, which the party must discharge by producing evidence to demonstrate the absence of a genuine issue of material fact or "by showing . . . that there is an absence of evidence to support the nonmoving party's case." Celotex Corp. v. Catrett, 477 U.S. 317, 323-25 (1986) (internal quotation marks omitted). If the moving party satisfies this burden, the nonmoving party "may not rest upon its . . . pleadings, but rather must set forth specific facts showing that there is a genuine issue for trial." Moldowan v. City of Warren, 578 F.3d 351, 374 (6th Cir. 2009) (citing Rule 56 and Matsushita, 475 U.S. at 586). The party opposing the summary judgment motion must present sufficient probative evidence supporting its...
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