By Georgia D. Koutouzos, J.D.
Concluding that it lacked jurisdiction over two product liability actions against the manufacturers and distributor of the antiarrhythmic medication amiodarone hydrochloride, a federal court in California remanded the lawsuits on the basis that the plaintiffs’ claims challenged only the behavior of private parties and not the actions of the U.S. Food and Drug Administration or the validity of the Food, Drug, and Cosmetic Act and/or its implementing regulations. As such, the two lawsuits did not raise an issue of importance to the federal system as a whole, the court held, remarking that were federal jurisdiction found to be appropriate in such an instance, the ruling essentially would invite all similar claims involving FDA-approved drugs into federal courts across the country (Streed v. Eon Labs, Inc., August 23, 2017, Chesney, M.).
On behalf of more than 100 others, two patients who had taken the prescription antiarrhythmic medication amiodarone HCl for atrial fibrillation filed suits in California state court against the drug’s original manufacturer, Wyeth Pharmaceutical, Inc., as well as the medication’s primary distributor and the various manufacturers of its generic formulations. Contending that they suffered various life-threatening and debilitating conditions such as pulmonary fibrosis, lung disease, and vision loss as a result of having purchased and ingested the medication, the plaintiffs alleged that amiodarone had been approved by the U.S. Food and Drug Administration only as a drug of last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia, but that Wyeth had instituted and maintained an aggressive marketing plan that positioned amiodarone as a first-line treatment for atrial fibrillation and had failed to warn prescribing physicians of the potential dangers associated with the drug’s toxicity and danger to atrial fibrillation patients.
In addition, the suits alleged that the manufacturers of the generic formulations took advantage of Wyeth’s aggressive marketing plan and actively had promoted their generic versions in the stream of commerce for the "off-label" uses openly promoted Wyeth. The suits also alleged that the companies: (1) failed to provide the FDA-required medication guide and continued to actively conceal and understate the drug’s nature and adverse risks; (2) failed to disclose specific material adverse information to the FDA, healthcare professionals, consumers, and plaintiffs; and (3) continued their fraudulent marketing, promotional, and sales practices in spite of FDA warnings and thousands of adverse patient experiences. As such, the suits asserted causes of action for failure to warn sounding in both strict liability and negligence, as well as negligence–marketing and sale, negligence per se, fraud/deceit, wrongful death, and violation of state-law unfair competition and consumer protection provisions.
Removal. The two cases were removed to California federal court on the asserted basis of federal-question jurisdiction; namely, that the plaintiffs’ claims either were inherently federal in nature or raised questions that were, in and of themselves, both substantial and disputed questions of federal law. The plaintiffs moved for remand of the lawsuits on the ground that they alleged no federal claims and that the state-law claims did not raise federal issues sufficiently significant to confer federal jurisdiction.
Federal jurisdiction. According to the defendant companies, the plaintiffs’ state-law claims raised two federal issues that met the requirements for federal jurisdiction: (1) violation of the Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations governing medication guides; and (2) violation of the FDCA by promotion of off-label use. However, the mere presence of a federal issue in a state cause of action does not automatically confer federal-question jurisdiction, and federal law is not a necessary element of a state-law claim when the claim can be supported by alternative and independent theories—one of which is a state-law theory and one of which is a federal-law theory.
In the instant case, the plaintiffs alleged claims for strict products liability, negligence, fraud, and wrongful death, as well as claims under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA), each of which could be supported by a theory independent of any violation of federal law or regulation. In particular, one independent theory on which plaintiffs’ fraud, UCL, and CLRA claims were predicated was common-law fraud; namely, the defendants’ affirmative misrepresentations as to the nature and intended use of amiodarone and failure to disclose material facts about its side effects. Similarly, an independent theory on which the plaintiffs’ strict products liability, negligence, and wrongful death claims were predicated arose under the common law, i.e., the defendants’ breach of their duty to adequately warn of known risks and to market and sell a safe product. Consequently, the lawsuits did not meet the federal jurisdictional requirement that the federal issue be "necessarily raised."
Furthermore, the plaintiffs challenged only the behavior of private parties, and not the actions of the FDA or the validity of the FDCA and/or its implementing regulations. Therefore, they did not raise an issue of importance to the federal system as a whole such that their state-law claims raised a substantial federal issue. Finally, the court found unpersuasive the defendants’ argument that, to the extent that the plaintiffs’ claims had alleged a failure to supply an accompanying medication guide, there was little risk of disrupting the federal-state balance because such claims are rare.
Were the court to find federal jurisdiction appropriate in this instance, the court reasoned, such ruling arguably would apply further, and essentially would invite all similar claims involving FDA-approved drugs into federal courts across the country. In sum, because federal question jurisdiction was lacking over the two cases, remand to state court was appropriate, the court concluded.
The case is Nos. 17-cv-02609-MMC and 17-cv-03825-MMC.
Attorneys: Alan M. Mansfield (Whatley Kallas, LLP) for Edwin Streed and Margaret Streed. Lori Gail Cohen (Greenberg Traurig LLP) for Eon Labs, Inc. Douglas Bently Maddock, Jr. (Shook Hardy and Bacon, LLP) for Upsher-Smith Pharmaceuticals, Inc. April Sun (Goodwin Procter LLP) for Teva Pharmaceuticals USA, Inc.
Companies: Eon Labs, Inc.; Upsher-Smith Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Wyeth Pharmaceutical, Inc.; McKesson Corp.
MainStory: TopStory JurisdictionNews DrugsNews CaliforniaNews
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