Important Notice: After years of dedicated litigation efforts, our law firm no longer accepts cases involving amiodarone. Multiple court rulings have shown that claims against amiodarone manufacturers are generally preempted by federal law. The only legal remedies typically available involve medical malpractice claims against prescribing doctors, which is not an area of practice for our firm. This article is provided only for informational purposes.
A Drug with an Unprecedented FDA Approval
Amiodarone, also sold under the brand names Cordarone® and Pacerone®, holds a unique distinction in modern FDA history as the only drug approved in the United States without undergoing the required randomized clinical studies normally necessary to show safety and efficacy.
In 1985, the FDA granted Wyeth Pharmaceuticals approval to market and sell Cordarone® (Amiodarone hydrochloride) in the United States before performing any clinical trials proving its safety. This extraordinary approval came with strict limitations—the FDA approved the drug only for use as a “drug of last resort” for patients suffering from recurrent, life-threatening ventricular fibrillation (VFib) for whom all other treatment options had failed.
For these patients facing likely death, the potential benefits of controlling VFib outweighed the unknown risks. Even with this approval, amiodarone was only to be used after all other treatment measures had failed, acknowledging its extreme dangers.
Post-Approval Regulatory Concerns
Following this conditional approval, the FDA repeatedly asked amiodarone manufacturers to perform clinical safety trials on amiodarone, particularly if they intended to promote it for less serious conditions. However, these drug manufacturers never conducted the requested trials.
Exacerbating this apparent disregard for safety is amiodarone having been approved under a unique “special needs” approval process, letting it bypass the usual clinical trials required before FDA approval. This was partly due to the intent that this drug would be used only by a small group of individuals who otherwise would have no treatment for their life-threatening VFib.
Wyeth Pharmaceuticals also performed no post-market clinical trials to show the drug’s safety and efficacy, despite specific requests to do so by the FDA.
To this day, the FDA has never approved amiodarone for any purpose other than as a treatment of last resort for people with life-threatening VFib.
From Last Resort to Common Prescription
The number of individuals suffering from life-threatening VFib, for whom all other forms of treatment have failed, is relatively small. In contrast, more than 6 million Americans suffer from atrial fibrillation (AFib), a less severe but far more common form of heart arrhythmia.
Despite this limited approval, Wyeth Pharmaceuticals began an aggressive campaign to promote the drug to doctors as a “first-line” treatment for AFib. Despite repeated warnings from the FDA to stop the misleading promotion of amiodarone as a safe and effective treatment for AFib, Wyeth continued its marketing campaign. Formal FDA letters from 1989–1992 criticized Wyeth for promoting Cordarone for off-label use for the treatment of AFib.
Amiodarone has become the most used anti-arrhythmic drug for treating AFib, with about 80% of all amiodarone prescriptions being written for off-label purposes, according to available data. Wyeth’s campaign to promote Cordarone for AFib treatment proved so successful that we estimated the company had generated billions of dollars in profit from its off-label use.
Today, most amiodarone prescriptions are not for the FDA-approved use in treating VFib, instead, the drug is prescribed as a first line treatment for patients with AFib. These individuals are the exact opposite of the intended users, which are people with life-threatening VFib for whom all other treatment options have failed. A drug of last resort.
Generic manufacturers are capitalizing on the market created by Wyeth and continuing the misleading promotion of amiodarone as a treatment for AFib.
Dangerous Complications and Life-Threatening Side Effects
This widespread off-label use has resulted in millions of AFib sufferers being prescribed amiodarone, unnecessarily exposing them to potentially deadly complications when several safer treatment options were available.
The most severe complication from amiodarone use is pulmonary fibrosis or toxicity, which causes death in many sufferers. Other serious complications include blindness and vision problems. These AFib patients, many of whom already have debilitating and deadly lung diseases, should never have been prescribed amiodarone.
Required Medication Guide: A Critical Warning System
Amiodarone is one of a few prescription drugs considered so dangerous that the FDA requires a special, direct warning to be given to the consumer at the time of purchase. The FDA requires this warning to come as a written “Medication Guide.”
The Medication Guide should ensure patients are directly warned of the drug’s serious and deadly complications outside of the physician-patient relationship. The manufacturers of amiodarone, along with the distributors and pharmacies, must make sure each patient prescribed amiodarone receives the Medication Guide.
However, most amiodarone patients we have spoken to have never received a Medication Guide and were unaware of any serious and potentially deadly complications. Many might never have taken the drug if they had been given the required Medication Guide.
Most doctors we have talked to are equally unaware of the history of amiodarone and the fact the FDA never approved the drug for the treatment of AFib.
The Evolution of Off-Label Marketing Practices
Understanding how amiodarone became widely prescribed requires examining off-label marketing practices. While doctors may legally prescribe medications for unapproved off-label uses based on their professional judgment, it is explicitly unlawful for drug companies to promote their products for unapproved uses.
Wyeth used various methods to promote Cordarone to treat AFib:
- Deploying sales representatives to meet with cardiologists
- Sponsoring conferences, symposiums, professional association meetings, and continuing education events
- Leveraging “key opinion leaders” to promote the drug to doctors at professional gatherings and in journal articles
- Funding research conducted by doctors who would then advocate for the drug’s off-label use
Eventually, the FDA cracked down on direct payments and gifts to prescribing doctors. In response, drug companies developed more sophisticated marketing strategies using digital tools:
- Social networks designed specifically for healthcare providers
- Industry-sponsored online discussion forums targeting doctors
- Electronic Health Record (EHRs) systems featuring banner ads and industry-sponsored clinical resources
- Prescribing sources like The Physician’s Desk Reference (PDR) and Epocrates
According to the New England Journal of Medicine, these digital marketing pathways are even more effective than traditional sales tactics because they deliver targeted messages at the critical moment when doctors are making prescribing decisions. These methods also provide drug companies some protection from regulatory scrutiny by letting them influence doctors indirectly through third parties and platforms.
Many prescribing doctors remain unaware of these marketing relationships. In the past, drug companies paid hefty regulatory fines as a cost of doing business, but now they leverage digital marketing to generate enormous profits from the growing off-label use of their prescription drugs.
Failed Legal Battles: A Valiant but Unsuccessful Fight
For many years, our attorneys dedicated substantial resources to fighting for patients harmed by amiodarone. These efforts represented a significant investment of time, expertise, and financial resources, often spanning multiple years of complex litigation against well-funded (and well-represented) drug companies.
Our firm filed many personal injury lawsuits against drug manufacturers on behalf of AFib patients who developed pulmonary fibrosis, toxicity, or vision problems after being prescribed amiodarone to treat AFib and failing to receive the required Medication Guide.
Despite compelling evidence of harm and clear violations of FDA requirements, courts across the United States consistently dismissed these cases on various technical legal grounds. The most significant obstacle proved to be federal preemption—a legal doctrine holding that federal law (in this case, the Food, Drug, and Cosmetic Act) supersedes state law claims. Courts repeatedly ruled that claims regarding the failure to provide Medication Guides were essentially attempts to privately enforce FDA regulations, which is not allowed under federal law.
Other legal hurdles included the statute of limitations or time barriers that prevented many injured patients from seeking compensation and application of the “learned intermediary” doctrine, which places responsibility on doctors rather than drug manufacturers.
Even after appeals to higher courts, including federal appellate courts, these cases met with consistent defeat. The California Court of Appeal, in a published 2022 opinion, definitively affirmed that federal law preempts state law failure-to-warn claims regarding Medication Guides, effectively closing the door on this litigation strategy.
This series of defeats came despite our attorneys’ tireless advocacy. It is one of those unfortunate situations where even clear evidence of wrongdoing and patient harm cannot overcome technical legal barriers established to protect drug companies. Courts have made it abundantly clear that the only viable legal claims related to amiodarone injuries are medical malpractice actions against prescribing doctors—claims that our firm does not handle.
The amiodarone litigation stands as a sobering reminder of the significant gaps in our legal system’s ability to protect patients from dangerous off-label drug use. Despite overwhelming evidence of inappropriate marketing, widespread distribution without required safety warnings, and catastrophic patient injuries, the current framework of federal preemption has effectively immunized drug companies from accountability.
This outcome—where patients injured by a drug that was never approved for their condition have no recourse against the companies that profited billions from its improper promotion—represents a profound failure of justice. The legal system has focused on procedural technicalities over substantive justice, leaving thousands of injured patients without remedy while letting drug companies retain billions in profits gained through questionable practices. Unfortunately, the door has firmly closed on these cases, and we can no longer advocate effectively for these victims in court.