In re Amiodarone Cases

• Decision Date: 03 November 2022
• Docket Number: A161023
• Parties: AMIODARONE CASES.
• Court: California Court of Appeals Court of Appeals

AMIODARONE CASES.

A161023

California Court of Appeals, First District, Second Division

November 3, 2022

Alameda County Superior Court No. JCCP004956 Hon. Brad Seligman Trial Judge

Consumer Law Group of California, Alan Mansfield; Doyle APC, Chris W. Cantrell; Wood Law Firm, E. Kirk Wood; Cole Legal Services, Samuel C. Cole, for Plaintiffs and Appellants

Goodwin Proctor, April Sun, Jaime A. Santos; Greenberg Traurig, Glenn S. Kerner, for Defendants and Respondents Teva Pharmaceuticals USA, Inc. and Barr Pharmaceuticals, LLC

DLA Piper, George Gigounas, Jeanette Barzelay; Bradley Arant Boult Cummings, Lindsey C. Boney IV, for Defendant and Respondent Wyeth Pharmaceuticals Inc.

Haight Brown &Bonesteel, Stephen J. Squillario, for Defendants and Respondents Zydus Pharmaceuticals USA, Inc. and Taro Pharmaceuticals USA, Inc.

Shook Hardy &Bacon, Amir Nassihi for Defendant and Respondent Upsher-Smith Laboratories, LLC

WFBM, Lisa M. Rice, Katie A. Stricklin, Amrit K. Dhaliwal, for Defendant and Respondent Aurobindo Pharma USA, Inc.

Greenberg Taurig, Karen L. Bohmholdt, Richard R. Tabura, for Defendants and Respondents Sandoz Inc. and Eon Labs

Lewis Brisbois Bisgaard &Smith, Pamela M. Ferguson for Defendant and Respondent Mayne Pharma Inc.

Goodman Neuman Hamilton, Farley J. Neuman, Tom Prountzos for Defendant and Respondent McKesson Corporation

Gordon Rees Scully Mansukhani, J. Dominic Campodonico for Defendants and Respondents Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc.

RICHMAN, ACTING P.J.

In the coordinated cases underlying these consolidated appeals, plaintiffs allege that they suffered serious side effects as a result of taking the prescription drug amiodarone, which their physicians prescribed for them "off-label"-that is, for uses not approved by the United States Food and Drug Administration (FDA). Plaintiffs sued the companies that promoted, distributed, and sold amiodarone, alleging that the companies failed to warn them about the dangers of the drug and promoted the drug aggressively and unlawfully for unapproved uses. The trial court sustained defendants' demurrers without leave to amend. Plaintiffs appeal, making two arguments: (1) as to all defendants, that it was error to dismiss as preempted their claims that defendants failed to warn them about the dangers of amiodarone because defendants did not ensure that they received the content of the FDA-required Medication Guide for the drug; and (2) as to one defendant, Wyeth Pharmaceuticals, Inc. (Wyeth), that it was error to dismiss common law fraud claims and statutory claims arising from Wyeth's

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allegedly unlawful promotion of the drug. We reject the arguments and we affirm.

FACTUAL AND PROCEDURAL BACKGROUND

The General Setting

The drug amiodarone was developed in Belgium in the 1960's for the treatment of angina, and about that time was released for marketing in most countries other than the United States. Amiodarone is associated with serious side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970's, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. The FDA allowed this activity, but did not approve or test the drug.

In 1985, foreign manufacturers of the drug threatened to cut off the supply to U.S. patients unless the FDA allowed the drug to be sold in the United States, and that year the FDA approved Wyeth's formulation of amiodarone, called Cordarone, as a drug of last resort for patients suffering from documented recurring life-threatening ventricular fibrillation and ventricular tachycardia when those conditions would not respond to other drugs and therapies. The FDA approval of amiodarone was, and remains, a "special needs" approval, issued without randomized clinical trials of the drug.

In December 1989, the FDA sent a letter to Wyeth's chairman describing Wyeth's current promotional activities and characterizing them as "false and misleading." Among other things, the letter stated that by claiming" 'an early decision for Cordarone can improve the odds,'" Wyeth was promoting an unapproved use of the drug, failing to "recognize the drug's unique role as a drug of last resort." The letter concluded that Wyeth was

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"promot[ing] Cordarone, an extraordinarily hazardous drug, in a manner we consider clearly misrepresentative of its known hazards."

In December 1990, Senator Ted Kennedy issued a press release claiming that Wyeth's promotional campaign for Cordarone was intended "to promote the drug's use for a large population of patients that could generate higher revenues, [and] to push a product beyond the limits of its scientific data, even if the company is putting patients at risk."

In February 1992, the FDA sent a letter to a Wyeth assistant vice present for regulatory affairs objecting that several promotional labeling pieces for Cordarone "present[ed] an unbalanced view of Cordarone's benefits as opposed to its risks," and explaining its concerns about specific statements in the labeling.

Various other manufacturers began developing generic amiodarone, which has been available since 1998.

Trial Court Proceedings

Several hundred individuals filed lawsuits in California superior courts alleging that they suffered unnecessary and serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common-and less serious-condition than ventricular fibrillation.^[1] The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis.^[2]

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The plaintiffs, who were prescribed amiodarone between 2005 and 2017, alleged that their physicians prescribed amiodarone for them as a result of aggressive campaigns by Wyeth and others that promoted the drug to physicians as a first-line treatment for atrial fibrillation and failed to disclose the dangers of the drug.^[3] Plaintiffs alleged these promotional efforts "would have materially affected" their physicians' decisions to prescribe amiodarone for off-label use. Plaintiffs also alleged that they would not have taken amiodarone if they had received a "Medication Guide," which contains warnings about the drug and which the FDA requires be provided to pharmacies for distribution to patients.^[4]

In March 2018, the cases were coordinated for pretrial proceedings in the Alameda County Superior Court, where they were assigned to the Honorable Brad Seligman. In May 2018, plaintiffs filed a Master Administrative Complaint (MAC) that combined the allegations of the underlying lawsuits.^[5] The MAC asserted multiple causes of action against Wyeth, 10 manufacturers of generic amiodarone, and McKesson Corporation,

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which was alleged to be the primary distributor of amiodarone.^[6] We refer to these parties collectively as "defendants."

As relevant here, the MAC alleged claims against all defendants for fraud, violation of California's unfair competition law (Bus. &Prof. Code, § 17200 et seq., UCL), and violation of California's Consumers Legal Remedy Act (Civ. Code, § 1750 et seq. CLRA), arising from defendants' allegedly misleading promotion of off-label uses of amiodarone. Plaintiffs also alleged claims for failure to warn against all defendants under theories of strict liability and negligence arising from defendants' alleged failure to ensure that consumers were provided with FDA-required Medication Guides.

In response to defendants' demurrer to the Second Amended MAC, the trial court struck the Medication Guide claims against all defendants without leave to amend on the ground that the claims were preempted by federal law and lacked any independent basis in state law. The court gave plaintiffs leave to amend their off-label promotion claims, and plaintiffs did so in their Third Amended MAC.

Defendants demurred to the Third Amended MAC. The court gave plaintiffs leave to amend their off-label promotion claims as to one of the defendants, Wyeth. The court dismissed the off-label promotion claims

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against the other defendants without leave to amend. Those defendants were dismissed from the case and plaintiffs timely appealed as to them.

Plaintiffs filed a Fourth Amended MAC alleging their off-label promotion claims as to Wyeth. In response to Wyeth's demurrer, the court dismissed the off-label promotion claims against it without leave to amend. The court noted that plaintiffs' fraud claims against Wyeth arose both from Wyeth's promotional activities and from statements made by third parties. The court then concluded that Wyeth's promotional activities did not support claims for fraud because the activities had not been alleged in sufficient particularity and were too remote in time from plaintiffs' injuries, and that the third-party statements did not support claims for fraud because plaintiffs failed to allege facts allowing a reasonable inference that Wyeth had control over the statements. The court further concluded that plaintiffs' UCL and CLRA claims were derivative of the fraud claims and failed for the same reasons, even under the lower pleading requirements that apply to the statutory claims. Wyeth was dismissed as a defendant. Plaintiffs timely appealed this as well, and the two appeals were consolidated.

DISCUSSION

Standard of Review

Our standard of review is well-established. We accept as true the well-pleaded allegations in the operative complaint. (Chiatello v. City and County of San Francisco (2010) 189 Cal.App.4th 472, 480.)" '" 'We treat the demurrer as admitting all material facts properly pleaded, but not contentions, deductions or conclusions of fact or law. [Citation.] We also consider matters which may be judicially noticed.' [Citations.] Further, we give the complaint a reasonable...