Attorneys representing plaintiffs in the US seeking compensation from the manufacturer and distributors of the birth defect-causing drug Thalidomide today lauded a $81 million settlement announced for Australian victims, but said progress for a similar settlement against GlaxoSmithKline (NYSE: GSK) and Sanofi-Aventis (NYSE: SNY), does not appear likely without moving to trial.
Steve Berman, managing partner of Hagens Berman, represents 49 victims who suffered birth defects after their mothers took the drug. Newly unearthed documents provide additional evidence that major pharmaceutical companies including GSK and Sanofi-Aventis distributed the dangerous birth defect-causing drug Thalidomide in the United States much more widely than previously believed.
"It is gratifying to see that the drug's distributor in Australia stepped up and reached an equitable settlement for its role in the devastation Thalidomide caused in Australia," Berman said. "In contrast, the primary marketers in the US, the defendants have been assertively belligerent in their approach to the US case, attempting every legal tactic available to deny a trial."
Diageo, the Australian and New Zealand distributor of Thalidomide announced $81 million settlement on Dec. 2, 2013.
According to Berman, GSK has put forth a long litany of claims in its defense with one of the more galling questioning the source of the drug that led to the birth defects in the US.
"GSK is disputing that it was the source of Thalidomide for women who took the drug prior to 1958, in spite of the fact that GSK was the only distributor in the US at that time," Berman said. "While we expect the company to construct a vigorous defense, we think that GSK should not be foisting such transparently spurious claims simply to slow the pace of the litigation."
In addition to GlaxoSmithKline and Sanofi-Aventis, many of the 49 cases filed by Hagens Berman also name Grunenthal GMBH as defendants.
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 and elsewhere 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 in a timely manner."
For more than fifty years, SKF never fully disclosed to the public that at least one of the mothers who had been given the drug gave birth to a severely deformed baby.
The suit also claims that both GlaxoSmithKline and Sanofi-Aventis - then Merrell Richardson - 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 shows that many of those assumptions are not correct and that 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 Thalidomide@hbsslaw.com.
More information about these lawsuits is available at www.hbsslaw.com/Thalidomide.