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That seems like it should be an obvious statement.  FDA regulations draw important distinctions between brand drugs and generic drugs.  A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials.  Once approved, that drug becomes the reference list drug.  If a manufacture wants to market a generic version of the drug, it need only prove the drug is equivalent to the reference list drug.  Further, while the manufacturer of the brand or reference list drug is responsible for ensuring the adequacy and accuracy of the drug’s warning label, the generic manufacturer is only responsible for ensuring that the generic label is the same as the brand’s.  Therefore, only brand manufacturers have the ability, in certain circumstances, to change the drug’s label without the need for prior FDA approval under the Changes Being Effected (“CBE”) regulations.  This key distinction led to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  Because generic drug manufacturers are prohibited from modifying a drug’s warnings except to match the brand’s warnings, failure to warn claims against generic manufacturers are barred by impossibility preemption—it is impossible for a generic manufacturer to comply with both the FDA’s requirements that the label remain the same and a state law requirement to make the label different.

But the plaintiff in Swinney v. Mylan Pharmaceuticals, Inc., 2023 WL 2090702 (N.D.Ga. Feb. 17, 2023) wanted the court to change the Mensing rules in cases where the brand manufacturer has opted to stop selling the branded drug.  Defendant manufactured a generic version of a birth control medication that was prescribed to plaintiff’s wife.  Plaintiff alleged that defendant’s drug caused his wife to suffer a fatal blood clot and that the drug’s label did not adequately warn of the increased risk for blood clots for women with a BMI over 30.  Id. at *1.  Plaintiff conceded that all of his claims were based on an alleged breach of the state-law duty to warn and that in most circumstances would be preempted by Mensing.  In this case, however, the brand drug was no longer on the market.  So, plaintiff argued that when the brand manufacturer leaves the market, the generic manufacturer must “assume” responsibility for the adequacy and accuracy of the warnings.  Plaintiff cited no support for this position that a generic drug’s status changes if the brand is withdrawn from the market.  Because there is none.  Moreover, plaintiff did not claim that the generic manufacturer could unilaterally change the drug’s warnings using CBE regulations.  Because it can’t.  The generic drug remains a generic drug and the generic drug manufacturer remains a generic drug manufacturer with no ability to change the drug’s label without prior FDA approval.  Id. at *3.  Therefore, Mensing’s “broad” preemption still applies. 

Plaintiff tried a second end-run around preemption by arguing that under Georgia law the generic manufacturer, knowing the brand manufacturer had left the market, owed a duty to provide safety data concerning the drug to the FDA.  Id. at *4.   Plaintiff argued that by providing information to the FDA, defendant could have complied with both federal and state law.  But while trying to dodge the “conflict,” plaintiff ran right into the “Mouse Trap game” Mensing prohibits.  Assuming defendant did provide the FDA with information, that only begs more questions.  The FDA may have decided the brand label needed to be changed, which may have led to a change in the generic label, which may have caused plaintiff’s prescribing physician not to prescribe the drug, which may have prevented her injury.  Id.  The causal link is simply too attenuated. 

Further, Georgia does not recognize a failure to warn claim premised on a failure to report to the FDA.  “Plaintiff identifies no state law duty to report safety information or take other steps to change a product’s label, whether independent or subsumed by the duty to warn.”  Id. To prove a failure to warn claim in Georgia requires proving that a stronger warning would have prevented plaintiff’s injury, which requires defendant change the drug’s warning which FDA regulations prohibit.  We end up right back at Mensing preemption. 

Of course, defendant also argued that plaintiff’s “failure to report” claim was barred by Buckman preemption.  And the court agreed citing both Eleventh Circuit and federal Georgia precedent.  Id. at *5.  Plaintiff tried to argue a “parallel” claim exception, but the court found no independent state duty to report and therefore, no claim for the federal requirements to run parallel to.  More important, however, was this ruling:  “There is no exception for parallel claims to the doctrine of impossibility preemption, which is grounded in the Supremacy Clause.”  Id. at *7n.5 (citing Lashley v. Pfizer, Inc., 750 F.3d 470, 476 (5th Cir. 2014)).   So-called “parallel claims” can exist only within the express preemption context, where the relevant question is whether state law is imposing a requirement “different from or in addition to” federal requirements.  It has no place in implied preemption, which is what is at issue here.  When dealing with the Supremacy Clause, the question is not whether there is a “parallel” claim that may not conflict with a federal statute, but rather whether the state law claim is impliedly preempted.  Just like the distinction between brand and generic drugs is important, so is the distinction between express and implied preemption.

Finally, the court ruled on defendant’s argument that preemption aside, plaintiff’s claims failed because he did not plead learned intermediary causation.  Georgia law requires a plaintiff allege that the prescribing physician “would have made a different decision had Defendants provided stronger warnings.”  Id. at *6.  While plaintiff alleged defendant failed to warn his wife, he failed to allege that defendant should have but did not warn her physician.  The complaint also lacked any allegations as to what warning should have been given.  Therefore, plaintiff’s pleading deficiencies were another ground for dismissal.