Today, the United States Court of Appeals for the Eighth Circuit heard oral argument on whether a failure to warn claim against a generic drug manufacturer is preempted.  We discussed this legal issue in a previous blog entry.

The case in which the 8th Circuit heard oral argument was Mensing v. Wyeth, Inc., et al., No. 08-3850.  Gladys Mensing took Metoclopramide, the generic version of Reglan.  She then developed Tardive Dyskinesia, an often permanent disorder that causes involuntary movements of the body, especially of the lower face.  Tardive Dyskinesia is now known to be caused by prolonged use of Reglan/Metoclopramide.  The district court dismissed Ms. Mensing’s claim on preemption grounds.

Gladys Mensing's attorneys are Michael K. Johnson and Lucia J.W. McLaren, both of Goldenberg & Johnson, P.L.L.C.  An audio recording of the complete oral argument is available HERE.

We often hear that generic drugs are the same as name brand drugs, only they cost less.  But not according to drug manufacturers.  Drug companies are currently arguing to courts around the country that they have less of an obligation to warn of dangerous side effects for the generic versions of their drugs.  This means if you’ve been injured after taking a generic drug, you may have less rights than if you were injured after taking the brand name version of the same drug.

Earlier, drug manufacturers claimed that once the Food and Drug Administration (FDA) approved a brand name drug’s label, including its warning, a person injured by a drug side effect could not sue the manufacturer for failing to warn of the side effect.  The Supreme Court of the United States rejected this argument in a decision issued earlier this year.  Wyeth v. Levine, 129 S. Ct. 1187 (2009).

Despite this Supreme Court decision, drug manufacturers are now asking courts to bar similar claims brought by persons injured by generic drugs.  The drug companies argue that because the FDA has approved their generic versions of the drugs with labels that are the same as the labels first approved for the brand name version of the drug, they cannot change their labels without violating federal law.  They make this argument despite the fact that manufacturers of the brand name drug must keep their warnings up to date, and can still be sued when their warnings are inadequate and cause an injury.

At the moment, California residents are safe from this absurd argument.  Last September, a California Court of Appeal rejected the preemption argument made by a manufacturer of metoclopramide, the generic version of Reglan.  McKenney v. Purepac Pharmaceutical Company, No. F052606 (Sept. 25, 2008).  Ms. McKenney developed tardive dyskinesia from taking metoclopramide, after the risk of this side effect was downplayed in Purepac’s warning label.

Unfortunately, generic drug manufacturers are continuing their fight to take away the rights of consumers injured by generic drugs.  While federal courts in New Hampshire, Illinois, Oklahoma and Louisiana have ruled against the drug manufacturers, they have appealed, and the issue is now pending before federal appellate courts in the 5th, 6th and 8th Circuits.  Also, Senator John Cornyn (R-TX) has filed an amendment to the health care reform bill that would make the generic drug manufacturers’ argument federal law.