Jones By Jones v. Lederle Laboratories, 85 CV 949.

• Decision Date: 01 August 1988
• Docket Number: No. 85 CV 949.,85 CV 949.
• Citation: 695 F. Supp. 700
• Parties: Melissa JONES, an infant under the age of 14 years, by her father and natural guardian, Richard JONES, Plaintiff, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., Defendant.
• Court: U.S. District Court — Eastern District of New York

695 F. Supp. 700

Melissa JONES, an infant under the age of 14 years, by her father and natural guardian, Richard JONES, Plaintiff, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., Defendant.

No. 85 CV 949.

United States District Court, E.D. New York.

August 1, 1988.

Glaser, Shandel & Blitz, New York City (Richard E. Shandell, and Jane Thea, of counsel), for plaintiff.

Donovan Leisure Newton & Irvine, New York City (J. Peter Coll, Jr., Daniel J. Thomasch, and Janis R. Hirohama, of counsel), for defendant.

MEMORANDUM AND ORDER

McLAUGHLIN, District Judge.

This is a products liability action based on diversity of citizenship. 28 U.S.C. § 1332(a)(1). The defendant moves for summary judgment to dismiss the Complaint. Fed.R.Civ.P. 56(b). For the reasons discussed below, the motion is granted in part and denied in part.

FACTS

Defendant, Lederle Laboratories ("Lederle"), is a division of American Cyanamid Company. Lederle manufactures Tri-Immunol, a diphtheria, tetanus, and pertussis ("DTP") vaccine. The Complaint alleges that the plaintiff, Melissa Jones, was administered this vaccine at the age of two-and-one-half months, and sustained severe and permanent neurological damage as a result. Lederle has moved for summary judgment on several grounds.

The parties agree that many of the facts are not in dispute. For purposes of diversity jurisdiction, the plaintiff is a citizen of New York and Lederle is a citizen of Maine and New Jersey. The amount in controversy exceeds $10,000.

I. Background

A. Pertussis and Pertussis Vaccines

Well into the twentieth century, the disease of pertussis, commonly known as "whooping cough," was responsible for thousands of deaths annually in the United States, mostly to infants. The disease is caused by Bordetella pertussis, a highly contagious bacterium.

In the 1940s, pertussis vaccines came into wide use. The first vaccine type was known as "whole-cell." In a whole-cell vaccine, entire dead pertussis cells are injected into the vaccine to induce immunity. Part, but not all, of the cell stimulates immune response. This part is known as the antigen. Other parts of the cell may contain neurotoxins, which do not induce immunity and may cause brain damage. For years, the scientific-medical community has been frustrated by its inability to determine precisely which part of the pertussis cell contains the antigen and which contains the toxins. As a result, the whole-cell vaccine, as its name suggests, consists of both antigenic and toxic material. Hence, the vaccine as administered stimulates immunity to pertussis, but at the fearsome risk of causing neurological damage.

In 1949, the federal Food and Drug Administration ("FDA") first licensed use of the whole-cell vaccine as a component of the DTP vaccine. The DTP vaccine also includes diphtheria and tetanus antigens. In contrast to the pertussis component of the vaccine, the biology of these cells is well understood. Thus, while the antigen in these cells is included in the vaccine, the potentially adverse reactants, the toxins, are left out. This DTP vaccine, as modified since the 1940s, is manufactured by Lederle under the tradename Tri-Immunol.

Since the 1940s, two other types of pertussis vaccine have been marketed. The first, the so-called "split-cell" design, was marketed by Eli Lilly & Company ("Lilly") from 1960-76 under the trade name Tri-Solgen. The split-cell vaccine contained pertussis cells that had been fragmented by a chemical process. Debris from some of the cell was discarded, although both antigens and toxins remained in the vaccine. After discontinuing production of Tri-Solgen, Lilly sold the right to produce it to a third party. After an abortive attempt to procure licensing from the FDA in 1982, this company elected not to make further attempts to license it. Because the FDA refused to certify Tri-Solgen, it would have been a crime to have manufactured and sold it in 1979. See 21 U.S.C. §§ 331(d), 333(a), 355(a).

The other type of vaccine, known as "acellular," has been marketed in Japan since 1981. It has not been marketed in the United States. In an acellular vaccine, a protein component from the whole cell is purified in part and placed in the vaccine. The rest of the cell is discarded. Acellular vaccines also contain toxins.

In the United States, DTP is administered to infants and young children via a series of inoculations and booster shots. This program has dramatically reduced the incidence of pertussis. In 1934, there were over 250,000 reported cases of pertussis in the United States, and 7500 deaths caused by the disease. By the 1980s, there were, at most, 3000 cases and twenty annual deaths.

As mentioned previously, however, administration of the vaccine can produce undesirable side-effects. There is evidence that whole-cell vaccines can cause severe and permanent neurological damage. See Edwards, Lawrence & Wright, Diphtheria, Tetanus, and Pertussis Vaccine, 140 Am. J. of Diseases of Children 867, 871 (1986); Leibel, Pertussis Vaccination: Benefits and Risks, Drug Therapy, Oct. 1984, at 46. No scientific study, however, has compared the incidence of permanent side-effects between whole-cell vaccines and the two other types.

Several studies and reports have compared temporary adverse reactions caused by the three types of vaccines. The earliest study was carried out in 1967 by a Dr. Russell J. Blattner. This "Blattner Study" concluded that Lederle's whole-cell vaccine caused statistically significant greater incidence of temporary reaction than Lilly's split-cell design for pain and irritability among infant males, for swelling among infant females, and for temperature rise among all infants. There is evidence that, as early as 1964, Lederle knew that the split-cell design was less reactive than Tri-Immunol. Internal Lederle memoranda over the following decade reflect this fact.

Later studies have examined rates of temporary reaction between whole-cell and acellular vaccines, and have concluded that whole-cell is more reactive. E.g., Edwards, et al., supra, at 871 (whole-cell vaccine produced more temporary fever, pain, agitation, abnormal gait, and irritation at vaccination site than did acellular vaccine); Lewis, Cherry, Holroyd, Baker, Dudenhoeffer & Robinson, A Double-Blind Study Comparing an Acellular Pertussis-Component DTP Vaccine with a Whole-Cell Pertussis-Component DTP Vaccine in 18-Month-Old Children, 140 Am. J. of Diseases of Children 872, 873 (1986) (whole-cell vaccine caused more swelling, redness, and tenderness than did acellular vaccine).

There is evidence that the whole-cell vaccine contains more toxins than does the acellular type. See id. at 874; Sato, Kimura & Fukumi, Development of a Pertussis Component Vaccine in Japan, Lancet, Jan. 21, 1984, at 124. In addition, there is evidence that the acellular vaccine is at least as effective as the whole-cell vaccine in immunizing infants against pertussis. See Aoyama, Murase, Kato & Iwata, Efficacy of an Acellular Pertussis Vaccine in Japan, J. Pediatrics 180, 182 (1985); Edwards, et al., supra, at 869-70.

B. FDA Licensing

In the United States, vaccine manufacturers are regulated by the FDA pursuant to the Public Health Service Act, as amended, 42 U.S.C. § 262, and the federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. § 301 et seq. The regulations promulgated by the FDA are quite detailed. See generally 21 C.F.R. Subchapter F.

In order to market any vaccine, a manufacturer must receive both an establishment license and a product license. See id. § 601.1. In order to procure an establishment license, the manufacturer must, inter alia, pass an inspection conducted by the FDA. See id. § 601.10(a). To retain the license, the manufacturer must receive FDA permission concerning any change in manufacturing methods or product labeling. See id. § 601.12(b).

To procure a product license, the manufacturer must comply with various regulations designed to ensure that the product is safe, effective, and correctly branded. See id. §§ 601.20(a), .25. A plethora of rules establish the procedure for review of drugs submitted for licensing. See generally id. § 601.25(a)-(c). In addition, standards for safety, effectiveness, and labeling are established. These regulations provide, in relevant part:

(1) Safety means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the biological product is safe under the prescribed conditions of use, including results of significant human experience during use.

(2) Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological or other effect of the biological product, when used under adequate directions, for use and warnings against unsafe use, will serve a clinically significant function in the diagnosis, cure, mitigation, treatment, or prevention of disease in man ...

(3) The benefit-to-risk ratio of a biological product shall be considered in determining safety and effectiveness.

....

(5) Labeling shall be clear and truthful in all respects and may not be false or misleading in any particular. It shall comply with section 351 of the Public Health Service Act and sections 502 and 503 of the Federal Food, Drug, and Cosmetic Act, and in particular with the applicable requirements of ... this chapter.

Id. § 601.25(d).

A manufacturer wishing to market a pertussis vaccine must also comply with several specific requirements. See generally id. §§ 620.1-.6. These requirements define the vaccine as "an aqueous preparation of either killed whole Bordetella pertussis bacteria or a fraction of Bordetella pertussis bacteria. The vaccine may be...