Mazur v. Merck & Co., Inc.

• Decision Date: 27 June 1991
• Docket Number: Civ. A. No. 85-6494.
• Parties: Lisa Marie MAZUR, a Minor, in her own right, and Anthony Mazur and Edna Mazur, as Parents and Guardians, and in their own right v. MERCK & CO., INC.
• Court: U.S. District Court — Eastern District of Pennsylvania

767 F. Supp. 697

Lisa Marie MAZUR, a Minor, in her own right, and Anthony Mazur and Edna Mazur, as Parents and Guardians, and in their own right v. MERCK & CO., INC.

Civ. A. No. 85-6494.

United States District Court, E.D. Pennsylvania.

June 27, 1991.

David R. Dearden, Sprague, Higgins, Creamer & Sprague, Philadelphia, Pa., for plaintiff.

Kenneth C. Frazier, Joanne Lahner, Drinker, Biddle & Reath, Philadelphia, Pa., for defendant.

OPINION

DITTER, District Judge.

In this case, a manufacturer is charged with failing to warn that the use of its vaccine might lead to serious consequences. Before me is the supplemental motion of defendant Merck & Co., Inc., for summary judgment and to exclude expert testimony.¹ Plaintiffs Lisa Marie Mazur and her parents, Anthony and Edna Mazur, claim that Lisa contracted subacute sclerosing panencephalitis ("SSPE"), a severe, often terminal, illness of the central nervous system, as a result of an inoculation with a measles, mumps, and rubella vaccine ("MMR II") manufactured by Merck.

Merck's first motion for partial summary judgment was denied in part and granted in part. Mazur v. Merck, 742 F.Supp. 239, 266 (E.D.Pa.1990). I denied Merck's motion as to the federal preemption and statute of limitations issues. Id. After a lengthy discussion of the many other matters raised by the parties, I found that additional discovery and briefing was necessary and gave the parties time to conduct both. Id. Specifically, I invited the parties to address whether or not:

a. Merck acted in accordance with due care when it contracted with the Center for Disease Control ("CDC") to ensure the presence of a physician at inoculation or an adequate warning of the risks associated with vaccination was conveyed to recipients or to their parents or guardians, id. at 261;

b. the school nurse who supervised the MMR II inoculation was a learned intermediary, id. at 255;

c. the package circular contained an adequate warning of the revaccination risks, id. at 258;

d. the proximate cause element of a duty to warn claim had been satisfied,² id. at 262-63; and

e. the cause-in-fact element of a duty to warn claim had been satisfied,³ id. at 266 and n. 33.

Merck's supplemental motion for summary judgment will be granted. Merck satisfied its duty to exercise reasonable care to inform the Mazurs of the vaccine's risks. Even though no doctor was present, Edith Frederick, the nurse who supervised the administration of the vaccine to Lisa Mazur, was a qualified learned intermediary. She was provided with a sufficient warning of the risks associated with MMR II inoculation. The package circular contained an adequate warning of vaccination risks and accurately reflected the medical evidence available in 1982. Therefore, Merck cannot be held liable for Lisa's illness.

I. Facts

The facts of this case are described in great detail in my prior opinion. See Mazur, 742 F.Supp. at 243-45. I will briefly summarize them here.

In response to a measles epidemic among school children in Philadelphia in the late 1970's, the City of Philadelphia, Department of Public Health ("health department") proposed a regulation, which was later adopted by the School Board of Health ("school board"), requiring all children attending a school in Philadelphia to be vaccinated against a variety of pediatric diseases. The school board's medical director, Dr. Robert G. Sharrar, selected Merck's MMR II vaccine for the simultaneous immunization against measles, mumps, and rubella. Affidavit of Robert G. Sharrar, M.D., ("Sharrar aff."), ¶ 8, attached as Merck's exhibit J.

MMR II was packaged in containers which included an insert describing the risks and benefits associated with its use.⁴ The school board purchased the MMR II vaccines from the CDC which had, in turn, purchased them from Merck. The Merck-CDC purchase contract stated the CDC would assure that a physician be present at each inoculation or that the CDC would provide MMR II recipients or their parents with what Merck and it believed to be an adequate warning of the risks associated with MMR II immunization. Opting to proceed under the latter clause, the CDC drafted an "Important Information Statement" to be sent to all parents of schoolage children. Affidavit of William B. Freilich, ("Freilich aff."), ¶ 22 and exhibit 6, attached as Merck's exhibit E. The Important Information Statement was sent to parents via their children.

Lisa Mazur received the MMR II vaccine on February 26, 1982. The vaccine was administered at Lisa's school under the supervision of Edith B. Frederick, a registered nurse. Mrs. Mazur claims she never gave her consent for her daughter's vaccination. She denies receiving an Important Information Statement or any other warning about MMR II's risks. She did, however, become aware of the scheduled immunization, protested Lisa's vaccination to the school board, and so she would not be vaccinated kept Lisa out of school for a week prior to the date of the vaccination.

On November 2, 1983, Lisa was diagnosed as having SSPE.⁵

II. Duty to Warn

A. The Manufacturer's Duty to Warn.

In my prior opinion in this case, I described and explained the nature and scope of a vaccine manufacturer's duty to warn. See Mazur, 742 F.Supp. at 251-53. I need not go into such a thorough review here, but a few comments are necessary.

The standard of care which applies in this case is set forth in Restatement (Second) of Torts § 388.⁶ "Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous." Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 219 n. 9 (1971) (emphasis added). Because MMR II is a prescription drug product, Merck can satisfy its duty to warn the vaccine recipient by exercising reasonable care to provide an adequate warning to a medical professional who acts as a "learned intermediary." Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974). The "learned intermediary rule" recognizes that a medical professional is qualified by knowledge, experience, and preparation to exercise his "individual medical judgment bottomed on a knowledge of both patient and palliative." Id.

If the vaccine is "dispensed to all comers at mass immunization clinics without an individualized balancing by a physician of the risks involved ..., it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or by obligating the purchaser to give warning." Davis v. Wyeth Laboratories, 399 F.2d 121, 131 (9th Cir.1968). Although this principle has been called the "mass immunization exception" to the learned intermediary rule,⁷ see, e.g., Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178-79 (5th Cir.1989), it is really one of several circumstances when the duty to warn the user directly is imposed on the manufacturer.

If the manufacturer chooses to obligate the purchaser of the vaccine to give warning, permissible under Davis and comment n of section 388, the general rule controls and the manufacturer's warning activities must be examined to see if they comport with its "duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous." Incollingo, 282 A.2d at 219 n. 9. The issue of whether or not the reasonableness standard has been met will most likely turn on the issue of foreseeability, (i.e., "was it foreseeable that the purchaser would not provide an adequate warning to the consumer?" or "was it foreseeable that a learned intermediary would not be present at inoculation?"). If the manufacturer acts in accordance with due care it cannot be liable for the injuries that happen to befall the plaintiff.

B. The Parties' Contentions.

The Mazurs charge Merck with failing to warn them of MMR II's risks before Lisa was inoculated. They allege that they never received any warning from Merck, the CDC, the health department, or the school board. The Mazurs posit claims for strict liability and negligence for failure to warn. These claims depend on proof of four facts: (1) Merck had a duty to warn adequately Lisa or her parents or a learned intermediary of the health hazards associated with MMR II use; (2) Merck breached that duty; (3) Merck's breach in fact caused Lisa's illness;⁸ and (4) Merck's breach proximately caused her illness.⁹

Merck argues it had no duty to warn the Mazurs directly and it fulfilled its duty to warn by entering into and relying on its purchase contract with the CDC. It contends its transactions with the CDC were in accordance with its "duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous." Incollingo, 282 A.2d at 219 n. 9. Merck also asserts it did not have a duty to warn Lisa or her parents directly, because Nurse Frederick was qualified and in fact acted as a "learned intermediary," Reyes, 498 F.2d at 1276, at the time Lisa received the MMR II inoculation. Thus, Merck argues it need only have made an adequate package circular available to Nurse Frederick. It posits that it has done so. Additionally, it also maintains that the Mazurs' contention that the revaccination warning was inadequate is without merit.

With that background in mind, I will first discuss whether Merck acted in accordance with due care when it contracted with and relied upon the CDC to provide a physician or the Important Information Statement to parents. It did. I will then consider whether or not Nurse Frederick was a learned intermediary. She was. Because she was, I will next address whether a warning was made available to her. It was. Finally, I will analyze whether the package circular contained an adequate warning of the revaccination risks. It did. Thus, Merck is entitled to summary judgment in its...