Hurley v. LEDERLE LAB., DIV. OF AMERICAN CYANAMID CO.

• Decision Date: 31 December 1986
• Docket Number: Civ. A. No. B-85-449-CA.
• Citation: 651 F. Supp. 993
• Parties: James L. HURLEY, Jr., et al. v. LEDERLE LABORATORIES, DIVISION OF AMERICAN CYANAMID COMPANY and Connaught Laboratories, Inc.
• Court: U.S. District Court — Eastern District of Texas

651 F. Supp. 993

James L. HURLEY, Jr., et al. v. LEDERLE LABORATORIES, DIVISION OF AMERICAN CYANAMID COMPANY and Connaught Laboratories, Inc.

Civ. A. No. B-85-449-CA.

United States District Court, E.D. Texas, Beaumont Division.

December 31, 1986.

Andrew Dodd, Dodd, Ward, Dodd & Gaunt, Torrance, Cal., Marcus A. Pitre, Wright & Pitre, Port Neches, Tex., for plaintiffs.

Richard L. Josephson, Baker & Botts, Houston, Tex., Richard McCarroll, Demaris Gullekson, Brown, Maroney, Rose, Barber & Dye, Austin, Tex., O.J. Weber, Mehaffy, Weber, Keith & Gonsoulin, Beaumont, Tex., for defendants.

MEMORANDUM OPINION

COBB, District Judge.

Plaintiffs, parents of James L. Hurley, III, had their son vaccinated against diphtheria, pertussis (whooping cough), and tetanus by using DPT vaccine when the child was less than a year old. The vaccine was manufactured and distributed by the defendants Lederle Laboratories (Lederle), and Connaught Laboratories, Inc. (Connaught). Thereafter, the child sustained severe and irreversible neurological damage.

Plaintiffs, parents and son, brought this diversity action and base their claims on negligence the alleged failure to adequately warn plaintiffs and properly design DPT, breach of express and implied warranties, and strict liability the alleged production and marketing of an unreasonably dangerous product. Plaintiffs also seek punitive damages, claiming the defendants recklessly, knowingly, and willfully failed to adequately warn of possible dangerous adverse reactions to DPT vaccine and willfully failed to rectify the product's design.

The case is presently before the court on defendants' motion for partial summary judgment. Defendants contend that federal law preempts plaintiffs' claims of defective design, inadequate labeling/warning, and punitive damages based thereon. After considering all well pleaded facts in favor of plaintiffs, it is the court's opinion that defendants' federal preemption defense is valid and the defendants are entitled to partial summary judgment as a matter of law. There are several trial courts, state and federal, which have dealt with the questions presented by defendants' motions, with varied results and conflicting holdings. Inasmuch as this opinion deals only with the design and labeling of defendants' DPT vaccine, it does not necessarily apply to other FDA approved drugs in general.

I. FACTS

Defendants Lederle and Connaught produce and market a vaccine commonly known as "DPT," a vaccine used to immunize children against the diseases of diphtheria, pertussis (whooping cough), and tetanus. DPT is comprised of three component parts: (1) diphtheria toxoids; (2) tetanus toxoids; and (3) a pertussis vaccine. 50 Fed.Reg. 51,013-14 (1985).

The pertussis component of DPT is a "whole cell" vaccine that contains, in an inactivated state, all of the components found in pertussis cells. 50 Fed.Reg. 51,043 (1985). Pertussis is a serious, highly contagious disease, primarily affecting infants and children. Before the introduction of this "whole cell" vaccine, pertussis crippled and killed thousands of children annually in the United States. 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: Reanalysis of Benefits, Risks and Costs, Journal of the American Medical Association (June 15, 1984). By the early 1940's, pertussis was responsible for two and one-half times the number of deaths as all of the following diseases combined: measles, mumps, rubella, diphtheria, polio, meningitis, chicken pox, and scarlet fever. Id. Although the disease pertussis has been largely brought under control,¹ it remains a leading cause of infant deaths in other countries which lack vaccination programs. Moreover, the bacteria causing pertussis remain persistent, even where the disease is under control, which leads to the substantial probability of epidemics whenever the use of the DPT vaccine declines significantly. For these reasons, federal public health authorities, including the Food and Drug Administration (FDA), the Centers for Disease Control, the National Institute of Health, and other agencies, have for almost forty years, promoted vaccination of the populace with a diphtheria-tetanus-pertussis vaccine containing the so-called "whole cell" pertussis vaccine, licensed by the FDA in 1949.

However, it is suspected that the pertussis component of DPT can cause adverse reactions such as those listed on the package insert and suffered by plaintiff, since it is not well understood which parts of the organism are responsible for creating immunity. See, 50 Fed.Reg. 51,043 (1985). In 1980, the time of plaintiff's injury, the "whole cell" vaccine was the only licensed DPT vaccine on the market.²

DPT vaccine is a prescription biological product, subject to the provisions of the Pure Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the Public Health Service Act (42 U.S.C. § 262), and the regulations promulgated thereunder. Moreover, the State of Texas, through its Department of Health, has required its use as part of its state-wide immunization program.³ TEX.ADMIN.CODE, Title 25, §§ 97.61, 97.63 (1979). As far as the court has been able to determine, all but nine of fifty-two jurisdictions (50 states, District of Columbia and Puerto Rico) require pertussis immunization of children at some time prior to their entry in day care centers, kindergarten, and grade school. Of those that do not absolutely require immunization, at least four states recommend it.

On November 19, 1980, a few months after his birth, the minor plaintiff James Hurley III was administered defendants' DPT vaccine by Dr. Lanier, who is not a defendant in this action. Shortly thereafter, the child developed a severe and irreversible neurological condition known as encephalopathy. For the purposes of ruling on the defendants' motions for summary judgment, the court assumes that the DPT vaccination was the legal cause of plaintiff's injuries, and that plaintiffs were neither negligent, nor assumed a risk in accepting the medication.

Lederle and Connaught furnished doctors purchasing DPT, such as Dr. Lanier, with pamphlets describing possible adverse side effects and contra-indications to the drug's use. The pertinent parts of the package insert provide:

Adverse reactions may be local and include pain, erythema, tenderness and induration at the site of injection. Significant reactions attributed to the pertussis vaccine component have been high fever (greater than 39° centigrade), a transient shock-like episode, excessive screaming, somnolence, convulsions, encephalopathy, and thrombocytopenia. Such reactions almost always appear within 24 to 48 hours after injection, but have been thought to occur after an interval as long as 7 days....

Neurological disorders, such as encephalopthy, possibly due to the pertussis component, have been reported to occur rarely following the injection of this product, and they may be fatal, or result in permanent damage to the central nervous system ...

Should symptomatology referable to the central nervous system develop following administration, no further immunization with this product should be attempted. Routine immunization should be postponed or avoided in patients with acute infections, or personal or family history of neurological disturbances ... (emphasis added)

According to Dr. Lanier's deposition testimony, he considered the above warnings to be accurate and adequate to apprise him of the risks involved in administering DPT. However, in spite of these warnings, injuries resulted from the drug's use, plaintiffs filed suit against Connaught and Lederle, and the court is faced with the difficult issue of preemption raised by the defendants' motion for partial summary judgment.

II. THE SUMMARY JUDGMENT STANDARD

Rule 56(c) of the Federal Rules of Civil Procedure provide that summary judgment should be rendered if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, show that there is no genuine issue as to any material fact, and that the moving party is entitled to a judgment as a matter of law. FED.R.CIV.P. 56(c). Thus, the crucial question for the court to consider is whether there is a genuine issue of fact concerning any essential element of the plaintiff's claim. Fontenot v. Upjohn Co., 780 F.2d 1190, 1195 (5th Cir.1986). If the moving party can show there is no evidence whatsoever to establish one or more of the essential elements of a claim on which the opposing party has the burden of proof, trial would be a "bootless" exercise. Fontenot, 780 F.2d at 1195.

Expanding on this concept, the Supreme Court in Anderson v. Liberty Lobby, Inc., ___ U.S. ___, 106 S.Ct. 50, 88 L.Ed.2d 40 (1986), stated:

If the defendant in a run-of-the mill civil case moves for summary judgment, or for directed verdict based on a lack of proof of material fact, the judge must ask himself not whether he thinks evidence unmistakably favors one side or the other, but whether a fair-minded jury could return a verdict for the plaintiff on the evidence presented. The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient. There must be evidence upon which the jury could reasonably find for the plaintiff.

See also, First National Bank of Arizona v. Cities Services Co., 391 U.S. 253, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968). Thus, the summary judgment standard is the mirror of the standard for a directed verdict. In the instant case, the court finds the summary judgment evidence is such that it must hold federal law preempts plaintiffs' claims based upon inadequate warning/labeling and design of DPT vaccine; therefore, defendants are entitled to partial summary on these issues as a matter of law.

III. THE PREEMPTION DOCTRINE

The doctrine of...