Miles Laboratories, Inc. v. Superior Court

KAUFMAN, J., Concurring and Dissenting.

I concurin the judgment on a very narrow basis as I shall explain. Otherwise, I dissent from the decision and opinion of the majority for two reasons. First, the majority purport to hold that liability may be imposed under Sindell v. Abbott Laboratories (1980) 26 Cal.3d 588 [163 Cal.Rptr. 132, 607 P.2d 924, 2 A.L.R.4th 1061], on a manufacturer of a genetically dispensed drug even though it did not manufacture or promote the drug for use by the person for whom it was prescribed or for the use for which it was prescribed, notwithstanding the fact the prescribed use was the sole cause of the plaintiffs injury. In so doing, the majority completely ignore the express language of and the social justification for the Sindell decision. Second, the majority import into the case a mislabeling or failure to warn concept which, as I shall explain, is utterly immaterial to the problem at hand since it could not have been a cause of plaintiffs injury.

In Sindell all of the defendants had allegedly manufactured, promoted and marketed the drug (DES) as a safe and effective miscarriage preventative (26 Cal.3d at pp. 594-595), and the decision was predicated upon that fundamental fact. The court in Sindell first rejected the imposition of liability strictly on the basis of the decision in Summers v. Tice (1948) 33 Cal.2d 80 [199 P.2d 1, 5 A.L.R.2d 91] (26 Cal.3d at pp. 598-603), the “concert of action” theory (id., at pp. 603-606), and the theory of “enterprise liability” (id., at pp. 607-610), but then, primarily on public policy bases, enunciated a new theory based on a modification of the rule of Summers v. Tice.

It did so in the following language: “Where, as here, all defendants produced a drug from an identical formula and the manufacturer of the DES which caused plaintiffs injuries cannot be identified through no fault of plaintiff, a modification of the rule of Summers is warranted. As we have seen, an undiluted Summers rationale is inappropriate to shift the burden of proof of causation to defendants because if we measure the chance that any particular manufacturer supplied the injury-causing product by the number of producers of DES, there is a possibility that none of the five defendants in this case produced the offending substance and that the responsible manufacturer, not named in the action, will escape liability.

“But we approach the issue of causation from a different perspective: we hold it to be reasonable in the present context to measure the likelihood that any of the defendants supplied the product which allegedly injured plaintiff by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire production of the drug sold by all for that purpose.

“The presence in the action of a substantial share of the appropriate market also provides a ready means to apportion damages among the defendants. Each defendant will be held liable for the proportion of the judgment represented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff’s injuries.” (26 Cal.3d at pp. 611-612; italics added.)

I agree with the majority that in the form it was presented the hearsay report attached to Mr. O’Donovan’s declaration was not competent evidence. However, the remainder of his declaration was based on his personal knowledge and established that Miles Laboratories manufactured and sold DES only for the palliative treatment of prostatic cancer; that its labeling referred only to that use; and that Miles Laboratories never marketed, promoted or sold DES in any form for use by women as a miscarriage preventative or for any other purpose.

If those are the facts, Miles Laboratories cannot be liable under Sin-dell and it is beyond my ken how in right reason it can be held liable under any legally recognized theory. To hold it liable under those circumstances would punish it for not promoting and marketing DES for experimental use and reward those manufacturers who did promote and market it for that use, allegedly without warning of its experimental status for that use.

As the majority state the basic allegation of the complaint is that the defendants, individually and in concert, promoted the sale of DES for use by pregnant women for the prevention of miscarriages and that they knew or should have known that DES was neither safe nor effective for that purpose. The O’Donovan declaration establishes that those allegations are not true as to Miles Laboratories. The majority nevertheless purport to find another theory of liability in allegations that the defendants knew or should have known and fully expected that promotion by any one of them of its DES as a miscarriage preventative was mutually advantageous to and exploited by all defendants in boosting sales of DES, that the defendants knew or should have known that pharmacists filled prescriptions for the drug on a generic basis, mixing and commingling various brands; and that the defendants planned for, exploited and reaped the profits from this marketing and promotional scheme. With reference to substantially similar allegations in the Sin-dell case,¹ the court in Sindell concluded: “[T]his litany of charges is insufficient to allege a cause of action [under the “concert of action” theory].” (26 Cal.3d at p. 605.) And that was in a case in which all the defendants had allegedly manufactured and advertised the drug for use as a miscarriage preventative.

The majority’s reference to “a question of fact ... as to the adequacy of the label described by the O’Donovan declaration” {ante, p. 596) is unfortunate and can only serve to confuse the development of the law in this area. Miles Laboratories’ label indicates only one use for the drug —“palliative treatment of prostatic cancer”; it says nothing whatever about use of the drug by women or as a miscarriage preventative. Apparently the majority would require the Miles Laboratories label to state affirmatively something like “not safe for use as a miscarriage preventative.” But suppose it had?

Plaintiff’s mother, of course, would have had no occasion to see the label. By hypothesis pharmacists fill prescriptions for DES from various brands indiscriminately. If the pharmacist who filled plaintiff’s mother’s prescription for DES were aware that Miles Laboratories’ Stilphostrol was nothing more or less than DES, he would have done one of two things: either he would have filled the prescription with the Miles Laboratories’ product despite any contraindication on the label or he would have filled the prescription with DES of another brand. In either case plaintiff’s mother would have still taken the drug and plaintiff would still have suffered the same injury. Thus, no failure to include on the label a warning against use as a miscarriage- preventative could have been a cause in fact of plaintiff’s injury, and the imposition of liability predicated on that immaterial fact would be irrational and violative of Miles Laboratories’ right to due process of law.

I observe also that the majority would apparently absolve Miles Laboratories of liability if its label had included a warning against use of its product as a miscarriage preventative even if its product were in fact used by the pharmacist to fill plaintiff’s mother’s prescription. Thus, apparently the majority acknowledge that the mere fact that Miles Laboratories’ product might in fact have been supplied to and used by plaintiff’s mother is not in itself a sufficient basis on which to impose liability on it. Properly so, for Miles Laboratories had no control over the licenses issued by the FDA to the other drug manufacturers nor any means of controlling or influencing their advertising or promotion of the drug. By hypothesis it likewise had no way to prevent pharmacists from filling prescriptions generically using drugs produced by it.

I concur in the judgment for one reason and one reason only. At the hearing on the motion for summary judgment plaintiff indicated to the court that if the court were inclined to grant the motion, plaintiff requested an opportunity to develop further evidence of a statistical nature. At oral argument in this court it became apparent for the first time, at least to me, what the plaintiff had in mind. Apparently plaintiff proposes to attempt to develop evidence that such a large proportion of Miles Laboratories’ sales of Stilphostrol was attributable to pharmacists using its product to fill prescriptions for DES as a miscarriage preventative that it must have been aware that much of its product was being sold for that use and, notwithstanding its protestations that it did not manufacture the drug for use as a miscarriage preventative, it must be deemed to have known it was in fact manufacturing the drug for that use.

I am persuaded that plaintiff’s request for additional time to develop evidence to that effect was what moved the trial court to deny the motion without prejudice. It is reasonable that plaintiff be given the opportunity to develop such evidence if she can, and I cannot conclude the trial court’s denial of the motion without prejudice constituted either an act in excess of jurisdiction or a manifest abuse of discretion. I would deny issuance of the peremptory writ solely on that basis. Regrettably, and to me incredibly, unless the Supreme Court is willing to add to its already burdensome caseload, the misconceptions of the majority will become the law of this case and, worse yet, the law of this state.

1 In Sindell the plaintiff alleged inter alia that the defendants’ wrongful conduct was “the result of planned and concerted action, express and implied agreements, collaboration in, reliance upon, acquiescence in and ratification, exploitation and adoption of each other’s testing, marketing methods, lack of warnings ... and other acts or omissions ...” and that “acting individually and in concert, [defendants] promoted, approved, authorized, acquiesced in and reaped profits from sales” of DES. (26 Cal.3d at pp. 604-605.)