United States: Brand & Generic Defendants Win In Amiodarone Litigation

Last Updated: March 6 2019
Article by Michelle Yeary

You'll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs' attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant's warnings were adequate as a matter of law. Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims. Plaintiff's wife suffered from fatal pulmonary disease caused by the administration of amiodarone. Id. at *2. While the complaint does not state why plaintiff's wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug's label, of which it took judicial notice. The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed "because of the life-threatening side effects and the substantial difficulties associated with its use." Id. at *5. The label further states that the drug has "several potentially fatal toxicities, the most important of which is pulmonary toxicity," which is fatal about 10% of the time. Id. The court noted that label discussed pulmonary toxicity at least 15 times. Id. at *2.

While plaintiff argued that the adequacy of a warning is "generally” a jury question, generally doesn't mean always. Id. at *6. In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff's wife suffered – they were adequate. Id. Moreover, plaintiff's complaint contained no allegations that explain why the warning provided was inadequate. Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can't be overlooked. Nor could the court overlook plaintiff's lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff's wife's death. Id. at *5. Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the "ordinary consumer." But that's not the standard. The manufacturer's duty to warn runs to the physician, not the patient. Id. Whether the warning was sufficient to inform plaintiff's wife's physician is the appropriate question. One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on. But failure to read does not equal failure to warn. "The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning." Id. at *6. Aside from the implication that physicians aren't people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied. A core element of breach of warranty of fitness for a particular purpose is the buyer's reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient's expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug's properties. For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer. [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted). In this case, plaintiff did not allege what information his wife's physician considered when deciding to prescribe the drug. What the evidence does show is that risk of pulmonary toxicity was adequately warned about. Id. And, the only inference that the court could draw was that plaintiff's wife was relying on the skill and judgment of her physician, not defendant. Id. at *8.

That left only plaintiff's fraud and misrepresentation claims which were all based on representations that the drug was "safe, fit, and effective for human use." Id. at *9. Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b). Id. Which the court informed him applied equally to negligent misrepresentation and concealment. The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made. Id. As to the "what" was misrepresented – safety and effectiveness – the court expressed "serious concerns over the plausibility of this allegation," given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years. Id. And, plaintiff's lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims. Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument. Because plaintiff had no allegation that the generic defendant's label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was. However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder. In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court. Id. at *11. "However, context is key." Id. Outside the removal/remand situation, courts have applied Mensing to distributors. "[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label." Id. at *12. The Supreme Court's concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors. Id. Mensing requires dismissal of all of plaintiff's claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation. It would not apply to a manufacturing defect claim if plaintiff was bringing one. Id.

Despite the court's "serious concerns" with the plausibility of plaintiff's claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile. But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff's case.

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

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