Take Two: Missouri Court Looks Past Mensing Pre-Emption in a Claim Against a Generic Drug Manufacturer and Rejects Innovator Liability for Brand-Name Drug Manufacturers


By: Gautam Y. Reddy

The liability of brand-name and generic drug manufacturers regarding failure to warn claims continues to be a hot button issue in state courts across the country. Just two weeks ago, we wrote about how the Alabama Supreme Court held that a brand-name manufacturer could be liable for injuries caused by ingestion of a generic version of its drug. This week, a Missouri appeals court reached the opposite conclusion with respect to a brand-name drug manufacturer, but recognized an end-around the typical Mensing pre-emption for the generic drug manufacturer. (The cases are Franzman v. Wyeth, Inc., et al., case no. ED100312, and Nicely v. Wyeth, Inc., et al., case no. ED100313, both in the Missouri Court of Appeals, Eastern District).

As stated above, these issues stem from a Supreme Court decision (Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011)) holding that generic drug manufacturers generally can’t be held liable under state law for failure to warn. This is because the generic manufacturers are legally required to use the exact warning labels that the brand-name manufacturer uses.

Circling back to our Missouri cases, the plaintiffs filed suit against both the brand-name and generic manufacturers for failure to warn. The generic manufacturers moved to dismiss the claims against them, arguing that Mensing barred all state law failure to warn claims against a generic manufacturer.  The trial court agreed and dismissed these claims.  The Missouri court of appeals, however, disagreed. It found that the generic manufacturers had failed to update the warning label on the drug at issue. Mensing is predicated on the duty generic manufacturers have to keep their warnings identical to the brand-name warnings. The appeals court reasoned that if a generic manufacturer fails to do this, it is no longer protected from liability by Mensing.

As to the brand-name manufacturer, the trial court also granted its motion to dismiss the plaintiff’s claims because the plaintiff never ingested its product. Here, the appeals court agreed with this reasoning and affirmed the dismissal of the brand-name manufacturer. Thus, unlike the Alabama Supreme Court, this Missouri court flat out rejected any notion of “innovator liability” on the part of the brand-name manufacturer.

These cases are an example of the constantly shifting landscape at the state level for generic drug and brand-name drug manufacturer liability. In just the past few weeks, we have seen two different approaches by state courts regarding innovator liability. We will be closely monitoring how other state courts address this issue and what consequences these decisions and any reactionary regulation from the FDA and/or Congress will have on both brand-name and generic drug manufacturers involved in this type of litigation.