Shackil v. Lederle Laboratories

Citation530 A.2d 1287,219 N.J.Super. 601
Parties, Prod.Liab.Rep. (CCH) P 11,578 Clara Morgan SHACKIL, Albert Shackil, and Deanna Marrero, p/p/a Her Mother and Next Friend Clara Morgan Shackil, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, a division of American Cyanamid Co.; and Wyeth Laboratories, a division of American Home Products Corporation; Wyeth Laboratories, Inc.; Parke-Davis, a division of Warner-Lambert Co.; Eli Lilly and Company, Defendants-Respondents, and Pittman-Moore and its successor, the Dow Chemical Company and Leo Feld, M.D., Defendants.
Decision Date12 August 1987
CourtNew Jersey Superior Court – Appellate Division

Jan Schlichtmann, Boston, Mass., pro hac vice, of the Massachusetts Bar, for appellant (Blume, Vazquez, Goldfaden, Berkowitz & Oliveras, Newark, attorneys; John M. Blume, Newark, of counsel; Michael R. Hugo, Boston, Mass., on the brief).

J. Peter Coll, Jr., New York City, pro hac vice, of the New York Bar, for respondent Lederle Laboratories (Morgan, Melhuish, Monaghan, Arvidson, Abrutyn & Lisowski, Livingston, attorneys; James L. Melhuish, of counsel and on the brief).

Anita Hotchkiss, Morristown, for respondent Wyeth Laboratories, Div. of American Home Products Corp., Wyeth Laboratories, Inc. and Parke Davis & Co. (Porzio, Bromberg & Newman, attorneys; Ms. Hotchkiss, of counsel and on brief; and Lisa Murtha, on the brief).

John L. McGoldrick, Newark, for respondent Eli Lilly & Co. (McCarter & English, attorneys; Mr. McGoldrick, of counsel and on the brief; John F. Brenner, Jerry P. Sattin, Newark, Richard A. Bagger and Marna L. Brown, Newark, on the brief; Shook, Hardy & Bacon, Kansas City, Mo., of counsel).

McDonough, Murray & Korn, Westfield, for Leo Feld, M.D. (William S. Mezzomo, on the brief).

Thomas F. Campion, Morristown, amicus curiae for Merck & Co., Inc. (Shanley & Fisher attorneys; Mr. Campion, of counsel and on the brief).

Tompkins, McGuire & Wachenfeld, Newark, filed a brief amicus curiae for Abbott Laboratories (William B. McGuire, of counsel and on the brief).

Lamb, Hartung, Coughlin, Kretzer & Reinman, Jersey City, filed a brief amicus curiae for The Upjohn Co. (Edwin A. Hartung, of counsel and on the brief).

Before Judges DREIER, SHEBELL and STERN.

The opinion of the court was delivered by

DREIER, J.A.D.

Plaintiffs have appealed, by leave granted, from an interlocutory order dismissing their negligence, warranty, misrepresentation, and strict liability action against Lederle Laboratories, Wyeth Laboratories, a Division of American Home Products Corporation, Wyeth Laboratories, Inc., Parke-Davis, and Eli Lilly & Co. By amended complaint plaintiff added Pittman-Moore as a defendant. National Drug Company, an additional manufacturer of the drug in question, was not joined, since plaintiffs contended that as a result of their discovery they found no basis to determine that the drug actually administered was manufactured by National Drug Company. 1

The claims in this case arose out of an administration of the pertussis (whooping cough) antigen component of a pharmaceutical product known as the diphtheria, pertussis and tetanus toxoid (DPT) vaccine. The DPT vaccine is not a formularized synthetic chemical substance, but rather a licensed prescription biological product subject to the provisions of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.A. § 301 et seq. (1972), and the Public Health Service Act, 42 U.S.C.A. § 262 et seq. (1982). Each manufacturer of a DPT vaccine has its own proprietary process for creating the vaccine, protected either by trade secret or patent, and often marketed under trade names. Some of the characteristics of the biological products may vary with the processes used. Immunization with the vaccine is required by law, N.J.S.A. 26:1A-7, 30:5B-5; N.J.A.C. 8:57-4.10, and the beneficial effect of the vaccine is generally acknowledged. The immunization program has reduced and in some areas virtually eliminated diphtheria, whooping cough and tetanus in young children.

Plaintiffs, however, contend that the product was defective in that it contained toxins which could have been eliminated by the use of the technology existing at the time the infant plaintiff, Deanna Marrero, was inoculated. Further, plaintiffs assert that the inoculations administered by the defendant physician caused Deanna to suffer a seizure disorder, resulting in chronic encephalopathy and severe retardation, and changing an otherwise normal two-year old into a mental incompetent requiring institutionalization. 2 Deanna's mother first noted the problem immediately following the booster shot, but was told by defendant physician that Deanna's conduct might well be indicative of her entering the "terrible twos." Thereafter, as Deanna's condition steadily worsened, her mother claims she had no indication of the relationship between the DPT injections and her daughter's condition. She testified in a deposition that in June 1984 she

... read an article that was in the Boston paper about the side effects of the D.P.T., well, mainly of the pertussis, and that it could cause brain damage and when I read it, it was like a light went off in my head and I finally saw something in black and white that I had suspected for many years but was never--no one ever really acknowledged that that was what it was.

She also described the regression in her daughter's development Her eyes were crossing, her speech regressed and she would not get up when lying down or sitting. She was no longer interested at looking at pictures in a book. She began negative self-stimulation behavior such as compulsively twisting her hands. She began seizure activity. At approximately 4 years she began to grit her teeth, hold her breath and contort her face. She did not reach many of her developmental milestones. At six years she began episodes of hysterical uncontrollable crying. Today as a result of the inoculations, Deanna is severely retarded and requires constant care.

This suit was filed April 12, 1985 when Deanna was 14 years old, nearly 13 years after the administration of the last injection. By that time records were unavailable to the parties as to the identity of the manufacturer of the particular DPT vaccine used by the treating physician. Plaintiffs, therefore, instituted this action against all manufacturers whose products had been used by the treating physician during the period in question, asserting a theory of collective responsibility. 3

Although the defendant manufacturers have raised various other defenses, treated later in this opinion, the trial judge correctly determined that he was bound by Namm v. Charles E. Frosst & Co., 178 N.J.Super. 19, 427 A.2d 1121 (App.Div.1981), which rejected all theories of collective responsibility. 4 While in no way impugning the decision of the trial judge who was bound by existing appellate authority to dismiss the complaint against the drug manufacturers, we now reconsider the Namm holding. Defendants have raised several bases upon which they claim the DPT cases differ from those in which any theory of collective responsibility has been applied. While they disagree that any such theory should apply, they contend that the theories are limited in application to generic or truly fungible products and to factual settings that differ from the one before this court. We will briefly treat these arguments before approaching the central issue of whether New Jersey should adopt one or more of the recognized theories or some modification thereof. These arguments, however, point out some flaws in the recognized theories of responsibility in non-identification cases, primarily in the failure of these rules to adapt to the specific factual settings of individual cases and to coordinate with other recognized tort principles.

I. Preliminary Considerations.
A.

First, defendants claim that they are without fault in plaintiffs being denied access to information concerning the identity of the manufacturer. This was not a case where there is a recognized long latency period and pharmaceutical records were destroyed in the interim, such as in the DES cases. See, e.g., Sindell v. Abbott Laboratories, 26 Cal.3d 588, 163 Cal.Rptr. 132, 607 P.2d 924, cert. den. 449 U.S. 912, 101 S.Ct. 285, 66 L.Ed.2d 140 (1980); and the other DES cases cited infra. The Federal Food & Drug Administration (FDA) has formulated rules and regulations which encompass the licensing, testing, production, distribution, review and approval of each DPT vaccine. One such requirement is that each manufacturer must make a written record of the name and address of each person to whom a specific lot of the vaccine has been distributed and that record must be retained for no less than five years after the date of manufacture or six months after the expiration date for that product, whichever is later. 42 C.F.R. § 73.502(b)(1) (1971); 21 C.F.R. § 600.12(a)(b)(1) (1986). Likewise, although the doctor and his drug distributor had retained their records for several years, they then destroyed them.

Defendants, however, misperceive the element of superior access to information discussed in some cases. It is not an element of a cause of action; rather, it is a consideration to be weighed in a balancing process to determine whether some form of collective responsibility should fairly be applied. In the case before us, there is no question that the applicable statute of limitations has not run since this action was filed during the infant plaintiff's minority. N.J.S.A. 2A:14-21. Even if there had been no tolling statute, the cause of action may well have been preserved under New Jersey's discovery rule. Vispisiano v. Ashland Chemical Company, 107 N.J. 416, 437, 527 A.2d 66 (1987); Lopez v. Swyer, 62 N.J. 267, 300 A.2d 563 (1973); cf. Hadden v. Eli Lilly & Co., 208 N.J.Super. 716, 506 A.2d 844 (App.Div.1986), certif. den. 104 N.J. 441, 517 A.2d 431 (1986).

While the cause of action itself...

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