A jury says that Janssen Pharmaceuticals, a Johnson & Johnson unit, must pay $3 million for not warning a woman that using Topamax during pregnancy could cause birth defects. The plaintiffs contend that 5-year-old Payton Anderson was born with a cleft lip because her mother was prescribed the drug for migraines during the first trimester of pregnancy. Already, she has had several operations and will need more surgeries as she grows older.
Janssen disagrees with the Topamax injury verdict. A spokesperson for the pharmaceutical company said that Mrs. Anderson was cautions by four physicians about the risks involved when taking Topamax. Janssen maintains that it has always warned about the possible side effects that could affect pregnant women.
Topamax is approved for treatment of serious migraines and epileptic seizures. Just last week, the US Food and Drug Administration approved it for use by adolescents belonging to the ages 12 to 17 group. Its generic name is topiramate.
Unfortunately, Topamax use has been linked to a greater risk of cleft palate and cleft lip in kids born to moms who were taking the medication while pregnant. Per a 2011 FDA warning, the risk of developing these types of birth defects is significantly greater than if a pregnant mother didn’t take the medication. Janssen, however, has said that birth defects involving Topamax users does not necessarily mean they were caused by the drug because oral clefts are common, impacting about 4,500 newborns each year.
A cleft palate is a facial disorder that creates an opening in the mouth’s roof because certain areas of the skull did not fuse together correctly. Multiple surgeries may be required to correct the tissues that were not properly formed.
In addition to the physical trauma, there also may be emotional injuries for a child with this type of birth defect. Babies whose moms took Topamax while pregnant may also suffer from spina bifida, other neural tube defects, persistent pulmonary hypertension, or heart defects.
Other serious side effects that have been associated with topiramate:
• Hyperthermia • Acute Myopia • Metabolic Acidosis • Hyperammonemia • Secondary Angle Closure Glaucoma • Suicide • Oligohydrosis • Neuropsychiatric adverse reactions • Serious eye problems
At Altman & Altman, LLP, our Boston Topamax injury lawyers represent adults and the families of children that suffered serious side effects from taking the medication. Drugs shouldn’t cause serious injury to those who take them and if there are serious side effects then the warnings of the risks involved should be made clear so that patients know what could go wrong. Contact our Massachusetts drug defect law firm today.
Going after a drug company can feel intimidating. This is not the kind of Boston birth defect case that you want to pursue without solid legal representation backing you.
FDA: Risk of oral birth defects in children born to mothers taking topiramate, Food and Drug Administration, March 4, 2011
Janssen Settles Some Pa. Topamax Birth Defect Cases, Will Appeal $3M Verdict, LexisNexis, March 11, 2014
Facts about Cleft Lip and Cleft Palate, Centers for Disease Control and Prevention
More Blog Posts:
Johnson & Johnson’s Janssen Must Pay $11M & $4M in Topamax Birth Injury Cases, Massachusetts Drug Injury Lawyers, November 25, 2013
Thalidomide Injury Lawsuits Leads to $81M Settlement, Massachusetts Drug Injury Lawyers, December 13, 2013
Medical Malpractice Payouts Increase for First Time in a Decade, Boston Injury Lawyer Blog, April 2, 2013