1981 DES Case: Ryan v. Eli Lilly & Co.

ABSTRACT

This is a pharmaceutical product liability action. The plaintiff, Nancy Ryan, alleges she has developed a pre-cancerous condition as a result of her prenatal exposure to diethyestilbestrol (hereinafter “DES”), a synthetic estrogen taken by her mother during 1952 and 1953. This drug was promoted in the late 1940’s and early 1950’s for use by pregnant women to prevent loss of the fetus by spontaneous abortion. Nancy Ryan was born May 1, 1953. Prior to that time her mother had ingested DES obtained by prescription from her doctor to prevent possible miscarriage. The complaint was filed on February 8, 1977. Although 118 companies were manufacturing and marketing DES in the dosage taken by plaintiff’s mother in 1952 and in 1953, the complaint named only eight companies as defendants. Plaintiff alleges that the DES ingested by her mother was manufactured by Eli Lilly & Company, or by E. R. Squibb and Sons. In addition to Lilly and Squibb, the plaintiff joined Rexall Drug Company, Upjohn Company, Blue Line Chemical Company, Abbott Laboratories, and McNeil Laboratories as party defendants, alleging a conspiracy in their production of synthetic estrogens. The plaintiff seeks legal as well as equitable relief, and claims numerous causes of action: negligence, breach of warranty and implied warranty, strict liability, civil conspiracy, fraud, and violation of the Federal Drug and Cosmetic Act of 1938.

RYAN v. ELI LILLY & CO, Leagle, decision/19811518514FSupp1004_11365, May 14, 1981.

The major weakness in plaintiff’s case, and one issue upon which defendants’ motion is based, is her inability to identify the manufacturer of the DES tablets taken by her mother nearly 28 years ago. Three and a half years of discovery have revealed nothing that would indicate which, if any, of the defendants is the culpable party.

It is elementary that in any action claiming injury from a product, the plaintiff must show causal connection between the defendant manufacturer and that product. The defendant manufacturer must be identified with the specific instrumentality that allegedly caused the injury, and this is the law of both North and South Carolina.

It goes without saying that if a drug manufacturer … is to be held liable for harm caused by a product, it is necessary to show that the drug or medicine was one with which the defendant is identified in the respect asserted — that is, it must be shown that the defendant actually manufactured, compounded, or sold the drug or medicine in question.

Proof connecting the defendant with the instrumentality of the alleged defect is necessary regardless of the theory upon which plaintiff relies.

The plaintiff cannot show who manufactured the DES ingested by her mother, but contends it was one of two defendants, Lilly or Squibb. Discovery as to identification was obtained from the plaintiff, her parents, their doctor, a pharmacist, representatives of defendant drug companies, and others. These efforts have not, however, been successful in uncovering any evidence connecting any of these defendants with the drug taken by Mrs. Ryan.

William Ryan, plaintiff’s father, testified that the prescription was filled at a certain Eckerd’s Drug Store in Charlotte, North Carolina. The primary source of identification of the drug, and its manufacture by Lilly or Squibb, is a statement alleged to have been made by an Eckerd’s Drug Store pharmacist, which statement has been denied by the pharmacist. Plaintiff’s mother claims that she was told by this pharmacist that the DES bought by Eckerd’s in 1952 was supplied by either Lilly or Squibb, or both. This statement is not only denied by the man who supposedly made it, but it is hearsay because it is offered to prove that Lilly or Squibb was the manufacturer. Furthermore, the pharmacist alleged to have made the statement did not even work for Eckerd’s until 1956; Eckerd’s has retained no prescription records from this 1952-53 period.

Plaintiff, of course, is unable to identify the particular manufacturer of the DES taken by her mother before she was born. Nor can Margaret C. Ryan, plaintiff’s mother, identify the manufacturer. Mrs. Ryan remembers only that the drug came from Eckerd’s; she did not know what it was when it was prescribed, she remembers none of the markings on the bottle, nor can she remember the size or the shape of the pill. She remembers only that she thinks the pill was red or white. Nor can Mr. Ryan remember the size, shape, color or manufacturer of the DES taken by his wife. Neither the attending physician nor his records specify the manufacturer of the DES he prescribed. The drug store records were destroyed years ago, and there is no one now employed by Eckerd’s Drug Company who can state which manufacturer’s product would have been used to fill a prescription for DES in 1952 or 1953. 

The defendants are merely seven of the one hundred eighteen companies manufacturing or distributing DES or its cogeners in 1952 and 1953. The plaintiff has offered nothing to show that one of these seven, and not one of the other one hundred eleven, manufacturers produced the drug in question. While the culpable manufacturer may be before the Court as a defendant, it is just as likely that it is not. The plaintiff is therefore unable to meet the threshold burden of maintaining this action — i. e., identifying the manufacturer of the drug taken and thereby establishing causation in fact. 

The applicable principle is summarized in Annot., “Products Liability: Necessity and Sufficiency of Identification of Defendant as Manufacturer or Seller of Products Alleged to Have Caused Injury”:

Regardless of the theory which liability is predicated upon … it is obvious that to hold a producer, manufacturer, or seller liable for injury caused by a particular product, there must first be proof that the defendant produced, manufactured, sold or was in some way responsible for the product, and this rule is supported in all of the cases examined in this annotation.

This fatal flaw in plaintiff’s case is nothing new in DES litigation. A number of courts have dismissed actions in which a plaintiff was unable to connect her injuries to a particular manufacturer. In Gray v. U. S. and Eli Lilly & Company, a case remarkably similar to the one here, the Court summarily granted the defendant drug manufacturer’s motion for summary judgment. After extensive discovery, the plaintiff still could not identify the defendant Lilly as the particular manufacturer of the drug which caused her injury. The Court found that summary judgment was appropriate for the moving defendant because it would be “only speculation and conjecture” that might link the defendant to the injury.

In a very recent decision, a New Jersey Appellate Court affirmed a lower court’s granting of summary judgment on the same grounds. Namm v. Eli Lilly & Company. The Court affirmed summary judgment finding that it was “a fundamental principle of products liability law” that a plaintiff must prove that the defendant manufacturer actually made the product which caused the injury.

The rule has been aptly stated by Dean Prosser:

Plaintiff still has the burden of establishing that the particular defendant has sold a product which he should not have sold, and that it has caused his injury. This means that he must prove, first of all, not only that he has been injured, but that he has been injured by the product. The mere possibility that this may have occurred is not enough, and there must be evidence from which the jury may reasonably conclude that it is more probable than not. 

Plaintiff cannot supply any direct evidence identifying the manufacturer of the drug taken by her mother. The claim that either Lilly or Squibb is the manufacturer is unsupported and unsupportable on the record. That one of these two defendants manufactured the DES at issue here is at best a guess. At the time Mrs. Ryan was prescribed DES, a number of companies marketed the product in the dosage she took. Lacking any basis for this essential element of proof, defendants Lilly and Squibb are entitled to summary judgment on all claims made solely against them.

In an attempt to circumvent the requirement that she causally connect her injuries to a particular DES manufacturer, plaintiff has placed additional reliance on claims of conspiracy among all these defendants in the licensing, manufacture, promotion and sale of DES. In her complaint, plaintiff alleges “the collective efforts of all defendants resulted in a conspiracy to defraud and deceive by virtue of their active agreement to fraudulently and deceptively misrepresent the alleged benefits of DES or the acquiescence to such misrepresentations ….” In considering this claim, an examination of the events surrounding the development and marketing of DES is therefore necessary. These facts have been revealed through extensive discovery, and have not been controverted by plaintiff in her opposition to this motion.

Crucial to an understanding of this conspiracy claim is some knowledge of the history of the development and marketing of DES. Much of this history is developed in the record here, and has been set forth in detail in several reported cases. Plaintiff alleges a long list of “collective efforts” made by these defendants in connection with DES since the early 1940s; these efforts she would have the Court call a “conspiracy.” This Court, however, is convinced that the facts in the record establish neither the claimed “collective efforts” nor the elements of civil conspiracy.

A review of the facts relating to the plaintiff’s conspiracy allegations is necessary to understand the second shortcoming of plaintiff’s case. “

… continue reading RYAN v. ELI LILLY & CO. on Leagle.

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