CANAVAN FOUNDATION JOINS LAWSUIT
AGAINST MIAMI CHILDREN’S HOSPITAL

October 30, 2000

BACKGROUND INFORMATION ON Greenberg v. Miami Children’s Hospital et al.

In Federal District Court in Chicago on October 30, 2000, the law offices of Chicago-Kent College of Law filed a lawsuit against Miami Children’s Hospital (MCH) and Dr. Reuben Matalon on behalf of parents of children afflicted with Canavan disease and Canavan Foundation, Dor Yeshorim, and National Tay-Sachs and Allied Diseases Association, Inc. (NTSAD). The case involves an alliance between parents and not-for-profit organizations who sought the help of researchers to develop prenatal and carrier testing for Canavan disease to be made accessible and affordable to the public. The suit alleges that unbeknownst to the Canavan families and organizations, Matalon and his employer, MCH, secretly obtained a patent for the Canavan disease gene they discovered using the genetic information and financial resources provided by the Canavan families and organizations and began to charge royalties and limit the availability of testing. The six-count lawsuit, the first of its kind, alleges breach of informed consent, breach of fiduciary duty, unjust enrichment, fraudulent concealment, conversion, and misappropriation of trade secrets.

One of the parents named as a plaintiff in the lawsuit, Dan Greenberg and his wife, live outside of Chicago. Little did the Greenbergs know when their son Jonathan was born in 1981 that they would not only wage a losing battle to save their son's life, but that they would also be subjected to the secretive misappropriation of their son's physical essence: his genetic material. By the age of three months, the Greenbergs began to worry when Jonathan was unable to control his head, make eye contact, or put his hand to his mouth. The Greenbergs sought the advice of one specialist after another until six months later Jonathan was diagnosed with Canavan disease.

Similar to Tay-Sachs disease, Canavan disease occurs most frequently in families of Ashkenazi Jewish decent and leads to a degeneration of the brain. The Greenbergs learned that this rare genetic disease had no known cure and that their son would never function past the developmental level of an infant for all of his short life and slowly succumb to the disease’s degenerative effects. Children affected with Canavan can smile, look around and hear, but as the illness progresses, they often lose most of their vision and are prone to seizures and infection. They develop difficulty chewing and swallowing and most eventually require tube feeding. Though the children become less responsive over time, they are never totally unresponsive or in a coma. Life expectancy varies, but most do not reach their teen years.

Not only was there no treatment to cure the disease or to arrest its development, but no carrier or prenatal testing existed that could help the Greenbergs or other families make plans for whether they could have healthy children in the future. Wanting to fulfill their dream of a large family, but effectively denied the option to adopt due to Jonathan’s condition, the Greenbergs risked another pregnancy, which resulted in the birth of a daughter, Amy. Unfortunately, Amy too was affected with Canavan disease.

Because there was no carrier or prenatal testing for Canavan disease at that time, the Greenbergs became involved in carrier and prenatal testing programs for Tay-Sachs disease and founded the Chicago chapter of the National Tay-Sachs and Allied Diseases Association (NTSAD). While working for NTSAD, the Greenbergs met Dr. Reuben Matalon. At a Tay-Sachs screening in 1987, the Greenbergs convinced Dr. Matalon to focus his research efforts on Canavan disease. Their goal was to convince a researcher to isolate the gene responsible for Canavan disease so that affordable and accessible carrier and prenatal testing would be available to the public in the same way Tay-Sachs screening is available, and ultimately to some day find a cure for the disease. Since the community-based Tay-Sachs screening programs began, incidence of the disease has decreased by 90%.

The Greenbergs began their quest by providing Dr. Matalon with numerous blood and urine samples from their children. At considerable personal expense and time, the Greenbergs located other affected families and arranged for them to provide urine, skin and even post-mortem tissue samples to Dr. Matalon. Under the auspices of the NTSAD of Chicago, they also established the first-ever Canavan Registry that provided multiple listings of families with a history of the disease, including which siblings were affected, what autopsy tissues had been preserved and where tissue samples were stored. Since Canavan disease is so rare, prior to the Greenbergs’ involvement, few of its victims and carriers had ever been identified making the registry crucial to Matalon’s research. Dor Yeshorim, a not-for-profit that provides carrier screening and counseling services to the Jewish community consistently sent Matalon blood, tissue and urine samples and the Canavan Foundation encouraged parents of Canavan children to give blood, tissue, urine, and autopsy samples, as well as financial support to Matalon.

Due to the collaborative efforts of the Greenbergs, other Canavan families, and not-for-profit groups, Dr. Matalon’s team, now located at Miami Children’s Hospital, was able to identify the Canavan gene in 1993, which allowed doctors around the country to offer accurate prenatal and carrier screening for Canavan disease. In 1996, the Canavan Foundation offered free Canavan testing at Mt. Sinai in New York. Unbeknownst to the Greenbergs or any of the Canavan families and organizations, the defendants filed a patent for the gene and related applications, including carrier and prenatal testing. The gene which had been found through the support of the Greenbergs and the other Canavan families, the gene which came from the tissue of their dead children, the gene which the Greenbergs and other plaintiffs had worked to find in order to save other families from their heartache, had now been patented by Dr. Reuben Matalon and Miami Children’s Hospital.

The defendants now forbid the free testing without payment to MCH for a license. Based on the patent, Defendants prevent doctors from testing or examining patients for the Canavan disease gene, even though the doctors could do so using traditional medical practices and such testing or examination would not require the use of any product or device invented by Defendants.

Rabbi Ekstein of plaintiff Dor Yeshorim stated that royalties for the Canavan test would either cause a price increase in the battery of tests they offer in their testing program or force its removal from their premarital screening program. Either way he has publicly stated that in his opinion, there is no question Canavan children will be born if MCH continues its current patent enforcement strategy.

During the more than thirteen years of collaboration with Dr. Matalon, none of the Canavan families and organizations, especially the Greenbergs, ever thought it would come to this. All had invested their time, their material resources and their buried children's tissue to help as many as possible. None of the Canavan families ever thought their efforts would result in MCH’s gene patent preventing others from gaining access to the testing they had worked so hard to make possible.

In the lawsuit, the Canavan families and organizations primarily seek injunctive relief to prevent Miami Children’s Hospital from restricting access to prenatal and carrier testing for Canavan disease and from impeding research on finding a cure or therapies for Canavan disease through enforcement of its patent.