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Topamax Lawsuits and Birth Defect Information

The families of children born with Topamax-related birth defects may be eligible to file a lawsuit for compensation.

Topamax, also known by its generic name topiramate, belongs to a category of drugs known as anticonvulsants. It is prescribed to treat epilepsy and prevent migraine headaches. Topamax is manufactured by Janssen Pharmaceuticals (formerly Ortho-McNeil), a Johnson & Johnson subsidiary, and controls 21 percent of the epilepsy drug market.

However, a March 2011 warning from the Food and Drug Administration (FDA) publicized a hidden danger behind this success: Infants born to mothers who were prescribed Topamax during pregnancy are 21 times more likely to develop oral cleft defects than those born to women who did not take the drug.

If you have taken Topamax while pregnant, your child may be at risk for developing birth defects. Because women were not adequately warned of the dangers, they may be entitled to compensation for their babies’ injuries. If you have suffered harmful side effects from Topamax use, a prescription drug attorney can explain your legal options and help you file a claim.

Status of Topamax Lawsuits

In September 2011, several Topamax lawsuits were filed in the Philadelphia Court of Common Pleas. In late 2013, that court’s first Topamax birth defect trials resulted in winning verdicts for the plaintiffs. Juries awarded $4 million to one family in October and $11 million to another family in November.

According to Janssen, instances of birth defects cannot necessarily be linked to Topamax because oral clefts are a common congenital birth defect affecting 4,500 newborns annually. At trial, the company also argued that Topamax’s labels adequately reflected what it knew at the time of the plaintiffs’ alleged injuries. However, plaintiffs argue that the company knew about the birth defect risks as early as 1997, but failed to warn doctors and even concealed safety reports in 2003 and 2005.

The juries that delivered the 2013 Topamax verdicts ultimately found that Janssen failed to warn doctors about the full extent of Topamax’s birth defect risks. They also determined that the company’s negligence was a substantial factor in causing the plaintiffs’ injuries.

Janssen intends to appeal both verdicts. But it remains to be seen whether the losses will encourage the company to settle some of more than 130 cases pending in Philadelphia’s Topamax docket. Several of the cases are scheduled for trial in early 2014. Meanwhile, families across the country that have suffered Topamax birth defect injuries continue to file personal injury claims.

Why People Sue for Topamax Injuries

Topamax is prescribed for epileptic seizures and migraines because it works to decrease abnormal nerve cell activity. It is also frequently prescribed with other medications to treat Lennox-Gastaut syndrome, a form of childhood-onset epilepsy that causes seizures and developmental delays.

Topamax has also been linked to serious birth defects, including:

  • Cleft lip or palate (which can lead to ear infections and difficultly eating or talking)
  • Hypospadias (a penile defect in male infants)
  • Limb malformations
  • Lung defects
  • Heart defects
  • Spina bifida

These injuries may require surgery and other costly medical treatment, but assistance with medical and other expenses may be available. These injuries could have been prevented if the drugmaker had not neglected its legal duty to warn about risks. That is why parents of children who have been injured by the drug may be entitled to compensation.

Using Topamax during the first trimester of pregnancy, when women may not realize they are pregnant, raises the risk of birth defects. Since Topamax may decrease the effectiveness of contraceptives, it is crucial that women of childbearing age and their doctors be warned about the risks. The basis of Topamax legal claims is that Janssen Pharmaceuticals had a legal duty to warn them and failed to do so.

With information about drug risks, women and health care providers can consider other health care options like different epilepsy or migraine treatments. By not warning them about the drug’s dangers, Janssen Pharmaceuticals deprived them of this choice. The company failed to issue adequate warnings despite evidence of increased birth defect risks that was available by at least 2008. For this reason, parents whose children have been injured by Topamax have decided to hold the drugmaker liable.

This is not the first time Ortho-McNeil (now Janssen Pharmaceuticals, owned by Johnson & Johnson) has faced legal trouble over its marketing of Topamax. A study disclosing increased birth defect risks was published in the Neurology medical journal in July 2008. By that time, Topamax’s U.S. sales had already topped $10 billion. Ortho-McNeil was also promoting Topamax for unapproved uses such as treatment of bipolar disorder and alcohol dependency. Its marketing efforts included a “Doctor for a Day” program, which enlisted doctors to join sales representatives and talk to other doctors about “off-label” Topamax uses.

In 2010, Ortho-McNeil pleaded guilty to illegally promoting Topamax and agreed to pay a $6.14 million fine. That year, its affiliate, Ortho-McNeil-Janssen Pharmaceuticals, also agreed to pay $75.37 million to resolve similar allegations under the federal False Claims Act.

People Who Filed Topamax Lawsuits

People who have filed Topamax lawsuits have claims similar to the plaintiffs who obtained the first Topamax birth defect verdicts:

Haley Powell was prescribed Topamax to treat migraines and hand tremors. She had been taking the prescription drug for more than a year when she became pregnant with her son, Brayden Gurley, in 2007. Brayden was born with a cleft lip. The birth defect also caused nasal malformations and will require him to have at least five surgeries before he turns 21. His family filed suit against Janssen in the Philadelphia Court of Common Pleas. A jury awarded them $11 million in November 2013 following seven hours of deliberation. The verdict included $335,000 for future medical expenses and $10.6 million for non-economic losses (e.g., pain and emotional distress).

April Czimmer was prescribed Topamax to treat migraines from August 2006 to February 2007. Her son, Blake, was born with a cleft lip and palate in September 2007. She filed a lawsuit on behalf of her son in Philadelphia. Following a 12-day trial, jury deliberations began on Oct. 30, 2013. The same day, the jury returned a $4 million verdict against Janssen, including $562,184.68 in future health care expenses and $3,440,000 for pain and suffering.

Others who have filed similar lawsuits allege, among other claims, that Janssen:
Negligently designed and marketed Topamax;
Knew about Topamax’s birth defect risks but failed to warn health care professionals;
Intentionally concealed information about the drug’s birth defect risks; and
Did not adequately label the drug.

Claimants allege that if Janssen had adequately warned about the drug’s risks, they would have chosen other treatment options.