Lawsuits blame Janssen Pharmaceuticals Inc. and its drug Topamax for birth defects, claiming had Janssen adequately warned about the drug’s risks, women would have chosen other treatment options. The U.S. Department of Justice has also come down on Topamax makers for illegally promoting Topamax for off-label uses, such as treatment of bipolar disorder and alcohol dependency.
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.
April Czimmer was also prescribed Topamax to treat 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 eventually stopped taking Topamax, she used the medicine early in her pregnancy, which is when the Centers for Disease Control (CDC) 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.
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 to highlight the increased risk of cleft palate and cleft lip.
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 were pending in Philadelphia’s Topamax docket. The basis of the Topamax legal claims was that Janssen had a legal duty to warn consumer of the risks but failed to do so.
In 2008, studies revealed evidence that Topamax carries an increased risk of birth defects. The FDA analyzed results of nearly 200 trials that indicated Topamax caused birth defects. Based on its review, the agency required the drug’s label carry cleft palate and cleft lip warnings.
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.
Using Topamax during the first trimester of pregnancy — when many women may not realize they are pregnant — raises the risk of birth defects. 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 like 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.
In late 2013, the first Topamax birth defect trials in the Philadelphia Court of Common Pleas resulted in winning verdicts for the plaintiffs. Juries awarded $4 million to Czimmer in October and nearly $11 million to Brayden Gurley’s 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 thousands of 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 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.
Czimmer’s trial lasted 12 days. Jury deliberations began on Oct. 30, 2013. That 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.
A jury awarded Brayden Gurley’s family nearly $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). The court later added $700,000 to the award, bringing the total to about $11.7 million.
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, 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.
The U.S. Department of Justice also came down on Topamax makers in 2010 for promoting off-label uses for Topamax, such as treatment of bipolar disorder and alcohol dependency, resulting in an $81 million fine.
Current FBI director Christopher A. Wray represented Topamax manufacturers in federal lawsuits over off-label marketing of the drug. The prosecution resulted in an $81 million fine in 2010, and the companies agreed to stop promoting Topamax illegally.
In mid-2010, Topamax manufacturers admitted to misbranding and illegally marketing the drug for several unapproved, or off-label, uses, including bipolar disorder, alcohol dependency, cocaine and methamphetamine addiction, obsessive-compulsive disorder, borderline personality disorder and post-traumatic stress disorder.
Under a plea agreement with the U.S. Department of Justice, the J&J subsidiaries agreed to pay fines of $81.5 million for promoting Topamax for off-label uses, misbranding and illegally marketing the drug, and causing false claims about it to be submitted to government health programs. The federal government received $50.69 million, state Medicaid programs shared $24.68 million, and three whistleblowers received the rest.
The program called “Doctors-for-a-Day” allowed drug officials to engage in off-market labeling by enlisting doctors to join sales representatives in visiting other doctors. Company documents show drug executives told physicians that their colleagues “can talk to you about things I can’t talk to you about,” Bloomberg News reported.
“This case should send a strong reminder that the off- label promotion of pharmaceuticals is illegal, whether it is done directly by company employees or through programs such as the doctor for a day program,” U.S. Attorney Carmen Ortiz told Bloomberg.
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