Schindler v. Lederle Laboratories

725 F.2d 1036
Court of Appeals for the Sixth Circuit·Decided August 22, 1983·No. No. 82-1232·Published·Cited by 2 cases

Opinion

McRAE, District Judge.

Plaintiffs-Appellants, Charles and Mary Schindler, appeal from a judgment of the United States District Court for the Eastern District of Michigan, entered on directed verdicts in favor of defendants-appellees at the close of plaintiffs’ proof. For reasons set forth below, we affirm.

This action was commenced on June 24, 1977 on behalf of Karl Michael Schindler, a minor, by his parents. In their complaint, plaintiffs alleged that in 1975 Karl received a routine series of doses of oral polio vaccine.1 This vaccine was produced by defendant Lederle Laboratories and was administered by Karl’s pediatrician, Dr. Robert Lugg. Because Karl was suffering from a congenital disease known as agam-maglobulinemia2 at the time he received the polio vaccine, the vaccine caused him to develop poliomyelitis. He has sustained a serious disability as a result.

The crux of plaintiffs’ case rests on the allegation that the defendants, Lederle Laboratories and the American Academy of Pediatrics, were negligent with regard to their pronouncements to physicians concerning polio vaccines. Specifically, plaintiffs maintain that if the defendants had adequately warned Dr. Lugg of the danger associated with giving the oral polio vaccine to persons suffering from agammaglobu-linemia, Dr. Lugg would have not given the vaccine to Karl.

In 1973, about 20 months prior to Karl’s birth, the Schindler’s first son, Jeffrey, died as a result of congenital agammaglobuline-mia. Dr. Lugg’s partner, Dr. Rady, was [1038] Jeffrey’s pediatrician during his final illness and he knew that Jeffrey died of agamma-globulinemia. When Karl developed polio in 1976, it was discovered that he likewise suffered from congenital agammaglobuline-mia.

Prior to Karl’s birth, but after Jeffrey’s death, Mrs. Schindler expressed fear about whether she should have more children. She consulted physicians at the Children’s Hospital of Michigan, her gynecologist, and Dr. Lugg. As a result of these consultations, Dr. Lugg apparently acquired a substantial file concerning Jeffrey’s death pri- or to Karl’s birth. This file contained a case summary written by Dr. Rady and Jeffrey’s autopsy report. Both of these documents indicated that Jeffrey died from a congenital absence of immunoglobulins. Additionally, the file contained a December 13,1973 letter from the Director of Clinical Immunology at Detroit’s Children’s Hospital, Dr. Flossie Cohen, to the Schindler’s family physician, Dr. Neruda. In this letter, Dr. Cohen noted that if Jeffrey’s agam-maglobulinemia was x-linked, “there would be a 50% chance of recurrence in other male offspring.” Dr. Cohen also noted that if Jeffrey’s disease was the “acquired” type, “male and 'female offspring will be subject to the same chance of inheriting the condition.” Although this letter was in Dr. Lugg’s file, he admitted during cross-examination in the trial below that he did not read the letter until after Karl developed polio.

When Dr. Lugg assumed treatment of Karl immediately following his birth, Dr. Lugg was aware of the cause of Jeffrey’s death. Although Dr. Lugg did not feel that the diagnosis of “x-linked” agammaglobu-linemia was conclusive, he testified at the trial that he realized that there was an increased risk that Karl would have agam-maglobulinemia. He had “extensive discussions” about this possibility with Mrs. Schindler in May, 1975 before he administered the first dose of oral vaccine.

After administering the third and final dose of polio vaccine to Karl on September 3, 1975, Dr. Lugg drew blood from Karl, at the insistence of Mrs. Schindler, to check Karl’s gamma globulin levels. He took this blood sample because he was cognizant of Jeffrey’s problem and the possibility that Karl might have an immunity deficiency. Dr. Lugg testified that he waited until this time to take a blood sample because, according to the “Janeway-Nelson Text,” there is a period of diagnostic uncertainty during the first year of life. The uncertainty apparently arises because it is hard to tell whether the gamma globulins were produced by the mother or child. Dr. Lugg stated that he believed that the only acceptable test available during these early months was performed by a lab in California. Dr. Stanley Schwartz, Karl’s treating immunologist and one of plaintiffs’ expert witnesses testified, however, that in 1975 there were at least five different gamma globulin tests available for infants at the University of Michigan Medical Center in Ann Arbor and at Children’s -Hospital in Detroit.

The results of Karl’s blood test showed that his gamma globulin levels were low when compared with infants of similar age, but Dr. Lugg testified that he was not concerned because Karl was healthy and showed no signs of infection. If Dr. Lugg had recognized that Karl was suffering from agammaglobulinemia, he could have begun administration of gamma globulins or plasma which, according to testimony adduced at trial, might have prevented Karl from contracting polio.

Dr. Lugg began administering the oral polio vaccine in the late 1960’s or early 1970’s. He testified that it was his custom to read the drug company’s package inserts when he first uses a product and then he assumes that there is no updating of the product warnings and information unless he hears otherwise from drug company detail men,3 medical meetings, or other sources. [1039] He testified that although he did not read Lederle’s package insert accompanying the oral polio vaccine doses given to Karl, he had read previous package inserts accompanying the oral vaccine. Only after Karl developed polio did Dr. Lugg check the latest Lederle insert, which specifically provided in part:

Vaccinations should also be delayed in conditions having a suppressive effect on the immune-response mechanism, such as therapy with immune serum globulin, steroids, radiation, cancer chemotherapeutic agents, and in patients with leukemia, lymphogenous disease, and disgam-maglobinemia 4

Dr. Lugg admitted during cross-examination that if he had read the latest Lederle insert before administering the vaccine to Karl, he would probably have made further inquiry concerning the vaccine’s safety. However, he conceded that he did not make any inquiries with Lederle until after Karl contracted polio.

Dr. Lugg further testified that he placed great reliance on the “Red Book,” a compilation of defendant American Academy of Pediatrics.5 Dr. Lugg pointed out that the “Red Book” is considered to be a very authoritative source which is republished every three or four years by the Academy. Although Dr. Lugg did not state that he specifically consulted the 1970 Red Book before giving the oral polio vaccine to Karl, he seemed to rely on the fact that neither that edition of the “Red Book” nor other sources listed any specific immunity related contraindications for live oral polio vaccine.

In 1974, however, more than a year before Karl’s first dose of vaccine, the Academy published the 1974 edition of the Red Book, which contained the following statement regarding live polio vaccine:

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Schindler v. Lederle Laboratories, 725 F.2d 1036 (6th Cir. 1983).

725 F.2d 1036 (Schindler v. Lederle Laboratories) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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Schindler v. Lederle Laboratories
725 F.2d 1036 (Sixth Circuit, 1983)