Schmidt & Clark, LLP Announces Launch of Topamax Birth Defects Website
The U.S. Food & Drug Administration (FDA) recently issued a safety warning regarding the increased risk of birth defects in babies born to mothers that took Topamax during pregnancy. Specifically, Topamax has been linked to cleft lip and/or cleft palate (oral clefts), cranial malformations, genital malformations and other serious birth defects.
Washington, DC (PRWEB) March 13, 2011
Schmidt & Clark, LLP, a nationally recognized products liability law firm, announced today that it has recently launched a new website regarding the recent U.S. Food & Drug Administration (FDA) birth defect warnings on Topamax (Topiramate).
On March 4, 2011, the FDA issued a warning about the risk of development of cleft lip and/or cleft palate (oral clefts), cranial malformations, genital malformations and other serious birth defects in babies born to women treated with the drug Topamax (topiramate) while pregnant. Because of new conclusive evidence about this risk, the administration has required Topamax to be placed in Pregnancy Category D which indicates there is direct evidence of birth defects based on human data.
Topamax is only approved by the FDA for the treatment of Epilepsy and the prevention of migraines, however it has often been prescribed “off-label” for various ailments including but not limited to: bipolar disorder, cluster headaches, eating disorders, obesity, fibromyalgia, depression, posttraumatic stress disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders, infantile spasms, autism, periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury, essential tremor, bulimia nervosa, obsessive-compulsive disorder, smoking cessation, idiopathic intracranial hypertension, neuropathic pain, and cocaine dependence.
The controversy surrounding Topamax is nothing new. According to an agreement reached with the government, the manufacturers of the drug (both subsidiaries of Johnson & Johnson) plead guilty to a misdemeanor and paid a $6.14 million criminal fine for the misbranding of the drug. In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals paid $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. The two cases, both filed in the District of Massachusetts are United States ex rel. Maher, et al. v. Ortho-McNeil Pharmaceutical, Civil Action No. 03-11445-WGY, and United States ex rel. Spivack v. Johnson & Johnson and Ortho-McNeil Pharmaceutical, Inc., Civil Action No. 04-11886-WGY.
Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP, has noticed an alarming number of inquiries to the firm related to Topamax and Topiramate. Mr. Schmidt stated, “Our firm has substantial expertise in the area of product liability litigation. As a result, we have received a number of inquiries from individuals regarding Topamax-induced birth defects.”
The Products Liability Litigation Group at Schmidt & Clark is an experienced team of Topamax lawyers that focus exclusively on the representation of plaintiffs in product liability lawsuits. The firm is pursing individual litigation nationwide and currently accepting new Topamax cases in all 50 states.
If you or a loved one has taken Topiramate or Topamax during pregnancy and given birth to a child with a cleft lip and/or cleft palate, cranial malformation, genital malformation, or other serious birth defect, the firm suggests that you visit their website. The site includes detailed information, news and more regarding Topamax birth defects.
About Schmidt & Clark, LLP
Schmidt & Clark, LLP focuses on helping individuals and families. The firm has built a reputation for success and represents their clients in group and individual lawsuits nationwide. Although Schmidt & Clark, LLP is national in scope, they level the playing field for their clients by providing them with access to a level of professional legal representation previously available only to large corporations while still providing personal attention to each client.
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