In recent court filings, attorneys for multinational pharmaceutical conglomerate GlaxoSmithKline have asked a Massachusetts federal judge to dismiss the fraud-based claims leveled by hundreds of families, who say the company’s anti-nausea drug Zofran causes major birth defects.
The Honorable F. Dennis Saylor IV, a federal judge for the US District Court of Massachusetts, presides over the Boston-based Multi-District Litigation, in which over 300 Zofran lawsuits have been consolidated.
GSK Says Fraud-Based Allegations Should Be Dismissed
In their lawsuits, parents claim that GlaxoSmithKline committed fraud in two basic ways: by promoting Zofran for unapproved use during pregnancy and by omitting crucial safety data from the drug’s warning label. GlaxoSmithKline denies these allegations, but has now gone even further than denial, arguing that the families haven’t even provided sufficient details to back up their claims, according to Law360.
The litigation’s Master Complaint, which outlines the fundamental allegations shared by each family’s lawsuit, lacks specificity, the company’s lawyers say. While the families may have outlined allegedly fraudulent schemes in broad brushstrokes, defense attorneys argue, their complaint is devoid of particulars.
Whistleblower Lawsuit Says GSK Promoted Zofran Off-Label
In their complaint, Plaintiffs have sketched the outline of a complex scheme designed to convince obstetricians into prescribing Zofran to pregnant women. The contours of this alleged fraud were first revealed in a whistleblower lawsuit filed in 2003. That year, two former GlaxoSmithKline employees went public, accusing their employer of expanding Zofran sales into off-label markets through unlawful promotion tactics.
As Thomas Gerahty and Matthew Burke told it, GlaxoSmithKline had already created a network of practicing obstetricians, who frequently received sales pitches for over-the-counter antacid Tums. Selling Zofran to pregnant women, the whistleblowers claimed, was relatively simple: just pair presentations on Zofran’s supposed benefits for morning sickness with presentations on Tums.
These allegations, first made by Thomas Gerahty and Matthew Burke, would eventually inspire the Department of Justice to file its own lawsuit against GlaxoSmithKline. The scope of Glaxo’s fraudulent promotion activities, according to federal prosecutors, went far beyond Zofran. In fact, the company had been promoting no fewer than 9 different drugs for off-label uses, the government alleged, using “misleading claims” and illegal kickback payments to persuade physicians into unapproved prescription. Zofran was only an isolated example of a much-larger pattern, federal authorities suggested.
Attorneys Fight Over Detail Of Zofran Allegations
GlaxoSmithKline has never admitted to any of these allegations. The company settled with the government for a total of $3 billion, but did not accept any liability.
Now, the allegations of fraudulent Zofran promotion have resurfaced, in the form of individual personal injury lawsuits filed by parents who believe that the potent nausea medication can cause congenital heart defects and cleft palate. But general contours aren’t enough, defense attorneys argue. Without reference to concrete instances of deceit, the fraud-based allegations should be dismissed, says Jennifer Stevenson, an attorney representing the interests of GlaxoSmithKline.
Thomas Ayala, an attorney representing parents, isn’t convinced by this line of reasoning. As Ayala told Judge Saylor, identifying specific misrepresentations that swayed the judgement of obstetricians should be an “individualized determination,” and would thus be inappropriate in a Master Complaint, which isn’t tailored to the specifics of any one family’s situation.
Federal Judge “Receptive” To Warning Label Fraud Allegations
As Law360 reports, Judge Saylor seems “receptive” to the fraud allegations involving Zofran’s warning label. Families say that GlaxoSmithKline allowed Zofran to enter the market without crucial information, including results from animal studies that allegedly demonstrated fetal harm. The Judge is not yet convinced, however, that Plaintiffs have adequately pled fraud in the drug’s marketing. “The marketing piece, I’m struggling with,” Judge Saylor was quoted as saying by Law360.