MANUFACTURER OF EPILEPSY (TOPAMAX) DRUG LINKED TO BIRTH DEFECTS SAID TO HAVE PROMOTED USE OF THE DRUG FOR APPROVED PURPOSES
On March 4, 2011, the FDA required the manufacturers of topiramate (Topamax) to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects, including cleft lip and palate. Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections.
The FDA’s action comes after several years of controversy surrounding the safety and efficacy of the drug as well as marketing practices used by at least one manufacturer. Topiramate has been approved by FDA to treat certain types of epilepsy or other seizure disorders. However, in 2009 Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc, manufacturers of the drug under the name Topamax, were accused by the Department of Justice of promoting the drug to physicians for unapproved purposes.
The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the “Doctor-for-a-Day” program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved psychiatric uses and at unapproved doses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as “unapproved” or “off-label uses.”
According to the agreement reached with the government, Ortho-McNeil Pharmaceutical LLC has agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act. In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals will pay $75.37 million to resolve civil allegations under the False Claims Act that they illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs.
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Again, if you or a loved one has given birth to a child with a congenital birth defect after taking Topamax while pregnant, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.