Hill v. Searle Laboratories, B-C-86-119.

• Decision Date: 08 August 1988
• Docket Number: No. B-C-86-119.,B-C-86-119.
• Citation: 686 F. Supp. 720
• Parties: Connie HILL and William Hill, Plaintiffs, v. SEARLE LABORATORIES, A DIVISION OF SEARLE PHARMACEUTICALS, INC., G.D. Searle & Company; Searle & Company; John Doe I and John Doe II, Defendants.
• Court: U.S. District Court — Eastern District of Arkansas

686 F. Supp. 720

Connie HILL and William Hill, Plaintiffs, v. SEARLE LABORATORIES, A DIVISION OF SEARLE PHARMACEUTICALS, INC., G.D. Searle & Company; Searle & Company; John Doe I and John Doe II, Defendants.

No. B-C-86-119.

United States District Court, E.D. Arkansas, Batesville Division.

May 25, 1988.

As Amended August 8, 1988.

David Hodges, Little Rock, Ark., for plaintiffs.

Elizabeth J. Robben, Friday, Eldredge & Clark, Little Rock, Ark., for defendants.

ORDER

ROY, District Judge.

Before the Court is the Motion for Summary Judgment filed by defendants G.D. Searle & Company and Searle & Company. The plaintiff has responded, and the matter is now ripe for determination.

Plaintiff, Connie Hill, initiated this action alleging that defendant, Searle Laboratories, the manufacturer and supplier of a copper intrauterine device (IUD) called a CU-7 had manufactured/supplied a product which was unreasonably dangerous and/or negligently designed.

The following statement of facts is drawn from those paragraphs in defendants' statement of material facts which are not disputed by plaintiffs.

The plaintiff was implanted with the CU-7 in July of 1981 at the Independence County Health Department Unit in Batesville, Arkansas. In October of 1983 plaintiff returned to the Batesville Health Department Unit believing that she was pregnant and that her CU-7 was still in place. The fact of her pregnancy was confirmed. On May 31, 1984 Mrs. Hill gave birth to her third child. On June 1, 1984, Mrs. Hill was taken to surgery for a tubal ligation. During this procedure her treating physician, Dr. Roland Reynolds, determined that the CU-7 had penetrated Mrs. Hill's uterus and was partially embedded in her small bowel. Accordingly, in addition to the tubal ligation, Dr. Reynolds removed the CU-7 from Mrs. Hill.

A CU-7 is a copper containing contraceptive manufactured by Searle. It is a prescription drug requiring the order of a physician to be used, and must be inserted by a physician. Information about the CU-7 was submitted to the United States Food and Drug Administration (FDA) in the form of a new drug application (NDA), pursuant to 21 C.F.R. § 310.502.

In February, 1974 the FDA approved the new drug application, finding the CU-7 to be safe and effective, and granted full approval to Searle to begin marketing the CU-7. The FDA also approved the contents of the package inserts or labeling which accompanied the CU-7 as well as the patient brochure which was subsequently developed.

In 1977, the FDA promulgated class labeling for use with all IUDs. These regulations mandate the warnings and information which must be provided in the package inserts and patient brochures. 21 C.F.R. § 310.502(b). Searle not only complied with these regulations, it also included additional information.

Searle's product literature for physicians included the following:

Warnings

(5) Perforation—Partial or total perforation of the uterine wall or cervix may occur with the use of the CU-7 usually during insertions into patients sooner than 2 months after abortion or delivery, or in the uterine cavities too small for the CU-7. The possibility of perforation must be kept in mind during insertion and at the time of any subsequent examination. If perforation occurs, laparotomy or laparoscopy should be performed as soon as medically feasible and the CU-7 removed. Abdominal adhesions, intestinal penetration, intestinal obstruction and local inflammatory reaction with abscess formation and erosion of adjacent viscera may result if the CU-7 is left in the peritoneal cavity.

The same labeling also contained this information:

Adverse Reactions

Perforations of uterus and cervix have occurred. Perforation into the abdomen has been followed by abdominal adhesions, intestinal penetration, intestinal obstruction, local inflammatory reaction with abscess formation and erosion of adjacent viscera.

(CU-7 package inserts for physicians February, 1981 attached as part of Exhibit D to Searle's Response to Plaintiffs' Interrogatories and Second Request for Production of Documents.)

Dr. Dennis Davidson, who inserted the IUD in the present case, was fully aware of the risk of perforation associated with the use of a CU-7 or any IUD. Dr. Davidson was also familiar and aware of the contents of the product literature accompanying the CU-7 and believed that it adequately informed him of the potential risks associated with the use of the CU-7.

Dr. Roland Reynolds, plaintiffs' expert witness, stated in his deposition that he was fully aware of the risk of perforation associated with the use of an IUD, and that he was as familiar with the product literature accompanying the CU-7 and believes in his medical opinion that the warnings contained therein were adequate to apprise physicians of the risks associated with the use of the CU-7. Dr. Reynolds does not believe that Searle did anything wrong in the manufacture and distribution of the Copper 7, nor does he believe that Searle was negligent in any way in connection with the manufacture, sale and distribution of the Copper 7.

In their brief, defendant contends that the only basis alleged in the complaint or revealed in discovery has been the plaintiff's claim that the defendants failed to adequately warn that there existed a risk of perforation of the uterus associated with the use of a CU-7 IUD.

In the plaintiff's response to defendant's statement of material facts as to which there is no dispute, plaintiff claims that Searle did, in fact, conduct extensive testing of the CU-7 but the results of these tests were falsified and that false information and literature containing false information about the CU-7 were submitted to the United States Food and Drug Administration in the form of a new drug application, pursuant to 21 C.F.R. § 310.502. In his brief, plaintiff merely contends that there are fact questions as to whether defendant properly prepared the drug and issued proper directions and warnings. However, plaintiffs have failed to support this allegation with any affidavits, answers and interrogatories, depositions, or other materials, while defendant has presented the deposition of plaintiff's own expert witness who stated that in his opinion defendant did nothing wrong in the manufacture and distribution of the CU-7.

In ruling on this motion for summary judgment, the Court is guided by a more liberal attitude displayed by the Eighth Circuit and the Supreme Court in the granting of such motions. In City of Mt. Pleasant v. Associated Electric Cooperative, Inc., 838 F.2d 268 (8th Cir.1988), the Eighth Circuit noted:

In any case, whatever the meaning of our earlier cases, a trilogy of recent Supreme Court opinions demonstrates that we should be somewhat more hospitable to summary judgments than in the past. The motion for summary judgment can be a tool of great utility in removing factually insubstantial cases from crowded dockets, freeing courts' trial time for those cases that really do raise genuine issues of material fact.

In Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986), the Supreme Court held that the burden on the party moving for summary judgment is only to demonstrate, i.e., "to point out to the District Court," id. 106 S.Ct. at 2554, that the record does not disclose a genuine dispute on a material fact. It is enough for the movant to bring up the fact that the record does not contain such an issue and to identify that part of the record which bears out his assertion. Once this is done, his burden is discharged, and, if the record in fact bears out the claim that no genuine dispute exists on any material fact, it is then the respondent's burden to set forth affirmative evidence, specific facts, showing that there is a genuine dispute on that issue. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 2514, 91 L.Ed.2d 202 (1986). If the respondent fails to carry that burden, summary judgment would be granted.

Id. at 273-74.

The Supreme Court held that under Rule 56(c) of the Federal Rules of Civil Procedure, "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). In Hufsmith v. Weaver, 817 F.2d 455 (8th Cir.1987), the Court discussed further the holding in Liberty Lobby:

In Liberty Lobby, the Supreme Court defined "material" facts as those "that might affect the outcome of the suit under the governing law," and explained that "while the materiality determination rests on the substantive law, it is the substantive law's identification of which facts are critical and which facts are irrelevant that governs." Id. The court also noted that the material fact must be "genuine," i.e., "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. The court thus stated that if the evidence is merely colorable or is not significantly probative, summary judgment is appropriate. Id. 106 S.Ct. at 2511 (citations omitted); see Celotex Corp. v. Catrett 477 U.S. 317, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986)

Id. at 460, n. 7.

Defendants argue first that the Copper 7 is a prescription product and is a comment k product as a matter of law. In support of this argument, defendants state that Arkansas has based its strict product liability statute (Ark.Code.Ann. §§ 16-116-101 et seq.) (the "Arkansas Product Liability Act of 1979") on Section 402A of the Restatement (Second) of Torts ("Section 402A") which imposes strict liability on the manufacturer of a defective or unreasonably dangerous product. Comment k to Section 402A provides an exception to the strict liability rule, however, in the case of an "unavoidably unsafe" product.¹ An unavoidably unsafe product is a product which cannot...