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In 2014, Simmons Hanly Conroy secured a $3 million verdict against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The damages were awarded to the family of a 5-year-old who was born with bilateral cleft palate and lip resulting from the Topamax her mother had taken during pregnancy. Simmons Hanly Conroy LLP, a national complex litigation firm, represented parents Kelly and Brian Anderson at trial in the Court of Common Pleas in Philadelphia County. Janssen Pharmaceuticals appealed the original decision; however, the verdict was upheld on appeal in May 2016.
Simmons Hanly Conroy has represented thousands of clients who have been harmed by dangerous drugs and has recovered more than $360 million in verdicts and settlements* on their behalf. Our experienced pharmaceutical attorneys are well-versed in handling complex medical and drug litigation involving Topamax, topiramate and other drugs that can cause birth defects.
Topamax (topiramate) is a drug indicated for use in patients with epilepsy or chronic migraines. In some instances, doctors may prescribe this drug “off label” to treat bipolar disorder, chronic pain, obesity, alcohol use disorder, essential tremor, and restless legs syndrome, among other ailments. Topamax is owned and marketed by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. More than 32 million prescriptions for Topamax were issued between January 2007 and December 2010. The drug was a multi-billion-dollar success for Johnson and Johnson, with sales of nearly $3 billion in 2008 alone.
Many clinical studies and case reports now show that taking Topamax (topiramate) during pregnancy increases the risk of cleft lip, cleft palate and/or genital birth defects in newborns. Data from the North American Drug Pregnancy Registry showed the risk of oral defects is 16 times higher among mothers who took Topamax or its generic versions during their first trimester of pregnancy compared to mothers who either did not take the drug or who took other antiepileptic drugs.
Topamax also passes in breast milk, which has been shown to cause a number of health problems in breastfeeding newborns. Breastfeeding while taking Topamax may cause the following symptoms in newborns:
If you believe your child may have been affected by Topamax or topiramate, contact your physician immediately.
For many years, Kelly Anderson took prescription Topamax to treat severe migraine headaches. These migraines were sometimes so debilitating that she could not work. In 2007, while taking the drug, Kelly became pregnant. Unfortunately, she was never warned about the serious side effects that Topamax can have on unborn babies, especially when taken during the first trimester. In 2008, Kelly and her husband Brian’s daughter was born with bi-lateral cleft lip and palate. Before the child’s 5th birthday, she had undergone over a dozen procedures to treat her condition.
Janssen Pharmaceuticals, along with its parent company, Johnson and Johnson, heavily marketed Topamax for use in the treatment of a variety of conditions—conditions for which the drug was indicated, but also for “off label” conditions. This “off label” promotion was the focus of separate legal action against the company. In the case brought by Simmons Hanly Conroy, the jury ruled that defendant Janssen Pharmaceuticals failed to include the appropriate warning addressing Topamax’s risk of causing birth injuries, like cleft palate, on the drug’s label.
In 2011, the FDA issued a warning to women of child-bearing age about the dangerous effects this drug can have on newborns. This warning came after potentially millions of children had already been exposed to the drug before birth or during breastfeeding. The Antiepileptic Drug Pregnancy Registry reported that 3.8 percent of oral birth defects were due to exposure to Topamax during the first trimester of pregnancy. The FDA required Janssen to change the drug’s pregnancy category from C to D, which means the drug poses a known risk to fetuses. For Kelly and Brian’s daughter and many others like her, the damage has already been done. Janssen failed to warn parents that their drug could cause serious birth defects.
The Anderson family contacted Simmons Hanly Conroy, and the pharmaceutical team led by partner Trent Miracle and attorney Andy Williams took the family’s case.
“No woman is going to put the health of her unborn baby at risk just to get rid of headaches,” Williams said.
For Kelly and Brian, the final outcome was not just about the money. Instead, “it’s about a jury giving us justice for us and our child,” they said in a prepared statement. “We hope this will help make sure no other children have to live with the injuries our daughter has endured.”
When it was filed in early 2014, the Anderson case was only the third case brought against Janssen Pharmaceuticals seeking recovery for birth defects caused by Topamax. Since that time, over 100 additional cases have been filed. The verdict obtained by the Anderson family was upheld on appeal in 2016.
“On behalf of the Anderson family and their child, we are proud to have held Janssen Pharmaceuticals responsible for its decision to sell Topamax without adequately warning families of the serious risks present during pregnancy,” Williams said.
The dangers that Topamax and its generic form topiramate pose to fetuses and breastfeeding infants rightly made national headlines. Indeed, the damages awarded to Kelly, Brian and their daughter were substantial and were reported by several media outlets.
* Please note that recovery results vary per client. The recovery amounts in each case reflect the facts of that case. Further, recovery amounts in past cases are not a guarantee of future results.