By Robert B. Barnett Jr., J.D.
In a class action against Abbott Laboratories for serious birth defects allegedly caused by the drug Depakote, Abbott is fully immune from suit under a broad Michigan law protecting manufacturers and sellers of drugs that have been approved by the FDA, a federal district court in Illinois has ruled in granting Abbott’s motion for summary judgment. Abbott’s civil and criminal problems related to its off-label marketing and use of Depakote did not negate the immunity because none of the plaintiffs used Depakote for off-label purposes (In re Depakote: Alexander v. Abbot Laboratories, Inc., September 27, 2017, Rosenstengel, N.).
The FDA approved the drug Depakote for treating conditions such as epilepsy, bipolar disorder, and migraines. Pregnant women who took Depakote, however, gave birth to children with serious birth defects. As a result, multiple class actions suits arose nationwide, alleging that Abbott failed to warn pregnant women of the risks even though Abbott knew or should have known the true risks. One of those class action suits was filed in the Southern District of Illinois. No dispute existed in this case that, under Illinois choice of law principles, Michigan law applied to the claims. Abbott filed a motion for summary judgment, contending that it was immune from suit under Michigan law.
Immunity. Under Michigan law, a drug manufacturer or seller is immune from suit if the drug has been approved by the FDA (Mich. Comp. Ann. §600.2946(5)). The Michigan legislature carved out two exceptions: (1) if the manufacturer or seller made misrepresentations to the FDA in obtaining approval, and the FDA would have withdrawn approval if the information were accurate and (2) if the manufacturer or seller bribed the FDA to obtain approval. Because neither exception applied here, the immunity provision seemed to protect Abbott.
The mothers, however, made one other argument. They argued that Abbott’s off-label use of Depakote negated FDA approval, and, thus, negated the immunity. It is true, the court said, that Abbott was guilty of off-label uses of Depakote to treat conditions such as dementia and schizophrenia. In fact, Abbott pleaded guilty to criminal charges for the off-label uses. But did that improper use of the drug negate immunity? The Sixth Circuit, in Marsh v. Genentech, Inc., 693 F. 3d 546 (6th Cir. 2012), found that the defendants’ post-approval conduct did not thwart the Michigan law’s immunity. In addition, the court said, no other authority exists for the proposition that misconduct unrelated to the allegations in the complaint eviscerated the immunity.
Three facts further undermined the mothers’ argument. First, all of the mothers’ prescribed uses of Depakote were on-label. Second, the Depakote labels did not vary from the FDA-approved label. Third, none of the mothers ever received any off-label marketing material.
Preemption. The court then returned to the argument of fraud upon the FDA, the first of the two exceptions in the Michigan immunity law. The court, accepting the rationale of the Fifth and Sixth Circuits, ruled that the mothers’ claims were preempted by federal law absent a federal determination of fraud, which never occurred. Furthermore, the court said, a determination of federal preemption did not render the remainder of the statute, including immunity, inoperable.
The case is No. 12-CV-52-NJR-SCW.
Attorneys: Christopher F. Cueto (Law Office of Christopher Cueto) for Rhealyn Alexander. David S. Gray (Venable LLP) for Abbott Laboratories Inc.
Companies: Abbott Laboratories Inc.
MainStory: TopStory DefensesLiabilityNews DrugsNews MichiganNews IllinoisNews
Interested in submitting an article?
Submit your information to us today!Learn More