Dyson v. Winfield, C.A. 97-1665(RCL).
| Decision Date | 21 September 2000 |
| Docket Number | No. C.A. 97-1665(RCL).,No. C.A. 97-1666(RL).,C.A. 97-1665(RCL).,C.A. 97-1666(RL). |
| Citation | 113 F.Supp.2d 35 |
| Parties | Lakeshia DYSON, personally and as Personal Representative for the Estate of Rico Monroe, Jr., Plaintiff, v. Joseph K. WINFIELD, M.D., Defendant. Lakeshia Dyson, personally and as Personal Representative for the Estate of Rico Monroe, Jr., Plaintiff, v. Pharmacia & Upjohn, Inc., Defendant. |
| Court | U.S. District Court — District of Columbia |
Robert A.W. Boraks, John Hugo Jamnback, Garvey, Schubert & Barer, Washington, DC, for plaintiff.
Vincent Hamilton Cohen, Stephen George Vaskov, Hogan & Hartson, L.L.P. Washington, DC, for Pharmacia & Upjohn, defendant.
On July 23, 1997, Lakeshia Dyson, the plaintiff, filed a complaint against Pharmacia & Upjohn ("P & U"), the defendant, alleging products liability, breach of warranty, and fraud. Now before the Court are several motions by the defendant, as well as one by the plaintiff. The defendant moves for summary judgment on each of the plaintiff's three allegations. The plaintiff moves, pursuant to Rule 56(f), to continue discovery of information relevant to her fraud claim. For the following reasons, this Court GRANTS each of the defendant's motions.
This case arises from Lakeshia Dyson's use of Provera in September and October of 1992. Concerned that she was pregnant, Ms. Dyson went to see Dr. Joseph Winfield, her OB/GYN, on September 26, 1992. She explained to Dr. Winfield that she had had unprotected sex a week prior and that her period was now late. Dr. Winfield gave her a urine pregnancy test which he interpreted as negative. Dr. Winfield then prescribed Provera to Ms. Dyson with the goal of inducing her menstruation.
Ms. Dyson took the Provera and, not having her period, returned to Dr. Winfield's office on October 17, 1992. During the consultation, Dr. Winfield took a blood sample to make certain whether or not she was pregnant. Although Dr. Winfield denies it, Ms. Dyson and her mother, who accompanied her on this visit, assert that they were told by the doctor that Ms. Dyson was pregnant. In any event, as the blood test later revealed, Ms. Dyson was indeed pregnant. At no point during this consultation did Dr. Winfield warn the patient of the risks associated with taking Provera in the early stages of pregnancy.
After her consultation, Ms. Dyson never talked with Dr. Winfield again, choosing instead to continue her prenatal care with a different doctor. In February of 1993, when she was over five months pregnant, Ms. Dyson received a sonogram that revealed the possibility of a birth defect. After considering abortion as an option, she decided to carry her pregnancy to full term because she felt that the child was "a baby" and not "a fetus." Dyson Aff. ¶ 9.
On May 15, 1993, Rico Monroe Jr. was born. Sadly, the child had numerous birth defects including, but not limited to, impairments of sight, hearing, ingestion, and intellect.1 The child required intense medical care, both in and out of the hospital, throughout his entire life. On November 24, 1996, at an age of about 3 and a half years old, the child died.
A short history of Provera is in order before moving on. Provera is a synthetic analog of the naturally occurring female hormone progesterone. It is available only by prescription from a physician. The drug was first marketed in 1959 primarily for treatment of secondary amenorrhea, a condition marked by infrequent or suspended menstruation. Although there has been debate over Provera's teratogenicity,2 in 1989 the FDA advised the manufacturer of Provera that it should delete warnings regarding the risks of pre-natal exposure to the drug. P & U wished to continue to include such warnings, and, pursuant to the mandates of 23 C.F.R. § 601.12, asked permission of the FDA to do this. The FDA refused the variance from its warning guidelines. P & U sought permission to depart from the guidelines again in 1992. Again, the FDA refused the request. Since 1992, P & U has been marketing Provera in accordance with the guidelines imposed by the FDA.
Basing her claims on the District of Columbia Wrongful Death statute, 16 D.C.Code § 2701, and Wrongful Survival statute, 12 D.C.Code § 101, the plaintiff brought suit on July 23, 1997 against the defendant on her own and her son's behalf. In her complaint, she alleged three counts. In her first count, products liability, the plaintiff alleged that the defendant's product was defectively designed and that it did not contain adequate warnings. In her second and the third counts, the plaintiff alleged breach of warranty and fraud respectively. On January 21, 2000, after a long period of discovery, defendant filed the motions now before this Court.
As a preliminary matter, the Court notes jurisdiction under 28 U.S.C. § 1332 (1994). All defendants are citizens of states other than the District of Columbia, where Ms. Dyson is a citizen. The amount in controversy exceeds $75,000 exclusive of interest and costs. In matters requiring the application of substantive law, the law of the District of Columbia will govern. Erie R.R. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).
Federal Rule of Civil Procedure 56(c) provides that a district court shall grant summary judgment "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is (1) no genuine issue as to any material fact and that (2) the moving party is entitled to judgment as a matter of law." See Fed. R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Diamond v. Atwood, 43 F.3d 1538, 1540 (D.C.Cir.1995). To survive a motion for summary judgment, the nonmovant must make a "sufficient showing to establish the existence of an element essential to that party's case." Celotex, 477 U.S. at 322, 106 S.Ct. 2548. A "sufficient showing" exists when the evidence is such that a reasonable jury could return a verdict for the nonmovant. Anderson, 477 U.S. at 248, 106 S.Ct. 2505.
In making her products liability claim, plaintiff alleges that Provera had a design defect in that it was "unreasonably dangerous to women in early pregnancy." Compl. for Plaintiff at 5. Plaintiff further alleges that P & U failed to include an "adequate warning" of the drug's potential side-effects. Id. On both the design defect and failure to warn count, this Court finds that the plaintiff has not adduced sufficient evidence to survive a summary judgment motion. Accordingly, the Court grants the defendant's motion for summary judgment.
It is well established that to recover under a products liability theory, a plaintiff must show, inter alia, that the product in question was defective, and that the defect caused the alleged harm. See, e.g., Word v. Potomac Elec. Power Co., 742 A.2d 452, 459 (D.C.1999). Since the adoption of section 402A, the products liability section of the Restatement (Second) of Torts, the chief dispute has been over what renders a product "defective." Prescription drugs, however, have partially escaped this melee over defectiveness. The escape route is known simply as "Comment k."
"Comment k" refers to the American Law Institute's special consideration of prescription drugs under section 402A. Prescription drugs garnered special attention from the Institute because drugs, unlike most other products, sometimes cause a great deal of pain that is nonetheless offset by a larger amount of health benefit. Comment k describes the phenomenon in detail:
Unavoidably Unsafe Products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended use. These are especially common in the field of drugs. An outstanding example in the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.
Restatement (Second) of Torts, § 402A, Comment k. The District of Columbia has adopted section 402A. See Berman v. Watergate West, Inc., 391 A.2d 1351 (D.C. 1978); Cottom v. McGuire Funeral Service, Inc., 262 A.2d 807 (D.C.1970). See also Raynor v. Richardson-Merrell, Inc., 643 F.Supp. 238, 247 (D.D.C.1986).
Comment k's association with strict liability may be misleading. As one court has noted, "[m]ost jurisdictions ... rely on Comment k as authority for applying what is effectively a negligence standard...." Shirkey v. Eli Lilly & Co., 852 F.2d 227, 232 (7th Cir.1988) (). See also Raynor, 643 F.Supp. at 247 () (quoting Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir.1969)). Thus understood, the issues here become those of any negligence case: duty, breach, causation, and injury. A drug manufacturer's duty comes from Comment k itself; the duty is to "properly prepare[]" the drug and include "proper directions and warning[s]" with it. The other elements, however, must come from the plaintiff, who, in this case, has faltered on the breach and causation elements. The plaintiff has adduced no evidence that the defendant breached its duty to properly prepare Provera. Regarding the defendant's duty to warn, the plaintiff has failed to present evidence that an inadequate...
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