Granddaughter of DES Victim Cannot Sue : Justice: Liability must remain within limits or pharmaceutical companies could be discouraged from developing new drugs, New York court says.

The effects of the synthetic hormone known as DES may well last for generations, but it is important not to discourage drug companies from making new drugs, New York’s highest court said.

Although the recent ruling by the Court of Appeals comforted six of the nation’s biggest drug companies, it was a blow to 9-year-old Karen Enright and people like her.

Karen’s family had tried to show that a direct link existed between the DES her grandmother took in 1959 and the severe cerebral palsy that keeps Karen in a wheelchair. The common bond is Karen’s mother, Patricia, who contends her capacity to reproduce properly was damaged by the DES she was exposed to while in her mother’s womb.

“Karen was born damaged because her mother was exposed to DES. Her mother was exposed to DES because the drug makers put a drug on the market that was not safe nor efficacious,” said Leonard Finz, a lawyer for the Enrights. “Karen, her mother and her grandmother are intertwined. They are interwoven. They are inseparable.”

The Enrights sued for $150 million. The court ruled that only those directly exposed to the drug, not their descendants, have a right to sue. Therefore, the Enrights themselves can sue--Mrs. Enright for her claim that DES harmed her reproductive system, and her husband because of the effect of that on him. But their daughter, conceived after the alleged injury, cannot.

“For all we know, the rippling effects of DES exposure may extend for generations,” Chief Judge Sol Wachtler wrote in the court’s decision. “It is our duty to confine liability within manageable limits.”

DES, or diethylstilbestrol, was a synthetic estrogen approved by the Food and Drug Administration and prescribed by doctors for three decades starting in the early 1940s to reduce the chances of miscarriage. Its use stopped when doctors found a possible link with rare forms of cancer in the female offspring of women who used it, and when studies showed that the drug did not in fact prevent miscarriage.

Some experts also believe that DES is responsible for the malformed uteruses in some women whose mothers took the drug. That can keep women from carrying babies to full term.

Five of six Court of Appeals judges were sympathetic to the “tragic” health and reproductive problems encountered by some DES daughters, as they are called. And they acknowledged that the drug could cause severe health problems in the descendants of women exposed to it--a contention the drug companies say is not borne out by scientific evidence.

However, the court said pharmaceutical companies could become more hesitant to test and market new medicines if claims like Karen’s are upheld. John McGoldrick, a lawyer representing Eli Lilly Co. and others, told the court that some drug makers have already pulled back because they fear litigation.

Wachtler wrote that the dangers of deterring the development of beneficial drugs “are magnified in this context, where we are asked to recognize a legal duty toward generations not yet conceived.”

The ruling left DES advocacy groups disappointed.

“We are dismayed,” said Nora Cody, executive director of the Oakland, Calif.-based DES Action, U.S.A. “We believe that Karen Enright has a right to recover damages because her injuries do stem from DES.”

Cody said she was surprised by the ruling because New York has been probably the most sympathetic state to DES victims.

In 1986, the Legislature passed a law creating a one-year window for women or their survivors to claim their health problems were caused by their mothers’ exposure to DES. Otherwise, they would have been blocked from suing by the expiration of the statute of limitations.

The U.S. Supreme Court denied a challenge by the drug companies to the law in 1990.

Finz said he may appeal Karen’s case to the U.S. Supreme Court. He said he may also seek legislative action to create a special right for people of Karen’s generation to sue for DES damages. That would, in essence, do legislatively what the court refused to do judicially.

“These young children, such as Karen Enright, were seeking only the opportunity to have their day in court and nothing more,” Finz said. “To deny them that basic right serves as a reward to the wrongdoers.”

To the drug companies, meanwhile, the court declined to make an “unreasonable” extension of liability to encompass Karen’s generation and very possibly of those that come after her, according to a statement from Eli Lilly.

More than 600 lawsuits filed by DES daughters or their families are pending in New York courts, according to lawyers in the Enright case. Several hundred others have been filed in other states, Cody said.

Some are being settled out of court. Drug companies invariably insist that details of such settlements be kept secret, making it difficult to ascertain just how much they cost the pharmaceutical industry, according to Margaret Braun of the Rochester, N.Y.-based DES Cancer Network.

Cody said no studies have shown conclusively that drug companies have actually been deterred from developing drugs, either because of DES litigation or lawsuits over other pharmaceuticals.

Finz said he knows of only one lawsuit outside New York similar to Karen’s. A family in Olney, Md., is suing Lilly, claiming the death of a 13-year-old girl from vaginal cancer was due to DES her grandmother took.

That lawsuit is trying to establish that DES created a genetic defect resulting in the girl’s cancer. The Enrights allege no such genetic harm.

In addition to Lilly, the other defendants in the New York case were the Upjohn Co., Merck & Co., E.R. Squibb & Sons, Abbott Laboratories and RXDC.

BACKGROUND

DES, or diethylstilbestrol, is a synthetic estrogen that was prescribed for about 30 years to millions of pregnant women to prevent miscarriages. The Food and Drug Administration ruled in 1971 that it should not be prescribed for that purpose after the drug was linked to rare forms of vaginal and cervical cancer in daughters of women who had taken it while pregnant. An earlier study had discredited DES’s effectiveness in preventing miscarriage. Legislatures and state supreme courts have relaxed traditional limits on litigation--such as time limits for filing suit and identifying the specific company who produced the drug in the specific case--to permit “DES daughters” to sue. Some courts have ruled that all drug makers who produced DES are liable for damages based upon their market share of the drug.