SEATTLE--(BUSINESS WIRE)--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 today by law firm Hagens Berman 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.
Steve Berman, managing partner of Hagens Berman, says that newly discovered and translated documents reveal that Smith, Kline and French (SKF), now owned by GlaxoSmithKline (NYSE: GSK) conducted a trial of the drug in 1956 and 1957, but buried the evidence, resulting in a missed opportunity to save thousands of lives.
“SKF concealed from the public that it tested thalidomide on at least 875 people, including pregnant women,” said Berman. “During those trials, we believe new documents reveal that at least one baby was born with severe birth defects. If SKF had come forward then, future trials might have been stopped and many lives saved.”
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 (NYSE: SNY) 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 Berman, 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.
“We think that many individuals who suffered severe birth defects and who thought they were merely the victim of nature, may have actually been injured by thalidomide,” Berman said. “We now believe that there could be hundreds of individuals in the United States who suffered severe birth defects as a result of thalidomide, but were incorrectly diagnosed at birth.”
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,” Berman added.
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.
The firm is also 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 Thalidomide@hbsslaw.com.
More information about the case can be found at www.hbsslaw.com/thalidomide.
About Hagens Berman
Seattle-based Hagens Berman Sobol Shapiro LLP represents workers, whistleblowers, investors and consumers in complex litigation. The firm has offices in Boston, Chicago, Colorado Springs, Los Angeles, Minneapolis, New York, Phoenix, San Francisco and Washington, D.C. Founded in 1993, HBSS continues to successfully fight for investor rights in large, complex litigation. More about the law firm and its successes can be found at www.hbsslaw.com. Visit the firm’s class-action law blog at www.classactionlawtoday.com.