Haley Powell was prescribed Topamax for 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.
April Czimmer also took Topamax for migraines. She took the drug from August 2006 to February 2007. Her son, Blake, was born with a cleft lip and cleft palate in September 2007. Though Czimmer stopped taking Topamax during her pregnancy, she had used the medicine during her first trimester, which is when the Centers for Disease Control says oral clefts occur.
These women are among the hundreds of people who sued Janssen over allegations that the company failed to adequately warn that its drug Topamax causes birth defects.
Topamax, also known by its generic name topiramate, belongs to a category of drugs known as anticonvulsants. Doctors prescribe it to treat epilepsy and to prevent migraine headaches, as well as for off-label, or unapproved, uses. Janssen Pharmaceuticals (formerly Ortho-McNeil) is a Johnson & Johnson subsidiary.
FDA Requires Birth Defect Warning
Families of babies born with birth defects began filing lawsuits against Janssen in 2011 — the same year the U.S. Food and Drug Administration (FDA) required Topamax’s makers to add a warning in the drug’s prescribing information highlighting the increased risk of cleft palate and cleft lip.
The new warnings were based on the FDA’s analysis of data from the North American Antiepileptic (NAAED) Pregnancy Registry, a surveillance effort that monitors the safety of seizure medications. The data showed that the risk of an infant being born with a cleft lip or palate was 21 times greater when a woman took topiramate during her first trimester of pregnancy.
The new data also elevated Topamax from a pregnancy Category C drug, which has not been shown to be harmful to human fetuses, to a Category D drug, which has “positive evidence of human fetal risk.” Generally speaking, Category D drugs should be used by expectant mothers only when there are no better alternatives and benefits outweigh the risks.
Cases were filed under a mass tort program in the Philadelphia Court of Common Pleas. Brayden Gurley’s family sued, as did Czimmer on behalf of her son. By 2013, more than 130 cases alleging that Janssen had failed to warn consumers of the risks of birth defects were pending in Philadelphia’s Topamax docket.
At the time, Topamax had been on the market for 15 years without such warnings. From January 2007 through December 2010, pharmacies dispensed about 32.3 million topiramate prescriptions, and about 4.3 million patients filled topiramate prescriptions from U.S. pharmacies.
Janssen’s ‘Legal Duty to Warn Consumers’
Those who sued Janssen argued that women of childbearing age and their doctors should have been warned about the risks, especially given that Topamax may decrease the effectiveness of contraceptives.
With information about drug risks, women and health care providers can consider other health care options, such as different epilepsy or migraine treatments, plaintiffs argued. By not warning them about the drug’s dangers, Janssen deprived them of this choice.
Lawsuits pointed to the fact that the company failed to issue adequate warnings despite evidence of increased birth defect risks. Plaintiffs maintained that cleft palate and cleft lip may require surgery and other costly medical treatment that could have been prevented if the drugmaker had not neglected its legal duty to warn about risks.
Multimillion Dollar Topamax Verdicts
In late 2013, the first Topamax birth defect trials in the Philadelphia Court of Common Pleas resulted in winning verdicts for the plaintiffs.
At trial, Janssen argued that instances of birth defects cannot necessarily be linked to Topamax because oral clefts are a common congenital birth defect affecting thousands of newborns annually. The company also argued that Topamax’s labels adequately reflected what it knew at the time of the plaintiffs’ alleged injuries.
However, plaintiffs argued 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.
Following a 12-day trial, a jury rendered a verdict in Czimmer’s favor, ordering Janssen to pay $4 million on her claim. Brayden Gurley’s family was awarded $11.7 million. Both awards included compensation for future medical expenses and pain and suffering.
Status of Topamax Birth Defect Lawsuits
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 appealed both verdicts and lost in 2015. In Czimmer’s case, the Pennsylvania Superior Court affirmed the lower court’s verdict and rejected a subsequent bid from Janssen to reconsider. A judicial panel in the Superior Court of Pennsylvania also upheld the trial court’s decision in the case brought by Brayden Gurley’s family.
Meanwhile, parent company J&J agreed to settle 76 other Topamax cases pending in Philadelphia Court of Common Pleas. The court closed the Topamax mass tort program on March 17, 2016.
Topamax Maker Pays $81 Million Fine for Off-Label Promotion
Topamax makers have also paid fines for improperly promoting the drug to treat bipolar disorder, drug and alcohol dependency, obsessive-compulsive disorder, post-traumatic stress disorder and a number of other psychiatric conditions.
The drug’s only approved uses are for treating seizure disorders and preventing migraine headaches. Off-label promotion of pharmaceuticals is illegal.
A federal investigation prompted by whistleblowers revealed that the makers of Topamax paid doctors as much as $3,000 a day to accompany sales representatives on visits with other physicians to promote off-label use of Topamax. Court records show that one physician participating in the “Doctors-for-a-Day” program received $500,000 for 200 meetings with doctors.
Company documents show that drug executives told physicians that their colleagues “can talk to you about things I can’t talk to you about,” Bloomberg News reported.
In 2010, under a plea agreement with the U.S. Justice Department, the manufacturers admitted to misbranding and illegally marketing the drug for unapproved uses and agreed to pay more than $81 million in fines.
Please seek the advice of a medical professional before making health care decisions.