Akman v. Bayer Healthcare Pharmaceuticals, Inc.

Background

Jennifer Akman alleged that she was prescribed Cipro or generic ciprofloxacin in November 2013, stopped taking it within 24 hours because of a severe adverse reaction, and continued to suffer nerve damage and other injuries. She alleged that the Food and Drug Administration had approved an updated warning about peripheral neuropathy in August 2013, but the generic defendants had not updated their labels and other product information to match it.

Akman filed claims under District of Columbia law against Bayer defendants, Cobalt Laboratories, and Actavis Pharma. The Bayer defendants were later dismissed under a stipulation. The case was transferred to the District of Minnesota for pretrial proceedings in the fluoroquinolone multidistrict litigation. Akman later filed a short-form complaint incorporating the multidistrict litigation’s master complaint.

Cobalt and Actavis, identified in the opinion as the generic defendants and succeeded by Teva Canada, moved for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). That procedure uses the same standard as a motion to dismiss for failure to state a claim: the complaint must include enough factual allegations to present a plausible claim for relief. Akman asked for permission to amend if the court found her allegations insufficient.

Federal Preemption

Federal preemption can prevent state-law claims when federal law makes it impossible for a private party to comply with both federal and state requirements. The Supreme Court has held that generic drug manufacturers generally cannot unilaterally strengthen their warnings or redesign their products because federal law requires generic and brand-name products to remain the same in relevant respects.

The court distinguished those decisions from Akman’s theory. She alleged that the generic defendants failed to update their product information to match an FDA-approved warning already adopted for the brand-name drug. The court held that such a failure-to-update claim is not facially preempted when it is limited to injuries caused by the difference between the non-updated and updated warnings, and when the claim is based on an independent state-law duty that would exist even without the federal law.

The court also explained that a plaintiff cannot use state law merely to enforce the federal Food, Drug, and Cosmetic Act. A claim may proceed only if the conduct both violates federal law and independently supports recovery under state law.

Pleading Deficiencies

The court found that Akman’s Initial Complaint and Short Form Complaint did not adequately state the potentially valid failure-to-update theory. First, the Initial Complaint was not limited to alleged injuries caused by the failure to update the product information. Second, it did not connect the defendants’ alleged duty to update to District of Columbia law. Third, it included allegations resembling traditional failure-to-warn claims, which the court treated as preempted, without making clear which causes of action relied on the potentially non-preempted theory.

Disposition

The court GRANTED the defendants’ Motion for Judgment on the Pleadings. It DISMISSED WITHOUT PREJUDICE both Akman’s Complaint and Short Form Complaint, granted her leave to file an amended complaint within 30 days, and required both parties to file memoranda within 15 days after that filing addressing whether the case should be transferred back to the U.S. District Court for the District of Columbia or continue in the fluoroquinolone multidistrict litigation. Chief Judge John R. Tunheim did not rule that every failure-to-update claim is preempted; instead, he ruled that Akman’s existing pleadings were insufficient and allowed her to amend.