German drugmaker Grunenthal GmbH and companies now part of GlaxoSmithKline Plc (GSK) and Sanofi hid results of studies that would have revealed birth defects caused by Thalidomide sooner, 13 Americans claimed in a lawsuit.
The seven men and six women, born with birth defects from 1957 to 1962, sued the drugmakers and distributors Oct. 25 in state court in Philadelphia, claiming the businesses conspired to withhold information to boost sales and protect themselves from liability. The drug was then prescribed for morning sickness early in pregnancies.
While the defects, including missing and malformed limbs, were known in Europe, they couldn’t have happened in the U.S., the companies allegedly told Congress, because the drug was available only on a limited clinical-trial basis.
“It was a carefully constructed lie sold to the public to protect defendants from having to accept responsibility for what they had done,” according to a 160-page complaint.
Claiming that concealment prevented them from knowing until recently the true cause of their deformities, the plaintiffs are seeking compensatory and punitive damages from the companies.
Research on the drug’s usefulness against cancer disproved some original assumptions about the symmetrical nature of the birth defects, according to a statement by the Seattle-based law firm Hagens Berman Sobol Shapiro LLP, which filed the suit.
“Babies born with unilateral defects, such as one deformed limb or hearing loss in only one ear, were not deemed Thalidomide victims even when their mothers were given the drug while pregnant,” according to the law firm.
There may be hundreds of such incorrectly diagnosed people in the U.S., firm partner Steve W. Berman said.
Sanofi-Aventis US, part of Paris-based Sanofi, and Grunenthal, based in Aachen, Germany, are accused of fraudulently claiming the relationship between Thalidomide and birth defects wasn’t known until November 1961 while the risks were knowable as early as 1955. Now part of Sanofi, Richardson- Merrell Inc., was a North American distributor of Thalidomide, according to the complaint.
Jack Cox, a U.S. spokesman for Sanofi, declined to comment immediately on the lawsuit. Frank Schoenrock, a Grunenthal spokesman, also declined to comment on the claims immediately.
“The thalidomide tragedy is now and always will be a part of Grunenthal’s company history,” according to its website. “Grunenthal and its family shareholders greatly regret the consequences of the thalidomide tragedy.”
Money for Damages
The company said in 2008 that it would pay 50 million euros ($70.9 million) to people injured by the drug.
Smith, Kline & French, now part of Brentford, U.K.-based GlaxoSmithKline, allegedly knew of the defects as early as 1958.
“The allegations in the complaint involve events dating back over 50 years and relate to actions by a predecessor company,” Mary Anne Rhyne, a Research Triangle Park, North Carolina-based spokeswoman for GlaxoSmithKline, said today in an e-mailed statement. The suit’s allegations are without merit, she said.
“SmithKineFrench never manufactured or sold Thalidomide in the U.S. or elsewhere in the world,” she said. After conducting animal studies and a limited clinical trial, SKF determined the drug was ineffective as a sedative and never sought regulatory approval, Rhyne said.
The case is Yeatts v. SmithKline Beecham Corp., 003316, Pennsylvania Court of Common Pleas, Philadelphia County (Philadelphia).
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