Testimony of Stephanie T. Kanarek

New York, New York

before the

Committee on the Judiciary

U. S. House of Representatives

105th Congress

on Product Liability Reform

April 10, 1997

Chairman Hyde and members of the committee, thank you for inviting me to share with you my experiences and views on products liability. What I offer is my personal statement; I invite you to consider how the legal modifications under consideration would affect families such as mine.

My name is Stephanie Kanarek and I reside in New York. My daughter Amy, who is 12 years old is severely disabled, unable to care for herself at all. Amy is this way because of an FDA approved drug. My mother, wanting to have a baby, followed the advice given to her by her ob-gyn, and ingested an FDA approved drug known as DES.

DES, or diethylstilbestrol, is a synthetic estrogen that was approved by the FDA in 1947 for use in pregnancy. This approval was given in spite of the fact that DES had never been tested for use during pregnancy. Furthermore, evidence documented 10 years earlier showed that synthetic estrogens given to pregnant animals resulted in cancer as well as the malformation of the reproductive organs in their offspring. In 1952 a study from the University of Chicago showed that DES was not effective in preventing miscarriage. Let me emphasize - I have a handicapped daughter because the pharmaceutical companies ignored evidence that told them not to market this chemical for use in pregnancy. By 1971, when DES was linked to a rare form of vaginal cancer, the FDA directed doctors not to prescribe DES to pregnant women.

DES caused deformities in the offspring of the women who took it. These deformities are easy to miss - a misshapen uterus too small to carry a pregnancy for 9 months, the inability to conceive or carry a child, an increased risk of ectopic pregnancies, testicular cancer, malformed sperm, to name a few. All hidden deformities. If DES produced deformed arms or legs, certainly Eli Lilly, its primary manufacturer, would not have dared request FDA approval for use in pregnancy.

Meet my daughter Amy. She is now 12 years old. I thought as time passed that the pain would be less. I was wrong. You want to limit the ability to recover for non-economic losses. Are Amy's damages only economic? She has cerebral palsy, she is legally blind, and her speech is severely delayed. She is wheelchair bound, wears braces on her legs, and has undergone 2 orthopedic surgeries. On a day to day basis, this all means that Amy requires total care. My husband and I are no longer able to care for her without help.

Let me share with you some of the impact this FDA approved drug has had on my life - - not the concrete realities of taking care of Amy, but what you don't see; more hidden damage caused by DES. After 12 years, my husband and I still cry for what never will be. Our other children don't understand why their sister cannot function in the world of regular children. Our 9 year old says, "Grandma took medicine she wasn't supposed to take." My husband and I cannot take the risk of another pregnancy; all the high risk pregnancy specialists we consulted advised us that I would most likely again deliver prematurely. Rationally, my mother knows that she was following doctors orders when she took DES for 8 months; emotionally, can you imagine what she must hold inside herself?

Handicapped children require a great deal of care and hands on involvement; you put an awful lot in and you don't get a whole lot back. Who will help bear the cost of Amy's care? Ultimately, it is the taxpayer who will pay for Amy's care. Who should be held responsible for Amy's loss of functioning and who will compensate my family for what we have endured? We strongly believe it should be the pharmaceutical companies who acted irresponsibly when they sold DES for pregnant women.

Why would you protect the wrongdoer at my expense? Nothing will ever compensate me for what I've lost. However, those who have caused my pain must be held accountable for their actions. They realized the profits from the sale of DES; they must also bear the responsibility. If a drug or medical device is found to be harmful, the victim must be allowed to recover, and the wrong-doer must be punished. The manufacturer must be sent a loud, strong message that, as a society, we will not tolerate such a callous disregard for the health of our mothers, wives, and daughters. Punitive damages were designed to do exactly that; to deter corporate decision-makers from putting harmful products into the marketplace. Punitive damages serve as a deterrent because they are unpredictable. A cap on punitive damages eliminates this unpredictability, allowing the drug industry to include this risk as just another cost of doing business. A cap on punitive damages would be a mistake. The drug industry produced a product that was marketed to 5 million pregnant women and they sold it for one reason and one reason only; and that was to make money. Look at my daughter now and tell them that they cannot walk away from what they did, not from me and not from Amy.

Despite FDA rules and regulations, the pharmaceutical industry continues to market products to women that are not safe. Just ask any DES daughter or son -- let's not forget the sons - any user of the Dalkon shield or any recipient of a silicone breast implant. Now they would have us believe that menopause is a disease, and that it should be treated with replacement estrogen. If you want to watch history repeat itself, compare DES and Hormone Replacement Therapies. Watch as millions of baby boomers approach and enter menopause, and their doctors tell them to take estrogen. The pharmaceutical industry is creating a disease so it can profit from the cure. Just as it tried to improve on normal pregnancies by selling DES to ensure bigger, healthier babies, they will tell millions of women that their menopause can be cured by taking estrogen. I do not believe that any regulatory agency, in spite of all the resources that might be made available, will prevent all damaging products from reaching the market. Ultimately, a manufacturer must be held accountable for what it does and the harm it may inflict.

My statement to you today will not impact my family's situation. The pharmaceutical companies who manufactured, sold and profited from the sale of DES have been victorious in their efforts to keep Amy out of court. New York State's highest court has refused to hear third generation DES cases. The opinion stated, "for all we know, the rippling effects of DES exposure may extend for generations. It is our duty to confine liability within manageable limits". In our attempt to sue the manufacturers of DES my husband and I have exposed every detail of our lives. It is cases such as these, where the pharmaceutical industry must stand and face the damaged victim, that are the final and only remedy for many of us. We are not asking for anything other than the opportunity to have our day in court.

Respectfully submitted,

Stephanie Kanarek

Summary: Stephanie T. Kanarek

DES Daughter

What I offer is my personal statement; I invite you to consider how the legal modifications under consideration would affect families such as mine.

- I am 42 years old. My daughter, Amy Smith is severely handicapped due to DES.

- DES, a synthetic estrogen, was approved by the FDA for use in pregnancy.

- My mother's doctor prescribed DES for use during her pregnancy with me.

- As a result of that exposure, I have "hidden" deformities; my reproductive system is deformed.

- Amy was born prematurely as a result of my reproductive deformities.

- That prematurity caused Amy's significant handicaps.

I am here today to tell you the story of an FDA approved drug.

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