FDA Files Amicus Brief on Generic Drug Preemption

November 16, 2010

By Kurt R. Karst –   

Following up on a June 11, 2010 invitation from the U.S. Court of Appeals for the Sixth Circuit to file an amicus brief in the consolidated appeals of Smith v. Wyeth, Inc. (Case No. 09-5460), Wilson v. Pliva, Inc. (Case No. 09 5466), and Morris v. Wyeth, Inc. (Case No. 09-5509),  FDA filed its brief earlier today answering the question: “Whether federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled.”  FDA’s amicus brief reflects the same position on generic drug preemption that the Solicitor General took in his November 2, 2010 amicus brief submitted to the U.S. Supreme Court on this topic (see our previous post here).

The consolidated Wyeth cases before the Sixth Circuit all concern the drug metoclopramide, which is marketed under the brand-name REGLAN.  The plaintiffs in each case allege that the metoclopramide they took was defective because both the generic and brand-name manufacturers failed to adequately warn of the risks of long-term use (i.e., tardive dyskinesia).  In each case, a district court dismissed the plaintiff’s claims against the generic drug manufacturers, holding that their failure-to-warn claims were preempted by federal law.

Although we are still poring over FDA’s 44-page amicus brief to see what nuggets it might contain, here is the summary of the Agency’s argument:

The district court incorrectly held that plaintiffs’ failure-to-warn claims against generic drug manufacturers are categorically preempted by the FDCA and FDA’s regulations.  The district court’s decision is inconsistent with the decisions of the only courts of appeals to address the question since Wyeth v. Levine, 129 S. Ct. 1187, 1196 (2009)Demahy v. Actavis, 593 F.3d 428, 449 (5th Cir. 2010); Mensing v. Wyeth, Inc., 588 F.3d 603, 612 (8th Cir. 2009).  Though federal law may circumscribe the possible theories of recovery by plaintiffs, it does not present an outright bar to recovery.

Plaintiffs’ failure-to-warn claims are not categorically preempted, because a generic pharmaceutical manufacturer, like a brand-name manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug.  Furthermore, though the “changes being effected” and prior approval supplement processes were not expressly available to generic manufacturers, the defendants could have asked FDA to coordinate appropriate “Dear Health Care Professional” letters or to take other action with respect to labeling.  Moreover, holding a generic pharmaceutical manufacturer liable on a failure-to-warn theory would not unacceptably frustrate the purposes of the Hatch-Waxman Amendments.

Now that FDA has shown its cards, it will be interesting to see whether the new Congress, once it convenes in January, will take interest in the issue of generic drug preemption.  In 2009, Sen. John Cornyn (R-TX) filed an amendment to pending legislation that, if enacted, would preempt tort suits against generic drug makers.  Specifically, Sen. Cornyn’s amendment would have amended the law to state:

Notwithstanding any other provision of State or Federal law, a person who manufacturers a generic drug approved under an abbreviated new drug application shall not be liable because the label did not warn against an adverse reaction, unless the Food and Drug Administration required a change to the label to provide such warnings and the manufacturer failed to comply with such requirement, or the manufacturer failed to provide to the Food and Drug Administration health and safety information otherwise required to be provided under regulations issued by the Secretary for Health and Human Services regarding such drug.

It is possible that similar legislation could be introduced in the 112th Congress. 

Categories: Hatch-Waxman