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In Zofran Lawsuit, Massachusetts Family Says Drug Caused Heart Defect

September 15, 2015 – – In a new Zofran lawsuit, made public by Monheit Law on the firm’s website ZofranLegal.com, parents from Massachusetts say the potent anti-nausea drug caused their son H.B. to develop heart defects.

Michael Monheit, Esq., lead attorney at Monheit Law, says this is one of at least 34 lawsuits filed against pharmaceutical giant GlaxoSmithKline, after a series of major research studies found an association between exposure to Zofran during early pregnancy and an increased risk for congenital heart defects and cleft palate.

The claim, brought by residents of Winthrop, Massachusetts, a suburb of Boston, was filed in the US District Court of the District of Massachusetts on July 17, 2015. It was registered under the case number 1:15-cv-12973. At least three other Zofran lawsuits have been filed in Massachusetts thus far, Monheit notes.

In court documents, the mother says she was prescribed Zofran “beginning early in her first trimester of pregnancy.” The family’s son, H.B., was born in 2007. But shortly after birth, an echocardiagram would reveal evidence of H.B.’s congenital heart defect: a ventricular septal defect, or “hole in the heart.” According to his parents, H.B. was also diagnosed with a systolic ejection heart murmur, a sound heard as blood flows abnormally through structural defects in the heart.

While some “hole in the heart” defects close on their own over time, H.B., now 8 years old, continues to live with the abnormality, his parents write, along with all the risks it entails. H.B. is at a greater risk of contracting infection; “his physicians fear that he will contract an infection that will spread to his heart and require emergency surgery,” the family claims. An additional risk lies in the patchwork of tissues lining H.B.’s septal defect. If the tissues detach, they could come to block central arteries in the heart, requiring “emergency surgery within the hour.” Plaintiffs’ physicians have requested they remain close to an emergency cardiac facility at all times, the family writes.

In 2012, the US Department of Justice accused GlaxoSmithKline of unlawfully promoting Zofran “off label,” for the unapproved purpose of treating morning sickness. More than 30 Plaintiffs have now raised this allegation anew, but the recent complaint in Massachusetts goes further into detail on this alleged “fraudulent marketing scheme” than previous Zofran lawsuits have.

Plaintiffs note that Zofran’s first approval came in 1991, for the treatment of nausea and vomiting in cancer patients. The parents say the initial marketing efforts behind Zofran fell to “GSK’s Oncology Division sales force,” oncology being the study and treatment of cancerous tumors. But as early as January 1998, Plaintiffs claim, the company began developing strategies to expand sales of the drug. Obstetricians and gynecologists served as the primary targets of this new promotional initiative, according to the family’s account.

Initial attempts to “create new relationships with obstetricians and gynecologists” proved inefficient, Plaintiffs write, and GSK turned next to “already established relations” with pregnancy specialists. The company’s Oncology Division partnered with its Consumer Healthcare Division in hopes of leveraging the other sales team’s pre-existing network of professional contacts, parents claim. By 2001, Plaintiffs allege, Oncology and Consumer Healthcare had hammered out a co-marketing agreement under which sales reps from Consumer Healthcare would promote Zofran to obstetricians and gynecologists.

Representatives from Consumer Healthcare were already visiting OB/GYN’s on a regular basis, in order to promote Tums, the popular antacid, allegedly to treat heartburn during pregnancy. Now they would be called on to advocate Zofran’s benefits in the management of morning sickness, Plaintiffs say. The company incentivized these new efforts, the family claims, by tethering quarterly bonuses to Zofran sales.

By 2002, Zofran sales would rise to $1.1 billion in the US alone. The drug had become America’s leading prescription remedy for morning sickness, Plaintiffs note.

In fact, more than 1 million Zofran prescriptions are written to pregnant women every year. Many other parents may have the right to file Zofran lawsuits against GlaxoSmithKline, says Michael Monheit. His firm has joined forces with an alliance of distinguished trial lawyers to investigate new claims. He urges women who were prescribed Zofran for morning sickness and delivered children with birth defects to call 1-877-620-8411 for a free consultation.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

ReleaseID: 60004179

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