Mazur v. Merck & Co., Inc., Civ. A. No. 85-6494.

• Court: United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
• Writing for the Court: DITTER
• Citation: 742 F. Supp. 239
• 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, Plaintiffs, v. MERCK & CO., INC., Defendant.
• Docket Number: Civ. A. No. 85-6494.
• Decision Date: 29 June 1990

742 F. Supp. 239

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

Civ. A. No. 85-6494.

United States District Court, E.D. Pennsylvania.

June 29, 1990.

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COPYRIGHT MATERIAL OMITTED

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COPYRIGHT MATERIAL OMITTED

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

Kenneth C. Frazier, Joanne Lahner, Sandra L. Ykema, Philadelphia, Pa., for defendant.

OPINION

DITTER, District Judge.

Plaintiffs Lisa Marie Mazur and her parents, Anthony and Edna Mazur, claim that Lisa contracted subacute sclerosing panencephalitis ("SSPE"), a debilitating, terminal disease of the central nervous system, as a result of an inoculation with a measles, mumps, and rubella vaccine manufactured by defendant Merck & Co., Inc. Before me is defendant's motion for summary judgment and to exclude plaintiffs' expert testimony.

The Mazurs brought this diversity action asserting claims of strict liability and negligence for both design and manufacturing defects and for failure to provide an adequate warning, breach and reckless breach

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of the implied warranties of merchantability and fitness for a particular purpose, intentional and negligent misrepresentation, and negligent infliction of emotional distress. They seek compensatory and punitive damages

Merck moves for summary judgment and for exclusion of the expert testimony of plaintiffs' witnesses.¹ It contends that federal regulation of vaccine manufacturing, distributing, and labeling preempts the Mazurs' tort claims in their entirety. Alternatively, Merck maintains that the tort claims of the Mazur parents are barred by the applicable Pennsylvania statute of limitations, 42 Pa.C.S.A. § 5524(2) and (7). It also argues that I should find as a matter of law that it did not breach the duty to warn recipients of the vaccine of its risks.

After considering the facts presented by the parties in a light most favorable to the plaintiffs, the motion for partial summary judgment will be denied in part. As I will explain more fully below, I find that Congress did not preempt state tort claims asserted by a victim of an adverse reaction to a Food and Drug Administration-approved vaccine. A reasonable jury could find for either side on the statute of limitations issue. However, I will reserve judgment on the question of whether Merck has shown as a matter of law that it did not breach its duty to warn of the dangers associated with the vaccine.

I. FACTS

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 that would require all children attending any school in Philadelphia to be vaccinated against certain pediatric diseases as a condition of continued school attendance. Affidavit of Robert G. Sharrar, M.D., ¶ 4, attached as Merck's exhibit B ("Sharrar aff."). The School Board of Health adopted the regulation and authorized the Health Department to exclude any student in kindergarten through twelfth grade from any Philadelphia school, public or private, if he or she was not vaccinated against measles, mumps, rubella, polio, diphtheria, and tetanus or had not naturally acquired immunity by having the disease. Sharrar aff. at ¶ 5. School nurses were instructed to review the health records of approximately 300,000 students to determine the vaccines each one needed, if any, and to obtain written permission from parents to have their child vaccinated. Id. at ¶ 15. Parents were required to document previous immunizations or prior illnesses. If adequate proof was not forthcoming, the child was considered unimmunized and was later vaccinated. Id. at ¶ 16.

The Health Department, through Dr. Sharrar, contacted the United States Center for Disease Control ("CDC") of the Department of Health and Human Services for assistance in designing a program for the children. Id. at ¶ 7. Following a recommendation of the CDC, Dr. Sharrar decided that combined vaccines would be used in the inoculation program. He chose M-M-R II ("MMR II") as the vaccine for the simultaneous immunization against measles, mumps, and rubella. Id. at ¶ 8.

MMR II is manufactured by Merck under a license from the Food and Drug Administration ("FDA"). MMR II is a live virus vaccine for immunization against all three childhood diseases. The measles portion of MMR II contains an attenuated line of measles virus, which when injected into the body causes it to generate antibodies to ward off a measles infection. MMR II is packaged in containers which include an insert describing the risks associated with

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the vaccine's use. The April, 1981, package insert contained the following pertinent information about the risk of contracting SSPE from the MMR II vaccine

There have been reports of subacute sclerosing panencephalitis (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 vaccination 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 conducted by the Center for Disease Control suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.

According to the package circular, the vaccine is indicated for immunization "in children 15 months of age or older, and adults." Additionally, it included the following paragraph about 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 FDA approved the package circular before it was included with the vaccine. Affidavit of William B. Freilich, ¶ 4, attached as Merck's exhibit A ("Freilich aff.").

The MMR II vaccines were purchased from Merck by the CDC at Dr. Sharrar's request. At first, Merck would not sell the vaccines to the CDC. Merck relented when the CDC contractually agreed either to assure that a physician would be present at inoculation or to 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.² Freilich aff. at ¶ 15. The CDC drafted an "Important Information Statement" to be sent to all parents of school age children. Id. at ¶ 22 and exhibit 6. The statement was designed to allow parents to weigh the benefits against the known risks of MMR II vaccination in a manner they would ordinarily comprehend. The Important Information Statement was sent home to parents via their children. Merck's exhibit R at 45.

Lisa Mazur, the Mazurs' fourth child, was born on August 11, 1969. Lisa's medical history prior to 1982 was for the most part unremarkable. Lisa's three siblings all had measles and German measles (rubella) prior to Lisa's birth. Mazurs' exhibit 2 at 59. On October 11, 1973, Lisa received a measles vaccine and a German measles vaccine from her private physician. Prior to February, 1982, Lisa had not received a mumps vaccine and had not naturally acquired immunity to the mumps. From late 1979 through January, 1982, Lisa was treated on a number of occasions for colds, a sore throat, allergies, and pharyngitis. On January 8, 1982, Lisa underwent a tonsillectomy. During that time, she was a student at the Morrison School in Philadelphia.

Mrs. Mazur claims that she never received the Important Information Statement or any other warning about the risks of MMR II inoculation. Yet, she admits that she saw two documents apprising her of the immunization program. Mazurs' exhibit

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2 at 106-108. One of the two documents she received was a letter from the School District with an attached student immunization record and parental permission form. Mazurs' exhibit 10. The letter explains the immunization program and what each parent must do either to allow inoculation or to prevent it. Id. Mrs. Mazur states that she read the letter and permission form but refused to sign it or return it unsigned to the school. Mazurs' exhibit 2 at 109. In any event, upon learning of the immunization program, Mrs. Mazur called the school principal and the Board of Education to inform them that Lisa had received a measles vaccine in 1973 and to protest any revaccination.³ Mazurs' exhibit 2 at 109-21. As a precaution, Mrs. Mazur kept Lisa out of school for approximately a week before sending her back just prior to the day of the immunization program at Lisa's school. Id. at 117. Mrs. Mazur claims that she did not provide written or oral permission for Lisa to receive the MMR II vaccination. Nevertheless, Lisa received an MMR II vaccine shot on February 26, 1982

On September 7, 1983, Lisa was admitted to St. Christopher's Hospital for Children in Philadelphia for tests because of "personality changes in the past six months with abnormal movements in the past few weeks." Mazurs' exhibit 14. After reviewing Lisa's electroencephalogram results, one of her doctors stated that SSPE should be "seriously considered" as a cause of her physical and behavioral problems.⁴ Mazurs' exhibit 14. In late September, 1983, Lisa's doctors at St. Christopher's made a "presumptive" diagnosis of SSPE. Mazurs' exhibit 15. On November 2, 1983, another doctor, who examined Lisa at her...