Topamax was first approved in 1998 by the FDA for the treatment of seizures due to epilepsy. The drug is also referred to by the generic name Topiramate. In 2004, it was also approved for treating migraine headaches. It has been increasingly reported that Topamax has been linked to serious birth defects such as cleft palate/cleft lip. On March 4 of this year, the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including cleft lip/cleft palate and genital malformations including Hypospadias.
It appears that the greatest risk to the unborn baby comes from exposure to the drug during the first trimester of the pregnancy. During this extremely important developmental period, the mother may or may not know that she is pregnant. Therefore, it is not just women that know they are pregnant that are risk, but any woman of childbearing age taking Topamax could get unexpectedly pregnant and have a child with a cleft lip/cleft palate. One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects (most notably, cleft lips or cleft palates) compared to the risk in a background population of untreated women.
Topamax is manufactured by Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States. Ortho-McNeil has made a fortune off of Topamax.
J&J has had a large amount of recalled products in the last year and a half, notably the DePuy ASR Hip device recalled in the fall of 2010. In fact in April of 2011, J&J recalled close to 57,000 bottles of Topamax because of complaints of an odor. This odor is believed to be caused by trace amounts of a chemical used to preserve the wooden pallets the medicine sits on in storage -- that's the same cause that prompted gigantic recalls of Tylenol and other over-the-counter medications at McNeil Consumer Healthcare. The two companies are both part of Johnson & Johnson. Generic versions of the drug have been available since 2006.
In March of 2010, Ortho-McNeil pled guilty and paid $6.14 million in criminal fines for the misbranding of Topamax. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims). The U.S. government said that Ortho-McNeil promoted Topamax by hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. Reports indicate they promoted the drug as a way to help with weight loss and pain. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.
Our firm is currently investigating claims for those people who have been injured by Topamax. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.
