Akman v. Bayer Healthcare Pharmaceuticals, Inc.

Background

Jennifer Akman alleged that she took ciprofloxacin in November 2013, stopped within 24 hours after a severe reaction, and then experienced continuing nerve damage and other injuries. She alleged that the generic ciprofloxacin label used when she received the medication did not include an updated warning approved by the Food and Drug Administration in August 2013. That warning described the potential rapid onset and risk of irreversible peripheral neuropathy and removed language stating that neuropathy was a rare side effect.

Akman brought claims under District of Columbia law for strict liability, products liability based on failure to warn, negligence, negligent misrepresentation, and unlawful or deceptive trade practices. The court had previously granted defendants’ first motion for judgment on the pleadings, but allowed Akman to amend her complaint. Defendants then filed a second motion under Federal Rule of Civil Procedure 12(c), which allows judgment based on the pleadings when no material factual issue remains and the moving party is entitled to judgment as a matter of law.

Claims That Could Proceed

The court held that District of Columbia law imposes a duty of ordinary or reasonable care on a manufacturer or seller. That state-law duty was enough for Akman to plead negligence-based claims that were not preempted by federal law. The court said the FDA-approved warning could plausibly serve as a measure of what a reasonable manufacturer should have done, even if federal law did not independently require the defendants to provide that warning.

The court therefore denied defendants’ motion as to Count III, negligence, and Count IV, negligent misrepresentation. It also denied the motion as to Count X, brought under the District of Columbia Consumer Protection Procedures Act. The court found that Akman had plausibly alleged violations of District of Columbia law and that the same conduct’s possible violation of federal law did not make compliance with state law impossible.

The court cautioned that allowing these claims to proceed did not establish that Akman would ultimately prove them. It noted possible factual issues concerning whether the defendants acted reasonably given the time between the August 2013 label update and the changes to their labels, as well as the possible effect of the learned-intermediary doctrine. The court also stated that any recovery for negligence would be limited to damages attributed solely to differences between the label Akman received and relied on and the FDA-approved August 2013 label.

Claims Dismissed

The court granted defendants’ motion as to Counts I and II, Akman’s products-liability claims. It found that those claims were not sufficiently connected to District of Columbia law. For example, one claim alleged only that defendants had a duty to provide warnings consistent with those required by the FDA.

The court concluded that the source of those claims was the federal requirement that generic-drug labels match the brand-name label, rather than the state-law duty of reasonable care. Because individuals cannot enforce the federal Food, Drug, and Cosmetic Act through a private lawsuit, the court found that Akman had not identified an independent, non-preempted state-law basis for Counts I and II.

Remand Recommendation

The case had been transferred to the multidistrict litigation proceeding in the District of Minnesota after removal from the District of Columbia. The parties jointly agreed that it should return to the federal court in the District of Columbia.

The court recommended that the Judicial Panel on Multidistrict Litigation remand the case to that transferor court. It reasoned that Akman’s case involved unique legal and factual issues, different defendants from the remaining cases, and no likely benefit from further pretrial coordination. The recommendation was not itself the final remand decision; the opinion states that the Judicial Panel has final authority to remand a case during the pretrial period.

Disposition

The order denied in part and granted in part defendants’ motion for judgment on the pleadings: it denied the motion as to Counts III, IV, and X and granted it as to Counts I and II. It also recommended remand to the United States District Court for the District of Columbia.