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Lawson v. G.d. Searle & Co.

MAY 28, 1975.




APPEAL from the Circuit Court of Cook County; the Hon. JAMES C. MURRAY, Judge, presiding.


This is an appeal from a judgment entered by the Circuit Court of Cook County in favor of the defendant. It is an action in strict liability in tort to recover damages for the death of Sarah Lawson and for injuries sustained by Joanne Holmes due to their use of the contraceptive drug, Enovid.

The issues presented on appeal are: (1) whether it was prejudicial error to send to the jury room a book, defendant's exhibit 45, which was never received in evidence at any stage of the trial, when both the trial court and opposing counsel believed the exhibit referred to after the proofs were closed was another document; (2) whether it was permissible to permit one of defendant's witnesses, on direct examination, to recite clinical studies made by third persons; (3) whether counsel for defendant engaged in prejudicial conduct by continually offering exhibits and asking questions which had previously been ruled on by the court; (4) whether defendant's failure to respect certain notices for production of documents under Supreme Court Rule 237 constituted prejudicial error; and (5) whether in a strict liability case where the issue is the unreasonably dangerous character of a drug, the benefits of the drug should be balanced against its risks.

In April, 1971, the plaintiffs, Robert Lawson, as administrator of the estate of Sarah Lawson, deceased, and Joanne Holmes and Karl Holmes, brought an action against the defendant, G.D. Searle & Company, to recover damages for the death of Sarah Lawson and for injuries sustained by Joanne Holmes due to their use of the contraceptive drug, Enovid.

Mrs. Lawson, 25 years old, the mother of five, was in generally good health until July, 1962, when the drug was prescribed for a menstrual problem. She developed symptoms. It became necessary to hospitalize her in August and again on September 1, shortly before she passed away. An autopsy confirmed the diagnosis of pulmonary embolism made by the attending doctor. Multiple blood clots, none older than 6 to 8 weeks, were found.

Mrs. Holmes, in prior good health, was prescribed the pill, and shortly thereafter suffered shortness of breathing and inability to talk. She was hospitalized and placed on anticoagulants. A diagnosis of pulmonary embolism was made.

The record shows Enovid has a significant history. In 1961, two young women, Enovid users, died in Los Angeles as the result of thrombophlebitis, causing pulmonary embolism and death. Doctors in the employ of defendant went to the west coast and could find nothing unusual in either person predisposing to these conditions.

In 1961, Dr. Rappaport, a hematologist, was employed to study the effects of the drug. He found a statistically significant difference in the blood clotting of nonusers as opposed to contraceptive users.

On July 24, 1963, Dr. Pilgeram, another hematologist, advised defendant: "Insofar as Envoid is concerned, it is now my opinion, in opposition to my early stand, that the current evidence militates against the use of Enovid."

In 1968, two English doctors, Vessey and Inman, extensively studied the relationship between the oral contraceptive and thromboembolic disorders. It was found that such conditions were found nine times greater in users than in nonusers.

In 1968, the Department of Health, Education and Welfare advised the American medical profession "The British studies (Inman and Vessey) confirm what long had been suspected, namely, there is a definite association between the use of oral contraceptives and the incidents of thromboembolic disorders."

In a publication of defendant entitled "Family Planning With The Pill, a Manual for Nurses," it is stated: "Studies conducted in Great Britain and reported in April 1968 estimate there is a seven to tenfold increase in mortality and morbidity due to thromboembolic diseases in women taking oral contraceptives."

In 1970, the Department of Health, Education and Welfare entered a regulation that the users of the drug be given a warning. (35 Fed. Reg. 9002-3.) This was the first time in the history of prescription drugs in the United States that the manufacturer was directed to warn the consumer.

In 1970, the prescribing doctor was advised, "An increased risk of thromboembolic disease associated with the use of hormonal contraceptives has now been shown in studies conducted in both Great Britain and the United States."

In 1970, Searle, in accord with the Food and Drug Administration, told the consumer, "the oral contraceptives are powerful and effective drugs which can cause side effects in some users and should not be used at all by some women. The most serious known side effect is abnormal blood clotting which can be fatal."

Inman in 1970 stated: "We conclude that the data collected independently in the three countries leaves no doubt that there is positive correlation between the risk of thromboembolism and the dose of estrogen in oral contraceptives." This was the same person whose earlier studies had been alluded to by defendant in its literature.

Plaintiffs offered medical evidence as to the relationship between the condition of both women and defendant's drug. Other substantial evidence was likewise received. There were 110 case reports to defendant from doctors with patients without predisposing causes who had developed thromboembolic conditions after using Enovid. Some of these were fatal and included autopsy reports.

On the cross-examination of defendant's experts, outstanding medical authorities were shown to recognize a definite relationship between oral contraceptives and blood clotting.

Defendant's position in the trial court in substance was that: (1) it was licensed by the Federal Drug Administration; (2) it is not known whether there is a relationship between thromboembolic disorders and oral contraceptives; and (3) "association" does not mean relationship.

• 1 Licensing by the Food and Drug Administration means no more than that the drug has met the standards of that body. These are minimum standards and not meant to encroach upon the law of products liability. D'Arienzo v. Clairol, Inc. (1973), 125 N.J. Super. 224, 310 A.2d 106; Arata v. Tonegato (1957), 152 Cal.App.2d 837, 314 P.2d 130; Rumsey v. Freeway Manor Minimax (Tex. Civ. App. 1968), 423 S.W.2d 387.

• 2 Defendant's position that it does not know whether there is a relationship between oral contraceptives and thromboembolic disorders is not consistent with its duty. As a manufacturer, it is held to the degree of knowledge and skill of experts. Lewis v. Stran Steel Corp., 57 Ill.2d 94; Moren v. Samuel M. Langston Co., 96 Ill. App.2d 133.

"Association" might well mean relationship, particularly when, amongst many of the documents in evidence, defendant in its own records or in advices from the Food and Drug Administration were aware of the significant association between thrombosis and the use of oral contraceptives.

Much of defendant's evidence attacked the British studies, which it had repeatedly alluded to in its literature. From the record as a whole, it appears that such studies were recognized throughout the world as the leading ones.

Defendant urged that if there is evidence to support the verdict, any errors should be ignored. We cannot do this. Duffy v. Cortesi, 2 Ill.2d 511; Crane Co. v. Hogan, 228 Ill. 338.

Defendant's exhibit 41, throughout the trial, was referred to as the "Ad Hoc Committee Report." This is a 1963 report to the Food and Drug Administration concerning oral contraceptives. Defendant's exhibit 45, labelled "Second Report On The Oral Contraceptives," was referred to as the "Hellman Report." Both documents were printed by the FDA.

Throughout the trial, on numerous occasions, defendant offered into evidence these exhibits. The offer was denied, with the court, on occasion, instructing the jury to disregard such offer.

The British reports of Doctors Inman and Vessey repeatedly referred to in defendant's literature were received in evidence on behalf of the plaintiffs.

At the conclusion of all the evidence, the trial court erroneously believed one of the two Government publications heretofore described should be received. His basis was that such was a corporate record of defendant.

• 3, 4 If these were corporate records (which they were not) they could not be admissible to support a corporate claim. In Nelson v. Union Wire Rope Co., 31 Ill.2d 69, 115, it is stated:

"As a general rule any statement, written or not, made by a party or in his behalf which is inconsistent with his present position may be introduced in evidence against him. (Conrad, Modern Trial Evidence, vol. 1, sec. 454; Cleary, Handbook of Illinois Evidence, sec. 13.10; Brown v. Calumet River Railway Co., 125 Ill. 600.) Where the question has arisen, authorities are in accord that advertisements, brochures, newspaper items, catalogs, and the like are admissible and relevant to the subject matter of the suit where they contain statements of a party inconsistent with a claim or a position asserted by such party in the action. (Henkle v. Smith, 21 Ill. 237; 20 Am. Jur. Evidence, 1960 Supp. p. 152; 44 A.L.R. 2d 1031; Hartford Steam Boiler Inspection & Insurance Co. v. Pabst Brewing Co. (7th Cir.) 201 F. 617, 629; Fryer v. New York Brokerage Co. 152 Iowa 688, 133 N.W. 110; cf. Mahlstedt v. Ideal Lighting Co. 271 Ill. 154.)"

At the afternoon instruction conference, plaintiffs were given a choice of which document they would agree to. Their position was that neither was admissible.

Before argument to the jury the following morning, counsel for defendant advised the court, "the only thing left open was his ruling on the Ad Hoc Committee Report." The court admitted into evidence the "Ad Hoc Committee Report." At the time of the offer, the exhibit was neither identified by number nor was it present.

During defendant's counsel's argument, defendant's exhibit 45, which had been referred to as the "Hellman Committee Report," was read from. Plaintiff's counsel objected, but was overruled. Certain parts of the document which defendant's counsel read from were objected to, and the objection was sustained. A recess was declared.

In response to inquiry by the court, defendant's counsel represented that before the arguments, he had referred to the exhibit by number. This was not correct. The court observed he believed there was only one "Ad Hoc Committee Report" and asked to be shown where defendant's exhibit 45, the "Hellman Committee Report," was referred to in defendant's literature, since this was the basis of his admission. He noted what counsel for defendant showed him was not in its literature. Obviously, court and counsel for plaintiffs did not know what document was being received.

Plaintiffs made a motion to withdraw a juror and declare a mistrial or, in the alternative, to recall the jury into the courtroom and instruct them that any reference to defendant's exhibit 45, the "Second Report On The Oral Contraceptives," or the "Hellman Committee Report" should be disregarded. This motion was denied, and the document sent to the jury room. The 7-week trial there ended.

Defendant's exhibit 45, "Second Report On The Oral Contraceptives," by the Advisory Committee on Obstetrics and Gynecology, Food and Drug Administration, is a book of 88 pages. It covers many matters completely immaterial to the issues.

The conclusion of the Committee, amongst other matters, read thus:

"Although the Kefauver-Harris Amendments of 1962 indicate that the term `safe' has reference to health of man, nowhere do they define safety. Discussing this subject before the Subcommittee of the Committee on Government Operations of the House of Representatives, the Commissioner of FDA pointed out that no effective drug can be absolutely safe. Therefore, evaluating safety of a drug requires weighing benefit against risk." (Italics ours.)

Again, it reads thus:

"Specific risks as well as requisite practices for follow up of patients have been detailed in the labeling of all hormonal contraceptives. When these potential hazards and the value of the drugs are balanced, the Committee finds the ratio of benefit to risk sufficiently high to justify the designation safe within the intent of the legislation." (Italics ours.)

• 5 Strict liability in tort is not predicated upon legislation, nor is it the law that "no effective drug can be absolutely safe." Singer v. Sterling Drug Co. (7th Cir. 1972), 461 F.2d 288, 292; Cunningham v. MacNeal Memorial Hospital, 47 Ill.2d 443.

The term "defect" in a strict liability in tort action has a broad and inexact definition, as was observed in Dunham v. Vaughan & Bushnell Manufacturing Co., 42 Ill.2d 339, 342:

"Although the definitions of the term `defect' in the context of products liability law use varying language, all of them rest upon the common premise that those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function."

The definition of "safe" in the pamphlet which went to the jury was contrary to the meaning of "defect" within the strict liability in tort doctrine.

During the direct examination of Dr. Drill, an employee of defendant, the court was advised defendant had "a room full of charts" to show the jury. Plaintiffs were granted a voir dire examination of the witness. It appeared that Dr. Drill had prepared charts based on the clinical studies published by others. For the most part, these were defendant's clinical investigators. From 53 studies, certain charts had been drawn. These had to do with whether a particular investigator had a case of thrombophlebitis and, if so, the number of persons using oral contraceptives. While the court would not allow the charts which contained excerpts to be shown the jury, he ruled that the witness would be permitted to state the specific reports and the studies made by others. Plaintiffs specifically objected, but the trial court stated his ruling was based on Darling v. Charleston Community Memorial Hospital, 33 Ill.2d 326.

Darling does not permit a witness to collect materials from experiences of third persons and to so relate them on direct examination. On the contrary, Darling is limited to cross-examination.

"To prevent cross-examination upon the relevant body of knowledge serves only to protect the ignorant or unscrupulous expert witness. In our opinion expert testimony will be a more effective tool in the attainment of justice if cross-examination is permitted as to the views of recognized authorities * * *." 33 Ill.2d 326, 336.

• 6 In this procedure, plaintiffs could not test the accuracy of the studies or the surrounding circumstances since none who made them was before the court for cross-examination. This was hearsay, and it was prejudicial error to allow the witness to give such evidence. In Mehochko v. Gold Seal Co., 66 Ill. App.2d 54, the trial court allowed a doctor on direct examination to read the results of a test conducted by an independent biological laboratory. The appellate court reversed, stating:

"The tests were not before the court and he [Dr. Lederer] could not be cross-examined about the method (save what he read about it) nor about the tester's qualifications to perform the experiments and correctly interpret the results. Dr. Lederer was a stranger to the evidence he introduced. He knew nothing about it save through hearsay; he could not be cross-examined about the essence of the independent tests." (66 Ill. App.2d 54, 58.)

Likewise in the instant case, Dr. Drill was unfamiliar with the studies he recited and could not be cross-examined about those studies.

• 7 Textbooks have never been admitted in Illinois to prove an issue of fact. (North Chicago Rolling Mill Co. v. Monka, 107 Ill. 340, 344; Brodie v. City of Lewistown, 164 Ill. App. 335, 337. Also, see 84 A.L.R. 2d 1338, 1341.) If such were proper, then plaintiffs could have offered as evidence the multiple writings adverse to defendant's position. We do not believe such a radical procedure would further the administration of justice. It was prejudicial error to overrule plaintiffs' specific and timely objections to such evidence.

• 8 Complaint is made concerning an alleged violation of Supreme Court Rule 237. The purpose of this rule is to obviate the necessity of the service of a subpoena upon a party to whom such notice is directed. Larson v. Commonwealth Edison Co., 33 Ill.2d 316, 325, 326.

On March 31, 1971, plaintiffs served upon defendant a notice to produce Dr. Winter, together with, among other things, the following:

"All contraindications, warnings, etc., pertaining to Enovid, as well as the date of the printing of each of the said contraindications or warnings and the vehicle in which such contraindications or warnings appeared from 1960 through 1970."

On April 6, 1971, prior to the commencement of the trial, this notice was considered paragraph by paragraph. The court ruled that the matters from 1960 through 1970 would be relevant. Counsel for defendant advised the court that he desired time to talk with Dr. Winter, whose presence was required by the notice, "in view of the court's rulings to produce these various documents."

On April 12, before opening statements had been made, the court again suggested that there be produced "all requested documentation under the rules of materiality or relevancy which have been in effect in Illinois on the principles of liability or the integrity of the product involved." The same date, counsel for plaintiffs again requested the documents. Defendant stated most of them were ready and would be produced in court. The court advised that he was not interested in "games" and that the material should be produced in his chambers. On the forenoon of April 13, when counsel for plaintiffs again requested the documents, the court stated he had ruled the documents were to be produced and their admissibility would be determined at the time they were offered. He referred to his memorandum statement of April 12. Subsequent requests were made from time to time.

After Dr. Winter had testified, and it had developed that in 1970 the Food and Drug Administration had enacted certain regulations concerning oral contraceptives, another request to produce correspondence between the defendant and the Food and Drug Administration was made. When plaintiffs insisted on compliance with the notices, defendant represented to the court that plaintiffs' counsel had agreed to accept only matters going to 1968. There is nothing in the record to support this, and it would seem strange that a lawyer who had urged from the outset he wanted material through 1970 should be content with 1968. The court, admitting he could not recall what occurred, stated he had to go on the representations of counsel for defendant. Accordingly, no material beyond 1968 was produced.

Plaintiffs were thus deprived of the following important evidence:

1. Correspondence between the defendant and the FDA in 1970 concerning a booklet, "What You Should Know About The Pill."

2. The booklet itself entitled, "What You Should Know About The Pill" distributed to all users.

3. The warning given dispensing physicians in May 1970 to the effect that an increased risk of thromboembolic disease associated with the use of oral contraceptives has been shown in studies in Great Britain and the United States.

4. The package insert employed in 1970, which unlike the one in evidence (1968) to the effect that side effects were not confirmed nor refuted, stated that a significant association has been demonstrated between oral contraceptives and thrombophlebitis. This change was pursuant to the Food and Drug Administration.

Such conduct by counsel for defendant cannot be countenanced. It is obvious the court first ruled the 1970 documents were to be produced and they were withheld because such material was particularly damaging.

Counsel for a litigant has a right to assume that his adversary, upon a notice to produce, has produced all the material called for unless there is a question of privilege. In this event, the matters claimed to be privileged should be shown to the court, who can in camera decide that question. See Drehle v. Fleming, 49 Ill.2d 293, for an expression of duty of disclosure.

It is urged it was error to permit evidence that oral contraceptives do not cause blood clotting. We have described how the defendant in its literature repeatedly referred to abnormal blood clotting as a known side effect, and that an association between oral contraceptives and thrombophlebitis had been demonstrated. Moreover, the Commissioner of Food and Drugs issued a regulation in 1970 concerning warnings to be given to oral contraceptive users to the effect that the most important known complication was blood clotting. Defendant did not object, but complied with the regulation. Lilly v. Grand Trunk Western R.R. Co., 317 U.S. 481, 488; Federal Security Administrator v. Quaker Oats Co., 318 U.S. 218, 228; Brunetto Cheese Manufacturing Corp. v. Celebrezze (2d Cir. 1966), 356 F.2d 874, 875, 876; Carter-Wallace, Inc. v. Gardner (4th Cir. 1969), 417 F.2d 1086, 1089.

• 9 Under all the facts and circumstances we conclude that oral contraceptives can cause blood clotting. (Pedrick v. Peoria & Eastern R.R. Co., 37 Ill.2d 494.) In so stating, we do not hold that any oral contraceptive user who suffers a vascular condition is entitled to recover as a matter of law automatically. Each case must be determined upon its own facts, particularly the causal relationship.

At the close of all the evidence, plaintiffs moved for a finding on the issue of liability. This was denied, but ...

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