Lyons v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 5835125 (N.D. Ga. Sept. 29, 2020), was a wrongful death action alleging that the anticoagulant drug Pradaxa was defective and not accompanied by adequate warnings that blood plasma concentrations should be monitored and that certain patient characteristics, such as age, renal impairments, and concomitant statin use, could increase risks of severe bleeding. The design defect claim turned out to be wholly premised on the alleged failure to warn, and the failure to warn claim turned out to be wholly preempted. Thus, the Lyons case is consistent with other Pradaxa cases arriving at the same result, and represents a sound application of the SCOTUS Albrecht opinion. (We discussed these Pradaxa cases here and here, for example.)
To try to get around the preemptive effect of an FDA-approved drug label,the plaintiff in Lyons contended that the drug manufacturer could have submitted a Changes Being Effected regarding the needs for plasma monitoring and paying attention to certain patient characteristics. But the Lyons court rejected this contention because there was no “newly acquired information” supporting the new warnings and, in any event, the extensive record of information exchanges between the manufacturer and the FDA provided “clear evidence” that the FDA would have rejected the proposed new warnings.
The issues of newly acquired information and likely rejection by the FDA go together, of course. All of the supposedly new papers, analyses, emails, European labels, etc. regarding the drug’s safety either contained information the FDA already had, or were not so much new information as mere “trial balloons.” There was simply no basis furnished by the plaintiff to suggest that the FDA would have seen fit to add warnings to the label. Moreover, based on all this information, the FDA had twice rejected some of the warnings, reasoning that “independent risk factors for bleeding … do not need to be specifically in the label” because “we do not want the [label] to become too long to be useful.”
One of the more interesting aspects of Lyons is the issue about whether the judge or jury decides the issue of “newly acquired information.” In Albrecht, SCOTUS decided that it is up to the judge, not the jury, to determine whether the FDA would have rejected the proposed warning. That means summary judgment is possible on that issue. But the plaintiff in Lyons argued that, despite Albrecht, “newly acquired information” is an issue for the jury. That position would go a long way toward making summary judgment impossible – the plaintiff’s goal. Like other courts that have tackled this point, the Lyons court held that the logic of Albrecht means that whether something is “newly acquired information” must be decided by the court, since that issue is usually a predicate for the issue of likely FDA rejection. Applying this analysis, the Lyons court granted the defendant summary judgment.
Inasmuch as Lyons falls in line with other cases, perhaps its ruling does not constitute newly acquired information. But it is helpful and reassuring nonetheless. Clear evidence of judicial rationality is always welcome.