Kociemba v. GD Searle & Co., Civ. No. 3-85-1599.

• Decision Date: 01 September 1988
• Docket Number: Civ. No. 3-85-1599.
• Citation: 695 F. Supp. 432
• Parties: Esther R. KOCIEMBA and William J. Kociemba, Plaintiffs, v. G.D. SEARLE & CO., Defendant.
• Court: U.S. District Court — District of Minnesota

695 F. Supp. 432

Esther R. KOCIEMBA and William J. Kociemba, Plaintiffs, v. G.D. SEARLE & CO., Defendant.

Civ. No. 3-85-1599.

United States District Court, D. Minnesota, Third Division.

September 1, 1988.

Michael V. Ciresi, Roger P. Brosnahan, David L. Suggs, Roberta Walburn of Robins, Larson, Miller & Ciresi, Minneapolis, Minn., for plaintiffs.

Paul Strain and Elizabeth Honeywell of Venable, Baetjer & Howard, Baltimore, Md., and Madge S. Thorsen of Oppenheimer, Wolff & Donnelly, Minneapolis, Minn., for defendant.

MEMORANDUM AND ORDER

RENNER, District Judge.

Before the Court is defendant's motion for directed verdict on the design defect issue. In essence, defendant requests this Court to reconsider its February 1, 1988 Order holding that the factfinder must determine the applicability of comment k to § 402A of the Restatement (Second) of Torts on a case-by-case basis.¹ Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293, 1300-1301 (D.Minn.1988). Defendant, citing Brown v. Superior Court, 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470 (1988), would have this Court hold that comment k applies to all prescription drugs as a matter of law regardless of whether a design defect cause of action is brought in negligence or strict liability. Accordingly, defendant argues that the only design defect issue that should be before the jury is whether Searle adequately warned plaintiffs of the risks of Cu-7 use.

The Minnesota appellate courts have not had an opportunity to determine whether this jurisdiction would adopt comment k. When this Court first addressed the issue in its February 1, 1988 Order, the Court predicted that the Minnesota courts would adopt comment k if given the opportunity. Kociemba, 680 F.Supp. at 1300. This Court further held that comment k does not apply to all prescription drugs as a matter of law but that the jury must make that determination based on the following factors:

(i) whether the product could have been designed in a safer manner;

(ii) whether a safer alternative product could have been available at the time of manufacture and sale to accomplish the same intended purpose in questions; and

(iii) whether the benefits of the product outweigh the interest in promoting enhanced accountability on the part of the manufacturer.

Kociemba, 680 F.Supp. at 1301 citing Patten v. Lederle Labs., 676 F.Supp. 233 (D.Utah 1987).

Upon review of the February 1, 1988 Order, this Court finds that the policy considerations underlying that Order are correct. However, for reasons stated below, this Court now finds that these policy considerations are implicitly reflected in the negligence-based "reasonable care" standard adopted by the Minnesota Supreme Court in strict liability design defect cases. See Bilotta v. Kelley Co., 346 N.W.2d 616 (Minn.1984) and Holm v. Sponco Mfg., Inc., 324 N.W.2d 207 (Minn.1982). Moreover, because of the importance this Court attaches to these policy considerations as they apply to prescription drugs, the Court further finds that it is appropriate to explicitly instruct the jury that it may consider the reasonable but unavoidable side effects of a prescription drug at the same time it considers the reasonableness of a design defect.

Analysis:

In 1966, Minnesota adopted § 402A of the Restatement (Second) of Torts which imposes strict liability on manufacturers of defective or unreasonably unsafe products. McCormack v. Hankscraft Co., Inc., 278 Minn. 322, 336-341, 154 N.W.2d 488, 499-501 (Minn.1967). Section 402A, as originally adopted by the Minnesota Supreme Court, employed a "consumer expectation" standard which holds that a product is unreasonably dangerous if it

is dangerous when used by an ordinary user who uses it with the knowledge common to the community as to the product's characteristics and common usage.

See JIG 118, paragraph 2, 4 Minnesota District Judges Ass'n, Minn.Pract. JIG II CIVIL (2d Ed.1974).

Under this standard, the manufacturer's conduct, whether egregious or highly responsible, is irrelevant. Rather, the factfinder, focusing solely on the condition of the product, can find a manufacturer liable even though the manufacturer reasonably could not know of the dangers inherent in its product.

Although strict liability can bring about a sometimes harsh result in that a reasonably-acting manufacturer can be found liable, the Minnesota Supreme Court adopted such an approach because of its belief that

enlarging a manufacturer's liability to those injured by its products more adequately meets public policy demands to protect consumers from the inevitable risks of bodily harm created by mass production and complex marketing conditions.

Id. at 338, 154 N.W.2d at 500.

The court added that strict liability:

imposes the costs of the injury upon the maker, who can both most effectively reduce or eliminate the hazard to life or health, and absorb and pass on such costs ...

Id.

Many jurisdictions have blunted the harshness of strict liability by adopting Comment k to § 402A. Under Comment k, a manufacturer is liable in a strict liability design defect case only if it fails to adequately warn the user of the unavoidable dangers.

The policy considerations behind comment k are straightforward: First, manufacturers should be encouraged to develop products such as prescription drugs even though such products are incapable of being made safe given the present state of knowledge. Such encouragement can only be accomplished by limiting the manufacturer's liability to instances where the manufacturer acted in an unreasonable manner which, in comment k terms, occurs when the manufacturer fails to adequately warn the user of the reasonable dangers inherent in the product.

Second, holding drug manufacturers up to a "consumer expectation" standard for injuries caused by unavoidably unsafe but necessary prescription drugs can increase product liability insurance rates and litigation costs to the extent that drug manufacturers are not able to sell pharmaceutical products at affordable prices.

As noted above, the Minnesota Supreme Court has not addressed the issue of comment k. They have, however, adopted a balancing test, much like the balancing test utilized in comment k, which implicitly acknowledges the above policy considerations. Bilotta, 346 N.W.2d at 621-622; Holm, 324 N.W.2d at 213.

In Holm, and then in Bilotta, the Supreme Court completely rejected the "consumer expectation" standard of strict liability in favor of a negligence-like "reasonable care" standard which focuses on the conduct of the manufacturer rather than the condition of the product. Bilotta, 346 N.W.2d at 622.

The Bilotta Court rationalized its decision to adopt the "reasonable care" standard in strict liability design defect cases by noting that the "defect" in a design defect case "lies in a consciously chosen design" in which the manufacturer "deliberately added or omitted the challenged component and has presumably made that decision after balancing a variety of factors." Id. 346 N.W.2d at 622. Therefore, the Bilotta Court reasoned that the manufacturer's conduct in balancing its product's risk against its utility is the key element in determining liability. Factors a jury may consider in evaluating the manufacturer's conduct include:

(1) the usefulness and desirability of the product;

(2) the availability of other and safer products to meet the same need;

(3) the likelihood of injury and its probable seriousness;

(4) the obviousness of the danger;

(5) common knowledge and normal public expectation of the danger;

(6) the avoidability of injury by care in use of the product (including the effects of instruction or warning); and

(7) the ability to eliminate the danger without seriously impairing the usefulness of the product or making it unduly expensive.

Krein v. Raudabough, 406 N.W.2d 315, 318 (Minn.App.1987); See Holm, 324 N.W. 2d at 212; Wade, Strict Liability of Manufacturers, 19 S.W.L.J. 5, 17 (1965).

After Holm and Bilotta, strict liability and negligence have been, in effect, merged into one negligence-type standard of recovery in design defect cases. Accordingly, the drafters of the Minnesota Jury Instruction Guide have composed a single jury instruction to be read in all design defect cases. That instruction, JIG 117, reads:

A manufacturer has a duty to use reasonable care when designing a product, so as to avoid any unreasonable risk of harm to (anyone who) (property that) is likely to be exposed to harm when the product is put to its intended use or to any use that is unintended but is reasonably foreseeable.

What constitutes reasonable care will vary with the surrounding circumstances. Reasonable care is the care that a reasonably prudent person would exercise under the same or similar circumstances.

The reasonable care to be exercised by a manufacturer when designing a product will depend on

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