It’s a sad situation when an adult is injured by a defective product or a bad drug, it’s tragic when an infant is hurt. That’s the case with Topamax, a drug touted to treat migraines and epilepsy. Unfortunately, besides treating these conditions pregnant women have exposed their unborn children to a devastating birth defect-cleft palate.
As a birth injury lawyer, I believe the manufacturer of Topamax along with its generic equivalents, knew about these devastating side effects. Topamax is manufactured by Ortho-McNeil Neurologics. Since the drug has been on the market so long, there are generic equivalents of Topamax (topiramate) made by pharmaceutical companies such as Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Ranbaxy Pharmaceuticals, Inc., Roxane Laboratories, Inc., and Teva Pharmaceutical Industries, Ltd.
Soon after its introduction to the marketplace in 1998, the FDA became concerned that Topamax was being marketed for uses not specifically approved by the federal regulatory agency. This concern led to a criminal probe and Johnson and Johnson paid $81 million in fines and pled guilty to misdemeanor criminal conduct for “misbranding” Topamax.
Criminal behavior that hurts adults, that’s one thing but when criminal behavior injures innocent babies, that’s quite another, that’s unforgivable.

Sounds like a loaded question, right? Actually, the answer depends upon the diocese or archdiocese, more specifically, the bishop or the archbishop in charge. After the Dallas Charter was adopted some nine years ago to deal with the priest abuse crisis in this country, each bishop was asked to form an independent review board within their own diocese to ensure priest sex abuse allegations were investigated and handled properly as well as avoid future occurrences. Most of the US bishops have complied and have active review boards. I can think of two who have refused to comply with the audits mandated by the Dallas Charter-Fabian Bruskewitz and Robert Vasa, the newly appointed bishop of Santa Rosa CA.
Yet, there are problems within the archdioceses and dioceses that have review boards. Some prime examples are the Archdiocese of Philadelphia, the Diocese of Kansas City-St. Joseph, and the Diocese of Gallup. There are others, but these three serve as prime examples of the inherent problems faced by these review boards. They are only as effective as the bishop allows them to be. In the three instances I’ve cited the bishop in charge didn’t bother communicating everything to the board, rendering their opinions and ability to make decisions ineffective.
In the end, the problem lies with the bishops since they are selective in what information they are allowing their own boards to see. This may be an insurmountable problem for the US Conference of Catholic Bishops when they gather to discuss this in June in Seattle. Each bishop acts as a sovereign in his own diocese. No other bishop can tell him what to do with his review board. Now, the Pope can intervene but no one truly believes he has such inclinations. Perhaps some bishops think it’s easier to ask for forgiveness once they’re caught rather than comply with the Dallas Charter. At least, that’s what the bishops in Philadelphia and Kansas City-St. Joseph have done.