In an important new development, the federal court in Massachusetts where Zofran birth defects lawsuits are docketed, has added Novartis Pharmaceuticals Corporation as a defendant. More than 260 cases are pending against Novartis and GlaxoSmithKline.
The lawsuits are consolidated before Judge Dennis Saylor in MDL2657, Zofran (Ondansetron) Products Liability Litigation.
The Master Long Form Complaint and Jury Demand state:
Effective March 23, 2015, Novartis AG, a Switzerland company, acquired GlaxoSmithKline PLC’s oncology business, including the right to sell Zofran products in the US. On March 23, 2015, Novartis Pharmaceuticals Corporation, a US corporation and subsidiary of Novartis AG, became the NDA holder for Zofran. On March 23, 2015, Novartis assumed responsibility for maintaining the content of Zofran’s labeling in the US, including warnings and precautions attendant to its use.
Until GSK’s sale of its Zofran business to Novartis, GSK designed, manufactured, marketed and, sold Zofran. After the sale, GSK continued to manufacture Zofran for sale in the US by Novartis, and it became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States.
Novartis is a Delaware corporation headquartered in East Hanover, NJ and it conducted business throughout the US. The company has derived substantial revenue from pharmaceutical sales throughout the US, including Zofran.
In connection with its acquisition of Zofran from GSK, Novartis gained knowledge of the false and misleading promotion of Zofran for treating pregnancy-related nausea, sometimes called 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.
Zofran is a prescription drug indicated only for preventing chemotherapy-induced nausea and vomiting, radiation therapy-induced nausea and vomiting, or post-operative nausea and vomiting. Drugs that prevent or treat such nausea and vomiting are called anti-emetics. Zofran is part of a class of anti-emetics referred to as selective serotonin 5-HT3 receptor antagonists.
Among patients who ingested Zofran, the drug has caused sometimes fatal cardiac arrhythmias such as:
- QT prolongation and Torsade de Pointes
- Serotonin syndrome
- Disruption of signaling pathways through neurotransmitters other than serotonin.
Defendants have been aware of these facts at all relevant times, but they have failed to tell healthcare providers, their patients, or the public of the impact of these potentially life-threatening conditions on the developing embryo and fetus.
In 1991, Zofran became the first 5-HT3 receptor antagonist approved for marketing in the US. Defendants have never applied for FDA approval of Zofran for treating pregnancy-related nausea or vomiting. Neither the safety nor efficacy of Zofran for treating pregnancy-related nausea or vomiting has been established.
With more than 6 million annual pregnancies in the US since 1991 and an estimated 70-85% incidence of pregnancy-related nausea, GSK had an extremely lucrative business opportunity to create a new market for Zofran. GSK seized that opportunity, but the effect of its conduct was tantamount to experimenting with the lives of unsuspecting mothers-to-be and their children throughout the US.
As early as January 1997, despite available evidence showing that Zofran presented an unreasonable risk of harm to babies exposed to Zofran prenatally, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare practitioners and consumers as a safe and effective treatment for pregnancy-related nausea and vomiting. In support of its misleading marketing efforts, at least as early as January 1997, GSK offered and paid substantial pay to healthcare providers and “thought leaders” to induce them to promote and prescribe Zofran to treat morning sickness.
GSK’s Zofran sales representatives received incentive-based compensation that included an annual salary and a quarterly bonus. The bonus amount was determined by each sales representative’s performance in the relevant market and whether the representative attained or exceeded quarterly sales quotas. The more Zofran sold by a GSK sales representative or prescribed by a provider in that representative’s sales territory, the greater the compensation and incentives.
As a result of GSK’s fraudulent marketing campaign, the precise details of which are uniquely within the control of GSK, Zofran achieved blockbuster status by 2002 and became the most frequently prescribed drug for treating morning sickness in the United States. In 2002, sales of Zofran in the United States reportedly totaled $1.1 billion.
GSK’s promotion of Zofran for use in pregnancy eventually led to a federal governmental investigation. On July 2, 2012 the U.S. Department of Justice announced that GSK “[a]greed to plead guilty and pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs,” which included Zofran, among numerous others.
Part of GSK’s civil liability to the government included payments arising from claims that GSK: (a) promoted and disseminated false representations about the safety and efficacy of Zofran concerning pregnancy-related nausea; and (b) paid and offered to pay illegal remuneration to healthcare professionals to induce them to promote and prescribe Zofran for this purpose.
Since before Zofran entered the U.S. market, GSK has known that serotonin also regulates developmental processes that are critical to proper embryonic development. Impeding serotonin signaling during embryonic development can increase the risk of developmental insult. GSK has likewise known that, when Zofran is taken, its established side effects in adults can also occur in embryos and fetuses, leading to birth defects. Novartis has been aware of these facts since before it began selling Zofran.