SEATTLE – Newly unearthed documents provide additional evidence for a series of lawsuits alleging that a number of major pharmaceutical companies widely distributed the dangerous birth-defect causing drug Thalidomide in the United States.

The new lawsuit, filed Aug. 9, 2012, in the Philadelphia County Court of Common Pleas, on behalf of 11 new alleged Thalidomide victims, is the latest in a series of suits filed against pharmaceutical giants GlaxoSmithKline (NYSE: GSK), Sanofi-Aventis (NYSE: SNY) and Grunenthal GMBH.

The suits claim that the companies or their predecessors participated in so-called "clinical trials" of Thalidomide in the United States during the late 1950s and early 1960s. Invented by one of the defendants in the cases, Grunenthal, Thalidomide caused thousands of infant deaths and extreme, disfiguring birth defects throughout Europe when used by women during pregnancy.

The latest lawsuit includes a number of new sources to substantiate the allegations. Investigators have unearthed and translated the indictment of Grunenthal executives in a German court, as well as new FDA documents that speak to the scale of the drug's distribution in the United States.

According to the suits, the companies downplayed and covered up their involvement in distributing the drug, creating a false historical narrative that there were very few, if any, Thalidomide victims in the United States.

"Through the discovery of newly unearthed documents, we now understand that as early as 1956, years before the public learned about the dangers of Thalidomide, Smith, Kline and French, now GlaxoSmithKline, conducted human tests with Thalidomide," said Steve Berman, the attorney representing the plaintiffs. "The documents show that at least one and possibly two babies were born with serious birth defects to participants, but SKF failed to take action to protect the public."

SKF concealed that it had conducted the tests from the public for more than fifty years, according to the complaint.

The suit also claims that Merrell Richardson, now Sanofi-Aventis, widely distributed Thalidomide as part of a marketing initiative thinly disguised as a "clinical trial," resulting in the exposure of thousands of people to the drug within the United States, including pregnant women. However, the lawsuit alleges the company did not conduct testing on pregnant animals to verify the drug was safe for pregnant women.

"Thalidomide was never approved by the Food and Drug Administration in the United States," Berman said. "Yet, we have unearthed evidence that suggests Merrell distributed more than 2.5 million doses to doctors who gave Thalidomide to more than 20,000 people. The FDA later estimated that 3,760 women of child-bearing age took the drug, of which at least 207 were pregnant."

New medical evidence also plays a role in the lawsuits. According to the complaints, researchers had previously concluded that Thalidomide causes bilateral birth defects, such as two missing or shortened arms or hearing loss in both ears. Babies born with unilateral defects, such as one deformed limb, or hearing loss in only one ear were assumed to not be Thalidomide victims, the complaint alleges.

However, new research involving Thalidomide as part of a treatment regimen in cancer patients show that many of those assumptions are not correct and the drug can cause unilateral injuries, attorneys allege. Many Thalidomide victims may have never been properly identified or diagnosed, according to the suits.

The firm is continuing to research the case. Those with additional information or who believe they might have suffered as a result of in utero Thalidomide exposure are encouraged to call Hagens Berman at (206) 623-7292 or email the firm at [email protected].

More information about these lawsuits is available at www.hbsslaw.com/cases/thalidomide.

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About Hagens Berman
Hagens Berman Sobol Shapiro LLP is a consumer-rights class-action law firm with offices in nine cities. The firm has been named to the National Law Journal’s Plaintiffs’ Hot List seven times. More about the law firm and its successes can be found at www.hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

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