Palmer v. A.H. Robins Co., Inc.

Decision Date04 June 1984
Docket NumberNo. 81SA149,81SA149
Parties38 UCC Rep.Serv. 1150 Carie M. PALMER, Plaintiff-Appellee, v. A.H. ROBINS CO., INC., a Virginia corporation, Defendant-Appellant.
CourtColorado Supreme Court

Bragg & Dubofsky, P.C., Douglas E. Bragg, John T. Baker, Denver, for plaintiff-appellee.

Tilly and Graves, James L. Tilly, Charles Q. Socha, Denver, McGuire, Woods & Battle Alexander H. Slaughter, E. Duncan Getchell, Jr., Mays, Valentine, Davenport & Moore, William R. Cogar, Clifford W. Perrin, Stephen W. Brewer, Richmond, Va., for defendant-appellant.

QUINN, Justice.

In this appeal the defendant-appellant, A.H. Robins Company, Inc. (Robins), challenges a judgment for compensatory and punitive damages in favor of the plaintiff-appellee, Carie Palmer. Robins raises a multitude of claims relating to several evidentiary rulings of the trial court, the sufficiency of evidence on Palmer's negligence claim, the submission to the jury of Palmer's claims for breach of express and implied warranties, the propriety of certain jury instructions on the burden of proof and negligence per se, and, in addition, the jury's award of punitive damages. Finding no reversible error, we affirm the judgment.

I. The District Court Proceedings

In order to place this case in a factual context, we briefly summarize the events leading up to the judgment. Occupying a central role in these events is the product itself, the Dalkon Shield (shield).

The shield is a plastic intrauterine device manufactured by Robins. It is small and oval shaped, about the size of a dime, with a row of fins or prongs on each side. It is designed to fit the shape and contour of the uterine cavity. A tailstring is attached to the shield as an aid in checking for proper placement and as an aid to its removal. When the shield is properly in place, the tailstring passes forward from the uterus through the cervix and into the vagina. The string, unlike the single strand employed in other intrauterine devices, is a multifilament strand placed inside a nylon sheath unsealed at both ends.

The shield was invented in 1968 by Irwin S. Lerner, who modified a previous design by Dr. Hugh J. Davis, an associate professor of obstetrics and gynecology at Johns Hopkins University. Lerner, Davis, and one other individual subsequently formed the Dalkon Corporation to market the shield. Beginning in September 1968, Davis conducted a test study for one year on the shield at a family planning clinic that he directed. According to Davis, 640 insertions resulted in only five pregnancies, the biostatistical equivalent of a 1.1% rate during the testing period. Without referring to his financial interest in the shield, Davis then published an article in the February 1970 issue of American Journal of Obstetrics and Gynecology, in which he reported on the results of the study and repeatedly referred to the shield as a "superior" IUD.

Robins, intrigued by Davis' test results, investigated the possibility of purchasing the shield. As a result of this investigation, two memoranda were sent to Robins' top management in early June 1970 by members of Robins' medical department. The first memorandum, authored by Dr. Fred Clark, indicated that Davis' claim of a 1.1% pregnancy rate in twelve months had jumped to the equivalent of a 5.5% pregnancy rate after fourteen months. A second memorandum, written by Dr. Jack Freund, in addition to noting that the 1.1% pregnancy rate of the Davis study had undergone some increase with a longer follow-up period, stated that the Davis study was "not long enough ... to project with confidence to the population as a whole." The existence and contents of these memoranda were never revealed to those Robins' personnel responsible for marketing the shield. On June 12, 1970, Robins purchased all rights to the shield from the Dalkon Corporation.

Robins made several modifications to the shield in late 1970. Without completing any clinical testing on the modifications or revealing them to the medical profession, Robins began to market the shield nationally in January 1971, carrying out an extensive promotional campaign directed to both the medical community and the lay public. Robins' product label is particularly indicative of the type of claims made about the device, namely: that the shield was "the modern superior I.U.D."; that it had the "lowest pregnancy rate [of] 1.1%"; that it "combin[ed] minimal pregnancy rates with exceptional patient tolerance"; that it "prevent[ed] pregnancy without producing any general effects on the body, blood or brain"; and that it "provid[ed] safe, sure, sensible contraception." The primary basis for these claims was the Davis study in 1968-69 prior to the modification of the shield in 1970.

In August 1971 Robins was informed that the quality control supervisor at Chapstick, a Robins subsidiary which assembled the shield, had performed a "wicking" test on the tailstring of the shield and determined that the interior of the string could "wick" fluid through its entire length. The existence of a wicking tendency in an intrauterine device is significant in that the uterus is normally sterile. Under ordinary conditions the cervix and cervical mucus will prevent the entry into the uterus of bacteria residing in the vagina. However, an IUD tailstring with a wicking tendency can provide a pathway for vaginal bacteria into the uterus, thereby causing infection. The director of pharmaceutical research for Robins, although aware that the tailstring could thus transmit body fluids containing bacteria into the sterile uterus and cause infection, nonetheless instructed Chapstick that no changes should be made in the product.

On June 23, 1972, Dr. Thad J. Earl, a Robins clinical investigator and consultant, sent a letter to the management of Robins in which he warned of the danger of septic abortion in shield users who might become pregnant. Dr. Earl stated in his letter:

"The next situation I have found is with women becoming pregnant and if the Shield is left in place the women abort at 3 1/2 to 5 months and become septic. I am advising physicians that the device should be removed as soon as a diagnosis of pregnancy is made. Numerous physicians have noted this. In my six pregnancies, I removed one and she carried full term, the rest all aborted and became septic. I therefore feel that it is hazardous to leave the device in and I advised that it be removed."

Robins did not contact Dr. Earl about this warning until after the shield had been removed from the market over two years later. During the seventeen month period between June 1972 and November 1973, when the plaintiff sustained grave injuries resulting from the use of the shield, Robins received twenty-two reports of spontaneous septic abortions in shield users, one of which resulted in death. Despite Robins' knowledge of the septic abortion danger, it it did not immediately alert the medical community to the danger. In October 1972 Robins revised its patient brochure, stating that if a woman becomes pregnant while wearing a shield, "the bag of water pushes the IUD to one side and the developing baby is not really touching the device at all. There is no evidence that the frequency of abnormal births is any greater among women wearing IUDs than among women not wearing IUDs." Also, as late as April 1973 Robins continued to advise physicians to leave the shield in place in the event the user became pregnant and desired the pregnancy to go to term.

On January 16, 1973, Carie Palmer, who was then a twenty-four year old wife and mother, was fitted by her obstetrician-gynecologist, Dr. Kenneth Petri, with a shield. Palmer, who wanted to wait several years before having more children, chose this device as a birth control method on the advice of Dr. Petri and on the basis of Robins' promotional materials describing the superior contraceptive and safety features of the shield. Dr. Petri had specifically relied on promotional claims made by Robins as to the safety and effectiveness of the shield in prescribing this device. After having been fitted with the shield, Palmer continued to use it as a method of contraception because, based on her review of Robins' promotional literature given to her by Dr. Petri, she believed the shield to be 98.9% effective in preventing pregnancy and safer than the birth control pill.

In August 1973 Palmer became pregnant. Dr. Petri, believing that removal of the shield might cause a spontaneous abortion, whereas leaving it in place could cause no harm, did not remove the device. Palmer's pregnancy progressed normally until November 18, 1973, when she became violently ill with influenza-like symptoms. Within hours of her admission into the hospital, she suffered a spontaneous septic abortion, an involuntary miscarriage caused by a blood borne bacterial infection centered in the uterine area. Palmer subsequently went into septic shock, a condition resulting from a massive infection with a concomitant fall in blood pressure to a dangerously low level. She also developed a blood disorder which impeded natural blood clotting ability. In order to save her life, it was necessary to perform a total hysterectomy in which her uterus, fallopian tubes and ovaries were removed. It was Dr. Petri's expert opinion that Palmer's uterine infection and the septic abortion were caused by the shield. As a result of the hysterectomy, Palmer experienced continued health problems thereafter.

In the fall of 1973 Robins had become aware that Dr. C.D. Christian, a professor of obstetrics and gynecology at the University of Arizona, was writing an article on the danger of mid-trimester septic abortions posed by IUDs, particularly the shield. Subsequently, in February 1974, Robins called a conference to examine the problem. The conference led to the issuance of a "Dear Doctor letter," dated May 8, 1974, to 120,000...

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