Graham v. Wyeth Laboratories

• Decision Date: 22 July 1987
• Docket Number: No. 85-1481-K.,85-1481-K.
• Citation: 666 F. Supp. 1483
• Parties: Michelle GRAHAM, an Infant Under the Age of Eighteen, Who Sues by Her Parents, Guardians and Next Friends, Charles GRAHAM and Tammy Graham; and Charles Graham and Tammy Graham, Individually, Plaintiff, v. WYETH LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, a Pennsylvania Corporation, Defendant.
• Court: U.S. District Court — District of Kansas

666 F. Supp. 1483

Michelle GRAHAM, an Infant Under the Age of Eighteen, Who Sues by Her Parents, Guardians and Next Friends, Charles GRAHAM and Tammy Graham; and Charles Graham and Tammy Graham, Individually, Plaintiff, v. WYETH LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, a Pennsylvania Corporation, Defendant.

No. 85-1481-K.

United States District Court, D. Kansas.

July 21, 1987.

Order Nunc Pro Tunc July 22, 1987.

Andrew Hutton, Michaud, Hutton & Michaud, Wichita, Kan., for plaintiff.

Albert J. Knopp, Baker & Hostetler, Cleveland, Ohio, Alvin D. Herrington, Wichita, Kan., Hedy M. Powell, Philadelphia, Pa., for defendant.

MEMORANDUM AND ORDER

PATRICK F. KELLY, District Judge.

This case is before the court on defendant's motion for summary judgment. Plaintiffs Charles and Tammy Graham claim their infant daughter, Michelle Graham, sustained severe and irreversible brain damage after being vaccinated against diptheria, pertussis (whooping cough) and tetanus. The DPT vaccine she received was manufactured and distributed by defendant Wyeth Laboratories ("Wyeth").

The plaintiffs, parents and daughter, brought this diversity action asserting claims of strict liability and negligence for design defect and failure to warn, breach of the implied warranties of merchantability and fitness for a particular purpose, and intentional misrepresentation. Plaintiffs also seek punitive damages, claiming the defendant willfully, wantonly and recklessly failed to adequately warn of the possible severe reactions to the DPT vaccine and willfully failed to rectify the product's design.

Defendant has moved for summary judgment, contending that federal law preempts plaintiffs' claims in their entirety. Alternatively, defendant contends that under Kansas laws as set forth in Johnson v. American Cyanamid, 239 Kan. 279, 718 P.2d 1318 (1986), this court must find as a matter of law that DPT vaccine is an "unavoidably unsafe" prescription drug which contains an adequate warning, and enter judgment in defendant's behalf.

After considering all well-pleaded facts in plaintiffs' favor, the court is convinced that defendant is not entitled to summary judgment and this case must proceed to trial. As will be explained herein, the court finds Congress did not intend to preempt state tort claims asserted by a victim of an adverse reaction to an FDA-approved drug. Further, the court finds that Johnson is distinguishable from the case at bar and does not require the entry of judgment in defendant's behalf.

FACTS

Defendant Wyeth manufactures the DPT vaccine which is used to immunize children against the diseases of diptheria, pertussis (whooping cough) and tetanus (lockjaw). The vaccine is administered to infants at two, four, six and eighteen months. A booster is administered prior to the child's entrance into school.

The DPT vaccine is comprised of three component parts which will be more thoroughly described herein. Those components are diptheria toxoids, tetanus toxoids, and a pertussis whole cell vaccine. It is the pertussis component which causes severe reactions such as suffered by Michelle Graham.

While plaintiffs contend the pertussis component of the vaccine could have been safer, they do not argue that a pertussis vaccine is unnecessary or that it has not saved millions of lives. In the early 1900s, pertussis was a leading cause of death in children in this country.

In 1934, when this country suffered its worst pertussis epidemic, there were 265,000 reported cases of pertussis per year, and 7500 related deaths. Hinman and Koplan, Pertussis and Pertussis Vaccine: Re Analysis of Benefits, Risks and Costs, Journal of the American Medical Association (June 15, 1984). By the early 1940s, pertussis was responsible for two and one-half times the number of deaths as all of the following diseases combined: measles, mumps, rubella, diptheria, polio, meningitis, chicken pox, and scarlet fever. Id.

Hurley v. Lederle Lab., Div. of American Cyanamid, 651 F.Supp. 993, 995 (E.D.Tex. 1986). The DPT vaccine containing the "whole cell" pertussis vaccine was licensed by the FDA in 1949. Due to the widespead use of the vaccine in this country, pertussis has virtually been eradicated. However, because of the persistent nature of the pertussis bacteria, there is a continuing and substantial risk of epidemics if the use of the vaccine were to decline significantly. Hurley, 651 F.Supp. at 995.

The nature of the DPT vaccine and its component parts was recently capsuled by the Ninth Circuit, and is instructive herein:

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 diptheria and tetanus, excrete soluble toxins insoluble 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. See Tinnerholm v. Parke, Davis & Co., 411 F.2d 48, 50 (2d Cir. 1969).

Toner for Toner v. Lederle Laboratories, 779 F.2d 1429, 1430 (9th Cir.1986). Because the whole cell vaccine retains its poisonous qualities, it is "neurotoxic" and can cause adverse reactions which may be mild (local), or severe. Mild reactions may include swelling, fever, irritability, and crying spells. Severe reactions include encephalopathy, paralysis and death. The expected rate of such reactions is controverted by the parties. Defendant claims about one out of every 7,000 children will suffer high fever or convulsions while one of every 100,000 children will suffer brain damage; plaintiffs claim these figures are inaccurate as to the Wyeth vaccine because they are based on faulty data. Plaintiffs further contend that Wyeth is aware that the incidence of severe reactions is actually much higher.

In recognition of the dangerous propensities of the whole cell vaccine, efforts have been made to develop a fractionated cell pertussis vaccine. During the 1950s, the Eli Lilly Company developed a "split cell" vaccine called Tri-Solgen. Early studies indicated this 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 DPT market. In 1975, Lilly withdrew from the vaccine business and sold its Tri-Solgen vaccine to Wyeth. According to plaintiffs, 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. Moreover, no such vaccine is licensed in this country today.¹ Of course, a pharmaceutical company is prohibited from marketing a product absent a license — to do so would constitute a criminal offense.² 21 U.S.C. §§ 331(d), 333(a), 355(a); see also Toner v. Lederle, 779 F.2d at 1431; but see 21 CFR 620.1 (allowing for manufacture of "either killed whole Bordetella pertussis bacteria or a fraction of Bordetella pertussis bacteria." emphasis added).

On March 17, 1980, plaintiff Michelle Graham, who was only a few months old, was administered defendant's DPT vaccine by a nurse at a county office of the Missouri Department of Health. Shortly thereafter Michelle developed a severe and irreversible neurological condition known as encephalopathy. For the purposes of this motion, the court will assume the plaintiff's condition was caused by the pertussis vaccine.

Wyeth furnished medical practitioners who purchased the vaccine with pamphlets describing contra-indications and possible adverse reactions to the drug's use. The pamphlet in use at the time of Michelle Graham's immunization stated, in pertinent part:

The below-listed serious, and occasionally fatal, adverse reactions have been reported following administration of pertussis-vaccine-containing preparations. The incidence of these reactions is unknown, but they seem to be exceedingly rare ...:

1. Severe temperature elevations — 105°F. or higher.

2. Collapse with rapid recovery.

3. Collapse followed by prolonged prostration and a shock-like state.

4. Screaming episodes characterized by a prolonged period of peculiar crying during which the infant cannot be comforted.

5. Isolated convulsion(s) with or without fever.

6. Frank encephalopathy with changes in the level of consciousness, focal neurological signs, and convulsions with or without permanent neurological and/or mental deficit.

7. Thrombocytopenic purpura.

The occurrence of sudden-infant-death syndrome (SIDS) has been reported following administration of DTP. The significance of these reports is unclear. It should be kept in mind that the three primary immunizing doses of DTP are usually administered to infants between the age of 2 and 6 months and that approximately 85 percent of SIDS cases occur in the period 1 through 6 months of age....

....

Occurrence of any of the following signs, symptoms, or conditions following administration is a contraindication to further use of this product and/or pertussis vaccine as the single antigen: fever over 103°F (39°C); convulsion(s) with or without accompanying fever; alterations of consciousness; focal neurological signs; screaming episodes (also call screaming fits); collapse; thrombocytopenic purpura.

The presence of an evolving or changing neurologic disorder is a contraindication to use.

(Emphasis added.) The...