Zofran Birth Defects Lawsuit Alleges Drug Caused Clubfoot

October 27, 2015 – – ZofranLegal.com reports on a family living in Bergen County, New Jersey, who are among those who have chosen to file a lawsuit against GlaxoSmithKline, manufacturer of anti-nausea medication Zofran. Through their complaint (no. 2:15-CV-04536-JLL-JAD,) the family alleges that because the mother used Zofran to combat morning sickness while pregnant with their son, he was later born with a congenital limb defect commonly referred to as “clubfoot” (or talipes equinovarus).

In the details of the complaint, the mother indicates that she was dehydrated and nauseous when first admitted to the hospital. It was quickly discovered that she was suffering from the most extreme form of morning sickness. To treat the condition, she was prescribed Zofran. At the time, she was around 5 weeks pregnant, and was initially given the drug through an IV while staying in the hospital.

After this time, the plaintiff began taking the drug orally through a 4 mg tablet every six hours. Her nausea continued, and her Zofran dose was raised to 8 mg. These 8 mg tablets were taken every four hours, and used throughout the remainder of her pregnancy.

The woman gave birth to a son on September 24th of 2011. Upon delivery, the infant was diagnosed with congenital defect talipes equinovarus or “clubfoot.” Beginning at only 9 days post-birth, physicians worked on manipulating the tissue of the child’s feet gently, to bend and straighten it. Just after this, his feet were placed into plaster casts.

Allegations by the plaintiffs describe this process as being one that was repeated to “maintain the degree of correction,” by removing old casts and replacing them with new ones each week for the entire first few months of the child’s life.

Following these corrective procedures, the baby then had to undergo surgery. In this case, court documents name the surgery as a tenotomy, which they detail involves the cutting and slicing of a division of the Achilles tendon. Following this surgery, a new cast was applied, which remained for several weeks.

After the incisions from the surgery had appropriately healed, the child was then prescribed a specially-crafted “mitchell shoe.” These shoes are attached with a metal bar or brace to hold the feet of the child at angles that are turned outward. The plaintiffs state that their son wore these shoes for 23 hours each day for six months, then 18 hours a day for an additional 6 months, and 12 hours a day for the next group of six months.

The device impaired his sleep and day-to-day living, and caused him to suffer, according to allegations “pressure blisters and sores” on his feet. The parents state that they worked to perform 45 minutes of physiotherapy every day by stretching and moving their child’s Achilles tendons and calf muscles in specified ways.

Now, at three years old, the child continues to wear Mitchell shoes each night, according to the parent’s complaint. They indicated that a recent physician exam showed that the child’s condition has, unfortunately, regressed and likely requires additional surgery, including a possible tendon transplant.

These plaintiffs are joined by over 60 other parents from across the nation who also claim that use of Zofran while pregnant caused their children to be born with birth defects. The most common defects range from cleft lip and palate, heart defects, kidney defects, and clubfoot. Women who are prescribed Zofran while pregnant are taking the drug for an “off-label” use. The drug was approved by the FDA, but not to treat expectant mothers. It was approved to treat those suffering from extreme nausea after undergoing chemotherapy, radiation, or anesthesia.

The medication was also recently part of a U.S. Department of Justice lawsuit, where even the Federal Government indicated that Zofran was unlawfully being promoted as a “safe and effective” treatment for morning sickness. The product has never been tested on expectant mothers. Today, many plaintiffs claim that GlaxoSmithKline conducted a “marketing scheme” in order to promote Zofran to the world of obstetrics and gynecology, thus increasing their profits.

The Zofran attorneys at Monheit Law are currently working to ensure that anyone who used Zofran while pregnant and subsequently gave birth to a child with defects will be able to look into their rights to legal action and potentially pursue compensation. They provide no-cost consultations to help everyone who may have been affected.

For additional information concerning Zofran or Zofran Birth Defects lawsuits, please contact Michael Monheit, Esq. at 877-620-8411.

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Contact ZofranLegal.com:

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

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