Was thalidomide the cause of unexplained deformities in U.S. babies?

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PHILADELPHIA — Debra Johnson saw it coming.

"Dear God. Not here, where everybody could hear," she thought.

She was at a packed college basketball game, sitting alongside her great-niece, who had just learned to count.

"And she was holding my hand, which we do all the time," Johnson, 54, recalled in a honeyed, Louisiana drawl. "I could see her counting her fingers, and then she would reach over and . count mine."

And then it came.

"I have five fingers. You have four?"

"Yes, I do."

"Why?"

After decades living with misshapen parts — thumbs fashioned from index fingers, an abnormally small forearm — Debra Johnson thinks she has the answer: thalidomide.

The scourge of birth defects from thalidomide in the 1950s and '60s remains one of the worst pharmaceutical disasters ever.

Yet it was one that largely spared the United States, thanks in no small part to the vigilance of Food and Drug Administration officer Frances Kelsey, who balked at approving the drug for sale here.

About 10,000 babies suffered horrible malformations because their mothers used the sedative while pregnant to treat morning sickness, anxiety, or insomnia. But only about 40 were born in this country.

So goes the generally accepted narrative.

Now, in 10 federal lawsuits pending in Philadelphia, Johnson and 48 other plaintiffs have turned that narrative on its head.

They've accused a group of drug firms of concealing for more than a half-century an unknown number of thalidomide babies born Stateside.

Those babies, the lawsuits claim, were born to pregnant women given thalidomide from companies that had cause to suspect the drug could harm a fetus and had not adequately tested it.

That hidden generation of American thalidomide victims — long told their injuries were simply congenital or an act of God — could number in the hundreds, even thousands, say lawyers at Hagens Berman, a Seattle firm representing the plaintiffs.

"There's this myth that has been propagated that the United States dodged the bullet," said Nick Styant-Browne, a lawyer with the firm. These cases could "dramatically change the conventional wisdom."

The drug companies are vigorously disputing the claims, and though the plaintiffs were buoyed by a recent ruling, their cases remain unproved.

It's true that Kelsey refused to green-light thalidomide for sale in the United States. Her stand did much to create the modern FDA.

But that doesn't mean thalidomide never made it to this country. Millions of thalidomide pills were collectively sent to U.S. doctors through programs conducted by Smith, Kline and French — a GlaxoSmithKline predecessor — and, likely to a far greater extent, Richardson-Merrell, a company absorbed by Sanofi-Aventis.

The programs were ostensibly legal; clinical trials required little FDA supervision at the time, though the thalidomide crisis changed all that.

More than 19,000 Americans received thalidomide before its widespread use was stopped in the early 1960s, with Richardson-Merrell distributing many of the 2.5 million tablets, according to a congressional report.

But who, exactly, took thalidomide here, and how many were pregnant women? Styant-Browne says we're closer than ever to finding out.

That's because U.S. District Judge Paul Diamond on Sept. 25 told the parties to proceed to the discovery phase of litigation.

Diamond's order requires drug firms for the first time to give plaintiffs a list of all the doctors who distributed thalidomide to Americans, Styant-Browne said.

That trove, he said, will be added to documents collected through the Freedom of Information Act and a two-year search of archives in Washington and overseas that suggest a vast cover-up by the drug firms, including Grunenthal, the German firm that introduced thalidomide in the 1950s.

Styant-Browne said his team began investigating after another attorney, Peter Gordon, who last year secured a major award in a class-action thalidomide case in Australia, told him there was more to be learned in America.

Kevin Colgan, a spokesman for GlaxoSmithKline, said its predecessor "studied thalidomide and conducted a small, short clinical trial on the drug in 1956 and 1957 that involved approximately 875 patients and a total of 67 investigators."The company "had no knowledge of any relationship between thalidomide and birth defects" when it studied the drug, he said.

Sanofi-Aventis does not comment on pending litigation, spokesperson Brandi Robinson said.

In July and September, the firms asked the judge to dismiss the earliest filed cases due to the statute of limitations, which in Pennsylvania bars personal-injury claims filed more than two years from the day a person should have discovered the injury and its cause.

It's called the "discovery rule," and it raises a key question Diamond will likely have to rule on: When should the plaintiffs have known that thalidomide caused their birth defects?

The companies do not concede that thalidomide caused the plaintiffs' injuries. But even if it did, the plaintiffs waited far too long to take their claims to court, the companies argued in their bids to dismiss some of the cases.

Last month, Diamond denied the dismissal requests but said the statute-of-limitations defense would be better raised after more information emerges in discovery.

Meanwhile, the plaintiffs will get a chance to convince Diamond that they weren't in a position to discover the thalidomide link until recently. They claim the companies misled Congress and the public, keeping them in the dark for decades about the true cause of their injuries. Their lawyers say an FDA memorandum suggests that Smith Kline's president lied to Congress in 1962, when he told Sen. Hubert Humphrey no malformed babies had been born to any mothers in the company's study. Yet a month earlier, he had told the FDA at least one such baby was born in 1958, it's alleged.

And the lawyers say a Richardson-Merrell director denied in a July 1962 public statement that the company had recommended using thalidomide for nausea during pregnancy, when internal documents show the firm's clinical trial was actually a vast marketing campaign aimed at generating positive word-of-mouth about thalidomide in hospital OB-GYN departments.