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15 September 2015

Massachusetts Parents Say Zofran Caused Son’s Heart Defect

On July 17, 2015, a family from Winthrop, Massachusetts filed a new Zofran lawsuit, claiming the anti-nausea drug caused their son’s ventricular septal defect. At least 3 other claims against GlaxoSmithKline have been filed in Massachusetts. Winthrop is a suburb of Boston.

The parents filed their lawsuit in the US District Court for the District of Massachusetts. It was registered under case number 1:15-cv-12973. A copy of the court documents can be found below:

View Complaint: 1:15-cv-12973

In New Zofran Lawsuit, Family Claims Drug Caused Son’s Ventricular Septal Defect baby crying

Like more than 1 million women every year, Plaintiff was prescribed Zofran to alleviate the symptoms of morning sickness, the parents write in their complaint. She began taking the drug, approved only for cancer and surgical patients, during the first trimester of pregnancy, she says.

Her initial exposure occurred at the Harvard-affiliated Mount Auburn Hospital in Cambridge, Massachusetts. There she was intravenously given “a dose of Zofran with dextrose,” the family writes, and subsequently prescribed the drug in tablet form. She took Zofran for around one and a half months.

Her son H.B. was born in 2007. Soon after birth, an echocardiagram would reveal that H.B. had a ventricular septal defect (VSD), a heart defect that involves a hole in the wall between the heart’s two large pumping chambers.

The parents note an additional diagnosis, systolic ejection heart murmur. This sound, heard through a stethoscope, is created by blood’s flow through a structural defect inside the heart. “Systolic” refers to “systole,” the phase of a heart beat in which the ventricles contract.

Surgical intervention was not attempted, Plaintiffs suggest, but H.B. has remained under “continuous monitoring since birth.” Diagnostic examinations indicate that his VSD has not yet closed of its own accord; Plaintiffs say that they have been advised that their son’s condition is likely permanent.

Risks Of Ventricular Septal Defect

In court documents, the parents describe living in a state of constant fear.

H.B.’s ventricular septal defect puts him at a greater risk of infection, they write, and his parents “must be extraordinarily careful to help H.B. maintain excellent hygiene to prevent him from contracting infections.”

They’ve also been warned about an additional “serious risk”: the patchwork of tissue lining H.B.’s VSD could detach, blocking arteries and requiring “emergency surgery within the hour.”

Parents say they have been instructed to remain within close proximity to an emergency medical facility, “preferably an emergency cardiac facility, at all times.”

Federal Government Charges GSK For Promoting Zofran “Off Label”

At least 34 Zofran lawsuits are currently awaiting a decision from the Judicial Panel on Multidistrict Litigation (JPML). The JPML will decide whether the multiple claims share allegations similar enough to warrant their transfer to a single court for coordinated proceedings.

Each claim has referenced a lawsuit, filed in 2012 by the US Department of Justice, in which the Federal Government charged GlaxoSmithKline for unlawfully promoting a number of drugs. One of those drugs, Zofran, had been actively marketed to obstetricians and gynecologists as an “off label” morning sickness treatment, the government claimed.

As all Plaintiffs have noted, GSK has never studied Zofran’s effects during pregnancy, or the risks it may pose to fetal development.

Plaintiffs Detail GlaxoSmithKline’s Complex “Off-Label” Marketing Scheme

But the recent Massachusetts complaint provides a detailed account of the company’s alleged “off label” promotion scheme matched by few other claims.

In 1991, Zofran achieved its initial FDA approval as a treatment for the nausea and vomiting experienced by cancer patients. As such, the drug’s promotion was delegated to GlaxoSmithKline’s Oncology Division, Plaintiffs claim. Plaintiffs say the company eventually sought to expand Zofran sales to another market of patients: pregnant women.

But the Oncology division lacked the contacts necessary to reach obstetricians and gynecologists, the parents write, and needed a new way to spread its alleged message that Zofran had been established as “safe and effective” for morning sickness.

A deal was struck, the family relates, between GSK’s Oncology Division and its Consumer Healthcare Division. Under this agreement, sales representatives from Consumer Healthcare would leverage their preexisting relationships with OB/GYNs to promote Zofran use during pregnancy. Sales reps from Consumer Healthcare already reached out to OB/GYNs on a regular basis, providing samples of Tums and promoting the over-the-counter antacid as a treatment for heartburn during pregnancy, Plaintiffs claim.

The company had already tied each sales reps’ quarterly bonus to a sales quota, but now that meant “the more Zofran sold […] the greater his or her compensation,” the parents write.

Zofran sales soon skyrocketed, achieving “blockbuster status by 2002” with US sales of $1.1 billion that year.

In 2010, GSK began phasing out its quota-based incentive program for sales representatives, FiercePharma reports. Rather than pegging bonuses to individual prescription sales, GSK’s new “Patient First” initiative would see sales reps evaluated on their knowledge of products and actual patient needs. But a recent decline in US sales, noted by Bloomberg Business, has prompted the company to consider revising that move.

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