United States: A Generic Drug Failure To Warn Claim?

Last Updated: April 25 2019
Article by Michelle Yeary

No.  It can't be.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that.  Just look at our generic preemption scorecard – the proof is there.  The warnings on generic drugs must be the "same" as those on branded drugs.  Generic drug manufacturers cannot unilaterally alter, amend, or change any warning and therefore all warning related claims against them are preempted.  Well, that is unless you're in the Seventh Circuit and the court finds a way to use the express preemption decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to taint what should otherwise have been a slam dunk implied preemption dismissal.

Lempa v. Eon Labs, Inc., 2019 U.S. Dist. LEXIS 54868 (N.D. Ill. Mar. 29, 2019) is an amiodarone case.  You'll find lots of amiodarone decisions on our blog.  Most of them, outside Illinois, are favorable.  So what happened here?  Plaintiff alleged that his wife was prescribed amiodarone, a generic drug, to treat her atrial fibrillation.  This was an off-label use.  Id. at *1.  Plaintiff's wife unfortunately suffered from respiratory failure which was fatal.  Id.  Which we also know from other amiodarone cases is a known and warned of risk of the drug.

Plaintiff brought claims for failure to warn, negligence per se, and fraudulent concealment.  All three claims were based on two allegations – defendant negligently promoted the drug for an off-label use and defendant failed to provide plaintiff with a Medication Guide in violation of FDA regulations.  The decision pays lip-service to both Mensing and Mutual Pharm. Co., Inc. v. Bartlett, 570 U.S. 472 (2013) by saying:

To the extent that [plaintiff's] claims are premised on an argument that [defendant's] warnings or labeling (or both) were inadequate, [defendant] is correct.

Lempa, 2019 U.S. Dist. LEXIS 54868 at *9.  And, that sentence should have continued with BUT . . . .  Because what comes next is a complete undermining of those Supreme Court decisions.

Rather than focusing on what plaintiff's off-label marketing claim really was – a claim that defendant's label should have contained different information or warnings about off-label uses – an impliedly preempted claim, the court got distracted trying to fit the case in under Bausch and started talking about parallel violation claims.  The court found that because plaintiff was alleging a violation of federal regulations, his claims "run parallel to [defendant's] state law duties," and thus were not preempted. Id. at *10-12.  The problem with this is that Mensing is not an express preemption case.  It was an implied preemption case, and the district court had no business applying "parallel claim" analysis to implied preemption, where a "parallel claim" exception does not exist.  It makes no difference whether plaintiff's off-label promotion claim is "parallel" to federal regulations, defendant could not have offered any different warning so any claim that the warning or information it provided was inadequate is preempted under Mensing.  The court was trying to fit a square peg into a round whole – and the only way that works is to cut off the corners.

As for the claim of failure to provide a Medication Guide.  Two circuit courts have ruled on the issue.  The Eleventh Circuit found the claim failed under the learned intermediary doctrine (Tutwiler v. Sandoz, Inc., 726 F. Appx. 753719024 (11th Cir. 2018) (discussed here)) and the Sixth Circuit found it was preempted (McDaniel v. Upsher-Smith Labs, Inc., 893 F.3d 941 (6th Cir. 2018) (discussed here)).  Either way, it didn't survive.  We already know where the district court came out on preemption.  It didn't get learned intermediary correct either.

Again, the court started with an acknowledgement that "prescription drug manufacturers have a duty to warn health-care professionals – but not the ultimate end-consumer – of the risks associated with its product. Lempa at *13.  Here comes another BUT . . . .  The court agreed with plaintiff that the learned intermediary doctrine doesn't apply if the defendant's warning was inadequate.  Specifically, the court found:

The Court agrees that there is, at least, a question of fact about [defendant's] warnings to [plaintiff's wife's] doctor about off-label uses of amiodarone. [Plaintiff] alleges, among other things, that [defendant] "did not include warnings to prescribing physicians of amiodarone of the potential dangers associate with amiodarone toxicity and dangers to atrial fibrillation patients." This precludes application of the learned intermediary doctrine at this stage of the litigation.

Id. at *13-14.  Whoa, whoa, whoa.  The court completely missed that it was basing its learned intermediary ruling on a failure to warn claim that should have been preempted under Mensing.  To go back to before the first BUT – the court did rule that plaintiff was "not permitted to argue that [defendant's] labels were inadequate, because those claims are preempted under Mensing and BartlettId. at *12-13.  So, any claim that defendant failed to include any warnings should be preempted.  But more importantly, the court misunderstands how the learned intermediary doctrine works.  That the doctor allegedly received an inadequate warning doesn't change to whom the warning must be given and spontaneously create a duty to warn the patient directly.  The adequacy of the warning goes to whether the defendant can prevail on the warning claim.  Something that shouldn't be an issue here because any adequacy claim is preempted.  Since there is no duty to warn a patient directly, plaintiff's Medication Guide claim is solely based on FDA regulations requiring that one be provided.  As such it's an impermissible attempt at private enforcement of the FDCA and therefore preempted by Buckman.  In other words, even if you accepted the court's introduction of "parallel violations" into generic drug warning claims – which you should by no means ever do – the court still got it wrong here by finding the duty to provide a Medication Guide was parallel to a state duty that doesn't exist.

The whole decision is improperly influenced by Bausch and the mixing of preemption concepts that simply don't combine.  Parallel violations and generic warning preemption should be considered like oil and water, like forks and power outlets, like orange juice and toothpaste, like celebrities and tweeting.  Two things that shouldn't be used together.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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