Werner v. Upjohn Co., Inc.
| Decision Date | 04 August 1980 |
| Docket Number | Nos. 78-1090,s. 78-1090 |
| Citation | 628 F.2d 848 |
| Parties | 6 Fed. R. Evid. Serv. 481 Jack WERNER, Appellee, v. The UPJOHN COMPANY, INC., a body corporate of the State of Delaware, Appellant, and Ralph J. Carbo, Jr., M.D. and Ralph J. Carbo, Jr., M.D., P.A., a body corporate of Maryland, Defendants. Jack WERNER, Appellee, v. Ralph J. CARBO, Jr., M.D., Appellant, and Ralph J. Carbo, Jr., M.D., P.A., a body corporate of Maryland and The Upjohn Company, Inc., a body corporate of the State of Delaware, Defendants. Jack WERNER, Appellant, v. Ralph J. CARBO, Jr., M.D. and Ralph J. Carbo, Jr., M.D., P.A., a body corporate of Maryland, and The Upjohn Company, Inc., a body corporate of the State of Delaware, Appellees. to 78-1092. |
| Court | U.S. Court of Appeals — Fourth Circuit |
M. King Hill, Jr., Baltimore, Md. (Jon H. Grube and Michael A. Pretl, Smith, Somerville & Case, Baltimore, Md., on brief), for appellant The Upjohn Co., Inc.
Melvin J. Sykes, Baltimore, Md. (Max R. Israelson, Stuart M. Salsbury, Israelson & Jackson, P.A., Baltimore, Md., on brief), for appellee Jack Werner.
Before RUSSELL and WIDENER, Circuit Judges, and MERHIGE, * District judge.
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. Dr. Carbo argues that the plaintiff failed to establish the basic elements of a malpractice case; that the jury instructions were improper; and that, since the jury found Upjohn's warning inadequate and no other evidence of malpractice was present, the jury verdict against him cannot stand. Both defendants argue that it was error to refuse a jury instruction on contributory negligence and to fail to reduce the damage award to present value. The plaintiff filed a cross-appeal arguing that the trial court erred in refusing to allow the plaintiff to present evidence on punitive damages.
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. 1 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 per cent 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 diphenoxylate 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.
The plaintiff began to feel nauseous approximately five days after he started taking the drug and stopped using it. About a week later he reported this fact to Carbo who testified that he advised the plaintiff to discontinue the drug and call him if any further problems developed. Once again, plaintiff denied receiving this warning from Carbo. Several days later while in New York City the plaintiff developed severe diarrhea and dehydration. During this time he was taking Lomotil, an antiperistaltic agent, for the diarrhea which according to the 1974 warning (but not the 1973 warning) was contraindicated for PMC. On January 11, 1975, a Dr. Axelrod sigmoidiscoped the plaintiff and discovered the presence of PMC. He then questioned the plaintiff and determined for the first time that he had taken Cleocin. The Lomotil was discontinued but the plaintiff's condition worsened. A large portion of his colon had to be removed and he underwent other operations to restore his excretory functions. The plaintiff presently is under dietary restrictions, has diarrhea, cannot engage in strenuous athletic activity, and tires easily.
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. Upjohn argued that the incidence of side effects was quite low and that if properly and timely treated the plaintiff would not have suffered permanent injury. Upjohn also relied heavily on the argument that everything which happened to the plaintiff was warned of in the 1974 warning. The plaintiff argued that, based on Upjohn's knowledge at the time the 1974 warning was released, the warning was inadequate and made Cleocin unreasonably dangerous and Upjohn negligent. Plaintiff also argued that even if the warning were adequate it was negated by Upjohn's advertising and the activities of Upjohn's detail men.
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...
To continue reading
Request your trial
-
Chandhok v. Companion Life Ins. Co.
...finding that the denial of benefits was ‘erroneous, even arbitrary’ is inherently a finding of culpability"); Werner v. Upjohn Co., Inc., 628 F.2d 848, 856-57 (4th Cir. 1980) (defining culpability as "implying that the act or conduct spoken of is reprehensible or wrong, but not that it invo......
-
Schelbauer v. Butler Manufacturing Co.
...to the cause of the accident in question. (See, e.g., Cann v. Ford Motor Co. (2d Cir.1981) 658 F.2d 54, 60; Werner v. Upjohn Co., Inc. (4th Cir.1980) 628 F.2d 848, 856-858, cert. den. 449 U.S. 1080, 101 S.Ct. 862, 66 L.Ed.2d 804; Haysom v. Coleman Lantern Co. (1978) 89 Wash.2d 474, 573 P.2d......
-
Carlin v. Superior Court
... ... The SUPERIOR COURT of Sutter County, Respondent; ... The UPJOHN COMPANY, Real Party In Interest ... No. S045912 ... Supreme Court of ... Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 27 Cal.Rptr. 697, 377 P.2d 897, a manufacturer " ... 528, 810 P.2d 549; see Barker v. Lull Engineering Co". (1978) 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443.) ... \xC2" ... Ortho Pharmaceutical Corp. (2d Cir.1980) 637 F.2d 87, 91; Werner v. Upjohn Co., Inc. (4th Cir.1980) ... Page 193 ... 628 F.2d 848, ... ...
-
Herndon v. Seven Bar Flying Service, Inc.
...697 F.2d 222, 228-29 (8th Cir.1983); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 93-94 (2d Cir.1980); Werner v. Upjohn Co., 628 F.2d 848, 856-58 (4th Cir.1980), cert. denied, 449 U.S. 1080, 101 S.Ct. 862, 66 L.Ed.2d 804 Although there is also a split of authority among state courts,......
-
Other Evidence Rules
...were not inadmissible under Rule 407; the “event” to which Rule 407 speaks is the accident, not the sale. Verner v. Upjohn Co., Inc., 628 F.2d 848 (4th Cir. 1980), cert denied, 449 U.S. 1080. Rule 407 is designed to protect the important public policy of encouraging defendants to repair and......
-
Renewed look at the duty to warn and affirmative defenses.
...938 F.2d 1463, 1466-67 (1st Cir. 1991) (Rhode Island law); Pottle v. Up-Right Inc., 628 A.2d 672, 674-75 (Me. 1993); Werner v. Upjohn Co., 628 F.2d 848, 858 (4th Cir. 1980), cert, denied, 449 U.S. 1080 (1981). (22.) Not all states have adopted strict liability. See, e.g., Wolford v. Budd Co......
-
Other Evidence Rules
...were not inadmissible under Rule 407; the “event” to which Rule 407 speaks is the accident, not the sale. Verner v. Upjohn Co., Inc., 628 F.2d 848 (4th Cir. 1980), cert denied, 449 U.S. 1080. Rule 407 is designed to protect the important public policy of encouraging defendants to repair and......
-
Other Evidence Rules
...were not inadmissible under Rule 407; the “event” to which Rule 407 speaks is the accident, not the sale. Verner v. Upjohn Co., Inc., 628 F.2d 848 (4th Cir. 1980), cert denied, 449 U.S. 1080. Rule 407 is designed to protect the important public policy of encouraging defendants to repair and......
-
28 APPENDIX U.S.C. § 407 Subsequent Remedial Measures
...Cir. 1981), cert. denied, 456 U.S. 960 (1982); Kelly v. Crown Equipment Co., 970 F.2d 1273, 1275 (3d Cir. 1992); Werner v. Upjohn, Inc., 628 F.2d 848 (4th Cir. 1980), cert. denied, 449 U.S. 1080 (1981); Grenada Steel Industries, Inc. v. Alabama Oxygen Co., Inc., 695 F.2d 883 (5th Cir. 1983)......