23 July 2015

New Jersey Parents Say Zofran Caused Child’s Clubfoot

On June 26, 2015, a new Zofran birth defect lawsuit was filed against GlaxoSmithKline. In their complaint, a family from Bergen County, New Jersey claims that prenatal exposure to Zofran caused their unborn son to develop talipes equinovarus, a congenital limb defect often referred to as “clubfoot.”

Plaintiffs filed their claim in the US District Court for the District of New Jersey, under the case number 2:15-cv-04536-JLL-JAD. You can read a copy of the complaint by clicking the button below:

View Complaint: 2:15-cv-04536-JLL-JAD

Zofran Caused Child’s “Clubfoot,” New Jersey Family Alleges

The mother claims that she was admitted to the hospital with severe symptoms of dehydration and nausea, three weeks after becoming pregnant in late 2010. After being diagnosed with hyperemesis gravidarum, morning sickness’ most extreme form, she was prescribed Zofran to alleviate the symptoms of nausea and vomiting, Plaintiff writes. She asserts that her Zofran prescription began “as early as five weeks into her pregnancy,” and that the drug was also administered intravenously during her hospital stay.

Plaintiff goes into substantial detail on the forms of Zofran she was allegedly prescribed. According to court documents, she initially began taking the drug as an oral tablet, 4 milligrams ingested every six hours daily. But her dosage was raised to 8 milligrams, after her nausea continued beyond eight weeks of pregnancy, Plaintiff claims. This is the first Zofran lawsuit to mention a “Zofran Pump,” which Plaintiff says she was prescribed for approximately four days. As described in the complaint, this device administers the drug every four hours “by way of premixed injection through [a patient’s] stomach.” Plaintiff was then issued a new prescription, this time for a dissolvable 8 milligram Zofran tablet to be taken every four hours, which she claims she took for the remainder of her pregnancy.

Her son, named as B.M. in court documents, was born on September 24, 2011, and diagnosed with a congenital defect: talipes equinovarus or “clubfoot.”

Clubfoot: Complaint Describes Child’s Extensive Treatment

Court documents describe “clubfoot” as a “congenital deformity involving one foot or both,” in which a child’s feet appear to have been rotated inwards at the ankle. The complaint continues to describe the lengthy treatment process B.M. allegedly underwent to repair the abnormality with which he was born.

Only nine days after birth, physicians began to “gently manipulate” the tissues of B.M.’s feet, bending and straightening them, Plaintiffs claim. His feet were then inserted into plaster casts, the complaint states, to maintain “the degree of correction.” Plaintiffs allege that this process was repeated, with old casts being removed, tissues manipulated further and a new cast applied, every week for the first two months of the child’s life.

B.M. next underwent a tenotomy, which court documents describe as a “surgical act, […] involv[ing] the literal cutting and slicing of a division of an Achilles tendon.” The procedure was intended, say the parents, to lengthen their son’s tendon and gradually realign his feet. A new cast, which remained for “several weeks,” was applied to maintain the correction, court documents state.

Plaintiff’s son was then prescribed a “Mitchell shoe,” parents write, consisting of a “molded plastic footplate and three soft leather straps.” Between the shoes, a metal bar (or “Ponseti abduction brace”) is attached to hold the child’s feet at angles turned outward from the body. Plaintiffs claim that their son wore the Mitchell shoes “for 23 hours a day for six months.” For the next six months, B.M. wore the shoes for 18 hours a day, Plaintiffs say, and then for 12 hours a day the next six months.

B.M.’s ability to sleep normally was inhibited by the device, his parents claim, and the shoes caused him to “suffer[…] pressure blisters and sores” on his feet. Plaintiffs say they performed 45 minutes of physiotherapy daily, manually “stretching and manipulating” their child’s Achilles tendons and calf muscles. During this entire treatment period, B.M.’s ability to walk was impaired, Plaintiffs claim; he “was reduced to crawling with plaster casts and subsequent orthopedic devices fastened to his feet.” Finding schools adequately equipped to accept their son was extremely difficult, Plaintiffs write.

B.M., now three years old, continues to wear the Mitchell shoes at night, according to the complaint, but “recent examination […] has shown that his clubfoot condition has regressed requiring more surgery and possible [sic] a tendon transplant.”

Plaintiffs Claim GlaxoSmithKline Promoted Zofran “Off Label,” While Concealing Potential Birth Defect Risks

As in at least 14 other Zofran birth defect lawsuits, the parents level serious allegations against GlaxoSmithKline.

Noting that Zofran is only FDA-approved for the treatment of severe nausea and vomiting in cancer and surgical patients, they accuse the company of unlawfully promoting Zofran to physicians as a “safe and effective” treatment for morning sickness. Citing a US Department of Justice lawsuit, in which the Federal Government made an identical allegation, Plaintiffs say that GlaxoSmithKline conducted “a marketing scheme to promote Zofran to obstetrics and gynecology […] healthcare practitioners, among others” as a “treatment alternative” for nausea and vomiting in pregnancy.

In their complaint, the family says that GSK marketed Zofran as a morning sickness treatment without any evidence as to its safety or efficacy in pregnancy. To the contrary, Plaintiffs claim that the company began receiving evidence of the drug’s potential to increase birth defect risks more than two decades ago.

While Zofran’s manufacturer has never studied the drug’s effects in pregnant women, a number of recent studies have identified a link between Zofran and an increased risk for major birth defects. Plaintiffs cite several of these studies, identifying an association between Zofran’s active ingredient ondansetron and congenital heart defects, and then allege that GlaxoSmithKline failed to warn patients of the drug’s potential risks.

Researchers have also found an association between Zofran and an increased risk for cleft palate.

Zofran Birth Defect Lawsuits: Other Families May Be Eligible To File A Claim

ZofranLegal.com is sponsored by an alliance of experienced plaintiffs’ attorneys devoted to protecting the rights of parents and birth defect survivors nationwide.

Led by Monheit Law, our lawyers continue to provide free consultations to families who believe that prenatal exposure to Zofran may have caused a child’s birth defects. If you were prescribed Zofran as an “off label” morning sickness treatment and delivered a baby with major birth defects, including congenital heart defects and cleft palate, you may be eligible to bring a claim against the drug’s manufacturer.

For more information, and a case eligibility evaluation at no cost and no obligation, contact our Zofran lawyers today. Call 1-877-620-8411 or complete our contact form.