prod.liab.rep.(cch)p 11,137 Elma Tatum, as Administrator of the Estate of Dixie v. Tatum, Deceased v. Schering Corporation

795 F.2d 925
CourtCourt of Appeals for the Eleventh Circuit
DecidedAugust 15, 1986
Docket85-7483
StatusPublished
Cited by9 cases

This text of 795 F.2d 925 (prod.liab.rep.(cch)p 11,137 Elma Tatum, as Administrator of the Estate of Dixie v. Tatum, Deceased v. Schering Corporation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
prod.liab.rep.(cch)p 11,137 Elma Tatum, as Administrator of the Estate of Dixie v. Tatum, Deceased v. Schering Corporation, 795 F.2d 925 (11th Cir. 1986).

Opinions

CORRECTED OPINION

GODBOLD, Chief Judge:

This is a wrongful death suit, removed from Alabama state court, against Scher-ing Corporation, a manufacturer of drugs. The district court granted summary judgment to Schering. We reverse.

The suit was brought under the Alabama Extended Manufacturer’s Liability Doctrine1 and negligence. Because ethical drugs are considered unavoidably unsafe products, they are defective only when not accompanied by an adequate warning. Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1304 (Ala.1984).

Plaintiff’s theory is that Schering failed to give adequate warning to the treating physician who, without adequate knowledge of the danger involved in administering Schering’s drug Solganol, allegedly administered it improperly, causing decedent’s death.

The case was originally brought against Schering, Dr. Charles Karst (the treating physician) and Merck, Sharpe and Dohme (another drug manufacturer). In state court, before removal, Dr. Karst and Merck entered into pro tanto settlements with plaintiff, and the case was then removed to federal court.

The district court granted summary judgment for Schering on a record containing several depositions from experts for both sides, and depositions from Dr. Karst, one given before he settled with plaintiff and another after he settled. The summary judgment record reveals the following. Plaintiff’s decedent, Mrs. Dixie V. Tatum, was diagnosed as having rheumatoid arthritis by Dr. Karst and received gold therapy treatments from December 1981 through August 1982. Gold therapy is recognized as an appropriate and effective method of treatment for rheumatoid arthritis despite its attendant risks. Two gold salts drugs were administered interchangeably on Mrs. Tatum by injection during the course of her therapy, Myoehrysine, manufactured by Merck, and Solganol, manufactured by Schering.

It is undisputed that during the administration of gold therapy a patient’s white blood count should be monitored. A white blood count below 4,000 indicates the possible presence of leukopenia, a potential forerunner of aplastic anemia, in which case gold therapy should be stopped at once. Both Schering and Merck had such instructions accompanying their products in package information sheets.

During the course of Mrs. Tatum’s gold therapy Dr. Karst did not personally check her to determine her white blood count (or for any other purpose). The gold salts injections were administered by Dr. Karst’s nurse. On July 19, 1982, although Mrs. Tatum’s white blood count dropped to 3,808, she was given another injection of the gold salts. On August 2, 1982 her white blood count had dropped to 2,882, but [927]*927she was given another injection of gold salts. By August 31,1982, her white count had dropped to 1,717. In October 1982, Mrs. Tatum died as a result of what was diagnosed as aplastic anemia.

The district court discussed the purpose of acquiring a manufacturer’s warning, the relation between the warning and the physician’s independent knowledge, and the proximate cause equation.

It is clear therefore that since the manufacturer’s goal in warning is to provide the physician with knowledge, when that physician has such knowledge, either from the manufacturer or independently, there can be no causal link between a failure to advise a physician of what he already well knows and the death of a patient treated by that physician.
* * * * * *
It all returns therefore to the critical inquiry of what Dr. Karst knew, for on the question of causation it matters not where the knowledge came from.

The district court did not address the issue of whether warnings given by Scher-ing were adequate. Rather it held that even if the warnings were inadequate, under the undisputed material facts Dr. Karst’s own knowledge acquired independently of warnings by Schering was such that Schering’s failure to warn him was not a sole or contributing proximate cause of decedent’s death.2 The court held that the evidence was uncontroverted that “Dr. Karst knew all that plaintiff contends he should have known” about Solganol. The court erred in concluding that there was no disputed issue of material fact concerning whether Dr. Karst had independent knowledge of the subject matter of warnings that plaintiff contends should have been given (and assumed by the court to be inadequate).

I. Extent or level of risk

Plaintiff identifies several areas in which he contends that Schering should have warned and that were not embraced in Dr. Karst’s independent knowledge. The first concerns what might be loosely described as extent or level of risk. Plaintiff says that Schering’s warning, in the Solganol box insert, was inadequate because it failed to state that a certain percentage of people to whom Solganol is administered will contract aplastic anemia regardless of the monitoring of such a person. The court disposed of this contention on the ground that, according to Dr. Karst’s testimony, before he began the gold therapy treatment he explained to Mrs. Tatum that the drug he would administer could kill her even though he would be monitoring her, and this statement demonstrated knowledge by Dr. Karst of what an adequate warning on the subject would have conveyed, thus the assumed inadequacy was irrelevant. But the court’s approach did not address extent or level of the risk of death or other serious adverse reaction. Dr. Karst’s statement to Mrs. Tatum established, for summary judgment purposes, that he knew there was some risk of death. But he testified that he did not know the percentage of patients treated with gold who developed leukopenia or aplastic anemia, that he was not aware of the incidence of fatality from the use of Solganol, nor was he aware that gold has a higher incidence of death than other drugs. This testimony is. inconsistent with the district court’s holding that Dr. Karst knew everything that plaintiff says he should have been warned about. The knowledge that Dr. Karst did have — that Solganol could kill — does not preclude a factfinder’s concluding that had Dr. Karst known the actual degree or extent of risk of death or other serious adverse effect, he would not have prescribed the drug for Mrs. Tatum in particular, or for other patients in general having the same state of severity of diagnosis or prognosis as Mrs. Tatum. Nor does it preclude a factfinder’s concluding that had Dr. Karst informed Mrs. Tatum of the information plaintiff says should have [928]*928been conveyed to him, Mrs. Tatum would not have agreed to the treatment.

Plaintiff makes a second point concerning failure to sufficiently warn of risks. Plaintiff’s expert testified that Schering’s use in the box insert of the word “rare” to describe the incidence of hematologic adverse reactions was weak, did not accurately describe the incidence, and failed to say that the drug should be discontinued at the first sign of adverse reaction. The district court disposed of these contentions, too, on the basis of irrelevance; ie., because Dr. Karst knew the drug was high risk and reactions might be irreversible and held some potential for death regardless of monitoring, the absence of the above information could not be a proximate cause. This is error for the same reasons set out above.

II. Establishing a baseline for blood comparison

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