1982 DES Case: Miles Laboratories, Inc v. Superior Court

ABSTRACT

Plaintiff (Susan Fisher) brought an action against a number of pharmaceutical companies, including Miles Laboratories, Inc. (Miles) for personal injuries allegedly sustained by reason of her mother’s ingestion during pregnancy of the drug diethylstilbestrol (DES), a synthetic compound of the female hormone estrogen. Defendant Miles moved for summary judgment on the ground it manufactured and marketed DES for use only as a palliative treatment of prostate cancer in males, not for female use as a miscarriage preventative. The trial court denied the motion without prejudice. Miles thereafter filed the instant petition seeking a peremptory writ of mandate from this court to compel the trial court to vacate its order denying the motion for summary judgment and to grant the same. We issued an alternative writ and order to show cause.

MILES LABORATORIES, INC. v. SUPERIOR COURT, Leagle, 1982720133CalApp3d587_1676, July 6, 1982.

… Defendants, individually and in concert, promoted the sale of DES from 1941 to 1971 for use by pregnant women for the prevention of miscarriages. Defendants knew or should have known that DES was neither safe nor effective for that purpose. In 1947 the FDA authorized production of the drug for use by pregnant women to avoid miscarriage but solely on an experimental basis and only with an express warning to that effect on labels. Despite the limited FDA authorization, defendants marketed and promoted the sale of DES on an “unlimited and wide-open basis” as a miscarriage preventative without any warning as to the experimental nature of the drug or of its potential carcinogenic effect.

In 1971 the FDA ordered defendants to cease marketing and promoting DES as a miscarriage preventative and to warn physicians and the general public that the drug should not be used by pregnant women because of the carcinogenic dangers to their children. The FDA action was based on hospital reports concerning the carcinogenic effect on daughters of women who used the drug. The form of cancer suffered by the daughters is known as adeno-carcinoma, a fast-spreading, deadly growth with minimum treatment calling for radical surgery. The disease manifests itself after a minimum latent period of 10 or 12 years.

Plaintiff was born in October 1961 and was exposed to DES through her mother who ingested the drug as prescribed during her pregnancy. Though there were other safe and effective drugs for the prevention of miscarriage, physicians were persuaded to prescribe DES by defendants’ promotional advertising concerning its safety and effectiveness. As a result of her exposure to DES, plaintiff was required to undergo surgical removal of her female reproductive organs.

Defendants acted in concert, on the basis of express and implied agreement and by the ratification, exploitation, and adoption of each other’s testing and marketing methods. Defendants were jointly liable regardless of the particular brand of DES ingested by plaintiff’s mother because defendants collaborated in testing, marketing and promoting the drug as fungible and interchangeable regardless of the brand name and because it was the practice of physicians to prescribe DES by its generic rather than brand name and of pharmacists to fill such prescriptions from whatever brand of DES they happened to have on hand and that “[d]efendants planned for, exploited and reaped the profits from this marketing and promotional scheme. 

In the recent landmark decision of Sindell v. Abbott Laboratories, our Supreme Court addressed the problem faced by plaintiffs, such as Susan Fisher herein, who are unable to identify the manufacturer of the DES which was ingested by their mothers. The court adapted the principle enunciated in Summers v. Tice (1948) to the circumstances of the DES cases. The court reasoned that in the context of the DES cases it would be reasonable “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.” (Sindell v. Abbott Laboratories) Accordingly, the court stated that “if plaintiff joins in the action the manufacturers of a substantial share of the DES which her mother might have taken, the injustice of shifting the burden of proof to defendants to demonstrate that they could not have made the substance which injured plaintiff is significantly diminished.” The court declined to require a specific percentage of the market to be joined, holding that it was only requiring “a substantial percentage.”

The Sindell court held that when a substantial share of the market has been joined, 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.” (Sindell v. Abbott Laboratories, supra.) The court noted that one DES manufacturer in Sindell was dismissed from the action upon proof by declaration that it had not manufactured DES until after plaintiff was born. ” …

… continue reading MILES LABORATORIES, INC. v. SUPERIOR COURT on Leagle.

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