On Oct. 23, U.S. District Judge F. Dennis Saylor IV approved the removal of a supplement within an expert report in a consolidated suit of 58 cases against pharmaceutical company GlaxoSmitheKline’s anti-nausea medication, Zofran. Plaintiffs argue that the drug causes birth defects when taken by pregnant women.

The supplement removed, provided by Swedish researcher Dr. Bengt R. Danielsson, added information about birth defects gleaned from then-recently released studies.

Judge Saylor stated that since “the [studies] do not change [Dr. Danielsson’s] opinion in this case,” the Zofran study exclusion was not damaging to Dr. Danielsson’s expert testimony and the plaintiffs “do not have a compelling need for the late evidence.”

Dr. Danielsson’s testimony was one of many pieces of evidence condemning the pharmaceutical company for promoting its anti-nausea drug for morning sickness, despite the fact that it wasn’t approved by the FDA for use in pregnant women at the time. 

According to the plaintiffs, whose suits were consolidated in 2015, Zofran has only been approved for nausea related to cancer and surgery.

GlaxoSmithKline argued there was a lack of general causation evidence to show Zofran caused any injuries aside from heart defects and isolated cleft palate. The plaintiffs have previously stipulated they lacked scientific evidence to prove Zofran caused those two conditions.

In reference to a particular suit, Judge Saylor wrote “the only issue is whether Zofran can cause heart defects of the type that the child suffered, with or without the presence of any other defects." That issue remains an open question, Judge Saylor said in allowing the case to proceed.

"At least two experts have opined that, based on their fields of expertise, Zofran can cause cleft lip with or without cleft palate," Judge Saylor wrote. "That expert testimony is sufficient to create a genuine dispute as to that issue."

Per the official court report, defendant GlaxoSMithKline LLC (“GSK”) moved for summary judgment of all individual cases based on a lack of general-causation evidence that Zofran can cause injuries other than cardiac defects and isolated cleft palate.

The report concluded, “[GSK’s] motion for summary judgment based on lack of general causation evidence is GRANTED as to plaintiffs Boswell (15-cv-13940), Griffin- 16 Sperbeck (17-cv-10097), Guzman (17-cv-11035), Jones (16-cv-11518), and Mandoyan (15-cv13564), and is otherwise DENIED.”

While the listed five cases were removed from the consolidated suit, 53 of the original 58 cases were allowed to proceed.

With over 200 filed complaints about birth defects tied to use of Zofran by pregnant women, the public demands an update to warning labeling. GlaxoSmithKline, however, has taken no such action to publicly address and warn of the patient-reported risks.

This is not GlaxoSmithKline’s first time facing legal lashback for its promotion of Zofran.

Between 2002 and 2004, the U.S. Department of Justice brought the pharmaceutical company to court for illegally promoting off-label uses for many of their products, including Zofran. GlaxoSmithKline settled these claims in 2012 for $3 billion without admission of guilt.

GlaxoSmithKline’s earlier motion this year attempting to motion for summary judgment dates back to July 2019. The company argued that the FDA already conducted exhaustive research on Zofran, after which they did not deem it fit to label birth defects as a potential side effect of the drug.

Though Judge Saylor decided the jury must make that decision, he has since been forced to decide the matter himself following the Supreme Court case Merck v. Albrecht which stated that judges, not juries, must interpret and apply the FDA’s rules about warnings and labels.

Zofran litigation continues, with the question of its safety for pregnant women still in dispute.