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Topamax victims awarded compensation

Victims of the antiepileptic drug Topamax (topiramate) heard for the second consecutive springtime the resounding crack of the gavel of justice.

In the spring of 2014, a judge overseeing the mass tort docket at the Philadelphia-based Court of Common Pleas filed an order declaring the settlement of 76 Topamax lawsuits.

In the spring of 2015, a Pennsylvania Superior Court judge upheld a 2013 trial court jury verdict that awarded the victims more than $300,000 for future health care costs and more than $10 million in non-economic damages. The court tacked on another $700,000 in delay damages, bumping the total award to well above $11 million. Non-economic losses, according to court documents, include the following:

(1) Pain and suffering

(2) Embarrassment and humiliation

(3) Loss of ability to enjoy the pleasures of life

(4) Disfigurement

Plaintiffs in Topamax lawsuits generally allege that the mother's use of the drug during pregnancy led to birth defects. Janssen Pharmaceuticals is the main defendant in this pharmaceutical injury litigation, which has often turned the victims' way.

The U.S. Food and Drug Administration approved Topamax in 1996. The coast was clear of risks at the time, but by the spring of 2011, the FDA had read so many credible findings that it had to announce, "New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy." The drug's medication guides reflected the then-newfound risk.

In the appeal that affirmed the more than $11 million jury award, a South Carolina mother used Topamax daily to control her headaches and seizures for 21 months, through Dec. 1, 2007. Her period of Topamax use included the first month or so of pregnancy. An ultrasound showed that her son would be born with cleft lip.

The boy was born in July 2008. Court documents showed that he "was born with a right side unilateral cleft lip and gum line defects."

The birth defects have lingering medical implications. The opinion upholding the multimillion-dollar jury verdict enumerated them, reading, in part, "[The child] had surgery to correct the cleft lip on Oct. 1, 2008. He still has a red scar running from under his nose to his lip as a result of the surgery. [His] tooth never grew in correctly in the area where there is a notch in his gum, which makes it appear as though he is missing a tooth. [He] has difficulties with speech and becomes extremely frustrated when people cannot understand him. He treats with a speech therapist twice a week and regularly visits a plastic surgeon as part of a cleft lip and palate team. Treatments that [he] will need in the future may include graft surgery to repair the notch in his gums, evaluations to test his hearing, psychological evaluations, dental care related to dental abnormalities, and rhinoplasty for his nasal deformity."

Janssen recently received a third springtime jolt within two calendar years. The March 2015 edition of the medical journal Reproductive Toxicology published a Canadian analysis of numerous studies that were centered on the birth defects risks associated with generic Topamax, which the co-authors abbreviated TPM. Most of the researchers were connected with the Motherisk Program at the Hospital for Sick Children and University of Toronto.

The meta-analysis concluded, "This study provides strong evidence that TPM is associated with an increased risk of [oral clefts] in infants exposed to TPM during embryogenesis and should lead to a careful review of TPM use in women of reproductive ages."

The parents of a child with birth defects whose mother used Topamax during pregnancy may be entitled to compensation, just as were the plaintiffs in 76 Topamax lawsuits and the South Carolina parents who won their appeal this spring. The way to find out is to contact an attorney experienced in handling pharmaceutical injury litigation such as the skilled attorneys at Reich & Binstock.

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