Werner v. Upjohn Co.

WIDENER, J. The plaintiff, Jack Werner, brought this action against the Upjohn Co. and Dr. Ralph J. Carbo, an ophthalmologist, to recover damages for injuries Werner received as result of his taking the prescription drug Cleocin which was manufactured by Upjohn and prescribed by Dr. Carbo. Jurisdiction is based on diversity of citizenship and the requisite amount in controversy.

The case was tried to a jury which found that Carbo was negligent in prescribing the drug and that his negligence proximately caused or contributed to plaintiff's injury; that Upjohn was negligent in either marketing or selling Cleocin and such negligence proximately caused or contributed to plaintiff's injury; that Upjohn was negligent in failing to warn properly of the dangerous side effects of Cleocin; that Upjohn breached either an express or implied warranty in its sale of Cleocin to Carbo; and that Upjohn was not liable in strict liability for marketing an unreasonably dangerous drug. Based on these findings the jury awarded damages of $400,000. The defendants appeal.

Upjohn argues that there is insufficient evidence on which the jury could find that Upjohn was negligent; that the jury verdicts are inconsistent; that a subsequently revised warning was improperly admitted into evidence; that several of the jury instructions were improper; and that it could not be found liable even if the warning was inadequate because Dr. Carbo admitted that he did not read the warning which was given....

We hold that the district court erred in admitting the subsequent warning into evidence. We therefore reverse and remand for a new trial.

The prescription drug at the base of this action is Cleocin (generic name Clindamycin HCl) a broad-spectrum antibiotic. The Food and Drug Administration (FDA) first approved Cleocin for general use in 1970, and it soon became a popular alternative antibiotic for those persons who were allergic to penicillin. As the use of Cleocin increased Upjohn began to receive reports of side effects from Cleocin use, such as diarrhea and colitis. The appearance of these side effects was reported to the FDA and several medical studies were done both independently and by Upjohn which sought to clarify the incidence and extent of these side effects. The plaintiff argued that Upjohn knew of serious side effects in 1974 and failed to act on this information until March 1975. Upjohn argued that its 1974 warning contained all the relevant information available at that time. In any event, as a result of the reported side effects and subsequent studies, the warning information accompanying Cleocin went through several revisions. Throughout this period the central concern over Cleocin was its capacity to cause pseudomembranous colitis (PMC) in some patients. Prior to 1974 the incidence of PMC in Cleocin users was thought to be quite low, but in late 1973 a Dr. Tedesco published a study which found signs of PMC in 10 percent of a test group who took the drug. However, it was not clear that the PMC found in Tedesco's patients was the same as the more commonly known and admittedly extremely serious PMC since Dr. Tedesco's patients recovered without any permanent problems. As a result of Tedesco's study and information provided by Upjohn and others a new warning was issued in the summer of 1974. This new warning was included in the package insert accompanying Cleocin and was the subject of what is called a "Dear Doctor" letter which was mailed to every physician in the United States. The adequacy of this warning at the time it was released is one of the central issues in this case. The 1974 warning stated:

WARNING

Severe and persistent diarrhea, which may be accompanied by blood and mucus, and which may be associated with changes in large bowel mucosa diagnosed as "pseudomembranous colitis," has been reported in association with the administration of Cleocin HCl (clindamycin HCl hydrate).

When significant diarrhea occurs (usually more than 5 bowel movements daily), the drug should be discontinued or, if necessary, continued only with close observation of the patient (large bowel endoscopy has been recommended). Mild cases of colitis may respond to drug discontinuance alone. Moderate to severe cases should be managed promptly with fluid, electrolyte and protein supplementation as indicated. Antiperistaltic agents--opiates, meperidine, and diphinoxylate with atrophine may prolong and/or worsen the condition. Systemic corticoid and corticoid retention enemas may help relieve the colitis. Other causes of colitis should also be considered.

Note: Diarrhea has been observed to begin up to several weeks following cessation of therapy with Cleocin HCl. The physician must be alert to this possibility.

The plaintiff first visited Dr. Carbo in Maryland on December 10, 1974 for treatment of a chalazion on his eyelid. Dr. Carbo prescribed Cleocin for the plaintiff's condition and stated that he advised plaintiff that he might experience some nausea, vomiting or diarrhea, and told him that if he experienced these side effects he should stop using the drug and report to him. The plaintiff testified that Carbo gave him no such warning. Carbo's warning was based on the 1973 package insert. He admitted that he did not read the 1974 Dear Doctor letter before prescribing Cleocin to the plaintiff even though it was available in his office....

As mentioned a central issue in the case against Upjohn and an important collateral issue in the case against Dr. Carbo was the adequacy of the 1974 warning, and both the plaintiff and Upjohn presented a great deal of evidence on the true dangers and incidence of side effects of Cleocin and whether the warning adequately conveyed the facts....

No evidence introduced by the plaintiff was more important on the adequacy of the 1974 warning, than the evidence he introduced, over objection, of a warning published in March 1975 which expanded on the 1974 warning. The 1975 warning stated:

Clindamycin can cause severe colitis which may end fatally. Therefore, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS section. It should not be used in patients with nonbacterial infections, such as most upper respiratory tract infections. The colitis is usually characterized by severe, persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis.

When significant diarrhea occurs, the drug should be discontinued or, if necessary, continued only with close observation of the patient. Large bowel endoscopy has been recommended.

Antiperistaltic agents such as opiates and diphinoxylate with atrophine (Lomotil) may prolong and/or worsen the condition.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin.

Upjohn moved to exclude all reference to the 1975 warning. The court denied this motion and allowed the plaintiff to introduce the warning into evidence. When the warning was offered into evidence, over objection, the district judge instructed the jury that the warning was not to be used as evidence of negligence or culpable conduct. However, the court did not inform the jury at that time for what purpose it was to be considered. Later, after all evidence was in, the judge instructed the jury that they should only consider the 1975 warning on the issue of feasibility, obviously referring to Federal Rule of Evidence 407.

Federal Rule of Evidence 407, which enacts the common law rule excluding subsequent remedial measures to prove negligence, does, however, permit evidence of subsequent remedial measures to be used to prove the feasibility of such measures, but only if feasibility is controverted by the defendant. But, despite the judge's limiting instruction on this point it is clear that the 1975 warning was used by the plaintiff to prove negligence. The warning was mentioned several times during the course of the trial when expert witnesses were asked whether the information in the 1975 warning should have been included in the 1974 warning if that information had been available to Upjohn at the time the 1974 warning was given. This use of the warning has no conceivable connection to feasibility. The plaintiff's expert witnesses were asked time after time whether Upjohn "should have" included the information in the 1975 warning in the 1974 warning. The obvious inference is that if Upjohn should have used the subsequent warning earlier, then it was negligent for failing to do what it "should have" done. This use of the 1975 warning clearly was impermissible and constitutes reversible error. Columbia & Puget Sound R. Co. v. Hawthorne, 144 U.S. 202 (1892)....

Plaintiff also made improper use of the 1975 warning in closing argument to the jury. Plaintiff's counsel stated:

If we were to boil this down to the least common denominator, if you were to be asked tomorrow, after, hopefully, the case is decided and done with, what was the biggest single thing that Upjohn did wrong that impells [sic] you to bring in a verdict for the plaintiff against Upjohn, would you not have to say Upjohn knew of the fatalities and didn't tell the doctors until much later, after this whole episode was over and done? That they knew it should not be used for other than serious, life-threatening infections? That they knew there were other less toxic antibiotics which were appropriate, and they told people that later? That they knew that they had, according to their people, cut off promotion of the drug in the middle of '74, but didn't tell the doctors that? Don't you think, honestly, and you have to answer this to yourselves, don't you think any one of those four things was a violation of a duty which any ethical drug manufacturer owes the public, to keep the public informed, or keep the doctors informed so the public can be informed?

Instead of that, they held it under their belt; they continued the advertising for at least four more months, in many instances. They held off the change until March of '75 [the date the 1975 warning was released], nine months after they knew this, and they cashed in as much as they could....

But, in this delay, from July 1 to March of '75, before they really cut and told the doctors what they should have told them long ago, in that nine month period....

The clear import of this argument is that Upjohn breached its duty of due care by failing to adopt the 1975 warning in 1974. Thus, plaintiff used the substance of the subsequent warning to prove antecedent negligence and thereby violated Rule 407....

Plaintiff also argues that since an instruction was given limiting the use of the 1975 warning to the issue of feasibility that any error caused by plaintiff's departure from this rule is harmless because it was cured by the limiting instruction. This argument is without merit. In the abstract, of course, evidence may be admissible for one purpose and inadmissible for another. The usual solution for this problem is to admit the evidence to prove the permissible inference, but limit its use by jury instructions. This does not mean, however, that the party offering evidence for a limited purpose is free to use it for a forbidden purpose, over objection, during the course of the trial and insulate reversal by pointing to a limiting instruction given at the close of the case....

Thus, plaintiff's efforts to expand the feasibility exception must fail. Since feasibility was not in issue in the case the evidence should have been excluded. See Advisory Committee Notes to Rule 407. Rule 407 is designed to protect the important policy of encouraging defendants to repair and improve their products and premises without the fear that such actions will be used later against them in a lawsuit. Several exceptions to the rule have developed, but it is clear that they must be narrowly construed if the central policy behind the rule is to be effectuated. If feasibility were to be found at issue in the case at bar, it is difficult to imagine a situation where it would not at least arguably be in issue. As Professor McCormick has said:

[T]he extrinsic policy of encouraging remedial safety measures is the predominant reason for holding evidence of these measures to be privileged. It is apparent that the free admission of such evidence for purposes other than as admissions of negligence is likely to defeat this paramount policy. It is submitted that before admitting the evidence for any of these other purposes, the court should be satisfied that the issue on which it is offered is of substantial importance and is actually, and not merely formally in dispute, that the plaintiff cannot establish the fact to be inferred conveniently by other proof, and consequently that the need for the evidence outweighs the danger of its misuse.

McCormick on Evidence, § 275, at 668-669 (2d ed. 1972). In sum, feasibility is not in issue in this case, and even if it were, it is clear that the use made by the plaintiff of the 1975 warning was not so limited.

Alternately, plaintiff argues that even if the 1975 warning was not admissible to show feasibility it was admissible on other grounds. It is arguable that this question is not directly before us on appeal because the 1975 warning was in fact used to prove negligence, and thus the fact that the evidence might have been admissible on some other ground not raised at trial should not prevent reversal and a new trial. Especially because this case must be tried again, and we do not believe that the 1975 warning was admissible, we examine plaintiff's other arguments for admitting the evidence.

Plaintiff argues, and we agree, that the exceptions listed in Rule 407--ownership, control or feasibility of precautionary measures (if controverted), and impeachment, are illustrative and not exhaustive. See Advisory Committee Notes to Rule 407. However, we note once again that Rule 407 promotes an important policy of encouraging subsequent remedial measures. If this policy is to be effectuated we should not be too quick to read new exceptions into the rule because by so doing there is a danger of subverting the policy underlying the rule.

Plaintiff's principal argument along this line is that the 1975 warning is admissible because the suit includes a strict liability claim. The courts have split on this proposition. We suppose, without making a numerical comparison, that the majority of courts would admit the evidence for one reason or another. Compare e.g., Smith v. E.R. Squibb & Sons, Inc., 405 Mich. 79, 273 N.W.2d 476 (1979); Price v. Buckingham Mfg. Co., 110 N.J. Super. 462, 266 A.2d 140 (1970); with Robbins v. Farmers Union Grain Terminal Assn., 552 F.2d 788 (8th Cir. 1977); Ault v. Intl. Harvester, 13 Cal. 3d 113, 117 Cal. Rptr. 812, 528 P.2d 1148 (1974).

In support of his argument to admit the evidence plaintiff first argues that Rule 407 in terms only bars the evidence to prove negligence or culpable conduct and that the rule therefore does not allow for exclusion on the strict liability issue. We disagree. The mere fact that Rule 407 by its terms only excludes evidence of subsequent precautionary measures to prove negligence or culpable conduct does not necessarily mean that the evidence should be admissible to prove strict liability. It is clear that in enacting the Federal Rules of Evidence Congress did not intend to wipe out the years of common law development in the field of evidence, indeed the contrary is true. The new rules contain many gaps and omissions and in order to answer these unresolved questions courts certainly should rely on common law precedent. This is true with respect to Rule 407 which merely enacts the common law rule. Rule 407 bars evidence of subsequent precautionary measures to prove negligence or culpable conduct with exceptions for control, ownership or feasibility (if controverted) and impeachment. The rule simply does not speak in terms to the question of whether the evidence should come in to prove strict liability. To resolve this question we must examine the policy behind Rule 407 and the common law basis for the rule, and then determine if admitting the evidence as evidence of strict liability is more akin to the use of it to prove negligence, or if it is closer to one of the recognized exceptions to the rule. That is to say, would the policy behind the common law rule be served or subverted if evidence of subsequent precautionary measures be admitted to prove strict liability.

We first note that Rule 407 excludes evidence of subsequent precautionary measures to prove negligence or culpable conduct. Culpable conduct normally involves something more than simple negligence and implies conduct which is "blamable; censurable; involving the breach of a legal duty or the commission of a fault.... [I]t implies that the act or conduct spoken of is reprehensible or wrong, but not that it involves malice or a guilty purpose." Black's Law Dictionary (4th ed. 1968). Thus, Congress has determined that such evidence should be excluded not only in cases involving negligence but where the defendant is charged with culpable conduct. Strict liability on the other hand involves conduct which is technically less blameworthy than simple negligence, since the plaintiff need not prove a breach of duty by the defendant other than placing the product on the market. From a policy standpoint it follows that if the rule expressly excludes evidence of subsequent repairs to prove culpable conduct that the same should be true for strict liability. Stated another way, if the common law and Congress were willing to exclude the evidence on the issue of culpable conduct, the result should be no different on policy grounds as long as strict liability is not distinguishable on some other ground.

Plaintiff argues that a fundamental distinction exists between negligence and strict liability since in a negligence action it is the reasonableness of the defendant's conduct which is in issue while in a strict liability case the issue is whether the product is unreasonably dangerous. Thus, the argument goes, in a negligence action the focus is on the defendant while in strict liability the focus is on the product. We concede the obvious distinction between negligence and strict liability, but we do not believe that this distinction should produce a different result. The rationale behind Rule 407 is that people in general would be less likely to take subsequent remedial measures if their repairs or improvements would be used against them in a lawsuit arising out of a prior accident. By excluding this evidence defendants are encouraged to make such improvements. It is difficult to understand why this policy should apply any differently where the complaint is based on strict liability as well as negligence. From a defendant's point of view it is the fact that the evidence may be used against him which will inhibit subsequent repairs or improvement. It makes no difference to the defendant on what theory the evidence is admitted; his inclination to make subsequent improvements will be similarly repressed. The reasoning behind this asserted distinction we believe to be hypertechnical, for the suit is against the manufacturer, not against the product....

Our conclusion is supported by the close similarity between negligence and strict liability. The elements of both are the same with the exception that in negligence plaintiff must show a breach of a duty of due care by defendant while in strict liability plaintiff must show the product was unreasonably dangerous. The distinction between the two lessens considerably in failure to warn cases since it is clear that strict liability adds little in warning cases. Under a negligence theory the issue is whether the defendant exercised due care in formulating and updating the warning, while under a strict liability theory the issue is whether the lack of a proper warning made the product unreasonably dangerous. Though phrased differently the issue under either theory is essentially the same: was the warning adequate?

Any remaining distinction in theories disappears when a failure to warn case involves an unavoidably dangerous drug which the product in this case admittedly was. The Restatement of Torts (2d) § 402A, comment k makes it clear that a drug manufacturer is not to be held strictly liable for injuries caused by an unavoidably dangerous new drug if the warning is adequate. The standard for liability under strict liability and negligence is essentially the same....

Plaintiff's final argument on the admissibility of the 1975 warning is that it was required by the FDA, and that since defendant Upjohn had no choice in the matter, the policy behind Rule 407 would not be served by excluding the evidence. While this argument may have a surface plausibility, we do not believe the evidence should be admitted for this reason. First, when a third party has required the change the relevance of the evidence is one more step removed from the central issue in the case, the adequacy of the warning at the time the product was marketed. When a third party makes a subsequent change the inference is removed not only in time but in who made the change. This is especially true in the case at bar since the FDA itself approved the 1974 warning at the time it was first used. Thus, it would appear that any separate relevance of the FDA's actions with regard to the 1975 warning is overridden by the fact that the FDA approved the 1974 warning as well.

Furthermore, plaintiff's argument overlooks the dual responsibility for preparing warnings for prescription drugs. The FDA can require that a warning be changed, but this does not tell the whole story. In addition to its broad regulatory sanctions it is clear that it also relies on voluntary compliance and compromise in determining the content of warnings and advertising for prescription drugs....

If subsequent warnings are admitted to prove antecedent negligence simply because FDA required or might have required the change, then drug companies may be discouraged from taking early action on their own and from participating fully in voluntary compliance procedures. Thus, we think that the FDA's regulatory power should not be read as in conflict with the protective policy of Rule 407. The FDA's regulations and policies encourage early unilateral action by the drug companies to improve their warnings, and Rule 407 promotes the same goal. We therefore hold that FDA regulations in the area of drug labeling do not require a new exception to Rule 407....

The judgment appealed from must be vacated and the case remanded for a new trial.