During my forty plus years practicing law, I heard many tragic stories from people seeking my help. Each and every one sought answers. Each case was interesting in its own right and told its own story of loss. Each was a different story.

Then one day in 1971 a family came into my office and related to me the details of their daughter's behavior directly after receiving a DPT vaccine. They told how, following the shot, their daughter had prolonged screaming episodes and seizures that progressed into permanent brain damage and neurological dysfunction. From that day forward their daughter changed from a normal, healthy, and happy baby to an individual who would never be able to function independently in our society.

As I sat there in my office watching that loving family and listening to the nightmare their lives had become, I was humbled that they had come to me for answers and challenged to find those answers. Little did I know that day that finding answers would turn into a twenty-four-year crusade.

Before continuing with my case, let me provide some background. By the 1970's the whole cell pertussis, delivered in the DPT vaccine, provided protection against whooping cough for approximately 70% of the children under age five. However, the vaccination came at devastating costs to an untold number of children. This problem was first noticed in the early 1970's, and in 1976, Dr. Charles Manclark, a scientist in charge of bacteriology, at the Bureau of Biologics, wrote:

We know the pertussis vaccine [although] passing the required toxicity and safety tests can cause adverse reactions in children--systemic reactions are less common, but include fever, collapse, seizures, persistent screaming and rarely, paralysis and death. Adverse reaction rates are not accurately reported, but more adverse reactions are probably experienced with the use of pertussis vaccine than the other biologicals.1

Following upon on Dr. Manclark's research,2 the U. S. Department of Health and Human Services drafted and published a proposed regulation regarding biological products adverse reaction experiences. If adopted, manufacturers would be required to include a package insert in their pertussis vaccine. The insert was a request that doctors and/or users report any adverse reactions or product defects to the manufacturer. The regulations further stated that procedures for reporting such incidents include clear instructions on how to report such incidents.

3. In response to the FDA's proposed regulations, the Pharmaceutical Manufacturers Association ("PMA") mounted active opposition to this modest monitoring proposal. The PMA had a membership of 140 companies and was headquartered in Washington, D.C. The Association's Biological Subcommittee met with the Director of the Bureau of Biologics to protest the proposed regulation. Following the meeting, PMA issued a written statement to the proposal. In their words, "The proposed changes are unnecessary or unworkable requirements." In short order, the FDA withdrew the proposed guidelines without a public hearing.

But there was more to the story. In addition to Dr. Manclark's research and efforts by the Department of Health and Human Services, I learned that a cellular vaccine was being used in Japan with fewer and far less severe reactions. The vaccine had been developed by Dr. Y. Sato, a Japanese scientist. He had filed an application for a patent with the Patent Office in Tokyo in 1979. The Sato patent application demonstrated the feasibility of:

1. removing 99% of the endotoxin;
2. toxoiding or purifying the pertussis toxin; and
3. mixing the toxoided pertussis components with the
Diphtheria and tetanus, making a purified DPT vaccine.4


Most surprising of all, I learned that Dr. Sato came to the United States in the late 1970's, and studied at the National Institute of Health ("NIH") at Bethesda, Maryland. There he obtained information about the vaccine, then returned to Japan, and made a purified DPT vaccine. He conducted clinical trials on his cellular vaccine and in one million immunizations, only one child experienced a convulsion.

The information to which Dr. Sato had accessed at NIH was public information; it was available to the pharmaceutical companies engaged in manufacturing pertussis vaccine. In addition to the information available at NIH, patents and learned treatises dating back over 50 years, demonstrated the feasibility of producing a vaccine equally protective and significantly less reactive than the whole cell vaccine.6 7 8 9 10 11 However, American drug companies had a guaranteed market on the whole cell vaccine, and it was the only vaccine available. Children were required to take it.
I did not know about Dr. Manclark's publications or the work of Dr. Sato when the family first visited me. However, in 1978 while doing research to help my client, I read about a seminar being offered in New York. The topic was on the DPT vaccine. I attended that meeting and met a number of lawyers from other states. We were all concerned with the mounting evidence of a relationship between the whole cell pertussis vaccine and brain damage in some children.
We exchanged information that we had gathered from our own research and through consultation with experts. By the end lf the meeting, we were convinced that there was substantial evidence of shortcomings in testing and manufacturing the vaccine and that the pertussis component was the culprit. It caused unnecessary reactions in many children and death or permanent brain damage in some. We were also convinced that Dr. Sato had demonstrated that it was feasible to make a safer vaccine. To that end, we organized, called ourselves "Advocates for a Safe Vaccine," and prepared to represent children negatively affected by the vaccine.

A few months after returning from the conference, I filed the first pertussis vaccination suit in Arkansas. The year was 1979. We processed this case successfully for this child, placing the funds in a trust for her future care and welfare.

In April 1982, a Washington, D.C. television station broke a story about the pertussis vaccine. The report stated that the drug companies had known about the risks for many years. Many physicians were also suspect of the vaccination. The reporter went on to say that while the DPT vaccine did provide protection to a majority of children, it caused reactions in most, and though rare, some children were severely and/or permanently injured.

The television story likened taking the vaccine to Russian roulette. The cat was out of the bag. I settled my suit in September after the story broke.
Over the years many families came to me seeking help with finding those same answers. The story they told was one that I had heard so many times before. All the cases were tragic examples of the injuries that could occur from the toxic effects of the whole cell pertussis vaccine.

These children had all been in good health, making a normal progress. They were disabled by an old bacterial vaccine with old problems, substantially the same as it was 50 years ago, and not belonging in the last quarter of this century.12 The McMath Law Firm represented a number of these children. After legal proceedings spanning a number of years, we were able to recover awards for these children. The funds recovered were placed in trust and are still being expended under the supervision of the courts for the welfare of the children.
They story of whole cell vaccine and the countless children injured in its wake is a shocking reminder of what can happen when health policies are unduly influenced by pharmaceutical companies. It further emphasizes the need for the heads of regulatory agencies and their employees to pay particular attention to the public's health during their tenure in office. Moreover, the pertussis cases demonstrate that the general welfare suffers when treating physicians and parents are not adequately informed of the contraindications of a prescribed medication or medical procedure.

We had no way of knowing how many children had neurological damage from the pertussis vaccine in this country. No one had a monitoring policy in place. Doctors were not directed or requested to:

1. Keep a record of severe adverse reactions in a child;
2. Record the lot number and the name of the manufacturer of the vaccine used; and

3. Make a report of severe reactions to the manufacturer or Center for Disease Control.

Until 1982, many pediatricians and general practitioners did not recognize the relationship between neurological reactions and the pertussis vaccine. Even when recognized, many doctors felt that they did not have time to become involved in the paperwork for reporting such incidents. Some doctors were reluctant to tell parents that the vaccine which they gave, or had been given by a colleague, may have caused brain damage to their child. Dr. Manclark, in the report mentioned earlier, noted:

Severe brain damage is so rare that most doctors will not have seen such a complication and may not associate it with the vaccine. Also, one is unlikely to associate a complication with a procedure which he has recommended and may have persuaded a mother to accept for her baby.13

The extent and severity of the reactions were not generally known because the manufacturers had a very passive monitoring program. PMA members responded to complaints and supplied copies of the report of the Bureau of Biologics, but they made no effort to survey the medical field, nor did they invite doctors to report adverse reactions observed when their product was used. Following the explosion of information by the television broadcast in April 1982, pharmaceutical companies battened down the hatches, went on the defensive, and prepared for the coming storm of litigation.

Over the years, after I filed that first case, I reviewed a mountain of documents produced by the drug companies. From my layman perspective, it appeared to me that the whole cell pertussis vaccine being used in the United States had biologically active toxins, endotoxins and dead cells of the pertussis bacteria. However, I knew that it was possible to make a cellular vaccine that had the pertussis bacteria removed--our own research labs had demonstrated that it could be done, and the Japanese had done it. This cellular vaccine had most of the endotoxins removed or deactivated and underwent additional steps to further purify the vaccine and reduce its toxicity.

After the news story, parents with children injured by the vaccine began to organize. Calling themselves "Distressed Parents Together" ("DPT"), they formed the National Vaccine Information Center and contacted thousands of concerned parents across the country. The pharmaceutical companies also began tentative steps towards making a safer cellular vaccine. Senator Paula Hawkins from Florida got involved and took a lead in pushing for a National Vaccine Compensation Act. A few other attorneys and I, involved in the push for a safer vaccine for our children, were asked to appear in Washington, D.C. before a Congressional Committee and to testify regarding the information that we had obtained over the years about the need for a Vaccine Compensation Act.

In 1986 Congress passed the bill. However, the program was not funded until October 1, 1988. The legislation not only provided for compensation to children injured by the DPT vaccine, but also the Measles, Mumps, Rubella, and Polio vaccines. In addition, the Fund provided for further research into vaccines and a system for reporting and monitoring vaccine-related injuries.

Ironically, the monitoring system required by the Vaccine Compensation Act is substantially the same as proposed by Dr. Manclark and first published April 24, 1979. That was the proposal opposed and defeated by the combined action of the pharmaceutical companies.

Less than a year after Congress passed the Vaccine Compensation Act, August 28, 1989, Connaught Laboratories, a member of the PMA, filed an application to produce and market a cellular (safer) vaccine. The company received a license to manufacture the vaccine in October 1992.

Over the years, my partner and son, Bruce McMath, my associate, Sandra Sanders, and I worked on many DPT cases. I witnessed their enthusiasm and commitment to help the children. In 1995, I settled the last DPT case that I had started years before. I then became "of counsel," turned the reins over to the next generation, and now serve in an advisory capacity.

In February 1997, the Arkansas Health Department received the first DPT vaccine with the cellular pertussis component, and since that time has continued with the use of only cellular vaccine. The Arkansas Vaccine Information Handout Sheet that is given to all parents of children receiving the DPT vaccine states:
DPT is a safer version of an older vaccine called whole cell DPT. The whole cell vaccine is no longer used in the United States.15 (Emphasis added.)

When I think of all the changes that have occurred in our vaccine program since that first meeting of our committee of concerned lawyers calling ourselves Advocates for a Safe Vaccine, I know, no mater what the cost, the time, or effort it took, it has all been worth it. Our children are our gift to the future, and their welfare is everyone's responsibility.





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1 Advances in Applied Microbiology, Vol. 20
2 The Current Status of Pertussis Vaccine: An Overview, by Dr. Charles R. Manclark,
Advances in Applied Microbiology, Vol. 20, 1976

3 Draft of FDA's proposed regulations regarding Adverse Reactions and Product Experiences,
published on April 24, 1979, requiring that manufacturers request, in their package insert, that
doctors keep lot numbers and to report adverse reactions and maintain records of reactions and
report them to the Bureau of Biologics

4 Japanese Patent Publication No. 57-5203

5 New Pertussis Vaccines Laboratory and Clinical Evaluation, Vol. 1, from DDHS, February 11, 1982

6 Patent Specification 512, 196, October 15, 1939, Lederle Laboratories, Inc.: Method of Preparing
Pertussis Toxin and Toxoid

7 Certified Copy of U. S. Patent No. 2,240,969, Patented May 6, 1961, Pertussis Toxin and Toxoid,
Edwin Voigt and Sara Phillips, assignors to Lederle Laboratories, Inc.

8 Studies on the Fractionation of Hemophilus Pertussis Extracts, Pennell and Thiele, September 29, 1950

9 U. S. Patent No. 2,701,226, Patented February 1, 1955, Prophylactic Agent Effective Against Hemophilus
Pertussis Infections (Whooping Cough) and Method of Producing Same. Louis Piliemer, assignor to
Western Reserve University, Cleveland, Ohio

10 U. S. Patent No. 2,837,460, June 3, 1958, Pertussis Vaccine Preparation, assignee: Eli Lilly and Company

11 U. S. Patent No. 3,141,824, July 21, 1964, Pertussis Antigen, by Robert V. Dahlstrom, assignor, to Eli Lilly
and Company

12 An Old Bacterial Vaccine with New Problems: Pertussis Vaccine--Recent Experience, by Drs. Cherry
and Mortimer, Pediatric Immunization Today: A Symposium, held in Toronto, Canada in 1979, in
conjunction with the American Academy of Pediatrics and Spring Meeting and sponsored by Connaught
Laboratories

13 Convulsive Disorders in Young Children, by Professor George Dick, Proceedings of Royal Society of
Medicine, Vol. 20, 1976

14 Joseph Stetler, President of PMA to Food and Drug Administration, June 18, 1979

15 Arkansas Information Handout Sheet, Arkansas Department of Health, July 30, 2001