A judge in Philadelphia has upheld a jury decision to award $11.6 million compensation for drug side effects to the family of a young boy who was born with a cleft palate and unilateral cleft lip.
In November 2013, Haley Powell and Michael Gurley from South Carolina successfully sued Janssen Pharmaceuticals for the side effects suffered by their son – Brayden – due to Haley taking the anti-epilepsy drug Topamax during her pregnancy.
Brayden was born in 2008 with a severe cleft palate and unilateral cleft lip; an abnormal facial development which means that Brayden cannot be understood when he speaks.
Although his condition can be alleviated with surgery, Brayden will have to undergo years of oral and dental surgery and speech therapy as he grows older.
Brayden is also likely to require psychological treatment related to his various surgeries, and in order to help him overcome the emotional challenges associated with having a cleft palate.
After discovering that his birth injuries may be a side-effect of Topamax, the boy´s parents sought legal advice and made a compensation claim for drug side effects against the manufacturer of the drug – Janssen Pharmaceuticals, a Johnson & Johnson company.
In their claim for drug side effects compensation, Brayden´s parents claimed that Janssen Pharmaceuticals knew about the potential side effects as early as 1997; but did not inform the medical community until they were ordered to by the FDA in 2011.
Janssen Pharmaceuticals argued that a cleft palate was a prevalent birth defect when measured across the general population and that the plaintiffs would have been sufficiently aware of the safety profile of Topamax at the time Haley used the drug.
When the case was heard at the Philadelphia Court of Common Pleas last November, the jury found that Janssen Pharmaceuticals had failed to warn Haley´s doctor as to the risks associated with Topamax and awarded the family $11.6 million compensation for drug side effects.
Janssen Pharmaceuticals appealed the decision on the grounds that their case was prejudiced by the admission of certain “irrelevant” evident and the testimonies of two medical experts who introduced adverse event reports from Topamax clinical trial participants.
However, Judge George W Overton denied the company´s request for a new trial – stating that Janssen Pharmaceuticals´ case had not been prejudiced by the adverse event reports because they were germane to causation – and upholding the original jury award of compensation for drug side effects.