Colville v. Pharmacia & Upjohn Company LLC, Case No. 4:07-CV-140-SPM.
| Decision Date | 10 July 2008 |
| Docket Number | Case No. 4:07-CV-140-SPM. |
| Citation | 565 F.Supp.2d 1314 |
| Parties | Cassandra COLVILLE, an individual, Plaintiff, v. PHARMACIA & UPJOHN COMPANY LLC, a Florida Limited Liability Corporation, Defendant. |
| Court | U.S. District Court — Northern District of Florida |
Reshonda Leshay Bradford, W. James Singleton Law Firm, Shreveport, LA, for Plaintiff.
Edward W. Gerecke, Carlton Fields PA, Tampa, FL, for Defendant.
ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
THIS CAUSE comes before the Court upon Defendant's motion for summary judgment (doc. 22) and supporting statement of material facts (doc. 23). Plaintiff has filed a response (doc. 29) and a supporting statement of facts (doc. 30). Plaintiff is a thirty-five year-old woman who has been diagnosed with osteopenia, or loss of bone mineral density. People diagnosed with osteopenia have a strong likelihood of developing osteoporosis. Plaintiff alleges that her development of osteopenia was the direct result of her use of Depo-Provera Contraceptive Injection as a form of birth control, which is manufactured and marketed by Defendant. Plaintiff is now suing Defendant under the theories of negligence and strict liability for their failure to warn patients that extensive use of Depo-Provera would cause osteopenia. For the reasons set forth below, Defendant's motion for summary judgment will be granted.
Plaintiff began Depo-Provera as her primary method of birth control in 1995, at the age of twenty-five. Plaintiff used Depo-Provera consistently for eight years, until 2002. Plaintiff initially stopped using Depo-Provera because she wanted to become pregnant. In April 2003, Plaintiff went on a website and read that women taking Depo-Provera should get a DEXA scan. At that time, Plaintiff did not know that the purpose of this scan was to evaluate a person's bone density level. On April 25, 2003, Plaintiff received a DEXA scan. This test showed that Plaintiff had osteopenia in her lumbar spine. The scan was also done on Plaintiffs left hip, but the result was normal.
In early 2004, Plaintiff gave permission for her 16-year-old daughter, Adrianne Oliver, to begin using Depo-Provera as her primary form of birth control. At that time, Plaintiff still had not yet made the connection between taking Depo-Provera and her osteopenia. Plaintiff alleges that neither she nor her doctors were advised that use of the medication for any extensive period of time would lead to the development of osteopenia.
Plaintiff did not have a family history of osteopenia or osteoporosis, nor was Plaintiff in a high-risk category for development of osteoporosis. After Plaintiffs daughter used Depo-Provera for two years, she was diagnosed with osteopenia. Plaintiff learned that this diagnosis was likely related to her use of Depo-Provera. It was at that time that Plaintiff realized that her own osteopenia was likely the result of her use of Depo-Provera.
On October 29, 1992, the United States Food and Drug administration ("FDA") approved Depo-Provera for use as a safe and effective prescription contraceptive. At that time, Defendant conducted a long-term post-marketing clinical trial to examine the product's effect on bone mineral density. When Depo-Provera was initially approved for use, the FDA approved a package insert for physicians who prescribed Depo-Provera. The package insert contained a "physician information" section and a "patient labeling" section. From 1992 through 2004, the "physicians information section" stated, under the heading "Warnings," information about bone mineral density changes. In substance, the section stated"
During the same time period, from 1992 through 2004, the "patient labeling" section had a subsection entitled "Risks of Using Depo-Provera Contraceptive Injection." This subsection stated:
In 2004, as the result of the clinical trial on bone mineral density, together with FDA approval, the package insert was revised to include a black box with bold lettered-font that stated:
Women who use Depo-Provera Contraceptive Injection may lose
significant bone mineral density. Bone loss is greater with increasing
duration of use and may not be completely reversible
It is unknown if use of Depo-Provera Contraceptive Injection during
adolescence or early adulthood, a critical period of bone accretion, will
reduce peak bone mass and increase the risk of osteoporotic fracture in
later life
Depo-Provera Contraceptive Injection should be used as a long-term birth
control method (e.g., longer than two years) only if other birth control
methods are inadequate (see WARNINGS)
Additionally, the revised package insert included a detailed discussion of the results of Defendant's clinical trials that led to the new warning.
Dr. Zinnah Holmes treated Plaintiff from 1994 through 2003. Dr. Holmes is the doctor who prescribed Depo-Provera to Plaintiff. Dr. Holmes testified that the language on the warning label for Depo-Provera was "clear and understandable" language advising physicians that Depo-Provera could be a factor for osteoporosis. Dr. Holmes also testified that she understood that the rate of bone loss was greatest in the early years of use of Depo-Provera and that this warning was adequate to advise her of the risk factors and the greatest period of bone loss when using Depo-Provera. Dr. Holmes said that she still prescribes Depo-Provera today and that she has not changed the method by which she prescribes it.
In 2005, when Plaintiff relocated to Louisiana, she became a patient of Dr. Rutu Mahajan. At this time, Plaintiff was no longer using Depo-Provera. At her first visit, on August 4, 2005, Dr. Mahajan learned that Plaintiff had been diagnosed with osteopenia by her previous doctor. Dr. Mahajan conducted Plaintiffs second bone density scan on August 5, 2005. He scanned her lumbar spine and left hip. The results were that Plaintiff had osteopenia of the lubar spine. The left hip bone density was normal. On March 9, 2006, Dr. Mahajan reviewed Plaintiffs DEXA scan with her. At that visit, neither Dr. Mahajan nor Plaintiff made a connection between Plaintiffs low bone density and her use of Depo-Provera. Dr. Mahajan also testified that there are no physical symptoms associated with osteopenia and that osteopenia is not an injury, it is "a slow process in the bone which leads to an injury." He also testified that Plaintiffs bone density scan from 2005 showed some improvement from the scan in 2003.
Dr. Leon Cass Terry was selected as Plaintiffs expert in this case.1 Dr. Terry has experience with synthetic hormones and its effects upon the female body. Prior to rendering an opinion, Dr. Terry reviewed Plaintiffs medical records (including the results of the first two DEXA scans); the court documents filed in this case; research linking Depo-Provera to osteopenia; and research showing the connection between osteopenia and osteoporosis. Dr. Terry testified that Plaintiffs first DEXA scan showed "definitive evidence of osteopenia" in Plaintiffs lumbar spine and left hip. Plaintiff also showed osteopenia in her left femoral neck. The second DEXA scan showed that there was still osteopenia in Plaintiffs lumbar spine. In this scan, there was "no significant loss of bone density in the left hip." Dr. Terry stated that there was "no known genetic history of osteopenia or osteoporosis." Dr. Terry's opinion stated that he believed that the osteopenia was "the direct result of the long-term administration of Depo-Provera for eight years."
In his testimony, Dr. Terry stated that "osteopenia is not a disease, but a term that describes low bone density". Later, he testified that Plaintiff does suffer "some injury as a result of using Depo-Provera" because her DEXA scan showed slight abnormalities. Additionally, Dr. Terry testified that because Plaintiff had not had a DEXA scan prior to taking Depo-Provera, there was no way to know "the extent to which Depo-Provera may have impacted" Plaintiffs bone density. Terry also testified that between Plaintiffs 2005 scan through her 2007 scan, she had improved, especially with regard to her lumbar spine results. Dr. Terry's testimony concluded with the statement that because Plaintiff had not done a baseline DEXA scan, it is possible that Plaintiff could have had low bone density prior to her use of Depo-Provera.
Federal Civil Procedure Rule 56(c) provides for the granting of summary judgment "if the pleadings, depositions, answers to the interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." "Only factual disputes that are material under the substantive law governing the case will preclude entry of summary judgment." Lofton v. Sec'y of the Dep't of Children & Family Servs., 358 F.3d 804, 809 (11th Cir.2004) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Tipton v. Bergrohr GMBH-Siegen, 965 F.2d 994, 998 (11th Cir.1992)). "An issue of fact is material and genuine if a rational fact-finder could find for the nonmoving party on a fact necessary to establish an element of the claim under applicable...
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