Supreme Court Agrees to Hear Warner-Lambert Preemption CaseSeptember 26, 2007
We previously reported on several cases involving FDA-regulated products and certain preemption of state law issues. Yesterday the Supreme Court agreed to hear (i.e., granted Cert. [see page 5]) in one of those cases – Warner-Lambert v. Kent. The case concerns Warner-Lambert’s REZULIN (troglitazone), certain people alleging injuries caused by the drug product, and a Michigan law immunizing pharmaceutical companies from products liability claims except in cases of "fraud-on-the-FDA." Warner-Lambert petitioned the Court for Cert. after the U.S. Court of Appeals for the Second Circuit ruled against the company earlier this year.
The questions presented for the Court’s review are:
1. Whether, under the conflict preemption principles in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), federal law preempts state law to the extent that it requires the fact-finder to determine whether the defendant committed fraud on a federal agency that impacted the agency’s product approval, where the agency — which is authorized by Congress to investigate and determine fraud — has not found any such fraud, and thus — as in Buckman — the state requirement would interfere with the agency’s critical functions.
2. Whether, under the conflict preemption principles in Buckman, federal law preempts the provision in a Michigan statute that allows a product liability claim to be maintained against a manufacturer of an FDA-approved drug where, without an FDA finding of fraud on that agency, the fact-finder is required to make a finding under state law as to whether the manufacturer committed fraud-on-the-FDA and whether, in the absence of that fraud, the FDA would not have approved the drug.
Copies of documents submitted in this case are available from our previous post and from SCOTUSblog.
Warner-Lambert is the second preemption case the Supreme Court is scheduled to hear next term. Earlier this year, the Court granted Cert. in Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval process (see 7/8/2007 FDA Law Blog post). It has been rumored, however, that the Court might toss out the case on a technicality. Specifically, because the man who brought the suit died in 2004 and no attempt was made to transfer the case from his name to his wife’s name until earlier this year, the Court’s rules, which do not permit such a long delay, might be grounds for rejecting the case.
Finally, the Supreme Court has asked the Solicitor General to submit comments in yet a third preemption case — Levine v. Wyeth (see 7/8/2007 FDA Law Blog post). The case concerns whether FDA-approved prescription drug labeling preempts state law product liability claims.