West v. G.D. Searle & Co.

Robert L. Brown, Justice,

concurring in part, dissenting in part. The majority is correct that the trial court’s dismissal of the causes of action for negligence, breach of warranty, and strict liability for manufacture or inadequate warning must be affirmed due to untimeliness.

I take issue with the affirmance of the dismissal of the defective design count regarding the birth control pill, Ovulen-28. We are dealing with an order for summary judgment. To withstand summary judgment, a party need only show that what is before the court presents a genuine issue of material fact. Ark. R. Civ. P. 56(c). Here, the Wests did that. They proved by the deposition of Frank Sturtevant, Ph.D., a retired Searle employee, that the estrogen levels of Ovulen-28 were high and twice the level of a companion pill, Demulen. In addition, Dr. Dean Kumpuris, a medical doctor, noted in his deposition that a correlation existed between estrogen levels in birth control pills and liver tumors: “. . . but as a general principle, estrogens and birth control pills cause —give you an increased chance of having hepatic adenomas.” Searle argued, based on Frank Sturtevant’s testimony, that in reality the estrogen levels of Ovulen-28 at 100 micrograms and Demulen at 50 micrograms were the same. The majority opinion accepts that. But Sturtevant also revealed that Ovulen28 was removed from the market due to an effort by Searle to replace it with a product with a lower dosage of estrogen. What follows is his testimony on that point:

Q. Is Ovulen-28 or 21 still on the market?
A. No.
Q. When was it taken off?
A. I don’t recall specifically.
Q. Do you know why it was taken off?
A. Yes.
Q. Why?
A. First of all, let me say that Ovulen had 100 micrograms of Mestranol, which is the estrogen.
There had been developing a consensus within the medical community that satisfactory and adequate estrogen dosage of 50 micrograms are lower and resulted in patient acceptance and acceptable efficacy; and, therefore, products with more than 50 micrograms were not necessary.
As a result of that, Searle did not summarily remove Ovulen from the market, but it merely phased it out.
It advised the medical and I believe the pharmacy communities that it was being phased out and no longer manufactured; and it dribbled out.
Q. Did they reduce the amount of estrogen to 50 milligrams?
A. Searle had a product Demulen that had 50 micrograms of a final Estradiol; however, depending upon what target tissues you measure, 50 micrograms of Estradiol would be equivalent to 100 micrograms of Nestranol (sic), which was in the Ovulen. Mestranol must be converted to Estradiol to become active as an estrogen.
So one could say well, there is really no difference between Ovulen and Demulen 150; however, companies were constantly investigating lower and lower doses in different ratios, and it came a point in time where Searle marketed Demulen 135, which has 35 micrograms of a final Estradiol.

This testimony from a retired Searle employee is a far cry from proof that the estrogen levels of Ovulen-28 equated to those of other Searle products or that Ovulen-28 did not contain higher levels of estrogen than other Searle products. Otherwise, why did Searle take pains to reduce its dosage levels to 35 micrograms and remove Ovulen-28 from the market? In short, whether Ovulen-28 was unreasonably dangerous before its removal from public consumption was for a jury to resolve.

I would reverse the order of summary judgment on defective design and remand that issue to the trial court for a trial on the merits.

Glaze and Corbin, JJ., join.