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Thalidomide Birth Defects Class Action Lawsuit Filed

Seattle, WA: New research suggests that thalidomide -- a drug that caused thousands of horrific cases of deformities in children -- caused far more deformities in the U.S. than were reported during the height of the pharmaceutical crisis of the early 1960s.

Invented by German drug company Grunenthal, thalidomide was widely used throughout Europe during the late 1950s and early 1960s, resulting in thousands of deaths and extreme, disfiguring birth defects when used by women during pregnancy. The drug was never approved in the United States, but the new lawsuit filed late October 2011 alleges that as many as 2.5 million doses of the drug were distributed by more than 1,200 doctors to more than 20,000 people, including pregnant women.

Newly discovered and translated documents reveal that Smith, Kline and French (SKF), now owned by GlaxoSmithKline conducted a trial of the drug in 1956 and 1957, but buried the evidence, resulting in a missed opportunity to save thousands of lives.

Instead, according to the filed lawsuit, brought on behalf of 13 men and women with severe birth defects, SKF concealed the results of its trial from the public, allowing another company, Richardson-Merrell, now owned by Sanofi-Aventis to move ahead with large-scale "clinical trials" that involved more than 20,000 people, including pregnant women.

The lawsuit also claims that conclusions made in the early 1960s about the types of birth defects caused by the drug were incorrect.

According to legal counsel, researchers concluded that thalidomide causes bilateral birth defects, such as two missing or shortened arms or hearing loss in both ears. As a result, 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.

However, new research involving thalidomide as part of a treatment regimen in cancer patients show that many of the assumptions used in the 1960s are incorrect. The lawsuit alleges that this new understanding of thalidomide means that many individuals who experienced unilateral defects may have been misdiagnosed when their doctors told them thalidomide could not have been the cause.

"Among other things we intend to show in court that thalidomide does not work through a neural mechanism as previously thought, but affects the vascular system," a lawyer for the plaintiffs said.

This is especially relevant for one of the plaintiffs named in the complaint, Philip "Hook" Yeatts, a professional race car driver who competes in the U.S. Legends Series. Yeatts was born without his right arm or right leg, a severely curved spine and a deformed tongue. He overcame his disability, competing in a modified car and rising through the ranks to become a professional driver.

Yeatts' mother suffered from morning sickness during pregnancy and was given thalidomide by her doctor, according to the complaint.

Yeatts would never have been considered a victim of thalidomide because the predominant medical view held that thalidomide could not cause unilateral injuries like his.

The complaint claims that the defendants are either guilty of or liable for a civil conspiracy, failing to report and covering up evidence that thalidomide was harmful, especially when taken during the early stages of pregnancy. The lawsuit also says that the defendants were negligent in continuing to manufacture, test and distribute the drug.

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Last updated on Oct-31-11