Austin v. Boehringer Ingelheim Corporation

Background

John Austin, who was representing himself, alleged that his wife, Lisa Austin, was prescribed and took Pradaxa (dabigatran), a prescription blood-thinning medication. He alleged that she later developed interstitial lung disease and died. Austin claimed that Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), which he said was responsible for Pradaxa in the United States, failed to warn about an association between the drug and interstitial lung disease. He asserted that BIPI had a duty to provide the warning under Food and Drug Administration rules and California law.

BIPI moved to dismiss Austin’s second amended complaint under Federal Rule of Civil Procedure 12(b)(6), which allows dismissal when a complaint does not plead enough facts to state a legally plausible claim.

Timeliness

BIPI argued that California’s two-year deadline for personal-injury and wrongful-death actions barred Austin’s claims. BIPI contended that the claims accrued when Lisa Austin died on November 2, 2018; that Austin’s original state-court complaint named Boehringer Ingelheim Corporation rather than BIPI; that BIPI was named in a later amended complaint that was not served on it; and that BIPI was not served with the second amended complaint until January 23, 2023.

The court declined to dismiss the case on this ground. It noted that the caption of the original complaint identified “Boehringer Ingelheim, a corporation,” while the complaint’s text referred to “Defendant Boehringer Ingelheim Pharmaceuticals, Inc.” The court also said the record was unclear about service and that BIPI, represented by the same counsel as Boehringer Ingelheim Corporation, would experience little or no prejudice.

Duty to Warn

BIPI argued that it had no duty to warn about an association between Pradaxa and interstitial lung disease. Under California law, the court explained, a drug manufacturer must warn physicians about risks that were known or scientifically knowable when the drug was distributed, but need not warn about risks that are merely speculative, remote, or insignificant.

The court found that Austin had plausibly alleged that BIPI knew or should have known about the association and failed to warn consumers and medical personnel. Austin cited and attached a report stating that Japan’s Ministry of Health, Labour and Welfare issued a 2011 alert that dabigatran might be associated with interstitial lung diseases, including deaths involving patients with preexisting interstitial pneumonia. The court said these allegations were sufficient at the pleading stage, while leaving open the possibility of revisiting the issue on a more developed factual record.

Federal Preemption

BIPI also argued that federal law impliedly preempted Austin’s failure-to-warn claim. Implied preemption can apply when it is impossible for a private party to comply with both state and federal requirements. The court discussed the federal “changes being effected” regulation, which permits a brand-name drug manufacturer to strengthen or add a warning without prior Food and Drug Administration approval when newly acquired information provides evidence of a causal association with a risk of harm.

The court explained that a state-law warning claim is preempted when there is clear evidence that the Food and Drug Administration would not have approved the required warning. It treated preemption as an affirmative defense, meaning a defense that generally must be established by the defendant. BIPI argued that Austin had to plead a labeling deficiency that BIPI could have corrected under the changes-being-effected regulation and had not alleged enough evidence of a causal association. The court declined to resolve that argument under Rule 12(b)(6), concluding that it raised factual issues better suited to a fully developed record. The court also noted that the Ninth Circuit had not adopted the threshold pleading rule urged by BIPI.

Disposition

Judge James Donato denied BIPI’s motion to dismiss. The court directed the parties to meet and confer about a proposed amended scheduling order allowing adequate time for discovery and trial preparation, and to file their proposed schedule jointly by June 2, 2023. The order did not decide whether BIPI is ultimately liable or whether Austin will prevail on his claims.