Lawson v. G. D. Searle & Co.

• Decision Date: 28 May 1975
• Docket Number: No. 58000,58000
• Citation: 331 N.E.2d 75,29 Ill.App.3d 670
• Parties: Robert H. LAWSON, Administrator of the Estate of Sarah Lawson, Deceased, et al., Plaintiffs-Appellants, v. G. D. SEARLE & COMPANY, a corporation, Defendant-Appellee.
• Court: United States Appellate Court of Illinois

Page 75

331 N.E.2d 75

29 Ill.App.3d 670

Robert H. LAWSON, Administrator of the Estate of Sarah

Lawson, Deceased, et al., Plaintiffs-Appellants, v. G. D. SEARLE & COMPANY, a corporation, Defendant-Appellee.

No. 58000.

Appellate Court of Illinois, First District, Fourth Division.

May 28, 1975.

James A. Dooley, Chicago, for plaintiffs-appellants.

Baker & McKenzie, Francis D. Morrissey, Sidley & Austin, Chicago, for defendant-appellee; Thomas F. Tobin, John T. Coleman, Edward J. Zulkey, William P. Richmond, James W. Kissel, Chicago, of counsel.

DIERINGER, Presiding Justice:

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, Ill.Rev.Stat.1973, ch. 110A, § 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 six to eight 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 Enovid 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 non-users.

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.

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., 125 N.J.Super. 224, 310 A.2d 106; Arata v. Tonegato, 152 Cal.App.2d 837, 314 P.2d 130; Rumsey v. Freeway Manor Minimax, 423 S.W.2d 387 (Tex.Civ.App.).

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, 311 N.E.2d 128; Moren v. Samuel M. Langston Co., 96 Ill.App.2d 133, 237 N.E.2d 759.

'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, 119 N.E.2d 241; Crane Co. v. Hogan, 228 Ill. 338, 81 N.E. 1032.

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.

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 Corp., 31 Ill.2d 69, 115, 199 N.E.2d 769, 794 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, 18 N.E. 283.) Where the question had 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...