906 F.2d 1399 (10th Cir. 1990), 88-1337, Graham by Graham v. Wyeth Laboratories, Div. of American Home Products Corp.

Docket Nº:88-1337, 88-2302, 89-3066 and 89-3121.
Citation:906 F.2d 1399
Party Name:Michelle GRAHAM, an infant under the age of eighteen who sues by her parents, guardians, and next friends, Charles GRAHAM and Tammy Graham, Plaintiffs-Appellees, v. WYETH LABORATORIES, DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, Defendant-Appellant.
Case Date:June 25, 1990
Court:United States Courts of Appeals, Court of Appeals for the Tenth Circuit

Page 1399

906 F.2d 1399 (10th Cir. 1990)

Michelle GRAHAM, an infant under the age of eighteen who

sues by her parents, guardians, and next friends,

Charles GRAHAM and Tammy Graham,




CORPORATION, Defendant-Appellant.

Nos. 88-1337, 88-2302, 89-3066 and 89-3121.

United States Court of Appeals, Tenth Circuit

June 25, 1990

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[Copyrighted Material Omitted]

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Albert J. Knopp, of Baker & Hostetler, Wayne C. Dabb, Jr., Mary M. Bittence, Cleveland, Ohio, and J. Jeffrey Zimmerman, Washington, D.C., James M. Clark and Fred M. Winner, of Baker & Hostetler, Denver, Colo., Alvin D. Herrington and Debra J. Arnett, of McDonald, Tinker, Skaer, Quinn & Herrington, P.A., Wichita, Kan., Hedy M. Powell (of counsel), Legal Dept. of Wyeth Laboratories, Radnor, Pa., for defendant-appellant.

Marlys A. Marshall, Andrew W. Hutton of Michaud & Hutton, Wichita, Kan., Ted M. Warshafsky of Warshafsky, Rotter, Tarnoff, Gesler, Reinhardt & Block, Milwaukee, Wis., for plaintiffs-appellees.

Before SEYMOUR and MOORE, Circuit Judges, and GARTH, Senior Circuit Judge. [*]

GARTH, Senior Circuit Judge:

This appeal arises as a result of a $15,000,000 verdict against Wyeth Laboratories (Wyeth), the manufacturer of a DTP vaccine. It presents us with a number of evidentiary and legal questions. The most significant of these are: (1) should judgment NOV have been granted to Wyeth? (2) Are state tort awards for the improper manufacture of vaccines preempted by federal regulation? (3) Does Kansas allow for tort awards based upon strict liability or the negligent manufacture of an "inherently unsafe" vaccine? (4) Were a number of Wyeth's experts improperly excluded from testifying at the trial? (5) What is the correct procedure for the use, redaction and admission of "learned treatises" as evidence under Fed.R.Ev. 803(18)? And (6) was Wyeth entitled to post-judgment relief when one of Graham's experts recanted much of his testimony in subsequent court proceedings? Other less significant allegations of error have also been raised, and will be addressed in the course of this opinion. 1

Our standard of review in reviewing a denial of motion for judgment NOV has been prescribed as follows:

The standard for determining whether to grant a motion for a Judgment N.O.V., as for a directed verdict, is not whether there is literally no evidence to support the party opposing the motion, but whether there is evidence upon which the jury could properly find a verdict for that party. The court may not weigh the evidence, pass on the credibility of witnesses, or substitute its judgment for that of the jury. Rather, it must view the evidence most favorably to the party against whom the motion is made and give that party the benefit of all reasonable inferences from the evidence. On appeal, we employ the same standard of review as does the trial court.

Brown v. McGraw, 736 F.2d 609, 612-13 (10th Cir.1984).

On the other hand, we test the various individual evidentiary rulings made by the district court and the denial of Wyeth's Fed.R.Civ.Pro. 60(b) motions, for an "abuse of discretion"; see In re International Coating Applicators, 647 F.2d 121, 124 (10th Cir.1981). On issues related to interpreting federal law the standard of our review is plenary, and on interpreting Kansas law we give some deference to the district court's interpretation, but review is ultimately de novo. See Wilson v. Al McCord Inc., 858 F.2d 1469, 1473 (10th Cir.1988) ("The issue for our consideration is the trial judges legal interpretation of

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state law to which we give some deference but ultimately review de novo.")

We will affirm the denial of judgment NOV, reverse the denial of the motion for a new trial, and remand to the district court for a new trial on all issues. Additionally, we will reverse the district court's denial of Wyeth's Fed.R.Civ.Pro. 60(b) motion for post-judgment relief. Inasmuch as we are ordering a new trial on all issues, we assume that the subject matter of Wyeth's 60(b) motion will find expression during that proceeding.



This appeal originated from a $15,000,000 jury verdict in favor of Michelle Graham ("Graham") and against Wyeth for the defective manufacture of Wyeth's DTP vaccine. Wyeth manufactured a DTP vaccine which is used to immunize children against the diseases of diphtheria, tetanus (lockjaw) and pertussis (whooping cough). The vaccine is administered to infants at two, four, six and eighteen months. A booster injection is administered prior to the child's entrance into school.

The DTP vaccine is comprised of three component parts, diphtheria toxoids, tetanus toxoids, and a pertussis whole cell vaccine. It is the pertussis component of the vaccine that is the subject of this litigation and which allegedly caused the severe reaction suffered by Graham. While Graham contends that the pertussis component of this vaccine could have been safer, and that in fact safer versions of the vaccine are available, she does not argue that a pertussis vaccine is generally unnecessary or that it has not saved thousands of lives. 2

The DTP vaccine containing the "whole cell" pertussis vaccine was licensed by the FDA in 1949. Due to the widespread use of the vaccine in this country, pertussis has virtually been eradicated. However, because of the persistent nature of the pertussis bacterium, there is a continuing and substantial risk of epidemics if the use of the vaccine was to be discontinued or was to decline significantly, and in fact epidemics have occurred in countries that have eliminated the pertussis vaccine from their list of mandatory vaccines. 3

The nature of the DTP vaccine and its component parts was recently described by the Ninth Circuit as follows:

By introducing an antigenic factor into the body, vaccines stimulate the production of antibodies that protect against disease. Some infectious organisms, such as those causing diphtheria and tetanus, excrete soluble toxins insolable [sic] by medical research. The toxin is inactivated with formaldehyde and transformed into a toxoid. The toxoid is then used in a vaccine, as it can immunize against disease by stimulating the production of antibodies in the recipient, even though it has lost its own poisonous qualities.

This is not the case, however, with [the pertussis component]. [The pertussis vaccine] is a so-called whole cell vaccine because it contains whole killed pertussis organisms. The whole organism is used because the pertussis organism contains fifteen or sixteen different antigens, and medical science has yet to isolate the one that stimulates protection against the disease.

Toner v. Lederle Laboratories, 779 F.2d 1429, 1430 (9th Cir.1986).

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Because the whole cell vaccine retains its poisonous qualities, it is neurotoxic and can cause adverse reactions which may be mild or severe. Mild reactions may include swelling, fever, irritability, and crying spells. Severe reactions can perhaps include encephalopathy, 4 paralysis and death. In recognition of the dangerous propensities of the whole cell vaccine, efforts have been made to develop a fractionated cell pertussis vaccine without any of the harmful toxoids. During the 1950's, the Eli Lilly Company developed a "split cell" vaccine called Tri-Solgen. Early studies indicated a fractionated vaccine was less toxic than the whole cell and it was approved by the FDA in 1967. At that time, Lilly occupied a substantial share of the DTP market. In 1975, Lilly withdrew from the vaccine business and sold its Tri-Solgen vaccine to Wyeth. According to Graham, in an effort to save on cost, Wyeth substituted its own "ingredients" (or "strains") into the Lilly "recipe" for the split cell vaccine. Wyeth then attempted to license this vaccine, but no license was granted by the FDA. Wyeth has made no further attempts to license a fractionated cell vaccine and no such vaccine is licensed in this country 5 today. Moreover, pharmaceutical companies are prohibited from marketing a product absent a license--to do so would constitute a criminal offense; (21 U.S.C. Secs. 331(d), 333(a), 355(a)).


This lawsuit had its origins in the tragic history of the plaintiff, Michelle Graham, a child who has suffered, and is suffering from brain damage, and who requires continuous treatment and care. Michelle Graham (by her parents) alleged that she sustained severe and irreversible brain damage after being vaccinated against diphtheria, pertussis and tetanus with a defective vaccine produced by Wyeth.

On March 17, 1980, Michelle Graham, who was only a few months old, was administered Wyeth's DTP vaccine by a nurse at a county office of the Missouri Department of Health. Shortly thereafter Graham was diagnosed as having suffered from a severe and irreversible neurological condition known as encephalopathy which caused retardation and prevents Graham from ever leading a normal life. Graham sued Wyeth alleging that its DTP vaccine caused the brain damage, and that this type of injury could have been avoided if only Wyeth had used more care in controlling the level of toxoid in its vaccine. Wyeth denied that its DTP vaccine did in fact cause Graham's brain damage, or that the DTP vaccine even could, in fact, cause this particular type of damage. Wyeth additionally maintained that, as a matter of law, it could not be liable even if the vaccine did cause Graham's injury because, vaccines, under applicable Kansas 6 law, are to be treated as inherently dangerous products and thus the vaccine manufacturers are deemed immune from liability. 7

The district court determined according to Kansas law 8 that Graham could proceed on its negligence theories. In the district court's summary judgment opinion, however, it held for Wyeth, and against Graham, on the strict liability "warning" issue. On...

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