Topiramate – Generic Forms of Topamax

Can generic drug makers be sued for not warning about potentially dangerous side effects on their drug labels, even when they follow federal rules that only require their labels to match those of their brand-name equivalents?  This is an interesting concern that has not yet been formally addressed.

Some generic manufacturers of Topamax® include:

  • Apotex Corporation
  • Aurobindo Pharma
  • Mylan Pharmaceuticals
  • Ranbaxy Pharmaceuticals, Inc.
  • Roxane Laboratories, Inc.
  • Teva Pharmaceutical Industries, Ltd.

There have been Failure to Warn claims filed against generic manufacturers of Topamax, but these claims may be in jeapardy.  In December of 2010, the United States Supreme Court upheld a decision that could preempt failure to warn claims against generic makers (Pliva v. Mensing).

In California, there was an innovator liability claim against the patent-holder for a generic maker’s failure to warn (Conte v. Wyeth), but so far, no other state has adopted this theory.

In sum, it is currently unclear whether the generic manufacturers of Topamax will be held liable for any birth injuries resulting from taking a generic form of Topamax during the first trimester of pregnancy.  If you have taken any of the generic medications above, and have given birth to a baby with birth defects, please call one of our Topamax side effects lawyers right away so we can discuss your case with you.