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17 June 2016

Novartis Named As Co-Defendant In Zofran Lawsuits

As of June 17, 2016, 268 Zofran lawsuits have been consolidated in the US District Court of Massachusetts. In each of these cases, a different family claims that GlaxoSmithKline’s anti-nausea drug Zofran causes severe congenital defects. Congenital heart defects and cleft palate appear most frequently, although many lawsuits name other abnormalities.

While the details of these cases vary widely, their core allegations have been strikingly consistent. In court documents, families claim GlaxoSmithKline ignored evidence link between Zofran’s active ingredient, ondansetron, and birth defects. Instead of notifying the health community of these potential risks, Plaintiffs say GlaxoSmithKline actually marketed the drug for use during pregnancy, despite never getting the FDA’s approval.

Zofran Birth Defect Cases Point To New Defendant

The first person to file suit, a mother from Minnesota, did so in February of 2015, after two major studies were published linking the common off-label morning sickness treatment to heart defects. Soon, parents across the nation were bringing their own complaints in numerous federal courts. This trend came to a head in October of that year, when a panel of federal judges decided to send the claims as a group to Boston.

In recent days, attorneys have been moving swiftly to finalize a set of documents that will organize the broad range of allegations leveled against GlaxoSmithKline. These “Master Long Form Complaints” will serve an administrative purpose, gathering together the core accusations shared by over 250 lawsuits. Each family will also file a “Short Form Complaint,” providing their own specific details, at which point both the Short Form and the Long Form Complaint will, together, become legally-binding.

But in several of these court documents, casual observers have been surprised to find a second Defendant listed alongside GlaxoSmithKline: Novartis, a Swiss pharmaceutical manufacturer with US operations based in East Hanover, New Jersey. Both companies, Plaintiffs claim, share in the alleged misconduct outlined in the lawsuits. Both should be held accountable, families say.

Why Novartis?

As the new Master Complaint makes clear, Novartis purchased GlaxoSmithKline’s oncology division in March of 2015. Along with Glaxo’s cancer business came the right to sell Zofran, since the drug was initially developed, and primarily approved, as a treatment for nausea and vomiting caused by chemotherapy.

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When this arrangement became official, Novartis itself became Zofran’s New Drug Application (NDA) sponsor, the party responsible for ensuring that a pharmaceutical’s label adequately warns patients and health care providers of risks. While GlaxoSmithKline continued to manufacture the brand name product, “Novartis became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States,” according to Plaintiffs.

The families’ main contention is that, in acquiring Zofran from GlaxoSmithKline, “Novartis gained knowledge of the false and misleading promotion of Zofran for treating pregnancy-related nausea, sometimes referred to as morning sickness, and of the risks of prenatal exposure to Zofran. Novartis had a duty and continues to have a duty to warn adequately and to correct GSK’s misrepresentations and has failed to do so.”

Novartis Only Involved For Alleged Injuries After March 23, 2015

Not every family will be suing both GlaxoSmithKline and Novartis, however. The latter company will only be included as a Defendant for parents who claim their child’s injuries occurred after March 23, 2015.

To be clear, only a portion of the families involved have filed suit over injuries allegedly caused by GlaxoSmithKline’s brand name Zofran product. Other parents, and children, were exposed to the drug’s active ingredient ondansetron after being prescribed one of more than 30 generic equivalents marketed in the US.

This has become a point of contention in the litigation, since some courts do not allow families to file suit against brand name companies over injuries that may have been caused by generics. Parents, however, insist that GlaxoSmithKline should be held liable for these birth defects, too. The company’s allegedly fraudulent promotion of Zofran created a new market for the drug, pregnant women, that generic manufacturers simply exploited, the families claim.

Separating Generic Lawsuits From Brand Name Cases

To ease potential confusion, the court has decided that attorneys will prepare a separate Master Complaint for Plaintiffs who were prescribed generic versions of ondansetron. Complicating matters, GlaxoSmithKline itself manufactured a generic version of ondansetron, which was distributed and sold by Novartis subsidiary Sandoz, Inc.

Parents who say they were prescribed Glaxo’s authorized generic ondansetron will be able to adopt allegations set forth in the Master Long Form Complaint for Brand Zofran Use. Families who were prescribed another generic version of ondansetron will be able to use a Master Long Form Complaint developed for Generic Ondansetron Use.

Novartis will be a Defendant for families who allege injuries after March 23, 2015, whether or not they claim being prescribed Glaxo’s brand name Zofran.

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