Morris v. Parke, Davis & Co., CV 82-5296-RJK (JRx).

• Decision Date: 12 June 1987
• Docket Number: No. CV 82-5296-RJK (JRx).,CV 82-5296-RJK (JRx).
• Citation: 667 F. Supp. 1332
• Court: U.S. District Court — Central District of California
• Parties: Lesta MORRIS and Eddie Morris, individually, and David Kent Morris, by his co-conservators, Lesta and Eddie Morris, Plaintiffs, v. PARKE, DAVIS & COMPANY, a corporation; Wyeth Laboratories, a division of American Home Products Corporation, a division of American Cyanamid Company; Eli Lilly and Company; the National Drug Company, a division of Richardson-Merrell, Inc., Defendants.

667 F. Supp. 1332

Lesta MORRIS and Eddie Morris, individually, and David Kent Morris, by his co-conservators, Lesta and Eddie Morris, Plaintiffs, v. PARKE, DAVIS & COMPANY, a corporation; Wyeth Laboratories, a division of American Home Products Corporation, a division of American Cyanamid Company; Eli Lilly and Company; the National Drug Company, a division of Richardson-Merrell, Inc., Defendants.

No. CV 82-5296-RJK (JRx).

United States District Court, C.D. California.

June 12, 1987.

Andrew W. Dodd, Denver & Dodd, Torrance, Cal., for plaintiffs.

Joann M. Zaleskas, Haight, Dickson, Brown & Bonesteel, Santa Monica, Cal., Timothy Bradford, Morgan, Wenzel & McNichol, Charles Smith, Lord, Bissel & Brook, Jeffrey Barron, Morris, Polich & Purdy, Los Angeles, Cal., Peter Hast, Hast & Sabatasse, Van Nuys, Cal., Phillip S. Berry, Carolyn Collins, Berry & Berry, Oakland, Cal., Harvey Kaplan, Shook, Hardy & Bacon, Kansas City, Mo., for defendants.

MEMORANDUM OF DECISION AND ORDER

KELLEHER, Senior District Judge.

I. INTRODUCTION

This is an action against five vaccine manufacturers in which plaintiffs allege that plaintiff David Morris was injured as the result of the administration of Diptheria-Pertussis-Tetanus vaccine ("D.P.T.") during 1965. Plaintiffs concede their inability to identify the manufacturer of the particular vaccine administered to plaintiff David Morris. As a result, they have chosen to proceed on the market share liability theory first delineated in Sindell v. Abbott Laboratories, 26 Cal.3d 588, 163 Cal.Rptr. 132, 607 P.2d 924 (1980), cert. denied, 449 U.S. 912, 101 S.Ct. 286, 66 L.Ed.2d 140 (1980).

Defendant Parke, Davis & Company ("defendant Parke") moves the Court for partial summary judgment on plaintiffs' claims based on an alleged manufacturing defect. All of the remaining defendants joined in said motion by filing appropriate notices of joinder.

Defendant Eli Lilly & Company ("defendant Lilly") moves the Court for partial summary judgment on plaintiffs' second and third causes of action for breach of express and implied warranty, respectively. Defendants Parke, Lederle Laboratories, and National Drug Company joined in said motion by filing appropriate Notices of Joinder. The remaining defendant, Wyeth Laboratories, joined in said motion by oral notice of counsel during the February 2, 1987, hearing on the pending matters.

II. ANALYSIS

A. MANUFACTURING DEFECT.

1. DEFINITION OF "MANUFACTURING DEFECT".

At least two different theories have been held to satisfy the "defect" prerequisite to the finding of strict liability in tort: the "manufacturing defect" theory and the "design defect" theory. Barker v. Lull Engineering Company, Inc., 20 Cal.3d 413, 429, 143 Cal.Rptr. 225, 236, 573 P.2d 443, 454 (1978). By Order entered on September 20, 1985, this Court determined that plaintiffs could not proceed on a design defect theory of strict product liability.¹ Therefore, it is crucial for the purpose of deciding the present motion to distinguish the concept of "manufacturing defect" from the concept of "design defect."

A product has a "manufacturing defect" if and only if the product caused a plaintiff's injury because it deviated from the manufacturer's intended result² or from other ostensibly identical units of the same product line. Barker, 20 Cal.3d at 429, 143 Cal.Rptr. at 236, 573 P.2d at 454. For example, when a product comes off the assembly line in a substandard condition, it has incurred a manufacturing defect. Id. A manufacturing defect is one which results from an error in the production process. Finn v. G.D. Searle & Co., 35 Cal.3d 691, 715, 200 Cal.Rptr. 870, 886, 677 P.2d 1147, 1163 (1984) (Bird, C.J., dissenting).

In contrast, in the case of a design defect the injury producing agent is common to all products of a certain line, and the defect lies in the original design or model. Finn, 35 Cal.3d at 691, 200 Cal. Rptr. at 886, 677 P.2d at 1163 (Bird, C.J., dissenting). A product has a design defect if and only if: (a) the plaintiff establishes that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably expected manner³, or (b) the plaintiff proves that the product's design proximately caused his injury and the defendant fails to prove that, on balance, the benefits of the challenged design outweigh the risk of danger inherent in such design. Barker, 20 Cal.3d at 432, 435, 143 Cal.Rptr. at 237-238, 239-240, 573 P.2d at 466-47, 468-69.

2. SUBSTANCE OF THE MOTION RE: MANUFACTURING DEFECT.

Defendants contend that the Court should grant their motion for partial summary judgment on plaintiffs' manufacturing defect theory for four (4) reasons. Defendants contend that plaintiffs: (a) are foreclosed from proceeding on said theory because of this Court's Order entered on September 20, 1985, that Restatement (Second) of Torts, section 402A comment K applies to this action; (b) are foreclosed from proceeding on said theory because of this Court's Order entered on September 20, 1985, finding that there is a "congressional intent to occupy the field"; (c) cannot, as a matter of law, proceed on a manufacturing defect theory in this, a Sindell market share liability case; and (d) have no evidence to support their allegation that the D.P.T. administered to Plaintiff David Morris had a manufacturing defect.

a. RESTATEMENT (SECOND) OF TORTS, SECTION 402A COMMENT K.

As noted above, by Order entered on September 20, 1985, the Court determined that Restatement (Second) of Torts, section 402A comment k applies to this action. Said Order noted parenthetically that a drug manufacturer lost its comment k protection if the drug at issue was not accompanied by the proper directions and warnings. From this, defendants argue that plaintiffs are limited to a failure to warn theory of recovery. Said argument is specious.

Restatement (Second) of Torts, section 402A comment k provides in pertinent part:

"k. 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 and ordinary use. These are especially common in the field of drugs. An outstanding example is 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 the use of the vacine are fully justified, notwithstanding the unavoidable high degree of risk which they impart. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous. * * * It is also true in particular of many new experimental drugs.... The seller of such products, again with the qualification that they are properly prepared and marketed ... is not to be held to strict liability for unfortunate consequences attending their use...."

(Emphasis added.) Comment k's protection is expressly conditioned by the requirement that the drug be "properly prepared and marketed"; i.e., that it not have a manufacturing defect. A drug that has a manufacturing defect is, by definition, not "unavoidably unsafe."

b. PREEMPTION.

As noted above, by Order entered on September 20, 1985, the Court determined that the testing requirements for D.P.T. mandated by the Public Health Service Act, 42 U.S.C. section 201 et seq., and the regulations promulgated thereunder evidence Congressional intent to occupy this field. Thus, the Court granted defendant Lilly's motion for summary adjudication on the issue of federal preemption. Defendants contend that said Order forecloses plaintiffs from proceeding on a manufacturing defect theory.

Defendants' contention has led the Court to reexamine its prior decision on the preemption issue in light of: (i) Hillsborough County, Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985); and (ii) the National Childhood Injury Act of 1986. The Court recognizes that its prior ruling is interlocutory in character and is subject to change at any time until entry of judgment. See: 1B J. Moore, J. Lucas & T. Currier, Moore's Federal Practice, para. 0.4044.-1, pgs. 124-126 (2nd ed. 1948); 18 C. Wright, A. Miller & E. Cooper, Federal Practice and Procedure, section 4477, pgs. 788-792 (1981). Moreover, the Court has broad discretion to reconsider its prior rulings. Id. The law of the case doctrine serves as a guide to the Court in exercising its discretion in this area, but in no way limits the power of the Court to reconsider its prior rulings under these circumstances. Id.

(i) HILLSBOROUGH v. AUTOMATED MEDICAL LABORATORIES, INC.

In Hillsborough the defendant county adopted two ordinances and implementing regulations governing plasmaphersis centers within the county. Hillsborough, 105 S.Ct. at 2373. Said county ordinances and regulations: (a) imposed a $225 license fee on plasmapheresis centers; (b) required such centers to allow the county reasonable and continuing access; (c) required potential donors to obtain a county identification card at a fee of $2; (d) established a county fee of $1 for each plasmapheresis procedure performed; and (e) imposed testing and recordkeeping requirements beyond those contained in the federal regulations. Hillsborough, 105 S.Ct. at 2373-2374. The additional testing and recordkeeping requirements included: (i) a pre-registration hepatitus test; (ii) a pre-donation alcohol breath analysis test; and (iii) the requirement that donors donate at only one center. Id.

Like defendants in the present case, the plaintiff plasma center in Hillsborough: (1) had to be licensed by the Secretary of Health and Human Services pursuant to 42 U.S.C. section 262(a); (2) could obtain the required license only on a showing that the vendor's establishment and products met certain safety, purity, and potency standards...