Windham v. Wyeth Laboratories, Inc., Civ. A. No. H88-0200(P).

• Citation: 786 F. Supp. 607
• Decision Date: 14 February 1992
• Docket Number: Civ. A. No. H88-0200(P).
• Parties: Beverly WINDHAM, and her husband, Mikell Windham, Plaintiffs, v. WYETH LABORATORIES, INC., Defendants.
• Court: United States District Courts. 5th Circuit. Southern District of Mississippi

786 F. Supp. 607

Beverly WINDHAM, and her husband, Mikell Windham, Plaintiffs, v. WYETH LABORATORIES, INC., Defendants.

Civ. A. No. H88-0200(P).

United States District Court, S.D. Mississippi, Hattiesburg Division.

February 14, 1992.

David J. L'Hoste and Charles R. Ward, Jr., New Orleans, La., for plaintiffs.

Lee Davis Thames and Anne V. Winter, Jackson, Miss., for defendants.

MEMORANDUM OPINION AND ORDER

PICKERING, District Judge.

This cause comes before the Court pursuant to the Motion for Summary Judgment of Defendant Wyeth Laboratories, Inc. Having reviewed the motion and the parties' authorities, exhibits and memoranda in connection with same, the Court finds as follows:

I.

FACTUAL BACKGROUND

The Plaintiffs in this case, Beverly Windham and her husband, Mikell Windham, are adult resident citizens of Marion County, Mississippi. The Defendant, Wyeth Laboratories, Inc., is a foreign corporation doing business in Mississippi with its principal place of business in a State other than Mississippi. Therefore, this Court has diversity jurisdiction pursuant to 28 U.S.C. § 1332.

Beverly Windham and her husband, Mikell Windham ("the Windhams") filed this action seeking actual and punitive damages from Wyeth Laboratories, Inc. ("Wyeth") based upon Wyeth's allegedly improper conduct in manufacturing and placing onto the market a certain Phenergan suppository. In their Complaint, the Windhams charge Wyeth with breach of warranty, strict liability in tort, and negligent development, design, manufacture, marketing and distribution of Phenergan suppositories.¹

Phenergan is a prescription drug which can only be obtained on doctor's orders. That is, the medication is not available over the counter to the average consumer but may only be obtained under a valid prescription from a physician.

On July 5, 1984, Mrs. Windham, who was approximately 12-15 weeks pregnant at the time, called and spoke with Dr. Lamar Gillespie seeking relief from persistent nausea and vomiting. Although Dr. Gillespie was not Windham's primary physician, Gillespie was a member of the obstetrical/gynecological group whom Windham had used for several years. Dr. Gillespie was "covering" for Windham's primary physician, Dr. Raulston, who was not available on the day in question.

After discussing the situation with Mrs. Windham, Dr. Gillespie prescribed four 50-milligram Phenergan suppositories for her nausea and vomiting. Mrs. Windham used one of the four suppositories at that time, on or about July 5, 1984, and experienced no adverse reaction to the medication.

When he prescribed Phenergan to Mrs. Windham, Dr. Gillespie was aware of possible adverse reactions to the medication. However, he prescribed Phenergan anyway because "I felt that she really needed a drug and she had to have a drug, and I felt that it had probably the fewest adverse reactions of anything I could use that worked and we used it enough to know it works better than most anything else." Deposition of H. Lamar Gillespie, M.D., Exhibit 1 to Motion for Summary Judgment at 43-44.

The direction circular included with Phenergan in 1984 did not contain any statement to the effect that extrapyramidal symptoms were a possible adverse reaction to Phenergan. Nor did the direction circular contain a statement to the effect that Phenergan should be used in pregnancy only if the potential benefit justified the potential risk. See Affidavit of P. Uses, Exhibit 8 to Motion for Summary Judgment, Exhibit "A" to Affidavit. The Phenergan direction circular, as revised in March 1987, now contains statements about possible extrapyramidal reactions and advises caution when using Phenergan during pregnancy. See Exhibit "B" to Exhibit 8 to Motion for Summary Judgment. However, Dr. Gillespie testified in his deposition that even if the 1987 circular had been available to him in 1984 when he prescribed Phenergan to Mrs. Windham, he would still have prescribed Phenergan. Deposition of H. Lamar Gillespie at 43.

Over three years after the Phenergan suppositories were prescribed by Dr. Gillespie, Mrs. Windham used one of the remaining suppositories from the 1984 prescription. On October 19, 1987, when she again was suffering from nausea, and without consulting any physician before doing so, Mrs. Windham used one of the Phenergan suppositories.

Within approximately ten minutes of inserting the suppository, Mrs. Windham's body began to cramp and she "drew up all over." Her apparent reaction to the drug included muscle spasms primarily of the face, neck, legs, and feet. When these spasms did not resolve themselves, Mrs. Windham sought treatment from Dr. Geoffrey Hartwig, a neurologist in Hattiesburg, Mississippi.

Fragmentary and incomplete body movement, muscle spasms, and abnormal posturing (or "drawing up" of the limbs or extremities) are part of a group of adverse drug reactions referred to generally as extrapyramidal symptoms because of the involvement of the extrapyramidal nervous system. These symptoms include dystonia (peculiar or involuntary posturing of the body), trismus (a spasm of the muscles of the lower jaw), torticollis (abnormal contraction or distortion of the neck muscles) opistholonus (spasms of the back and limbs), muscle rigidity and similar symptoms.

Over the next several months, from October 1987 through January 1988, Mrs. Windham was hospitalized on no fewer than four occasions for treatment involving the dystonia (i.e., involuntary muscle movements or contractions) which began after she used the Phenergan suppository on October 19, 1987. Although the spasms of her muscles improved with time, the posturing of Mrs. Windham's left ankle and foot persisted for some time. Windham also attributed difficulties she experienced with temporo-mandibular joint disorder ("TMJ"), headaches, and a hypotonic bladder to the adverse reaction she suffered to the Phenergan suppository. On the issue of causation, Dr. Hartwig, Windham's treating physician, testified by deposition that "I don't have the origin for that...." Deposition of Geoffrey Hartwig at 39. In his deposition, Dr. Hartwig stated that he was of the opinion that the dystonia may have been related to Mrs. Windham's use of the Phenergan suppository but also may have been caused by an upper respiratory viral infection Mrs. Windham had at the time she used the suppository. Id. Mrs. Windham had been taking the drug Rondec DM, a prescription antihistamine, for some eleven days prior to the time she used the Phenergan suppository on October 19, 1987. However, the medical records prepared by Dr. Hartwig reflect that when he saw Windham on or about November 2, 1987, he diagnosed her problem as "prolonged dystonic reaction, presumably Phenothiazine-induced." Plaintiff's Exhibit 9 in Opposition to Motion for Summary Judgment. Again on November 9, 1987, Dr. Hartwig reported in his office notes that Mrs. Windham's problem was "prolonged dystonic reaction secondary to Phenothiazines." Id.

Mrs. Windham and her husband attribute all of her physical ailments to the adverse reaction she experienced to use of the Phenergan suppository on October 19, 1987. Thus, they seek to impose liability upon Wyeth under various theories, including strict liability in tort, breach of warranty, and negligent design, manufacture, marketing and distribution of the Phenergan suppositories. Wyeth moves for summary judgment on all aspects of the Complaint.

II.

CONCLUSIONS OF LAW

A. Summary Judgment Standard

The language of Rule 56 of the Federal Rules of Civil Procedure states clearly that:

Summary judgment shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.

Fed.R.Civ.P. 56(c) (emphasis added). The compulsory language of Rule 56(c) has lead the United States Supreme Court to conclude that the Rule "mandates entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing to establish the existence of an essential element of that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). Even so, summary judgment may only be granted when everything in the record demonstrates that no genuine issues of material fact exist. Thus, summary judgment is proper when it can be shown that a trial would serve no useful purpose. Fontenot v. Upjohn Company, 780 F.2d 1190, 1197 (5th Cir.1986).

In reviewing a motion for summary judgment, "the evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 2513, 91 L.Ed.2d 202 (citations omitted). In evaluating Wyeth's motion for summary judgment, the Court must afford the Windhams the benefit of all favorable inferences which the jury could justifiably draw from the facts alleged in the opposing affidavits and materials presented. See Matsushita Electric Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986).

The various claims made by the Windhams against Wyeth all relate primarily to the issue of the adequacy of Wyeth's warning and merge into two principal issues: (1) whether Wyeth failed to warn of the possible adverse reaction of extrapyramidal symptoms from the use of Phenergan suppositories; and, (2) whether that failure to warn, if any, proximately caused Mrs. Windham's alleged injuries. Based upon the record presented in this matter, the Court finds that Wyeth's motion for summary judgment should be sustained as to last of these issues, causation.

B. Failure to Warn

While Plaintiffs assert in their Complaint a broad-based negligence claim alleging negligent development,...