Heart Medication Amiodarone Related Case Dismissed: Amiodarone is the generic form of the brand-name drug Cordarone. Teva Pharmaceuticals USA Inc. (“Teva”) is a manufacturer of generic Amiodarone. Amiodarone is a drug of “last resort” for patients suffering from ventricular fibrillation and tachycardia. The FDA has not approved Amiodarone for the treatment of a-fib, but physicians prescribe it for this “off-label” purpose.
The plaintiffs were patients, spouses, heirs, and the estates of decedents who used the drug for its off-label use to treat atrial fibrillation (“a-fib”). They alleged that the patients suffered significant side effects (such as pulmonary fibrosis, pulmonary toxicity, and respiratory failure) as a result of using Amiodarone, including, in some cases, death. The plaintiffs commenced two actions against Teva relating to Teva’s manufacture and distribution of Amiodarone.
The plaintiffs alleged that they did not receive Medication Guides when their Amiodarone prescriptions were dispensed, as required by federal regulations, because Teva failed to make them available to pharmacists in sufficient numbers. The plaintiffs further alleged that Teva failed to report known adverse events to the FDA. Lastly, the plaintiffs alleged that Teva negligently and fraudulently promoted Amiodarone as approved for the treatment of a-fib or benefitted from others’ fraudulent promotion of the off-label use of the drug.
In its non precedential opinion dated September 7, 2022, the United States Court of Appeals for the Third Circuit (“Federal Appellate Court”) stated, “21 C.F.R. § 208.24(b)(2) does not impose a requirement that drug manufacturers deliver Medication Guides directly to patients. Rather, § 208.24 permits manufacturers to “[p]rovid[e] the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers.” 21 C.F.R. § 208.24(b). Appellants make no factual allegations that support the inference that Appellee failed to do so. Thus, their Medication Guide claim is not plausibly alleged.”
The Federal Appellate Court further stated, “Appellants cannot rely on the assumption that because millions of patients are diagnosed with a-fib and Amiodarone is prescribed off-label to treat it, Appellee failed to report or otherwise concealed adverse events. At the very least, Appellants would need to provide examples of countless adverse events that Appellee knew or should have reasonably known about but failed to report to the FDA. Appellants’ failure to sufficiently plead such claims necessarily means that their pleadings, to the extent they allege fraud, likewise fail to satisfy the heighted pleading standard of Rule 9.”
Lastly, the Federal Appellate Court stated, “Appellants allege “Teva ‘provided or failed to correct false and misleading information about the indications and uses of Amiodarone provided to physicians via reference materials like the PDR and Epocrates, that are used by physicians in prescribing situations and which the prescribing physicians read and rely on in prescribing Amiodarone to Plaintiffs.’” Appellants’ Br. at 49 (citing App. 363). Such allegations are similarly insufficient under Rule 9’s heightened pleading standard. Appellants do not identify any specific misrepresentations and instead, generally assert that the information provided in the reference materials, which Appellants characterize as labeling, was false and misleading. In addition, Appellants do not plead sufficient factual allegations to support the inference that Teva is responsible for or otherwise contributed to these reference materials. Teva, as a generic drug manufacturer, does not have any control over labeling—that was solely Wyeth’s responsibility.”
Source Bennett v. Teva Pharmaceuticals USA Inc., Nos. 21-1642 & 21-2304.
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