Plaintiffs’ Fraud-On-The-FDA Claim Preempted By Federal Law

Print Print

Last month, a West Virginia state judge granted summary judgment for Pfizer on the basis that the manufacturer was immune from suit pursuant to statutory state law barring product liability suits for manufacturers, like Pfizer, who properly obtained FDA approval of its drug. The Court further held that Plaintiffs failed to make out any exception to such bar because the fraud-on-the-FDA exception Plaintiffs attempted to rely on was preempted by federal law.

In M.M., and Maskill v. Pfizer, Inc., et al., Plaintiffs sued Pfizer based on alleged injuries caused by ingesting Zoloft while pregnant, which Plaintiffs claimed caused birth defects.  Plaintiffs pled various causes of action including strict liability, failure to warn, and negligence.  Plaintiffs also sought punitive damages.

The Court first addressed what is often an initial question in product liability suits: what substantive law applies?  Here, the West Virginia Court concluded that Michigan law governed Plaintiffs’ claims because Plaintiffs were nonresidents and Michigan was the place of Plaintiffs’ injury, where Plaintiff was prescribed Zoloft, ingested the drug, resided during her pregnancy, and where the minor was born and treated for her injuries.

Under Michigan law, a drug manufacturer that has properly obtained FDA approval of a drug has acted sufficiently prudent that “no tort liability may lie.” See Mich. Comp. Laws § 600.2946(5).  The Court found that the elements of this statutory bar had been satisfied because Zoloft was approved by the FDA and its labeling was in compliance with the FDA’s approval.  As a result, the Court found that the Michigan statute required dismissal of Plaintiffs’ claims, unless Plaintiffs could establish an exception to Pfizer’s immunity.

In an attempt to sidestep Michigan’s statutory bar, Plaintiffs argued that the so-called “fraud-on-the-FDA exception” applied.  In order to make out such an exception, Plaintiffs were required to establish that: 1) Pfizer intentionally withheld from or misrepresented to the FDA information concerning Zoloft; 2) the information was required to be submitted under the federal Food, Drug, and Cosmetic Act (“FDCA”); and 3) the drug would not have been approved or the FDA would have withdrawn approval of Zoloft had the information been accurately submitted.

The Court concluded that Plaintiffs failed to make out the exception in order to defeat Pfizer’s immunity.  In doing so, the Court explained that Plaintiffs merely cited to vague allegations that Pfizer represented to the FDA that Zoloft was safe and effective and concealed knowledge that Zoloft can cause birth defects to persons exposed in utero.  The Court, however, emphasized that Plaintiffs could not establish the exception without “concrete evidence,” which Plaintiffs failed to allege.  The Court found that Plaintiffs failed to show that relevant material information required to be submitted to the FDA was withheld or that any information allegedly withheld would have caused the FDA to refuse to approve Zoloft or to withdraw the drug’s approval.  Indeed, the FDA was aware of the results of animal tests, adverse event reports, and language regarding contraception use in Pfizer’s foreign labels, but Zoloft continues to be marketed with FDA approval.  As a result, the Court held that Plaintiffs failed to satisfy their burden of proving an exception to Michigan’s statutory bar preventing suit against Pfizer.

Despite finding that Pfizer was immune from suit, the Court still went on to conclude that even if Plaintiffs had presented sufficient evidence, their claims would nevertheless fail because the fraud-on-the-FDA exception was preempted by federal law based on the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  There, the Supreme Court held that state law causes of action that require evidence that a manufacturer submitted false or misleading information to the FDA are impliedly preempted because “the federal statutory scheme empowers the FDA” and not citizens “to punish and deter fraud against the administration.”  The Supreme Court emphasized that such fraud-on-the-FDA claims would cause “applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.  Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA’s evaluation of an application.”

In further support of its conclusion that the exception was preempted, the West Virginia Court also relied on the Sixth Circuit’s decision in Garcia v. Wyeth-Ayerst Laboratories, which interpreted Buckman, and held that the fraud-on-the-FDA exception in the Michigan statute was preempted and thus, was only available if the FDA itself determined that a fraud was committed on the agency during the regulatory-approval process.  Moreover, the Fifth Circuit likewise held the same under an analogous Texas statute.  Applying the same reasoning here, this Court found that Plaintiffs failed to allege the FDA had ever made a determination of fraud regarding Zoloft or that Pfizer fraudulently obtained FDA approval for the drug.

Despite this clear preemption law dictated by the Supreme Court, and likewise followed by other circuits, Plaintiffs asked the Court to instead follow the Second Circuit’s decision in Desiano v. Warner Lambert & Co.  However, the Court found that the Desiano decision was not only inconsistent with other more recent circuit court decisions, but could not be reconciled with the Supreme Court’s decision in Buckman, which clearly held that a plaintiff must plead and prove that the FDA itself determined that it was defrauded.  In sum, the Court found that allowing fraud-on-the-FDA claims to proceed would “risk[] causing the deluge of information to the FDA that the Supreme Court feared.”

We will continue to report on notable preemption cases, like this one, as they arise.