Ortho-McNeil’s Topamax drug, initially approved to treat partial onset seizures and migraines, has been re-categorized to a Pregnancy Class D drug due to the high risk
of cleft lip or cleft palate development.
Previously listed as a Pregnancy Category C drug, the North American Antiepileptic Drug Pregnancy Registry found mothers were 21 times more likely to give birth to a child with cleft lip or cleft palate when taking Topamax during the first trimester of pregnancy.
The FDA notified the medical community and the public in May 2011 that women should seek options other than Topamax during pregnancy.
Ortho-McNeil, a Johnson & Johnson company, was fined $6.14 million for illegally promoting Topamax uses which were not approved by the FDA as the company pled guilty to one count of a misdemeanor violation for the Food, Drug and Cosmetic Act.
Janssen Pharmaceuticals, also associated with Ortho-McNeil, agreed to pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax for non-FDA approved uses.
The FDA recommends that women who continue to take Topamax should use effective birth control, noting that these contraceptives may be less effective when used with Topamax.
Steps to Take After Injury or Death Due to a Defective Product
The first step to take if you have been injured by a product that is defective is to ensure that the product is not lost or destroyed.
If you do not have access to the product, contact us immediately because we will take the steps necessary to preserve the product before it’s destroyed.
Under products liability law, it’s the injured party’s burden to prove that the product was defective. Therefore, it is important that the product be inspected by one or more qualified experts to determine the exact nature of the defect and whether that defect caused the harm suffered. If the product is not recovered, the customer may be left with no proof that the product was defective.
Dangerous, defective, improperly labeled or improperly used products are everywhere.
Examples of products which we believe to be defective products include:
- Durom Cup
- Yaz
- Chinese Drywall
- LG washers
Defective and dangerous products, marketing defects, and manufacturing defects have the ability to cause serious injuries, permanent disabilities, and potentially death. Types of defective products may include consumer products, defective automobiles, defective medical products, and dangerous drugs.
You need an experienced products liability attorney to protect your rights. The defective drug and device lawyers at the Strom law firm are experienced in investigating the injury, determining all potentially responsible parties, and proving that the defective product caused your injuries.
As your products liability attorneys, we know how to protect your rights, establish liability for the product and recover the maximum amount of compensation for a defective product injury available to you under the law.
If you or a loved one has been seriously injured or died as a result of a defective product, contact the Strom Law Firm, LLC today for a free consultation with one of our dangerous products and South Carolina wrongful death attorneys today to discuss the facts of your case.
