Mazur v. Merck & Co., Inc.
| Decision Date | 18 June 1992 |
| Docket Number | No. 91-1613,91-1613 |
| Citation | 964 F.2d 1348 |
| Court | U.S. Court of Appeals — Third Circuit |
| Parties | , 75 Ed. Law Rep. 745, Prod.Liab.Rep. (CCH) P 13,183 Anthony MAZUR and Edna Mazur as Parents and Guardians of Lisa Marie Mazur, a Minor, and Anthony Mazur and Edna Mazur, in their own right, Appellants, v. MERCK & CO., INC. |
David R. Dearden (argued), Thomas A. Sprague, Richard A. Sprague, Paul Crowley, Sprague, Creamer & Sprague, Philadelphia, Pa., for appellants.
Kenneth C. Frazier (argued), Joanne Lahner, Drinker, Biddle & Reath, Philadelphia, Pa., for appellee.
Before: STAPLETON, SCIRICA and ALITO, Circuit Judges.
In this products liability action appellants Lisa Mazur and her parents seek compensatory and punitive damages from appellee Merck & Co., Inc. for failure to warn that the use of its vaccine could result in serious neurological illness. The district court entered summary judgment for Merck on the ground that it provided an adequate warning to a learned intermediary, and, in the alternative, exercised reasonable care to inform users of the risks of its vaccine by contractually obligating the United States Centers for Disease Control (CDC) 1 to warn vaccinees directly. Mazur v. Merck & Co., 767 F.Supp. 697 (E.D.Pa.1991). Because we conclude that Merck satisfied its duty to warn by contractually obligating the CDC to warn vaccinees directly, we will affirm.
In response to a measles epidemic in the late 1970s, the Philadelphia Department of Public Health proposed a regulation, later adopted by the School Board of Health, requiring all school children to be vaccinated against a variety of pediatric diseases. Under the regulation, school nurses were instructed to review the health records of about 300,000 students city-wide to determine which vaccines, if any, they needed, and to obtain written permission from students' parents for vaccination in appropriate cases. Where adequate proof of prior vaccinations or diseases was not forthcoming, students were considered unimmunized.
Based on a recommendation and information from the CDC, Dr. Robert G. Sharrar, a director of the Philadelphia health department, selected M-M-R II (MMR II) as the measles vaccine for the city's immunization program. MMR II is a live-virus vaccine for simultaneous immunization against measles, mumps, and rubella. It is a prescription drug and has been manufactured by Merck since 1978 under a license from the United States Food and Drug Administration.
The MMR II vaccine is distributed in vials containing an FDA-approved "package circular," describing the risks attendant to the vaccine's use. In April 1981 the package circular contained the following statement about the risk of contracting subacute sclerosing panencephalitis (SSPE), a fatal, slowly progressing neurological disease, from inoculation with the MMR II vaccine:
There have been reports of [SSPE] in children who did not have a history of natural measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with natural measles, 5-10 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study concluded by the [CDC] suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
The package circular also contained the following paragraph on revaccination:
Based on available evidence, there is no reason to routinely revaccinate children originally vaccinated when 12 months of age or older; however, children vaccinated when younger than 12 months of age should be revaccinated. The decision to revaccinate should be based on evaluation of each individual case.
The Philadelphia health department purchased the MMR II vaccine for the city's immunization program from the CDC which had purchased it from Merck. Merck was at first reluctant to sell its MMR II vaccine to the CDC, but relented after the CDC agreed to the following contractual provision:
The [CDC] represents and agrees that it will (1) take all appropriate steps to assure that all vaccine supplied to various locations within the 50 states, ... pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician, or (2) take all appropriate steps to provide to such a patient (or to the patient's parent or guardian) meaningful warnings relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent or guardian. 2
Opting to proceed under the latter clause, the CDC drafted an "Important Information Statement," designed to inform parents of the risks of inoculation with the MMR II vaccine in lay terms. It then obligated state and local health agencies who purchased MMR II vaccine from it, including the Philadelphia health department, to distribute the Important Information Statement to vaccinees, parents, or their guardians. The Important Information Statement was distributed to nurses at a district-wide informational meeting on the city's immunization program, and was forwarded to parents by way of their children.
Lisa Mazur's mother claims that she never received the Important Information Statement, or any other document pertaining to the risks associated with use of the MMR II vaccine. But she admits to having been notified of the immunization program, and, in particular, receiving a letter from the school district explaining the program with an attached immunization record and written permission form. Mrs. Mazur neither signed nor returned the permission form.
Instead, she called Lisa's school principal and an official at the Board of Education, and told them that Lisa was immunized for measles in 1973 and that she would not consent to her revaccination. Then, to prevent Lisa from being revaccinated, Mrs. Mazur kept her out of school for a week. But she eventually relented under pressure from school officials, and sent Lisa back to school. Shortly thereafter, students were immunized at Lisa's school, the Andrew J. Morrison School.
The immunization program was administered at the Morrison School by Edith B. Frederick, a registered nurse. Nurse Frederick was responsible for personally reviewing student health records to determine which students had been previously vaccinated and to check for medical conditions that might heighten the risks of vaccination. She also arranged the immunization forms that were sent home with students, including the Important Information Statement, distributed them to students, and collected the permission forms that were returned.
Students were inoculated at the Morrison School on February 26, 1982. They were led into the school gymnasium single file, one classroom at a time. Nurse Frederick and a technician who administered the vaccination shots were situated at a table. As students approached them, Nurse Frederick took each student's permission form, checked it against her health records, and informed the technician which vaccine to administer. Nurse Frederick also examined the "overall appearance" of students as they passed by her, and, sometimes, asked them how they felt. On average it took students three to four minutes to pass through the line and be vaccinated. No physician was present during the inoculation, nor was any representative from either Merck or the CDC.
Although Nurse Frederick's records do not include a signed permission form for Lisa Mazur, they indicate that she was inoculated with the MMR II vaccine that day. On September 7, 1983, shortly after her fourteenth birthday, Lisa was admitted to St. Christopher's Hospital for Children in Philadelphia because of "personality changes" and "abnormal movements." On November 2, 1983, she was diagnosed with SSPE.
On October 18, 1985, the Mazurs filed this action in the Philadelphia Court of Common Pleas seeking compensatory and punitive damages. Their complaint alleges negligence and strict liability claims against Merck under Pennsylvania law for, among other things, failure to provide an adequate warning. Merck removed the action to federal district court, and moved for summary judgment on the Mazurs' failure to warn claims.
Merck contended that (1) the Mazurs' state law claims were preempted by the pervasive scheme of federal regulations governing the production, labeling, and distribution of vaccines; (2) the Mazurs' action was barred by Pennsylvania's two-year statute of limitations for tort claims; and (3) Merck met its duty to warn by informing Dr. Sharrar of the risks associated with the MMR II vaccine, and, alternatively, obligating the CDC to ensure that the vaccine was administered by a physician or to provide meaningful warnings to vaccinees.
The district court issued an opinion and order denying Merck's motion for summary judgment on the federal preemption and statute of limitations issues. Mazur v. Merck & Co. (Mazur I), 742 F.Supp. 239 (E.D.Pa.1990). But it reserved judgment on the issue whether Merck met its duty to warn, and instead allowed further discovery and additional filings on this matter. Merck then filed a supplemental motion for summary judgment, which the district court granted. Mazur v. Merck & Co. (Mazur II), 767 F.Supp. 697.
Drawing on its earlier opinion, the district court held that (1) Merck had a "duty to exercise reasonable care to inform those for whose use [its MMR II vaccine] was supplied of the facts which make it dangerous"; (2) Nurse Frederick acted as a learned intermediary, because s...
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