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A tip of the hat to our friend and former colleague Ken Zucker from Pepper Hamilton, who achieved this victory and sent us the decision.  In the consolidated California Byetta litigation, 2015 WL 663211 (Cal. Super. Feb. 26, 2015), defendant Eli Lilly & Co. moved for summary judgment in a Byetta pancreatitis case, arguing that, under the “learned intermediary” doctrine, it was entitled to summary judgment on plaintiff’s claims that Byetta’s pancreatitis warnings were inadequate.

Plaintiff cross-moved for summary adjudication, arguing that manufacturer’s duty to warn ran to the plaintiff because, pursuant to 21 C.F.R. §208, a required Medication Guide was provided to the patient when the drug was dispensed.    Id. at *1.  The plaintiff claimed that “the [Medication Guide] given directly to a patient changes or eliminates the traditional ‘learned intermediary’ defense [sic] for prescription medicines where the entire focus is on the adequacy of the warnings given to the  prescribing doctor, not the quality or accuracy of communications that may have come to the patient user’s attention.”  Id.

This was an attempt to revive a moribund would-be “exception” to the doctrine – involving then-novel FDA-mandated direct-to-patient oral contraceptive warnings – that gained a couple of adherents in the early to mid 1980s (Massachusetts and Oklahoma), and then promptly died out as its contradictions became increasingly overwhelming.  See In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law), which debunks this purported “exception” at some length.  Not a single jurisdiction had signed on with this exception in the last thirty or so years, and California in particular has never given it the time of day.

In the meantime, the FDA replaced its ad hoc oral contraceptive decision with a general medication guide requirement, such guides became routine, and adherence to the learned intermediary doctrine grew simultaneously with the ubiquity of medication guides.

The Byetta Court recognized this as it disagreed with the plaintiffs disco-era theory, holding, “[T]he Court is not persuaded in the absence of even one citable decision on point from any American jurisdiction that the now somewhat common FDA practice of requiring a Medication Guide for more than a trivial subset of all approved prescription drugs changes the entire existing common law.” Id.

Having confirmed that the “learned intermediary” doctrine was applicable to the case, the Court turned to testing the evidence of record on warnings.  The Court held, “After a careful review of the testimony of [the prescribing doctor] and the other relevant evidence, the Court concludes that defendants . . . have met their burden  to establish  . . . that [the doctor] would still have prescribed Byetta to the patient even if the label had been more direct or unequivocal in stating that Byetta “causes” pancreatitis for certain patients.”  Id.  Key to the Court’s holding was evidence demonstrating that:

  • Warnings given to the doctor and also to the patient alerted both to the association between Byetta and pancreatitis;
  • The doctor and the patient discussed the risk of pancreatitis before Byetta was described;
  • The doctor examined the plaintiff’s medical history to determine whether she was at a higher risk for pancreatitis but ultimately decided to prescribe Byetta instead of other diabetes drugs.

Id.  As such, “Plaintiff’s efforts to reconstruct  in the context of this litigation what ‘might have happened’ if a stronger warning was used by defendants is based on conjecture rather than admissible or persuasive evidence.”  Id. Check and mate – summary judgment for Lilly.  This simple analysis — doctor was aware of warning – doctor considered warning in light of patient’s circumstances – doctor prescribed drug anyway – is the essence of the learned intermediary doctrine and is so often obfuscated by courts superimposing “maybes” on the clear facts of a case.   Add to this the Court’s refusal to allow the presence of the Medication Guide to alter its analysis, and score a double victory for law and logic.