Lyons v. Premo Pharmaceutical Labs, Inc.

• Decision Date: 08 August 1979
• Citation: 406 A.2d 185,170 N.J.Super. 183
• Parties: Thomas LYONS, Administrator of the Estate of Joan Lyons, Claire Lyons and Thomas Lyons, Plaintiffs-Appellants, v. PREMO PHARMACEUTICAL LABS, INC., a corporation of the State of New Jersey, Chemetron Corporation, and Specific Pharmaceuticals, Incorporated, Defendants, and Merck & Company, Inc., a corporation of the State of New Jersey, Sharp & Dohme, Inc., a corporation of the State of New Jersey, Merck, Sharp & Dohme, Division of Merck & Co., Inc., Winthrop Laboratories, Division of Sterling Drugs, Abbott Laboratories, Armour Pharmaceutical Co., Division of Armour and Co., Subsidiary of Greyhound Corp., Ayerst Laboratories, Division of American Home Products Corp., Breon Laboratories, a Subsidiary of Sterling Drugs, Eli Lilly & Company, E. R. Squibb & Sons, Inc., Wyeth Laboratories, Division of American Home Products Corp., the Upjohn Company, and R. W. Greeff & Co., Inc., Defendants-Respondents.
• Court: New Jersey Superior Court — Appellate Division

Page 183

170 N.J.Super. 183

406 A.2d 185

Thomas LYONS, Administrator of the Estate of Joan Lyons, Claire Lyons and Thomas Lyons, Plaintiffs-Appellants, v. PREMO PHARMACEUTICAL LABS, INC., a corporation of the State

of New Jersey, Chemetron Corporation, and Specific

Pharmaceuticals, Incorporated, Defendants,

and

Merck & Company, Inc., a corporation of the State of New

Jersey, Sharp & Dohme, Inc., a corporation of the State of

New Jersey, Merck, Sharp & Dohme, Division of Merck & Co.,

Inc., Winthrop Laboratories, Division of Sterling Drugs,

Abbott Laboratories, Armour Pharmaceutical Co., Division of

Armour and Co., Subsidiary of Greyhound Corp., Ayerst

Laboratories, Division of American Home Products Corp.,

Breon Laboratories, a Subsidiary of Sterling Drugs, Eli

Lilly & Company, E. R. Squibb & Sons, Inc., Wyeth

Laboratories, Division of American Home Products Corp., the

Upjohn Company, and R. W. Greeff & Co., Inc., Defendants-Respondents.

Superior Court of New Jersey, Appellate Division.

Argued May 16, 1979.

Decided Aug. 8, 1979.

Frank P. Marano, Upper Montclair, for plaintiffs-appellants.

Thomas F. Campion, Newark, for respondents Merck & Co., Inc., Sharp & Dohme, Inc., and Merck, Sharp & Dohme, a Division of Merck & Co., Inc. (Shanley & Fisher, Newark, attorneys; John Zen Jackson, on the brief).

Thomas M. Mulcahy, Pluckemin, for respondents Winthrop Laboratories and Breon Laboratories (Purcell, Ries & Shannon, Pluckemin, attorneys; Eugene M. Purcell, Pluckemin, of counsel).

William B. McGuire, Newark, for respondent Abbott Laboratories (Lum, Biunno & Tompkins, Newark, attorneys; Steven E. Brawer, Newark, on the brief).

James L. Melhuish, Livingston, for respondent Armour Laboratories (Morgan, Melhuish, Monaghan & Spielvogel, Livingston, attorneys).

Anita Hotchkiss, Morristown, for respondents Ayerst Laboratories, Div. of American Home Products Corp., and Wyeth Laboratories, Div. of American Home Products Corp. (Porzio & Bromberg, Morristown, attorneys; Myron J. Bromberg, Morristown, of counsel).

John L. McGoldrick, Newark, for respondent Eli Lilly and Co. (McCarter & English, Newark, attorneys; Stuart E. Rickerson, Newark, of counsel).

Susan Eleff, for respondent E. R. Squibb & Sons, Inc. (Sills, Beck, Cummis, Radin & Tischman, Newark, attorneys; Barry M. Epstein, Newark, of counsel; Donald Zarin, Newark, on the brief).

Mary B. Rogers, Jersey City, for respondent The Upjohn Co. (Lamb, Hutchinson, Chappell, Ryan & Hartung, Jersey City, attorneys; Edwin A. Hartung, Jersey City, of counsel, and on the brief).

Jonathan Kohn, Newark, for respondent R. W. Greeff & Co., Inc. (Rothbard, Rothbard & Kohn, Newark, attorneys; Alexander L. Caccia, Paul F. Nash and Joseph P. Giasi, Jr., New York City, on the brief).

Before Judges MATTHEWS, KOLE and MILMED.

PER CURIAM.

This is an appeal from two judgments, both resulting from the same cause of action. It presents questions relating to liability for injuries caused by the taking of a drug during pregnancy.

On September 26, 1956, near the end of her first trimester of pregnancy, plaintiff Claire Lyons notified her obstetrician that she was experiencing some bleeding. To prevent spontaneous abortion, he prescribed a drug generically known as stilbestrol or diethylstilbestrol (DES). The prescription, which specified no particular brand, was phoned in to a local pharmacy and filled with stilbestrol tablets manufactured by Premo Pharmaceutical Labs, Inc. Mrs. Lyons took four of the 25 milligram pills daily for 12 days, after which the medication was discontinued because the bleeding had stopped. On April 20, 1957 after an otherwise normal pregnancy, she gave birth to a girl, Joan.

In the fall of 1973, when Joan was a junior in high school, it was discovered that she was suffering from clear cell adenocarcinoma of the cervix. Surgery was performed at that time to correct the condition. Although it appeared initially that the doctors had succeeded in arresting the spread of the malignancy, Joan died on November 3, 1977 of "(w)idespread metastasis of clear cell adenocarcinoma and bronchopneumonia."

Clear cell adenocarcinoma of the cervix, a rare form of malignancy in Joan's age group, has been observed in recent years in girls of 14-22 and related to In utero exposure to DES.

The present case began with the filing of a complaint by Joan Lyons, her mother Claire and her father Thomas, on September 29, 1975. The complaint identified Premo as the manufacturer of the medication taken by Claire during her pregnancy with Joan and alleged, against that defendant, negligence, breach of warranty, strict liability in tort and false representation. Merck & Co. was charged also with essentially the same acts and theories on the assertion that it had licensed Premo to produce stilbestrol. Eleven other drug companies were joined as defendants, the allegation against them being that it was through their joint efforts that DES was placed on the market. Compensatory and punitive damages were demanded.

Plaintiffs requested that the court relax R. 4:14-1 to allow for the early taking of depositions so that "we can determine whether or not we have all the defendants" and "the proper defendants." The motion was granted by the assignment judge.

A second order issued in January 1976 allowed plaintiffs to proceed with taking depositions from representatives of Premo, but limited them "to the discovery of such facts as may be necessary to permit plaintiff to make a determination as to the joinder of additional parties."

The discovery pursuant to these orders revealed that the DES used by Premo in the tablets taken by Claire Lyons was purchased from the manufacturer, Specific Pharmaceutical Labs, Inc., through a brokerage firm, R. W. Greeff & Co., Inc. As a result, the complaint was amended to add these two parties and Chemetron Corp., which since had acquired Specific.

All defendants but Premo moved for summary judgment. Judgment was granted on May 23, 1977 for all those not within this particular chain of distribution. The motions of Greeff and Chemetron were denied without prejudice.

On June 9, 1977 the trial judge denied plaintiffs' motion to pursue discovery against all defendants, with the exception of Specific, Chemetron, Premo and Greeff.

In October 1977 plaintiffs agreed to a settlement with both Premo and Chemetron (for Specific). The following month Joan died.

The case continued against Greeff on the basis of strict liability in tort. For the purposes of a motion by Greeff for summary judgment, both parties stipulated to a series of facts. Essentially, it was agreed that the sale of DES from Specific to Premo had been arranged by Greeff and that the drug was shipped directly from Specific to Premo, with Greeff never having physical control of the product.

Finding that the drug did not become dangerous until Premo obtained it, added to it other ingredients and packaged it for sale, the trial judge dismissed the complaint against Greeff.

This appeal from both judgments followed.

Before going into the issues raised on appeal, we believe a brief account of the history and development of the drug itself will be helpful.

DES is a synthetic estrogen which provides the same effects as a natural estrogenic substance. It was first produced by Professor E. C. Dodds and his associates at Middlesex Hospital in London. The drug was not patented by Professor Dodds, but was left available for general production by pharmaceutical companies.

American drug manufacturers were interested and in 1940 began submitting applications to the FDA seeking permission to produce and market the drug. According to a deposition taken in another matter from Dr. Theodore G. Klumpp, then Chief of the Drug Division of the FDA, by the end of 1940 there were ten new drug applications (NDAs) for DES on file with the agency. It was feared that to consider each separately would present "an overwhelming problem" and so it was decided, "in the public interest," to request that the drug companies pool all their clinical materials and present them together. The companies apparently received this suggestion with little enthusiasm, but accepted it when it was pointed out that consideration of individually submitted data would mean delays in approving the applications. As a result, a committee, whose members represented the drug companies was formed which put together and summarized all clinical data supplied by the individual pharmaceutical companies eventually presenting this data to the FDA.

The NDAs filed in the early 1940's, sought authorization to manufacture and distribute DES for four purposes: the treatment of post-menopausal symptoms; senile vaginitis, gonorrheal vaginitis in the pre-pubertal girls, and suppression of lactation.

At the same time research, apparently independent of the drug companies, was being conducted into the use of DES for threatened abortion and other problems in pregnancy. More enthusiasm was generated in the medical profession over the possibilities of the drug, particularly for diabetics and other women with a history of problem pregnancies. There was a great deal of activity in this area from the mid-1940s to the mid-1950s, much of it coming out of Boston. Information was exchanged among the obstetricians, based both on personal experience with the drug and numerous articles in medical journals.

In 1947, in order to benefit from all this interest and activity, many drug companies filed additional NDAs requesting authorization to market DES in larger dosages to treat pregnancy problems.

Both the enthusiasm and the activity waned in the late 1950s. In 1971 a statistical correlation was discovered between clear cell adenocarcinoma and DES. As recently as 1970, however, it was still prescribed, although rarely for pregnant women. It was in that year that a report was published which documented observation of the previously rare malignancy in girls of 14 to 22. In November...